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Rheumatology
 * Rheumatology
 * Moderate to Severe Rheumatoid Arthritis
 * Active Psoriatic Arthritis
 * Active Ankylosing Spondylitis
 * Moderate to Severe Juvenile Idiopathic Arthritis
 * Non-Infectious Intermediate, Posterior and Panuveitis
 * 
 * 
 * 

Dermatology
 * Dermatology
 * Moderate to Severe Chronic Plaque Psoriasis
 * Active Psoriatic Arthritis
 * Moderate to Severe Hidradenitis Suppurativa
 * Refractory, Moderate to Severe Atopic Dermatitis

Gastroenterology
 * Gastroenterology
 * Moderate to Severe Crohn's Disease
 * Moderate to Severe Pediatric Crohn's Disease
 * Moderate to Severe Ulcerative Colitis
 * Moderate to Severe Pediatric Ulcerative Colitis

Ophthalmology
 * Ophthalmology
 * Non-Infectious Intermediate, Posterior and Panuveitis


OUR PRODUCTS

Please see Important Safety Information, including BOXED WARNING on Serious
Infections and Malignancy.
Please see important Safety Information, including BOXED WARNING on SERIOUS
INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE),
AND THROMBOSIS



RHEUMATOLOGY

Please see Important Safety Information, including BOXED WARNING on Serious
Inflections and Malignancy.
Please see important Safety Information, including BOXED WARNING on SERIOUS
INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE),
AND THROMBOSIS

MODERATE TO SEVERE


RHEUMATOID ARTHRITIS

Please see Important Safety Information, including BOXED WARNING on Serious
Inflections and Malignancy.
Please see important Safety Information, including BOXED WARNING on SERIOUS
INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE),
AND THROMBOSIS

ACTIVE


PSORIATIC ARTHRITIS

Please see Important Safety Information, including BOXED WARNING on Serious
Infections and Malignancy.
Please see important Safety Information, including BOXED WARNING on SERIOUS
INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE),
AND THROMBOSIS

ACTIVE


ANKYLOSING SPONDYLITIS

Please see Important Safety Information, including BOXED WARNING on Serious
Infections and Malignancy.

MODERATE TO SEVERE


JUVENILE IDIOPATHIC ARTHRITIS



NON-INFECTIOUS


INTERMEDIATE, POSTERIOR AND PANUVEITIS










DERMATOLOGY

Please see Important Safety Information, including BOXED WARNING on Serious
Inflections and Malignancy.

Please see important Safety Information, including BOXED WARNING on SERIOUS
INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE),
AND THROMBOSIS

MODERATE TO SEVERE


CHRONIC PLAQUE PSORIASIS

Please see Important Safety Information, including BOXED WARNING on Serious
Inflections and Malignancy.


ACTIVE


PSORIATIC ARTHRITIS



MODERATE TO SEVERE


HIDRADENITIS SUPPURATIVA



REFRACTORY, MODERATE TO SEVERE


ATOPIC DERMATITIS




GASTROENTEROLOGY



MODERATE TO SEVERE


CROHN'S DISEASE



MODERATE TO SEVERE


PEDIATRIC CROHN'S DISEASE



MODERATE TO SEVERE


ULCERATIVE COLITIS



MODERATE TO SEVERE


PEDIATRIC ULCERATIVE COLITIS




OPHTHALMOLOGY



NON-INFECTIOUS


INTERMEDIATE, POSTERIOR AND PANUVEITIS


US-MULT-200779

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 * Psoriatic Arthritis
    * Rheumatoid Arthritis
   
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 * Home
 * Disease Control Data
    * Clinical Trial Overview
   
    * Minimal Disease Activity

 * Joint Efficacy
    * Clinical Trial Overview
   
    * ACR Response
   
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    * Physical Function
   
    * Enthesitis
   
    * Dactylitis

 * Skin Efficacy
    * Clinical Trial Overview
   
    * PASI Data

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    * Week 24
   
    * Long-term Exposure Data
   
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For moderate to severe rheumatoid arthritis (RA) in adult TNFi-IR patients1
For active psoriatic arthritis (PsA) in adult TNFi-IR patients1


CHALLENGE TREATMENT GOALS IN PSA

RINVOQ met its primary endpoint (ACR20 at Week 12) in two clinical trials1

RINVOQ met its primary endpoint (ACR20 at Week 12) in two clinical trials1

See ACR results below

EXPLORE THE DATA

ACR=American College of Rheumatology; ACR20=improvement of at least 20% in
tender joint count, swollen joint count, and at least 3 of the 5 other core
criteria, including patient and physician global assessments, health assessment
questionnaire — disability index (HAQ-DI), pain assessment, and high-sensitivity
C‑reactive protein (hs‑CRP); IR=intolerance or inadequate response;
PsA=psoriatic arthritis; TNFi=tumor necrosis factor inhibitor





RINVOQ® (UPADACITINIB) MET ITS PRIMARY ENDPOINT IN TWO CLINICAL STUDIES1

Significant ACR20 Response
at Week 12 vs placebo2,3



Rapid ACR20 response seen as early asWEEK 21,3,4

Rapid ACR20 response seen as early asWEEK 21,3,4

SELECT-PsA 2: 33% RINVOQ 15 mg vs 11% placebo (P≤0.05)3
SELECT-PsA 1: 28% RINVOQ 15 mg vs 12% placebo (P<0.001)4

SELECT-PsA 2: 33% RINVOQ 15 mg vs 11% placebo (P≤0.05)3
SELECT-PsA 1: 28% RINVOQ 15 mg vs 12% placebo (P<0.001);4

SELECT-PsA 2 Study Design Intro:1
24‑week, double‑blind, placebo‑controlled study of 642 adult patients with
moderate to severe PsA who had an inadequate response or intolerance to at least
one biologic DMARD. Patients were randomized to receive upadacitinib or placebo.
The primary endpoint was proportion of patients achieving ACR20 response at Week
12 vs placebo.


See details

SELECT-PsA 1 Study Design Intro:1
24-week, double‑blind, placebo and active comparator-controlled study of 1705
adult patients with moderate to severe PsA who had an inadequate response or
intolerance to at least one non‑biologic DMARD. Patients were randomized to
either receive upadacitinib, active comparator, or placebo. The primary endpoint
was proportion of patients achieving ACR20 response at Week 12 vs placebo.


See details

Data Limitations:5 Week 2 data for all comparisons were not adjusted for
multiplicity; therefore, statistical significance has not been established.
P‑value obtained through nominal statistical testing.

See Study Details
See ACR Response Criteria

ACR=American College of Rheumatology; ACR20=improvement of at least 20% in
tender joint count, swollen joint count, and at least 3 of the 5 other core
criteria, including patient and physician global assessments, health assessment
questionnaire — disability index (HAQ‑DI), pain assessment, and high‑sensitivity
C‑reactive protein (hs‑CRP); DMARD=disease‑modifying antirheumatic drug;
IR=intolerance or inadequate response; NRI=non‑responder imputation;
PsA=psoriatic arthritis; QD=once per day; TNFi=tumor necrosis factor inhibitor





RINVOQ IS A ONCE-DAILY JAK INHIBITOR1


POWERFUL DISEASE CONTROL3,5

 * Minimal Disease Activity (MDA) at Week 24 with results up to ~1 year

See Disease
Control Data


DURABLE JOINT EFFICACY1,3,5

 * ACR20/50/70 at Week 12 with results up to ~1 year
 * ∆mTSS* and complete resolution of enthesitis (LEI=0) and dactylitis (LDI=0)
   evaluated at Week 24, with results up to ~1 year

*∆mTSS was evaluated in non-bDMARD-IR patients.6 RINVOQ is indicated for TNFi-IR
patients.

See Joint Efficacy


SKIN EFFICACY3,5

 * PASI75 at Week 16 with results up to ~1 year
 * Results in additional skin measures

RINVOQ is not indicated for the treatment of plaque psoriasis

See Skin Efficacy


SAFETY DATA FROM 8 TRIALS ACROSS 2 RHEUMATOLOGY INDICATIONS7,8,†

 * >6200 patients evaluated on upadacitinib‡
 * >8200 patient-years of exposure to RINVOQ 15 mg as of 6/30/20§
 * Up to ~4.5 years maximum exposure in RA (~2.6 years median), ~3 years maximum
   exposure in PsA (~1.3 years median) to RINVOQ 15 mg as of 6/30/2020

See Safety Profile


ABBVIE'S COMMITMENT TO EXCEPTIONAL ACCESS AND PATIENT SUPPORT

 * >9 out of 10 commercial patients have access to RINVOQ in RA and PsA through
   national commercial insurance or through RINVOQ Complete9,II
 * 1:1 support to help patients start and stay on track with their prescribed
   treatment plan

See Access & Support

 

RINVOQ 15 mg is the approved dose in RA and PsA. 

†Includes 6 RA Phase 3 studies (SELECT‑EARLY, SELECT‑MONOTHERAPY, SELECT‑NEXT,
SELECT‑COMPARE, SELECT‑BEYOND and SELECT‑CHOICE). Includes 2 PsA Phase 3 studies
(SELECT‑PsA 1 and SELECT‑PsA 2).10 
‡RA: RINVOQ 15 mg, upadacitinib 30 mg; PsA: RINVOQ 15 mg, upadacitinib 30
mg.1,7,8
§Includes 7023.8 patient-years in RA trials, and 1247.2 patient-years in PsA
trials

‖Program is not available to patients receiving prescription reimbursement under
any federal, state, or government‑funded insurance programs (for example,
Medicare [including Part D], Medicare Advantage, Medigap, Medicaid, TRICARE,
Department of Defense, or Veterans Affairs programs) or where prohibited by law
or by the patient’s health insurance provider. If at any time a patient begins
receiving prescription drug coverage under any such federal, state, or
government‑funded healthcare program, patient will no longer be eligible to
participate in program. Available to patients between the ages of 18‑63 with
commercial prescription insurance coverage who meet eligibility criteria.
Eligibility: Patients must be diagnosed with active psoriatic arthritis, have a
valid prescription for RINVOQ and participate in a commercial insurance plan
that has denied or not yet made a formulary decision for RINVOQ. Once the
patient’s insurance plan has made a formulary decision and established a process
for reviewing coverage requests for RINVOQ, continued eligibility for the
program requires the submission of a Prior Authorization prior to the next
scheduled dose and appeal of the coverage denial within 180 days. Program
provides RINVOQ at no charge to patients for up to 2 years or until they receive
insurance coverage approval, whichever occurs earlier. Offer subject to change
or discontinuance without notice. This is not health insurance and program does
not guarantee insurance coverage.

ACR20/50/70=improvement of at least 20%/50%/70% in tender joint count, swollen
joint count, and at least 3 of the 5 other core criteria, including patient and
physician global assessments, health assessment questionnaire — disability index
(HAQ-DI), pain assessment, and high-sensitivity C-reactive protein (hs-CRP);
LDI=Leeds dactylitis index; LEI=Leeds enthesitis index; MDA=minimal disease
activity; mTSS=modified total Sharp/van der Heijde score; PASI75=at least 75%
improvement in psoriasis area severity from baseline; PsA=psoriatic arthritis;
RA=rheumatoid arthritis; TNFi=tumor necrosis factor inhibitor



DISEASE CONTROL DATA



IMPORTANT SAFETY INFORMATION & INDICATIONS1


INDICATIONS1

RINVOQ is indicated for the treatment of:

 * Moderately to severely active rheumatoid arthritis in adults who have had an
   inadequate response or intolerance to one or more TNF blockers.
 * Active psoriatic arthritis in adults who have had an inadequate response or
   intolerance to one or more TNF blockers.

Limitation of Use: Use of RINVOQ in combination with other JAK inhibitors,
biologic DMARDs, or with potent immunosuppressants, such as azathioprine and
cyclosporine, is not recommended.


IMPORTANT SAFETY INFORMATION


SERIOUS INFECTIONS

Patients treated with RINVOQ are at increased risk for developing serious
infections that may lead to hospitalization or death. Most patients who
developed these infections were taking concomitant immunosuppressants, such as
methotrexate or corticosteroids. If a serious infection develops, interrupt
RINVOQ until the infection is controlled.

Reported infections include:

 * Active tuberculosis (TB), which may present with pulmonary or extrapulmonary
   disease. Test patients for latent TB before RINVOQ use and during therapy.
   Consider treatment for latent TB infection prior to RINVOQ use.
 * Invasive fungal infections, including cryptococcosis and pneumocystosis.
 * Bacterial, viral, including herpes zoster, and other infections due to
   opportunistic pathogens.

Carefully consider the risks and benefits of treatment with RINVOQ prior to
initiating therapy in patients with chronic or recurrent infection. Monitor
patients closely for the development of signs and symptoms of infection during
and after treatment with RINVOQ, including the possible development of TB in
patients who tested negative for latent TB infection prior to initiating
therapy.


MORTALITY

In a large, randomized, postmarketing safety study comparing another Janus
kinase (JAK) inhibitor with tumor necrosis factor (TNF) blockers in rheumatoid
arthritis (RA) patients ≥50 years old with at least one cardiovascular (CV) risk
factor, a higher rate of all-cause mortality, including sudden CV death, was
observed with the JAK inhibitor. Consider the benefits and risks for the
individual patient prior to initiating or continuing therapy with RINVOQ.


MALIGNANCIES

Lymphoma and other malignancies have been observed in patients treated with
RINVOQ.

In a large, randomized, postmarketing safety study comparing another JAK
inhibitor with TNF blockers in RA patients, a higher rate of malignancies
(excluding non-melanoma skin cancer [NMSC]), lymphomas, and lung cancer (in
current or past smokers) was observed with the JAK inhibitor. Patients who are
current or past smokers are at additional increased risk.

With RINVOQ, consider the benefits and risks for the individual patient prior to
initiating or continuing therapy, particularly in patients with a known
malignancy (other than a successfully treated NMSC), patients who develop a
malignancy when on treatment, and patients who are current or past smokers.
NMSCs have been reported in patients treated with RINVOQ. Periodic skin
examination is recommended for patients who are at increased risk for skin
cancer. Advise patients to limit sunlight exposure by wearing protective
clothing and using sunscreen.


MAJOR ADVERSE CARDIOVASCULAR EVENTS

In a large, randomized, postmarketing study comparing another JAK inhibitor with
TNF blockers in RA patients ≥50 years old with at least one CV risk factor, a
higher rate of major adverse cardiovascular events (MACE) (defined as
cardiovascular death, myocardial infarction, and stroke) was observed with the
JAK inhibitor. Patients who are current or past smokers are at additional
increased risk. Discontinue RINVOQ in patients that have experienced a
myocardial infarction or stroke.

Consider the benefits and risks for the individual patient prior to initiating
or continuing therapy with RINVOQ, particularly in patients who are current or
past smokers and patients with other CV risk factors. Patients should be
informed about the symptoms of serious CV events and the steps to take if they
occur.


THROMBOSIS

Thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial
thrombosis have occurred in patients treated with JAK inhibitors used to treat
inflammatory conditions. Many of these adverse events were serious and some
resulted in death.

In a large, randomized, postmarketing study comparing another JAK inhibitor to
TNF blockers in RA patients ≥50 years old with at least one CV risk factor, a
higher rate of thrombosis was observed with the JAK inhibitor. Avoid RINVOQ in
patients at risk. Patients with symptoms of thrombosis should discontinue RINVOQ
and be promptly evaluated.


HYPERSENSITIVITY

RINVOQ is contraindicated in patients with known hypersensitivity to
upadacitinib or any of its excipients. Serious hypersensitivity reactions, such
as anaphylaxis and angioedema, were reported in patients receiving RINVOQ in
clinical trials. If a clinically significant hypersensitivity reaction occurs,
discontinue RINVOQ and institute appropriate therapy.


GASTROINTESTINAL PERFORATIONS

Gastrointestinal (GI) perforations have been reported in clinical trials with
RINVOQ. In these trials, many patients with RA were receiving background therapy
with nonsteroidal anti-inflammatory drugs (NSAIDs). Monitor RINVOQ-treated
patients who may be at risk for gastrointestinal perforation (e.g., patients
with a history of diverticulitis or taking NSAIDs). Promptly evaluate patients
presenting with new onset abdominal pain for early identification of GI
perforation.


LABORATORY ABNORMALITIES

Neutropenia

Treatment with RINVOQ was associated with an increased incidence of neutropenia
(absolute neutrophil count [ANC] <1000 cells/mm3). Treatment with RINVOQ is not
recommended in patients with an ANC <1000 cells/mm3. Evaluate neutrophil counts
at baseline and thereafter according to routine patient management.

Lymphopenia

Absolute lymphocyte counts (ALC) <500 cells/mm3 were reported in RINVOQ clinical
studies. Treatment with RINVOQ is not recommended in patients with an ALC <500
cells/mm3. Evaluate at baseline and thereafter according to routine patient
management.

Anemia

Decreases in hemoglobin levels to <8 g/dL were reported in RINVOQ clinical
studies. Treatment should not be initiated or should be interrupted in patients
with hemoglobin levels <8 g/dL. Evaluate at baseline and thereafter according to
routine patient management.

Lipids

Treatment with RINVOQ was associated with increases in lipid parameters,
including total cholesterol, low-density lipoprotein (LDL) cholesterol, and
high-density lipoprotein (HDL) cholesterol. Manage patients according to
clinical guidelines for the management of hyperlipidemia. Evaluate patients 12
weeks after initiation of treatment and thereafter according to the clinical
guidelines for hyperlipidemia.

Liver enzyme elevations

Treatment with RINVOQ was associated with increased incidence of liver enzyme
elevation compared to placebo. Evaluate at baseline and thereafter according to
routine patient management. Prompt investigation of the cause of liver enzyme
elevation is recommended to identify potential cases of drug-induced liver
injury. If increases in aspartate aminotransferase (AST) or alanine
aminotransferase (ALT) are observed during routine patient management and
drug-induced liver injury is suspected, RINVOQ should be interrupted until this
diagnosis is excluded.


EMBRYO-FETAL TOXICITY

Based on findings in animal studies, RINVOQ may cause fetal harm when
administered to a pregnant woman. Advise pregnant women of the potential risk to
a fetus. Advise females of reproductive potential to use effective contraception
during treatment with RINVOQ and for 4 weeks after the final dose. Verify
pregnancy status of females of reproductive potential prior to starting
treatment with RINVOQ.


VACCINATION

Avoid use of live vaccines during, or immediately prior to, RINVOQ therapy.
Prior to initiating RINVOQ, patients should be brought up to date on all
immunizations, including varicella zoster or prophylactic herpes zoster
vaccinations, in agreement with current immunization guidelines.


LACTATION

There are no data on the presence of RINVOQ in human milk, the effects on the
breastfed infant, or the effects on milk production. Available data in animals
have shown the excretion of RINVOQ in milk. Advise patients that breastfeeding
is not recommended during treatment with RINVOQ and for 6 days after the last
dose.


HEPATIC IMPAIRMENT

RINVOQ is not recommended for use in patients with severe hepatic impairment.


ADVERSE REACTIONS

The most common adverse reactions in RINVOQ clinical trials (≥1%) were upper
respiratory tract infections, herpes zoster, herpes simplex, bronchitis, nausea,
cough, pyrexia, acne, headache, blood creatine phosphokinase increased,
hypersensitivity, folliculitis, abdominal pain, increased weight, influenza,
fatigue, neutropenia, myalgia, and influenza-like illness.

Inform patients that retinal detachment has been reported in clinical trials
with RINVOQ. Advise patients to immediately inform their healthcare provider if
they develop any sudden changes in vision while receiving RINVOQ.

Dosage Forms and Strengths: RINVOQ is available in 15 mg and 30 mg
extended-release tablets.

US-RNQ-210031

Please see full Prescribing Information.



REFERENCES

 1.  RINVOQ [package insert]. North Chicago, IL: AbbVie Inc.
 2.  McInnes IB, Anderson JK, Magrey M, et al. Trial of Upadacitinib and
     Adalimumab for Psoriatic Arthritis. NEJM. 2021;384(13):1227-1239.
     doi:10.1056/nejmoa2022516.
 3.  Mease PJ, Lertratanakul A, Anderson JK, et al. Upadacitinib for psoriatic
     arthritis refractory to biologics: SELECT-PsA 2. Ann Rheum Dis.
     2021;80(3):312-320.
 4.  Data on File. ABVRRTI71685.
 5.  Mease PJ, Lertratanakul A, Anderson JK, et al. Supplement - Upadacitinib
     for psoriatic arthritis refractory to biologics: SELECT-PsA 2. Ann Rheum
     Dis. 2021;80(3):312-320.
 6.  McInnes IB, Anderson JK, Magrey M, et al. Supplement - Trial of
     upadacitinib and adalimumab for psoriatic arthritis. N Engl J Med.
     2021;384(13):1227-1239. doi:10.1056/NEJMoa2022516.
 7.  Cohen SB, Van Vollenhoven R, Curtis JR, et al. Integrated safety profile of
     upadacitinib with up to 4.5 years of exposure in patients with rheumatoid
     arthritis. Poster presented at: The European Congress of Rheumatology, 2-5
     June 2021, E‑Congress.
 8.  Burmester GR, Winthrop K, Blanco R, et al. Safety Profile of Upadacitinib
     Up to 3 Years in Patients with Psoriatic Arthritis: An Integrated Analysis
     from the Phase 3 Program. Presented at: The European Congress of
     Rheumatology, 2-5 June 2021, E‑Congress. Data on File. ABVRRTI71686.
 9.  Data on File, AbbVie Inc. Payer reported lives. December 2021.
 10. Data on File. ABVRRTI71618. 


Disease Control Data
Clinical Trial Overview
Minimal Disease Activity
Joint Efficacy
Clinical Trial Overview
ACR Response
Radiographic Inhibition
Physical Function
Enthesitis
Dactylitis
Skin Efficacy
Clinical Trial Overview
PASI Data
Safety Profile
Week 24
Long-term Exposure Data
Common Adverse Reactions
Monitoring & Dose Interruptions
Important Safety Information
Access & Support
Commercial Access
Complete Program
How To Enroll Patients
Downloadable Resources
Dosing & MOA
Dosing
Lab Monitoring
Mechanism of Action
Important Safety Information
Prescribing Information (English)
Información en español
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©2021 AbbVie Inc. North Chicago, IL 60064. If you have any questions about this
website that have not been answered, click here. This website and the
information contained herein is intended for use by US physicians only and is
provided for informational purposes only.

US-MULT-211444






ACR RESPONSE CRITERIA1-4

To achieve an ACR20, 50, or 70 response, a patient must have at least a 20%,
50%, or 70%, respectively, improvement in tender and swollen joint counts
and three of five scores of individual elements:

 * patient pain;
 * physician's global assessment of disease activity;
 * patient's global assessment;
 * physical function (HAQ-DI);
 * and an acute phase reactant (hs‑CRP).



ACR=American College of Rheumatology; HAQ‑DI=health assessment questionnaire —
disability index; hs‑CRP=high‑sensitivity C‑reactive protein; NRS=numeric
rating scale; ULN=upper limit normal

REFERENCES

 1. Mease PJ, Antoni CE, Gladman DD, et al. Psoriatic arthritis assessment tools
    in clinical trials. Ann Rheum Dis. 2005;64(Suppl II):ii49–ii54.
 2. RINVOQ [package insert]. North Chicago, IL: AbbVie Inc.
 3. Data on File. ABVRRTI71868.
 4. Mease PJ, Lertratanakul A, Anderson JK, et al. Upadacitinib for psoriatic
    arthritis refractory to biologics: SELECT-PsA 2. Ann Rheum Dis.
    2021;80(3):312-320.

US-MULT-211444




STUDY DESIGN & BASELINE CHARACTERISTICS

SELECT-PsA 2
SELECT-PsA 1


SELECT‑PSA 2

Adults with active PsA who had an inadequate response or intolerance to
≥1 biologic DMARDs.1
RINVOQ is indicated for TNFi-IR patients




Upadacitinib 30 mg is not an approved dose for PsA.

aStarting at Week 16, patients who did not achieve ≥20% improvement in tender
and/or swollen joint counts (TJC68/SJC66) compared to baseline at Weeks 12 and
16 had background medications, adjusted or initiated.3
bAt Week 24, all remaining placebo patients were switched to RINVOQ 15 mg QD or
upadacitinib 30 mg QD.2
cAfter Week 16, the use of concomitant treatments for psoriasis therapies were
permitted.2
dStarting at Week 36, patients who did not achieve ≥20% improvement in TJC68 and
SJC66 compared to baseline at 2 consecutive visits were discontinued from the
study.3

Primary Endpoint1

 * Proportion of patients achieving ACR20 response at Week 12 vs placebo

Select Ranked Key Secondary Endpoints3

 * Change from baseline in HAQ‑DI at Week 12
 * Proportion of patients achieving PASI75 response at Week 16 (for patients
   with ≥3% BSA‑Psoriasis at baseline)
 * Proportion of patients achieving MDA at Week 24

Additional Key Secondary Endpoints3

 * Proportion of patients achieving ACR50/70 response at Week 12
 * Proportion of patients achieving ACR20 response at Week 2

Select Prespecified Nonranked Endpoints3

 * Proportion of patients achieving PASI90/100 response
 * Proportion of patients with resolution of enthesitis defined as LEI=0 (for
   patients with baseline LEI>0)
 * Proportion of patients with resolution of dactylitis defined as LDI=0 (for
   patients with baseline LDI>0)
 * Change from baseline in individual components of ACR response

Data Limitations3

Prespecified nonranked endpoints were not controlled for multiplicity;
therefore, treatment differences could represent chance findings. No conclusions
regarding these comparisons can be made.

BASELINE CHARACTERISTICS3,4



*Patients with intolerance but not inadequate response to a biologic DMARD.
†ULN=2.87 mg/L

ACR=American College of Rheumatology; ACR20=improvement of at least 20% in
tender joint count, swollen joint count, and at least 3 of the 5 other core
criteria, including patient and physician global assessments, health assessment
questionnaire — disability index (HAQ‑DI), pain assessment, and high‑sensitivity
C‑reactive protein (hs‑CRP); ACR50=improvement of at least 50% in tender joint
count, swollen joint count, and at least 3 of the 5 other core criteria,
including patient and physician global assessments, health assessment
questionnaire — disability index (HAQ‑DI), pain assessment, and high‑sensitivity
C‑reactive protein (hs‑CRP); ACR70=improvement of at least 70% in tender joint
count, swollen joint count, and at least 3 of the 5 other core criteria,
including patient and physician global assessments, health assessment
questionnaire — disability index (HAQ‑DI), pain assessment, and high‑sensitivity
C‑reactive protein (hs‑CRP); BSA=body surface area; CCP=cyclic citrullinated
peptide; DMARD=disease‑modifying antirheumatic drug; HAQ-DI=health assessment
questionnaire — disability index; hs-CRP=high-sensitivity C-reactive protein;
IR=intolerance or inadequate response; LDI=Leeds dactylitis index; LEI=Leeds
enthesitis index; MDA=minimal disease activity; MTX=methotrexate; NRS=numerical
rating scale; NSAID=nonsteroidal anti‑inflammatory drug; PASI=psoriasis area
severity index; PASI75/90/100=at least 75%/90%/100% improvement in psoriasis
area severity score from baseline; PsA=psoriatic arthritis; QD=once per day;
RF=rheumatoid factor; SD=standard deviation; SJC66=swollen joint count using 66
joints; TJC68=tender joint count using 68 joints; TNFi=tumor necrosis factor
inhibitor; ULN=upper limit normal

REFERENCES

 1. RINVOQ [package insert]. North Chicago, IL: AbbVie Inc.
 2. Mease PJ, Lertratanakul A, Anderson JK, et al. Supplement - Upadacitinib for
    psoriatic arthritis refractory to biologics: SELECT-PsA 2. Ann Rheum Dis.
    2021;80(3):312-320. doi:10.1136/annrheumdis-2020-218870.
 3. Mease PJ, Lertratanakul A, Anderson JK, et al. Upadacitinib for psoriatic
    arthritis refractory to biologics: SELECT-PsA 2. Ann Rheum Dis.
    2021;80(3):312-320. doi:10.1136/annrheumdis-2020-218870.
    
 4. Mease PJ, Lertratanakul A, Strober B et al. Efficacy of upadacitinib in
    patients with psoriatic arthritis stratified by number of prior biologic
    disease-modifying anti rheumatic drugs. Poster presented at: The American
    College of Rheumatology Convergence, 5-9 November 2020, E-Congress.



US-MULT-211444


SELECT‑PSA 1

Adults with active PsA who had an inadequate response or intolerance to ≥1
non-biologic DMARDs.1
RINVOQ is indicated for TNFi-IR patients




Upadacitinib 30 mg is not an approved dose for PsA.

aAll patients will receive X‑rays of hands and feet.3
bStarting at Week 16, patients who did not achieve ≥20% improvement in tender
and/or swollen joint counts (TJC68/SJC66) compared to baseline at Weeks 12  and
16 had background DMARDs, NSAIDs, acetaminophen, low potency opioids, or
corticosteroids adjusted or initiated.4
cAfter Week 16, the use of concomitant treatments for psoriasis therapies were
permitted.2
dAt Week 24, all remaining placebo patients were switched to RINVOQ 15 mg QD or
upadacitinib 30 mg QD (1:1 ratio) regardless of response.1
eStarting at Week 36, patients who did not achieve ≥20% improvement in TJC68 and
SJC66 compared to baseline at 2 consecutive visits were discontinued from the
study.5

Primary Endpoint1

 * Proportion of patients achieving ACR20 response at Week 12 vs placebo

Select Ranked Key Secondary Endpoints3

Upadacitinib vs placebo if not otherwise specified

 * Change from baseline in HAQ-DI at Week 12
 * Proportion of patients achieving PASI75 response at Week 16 (for patients
   with ≥3% BSA-Psoriasis at baseline)
 * Change from baseline in mTSS at Week 24
 * Proportion of patients achieving MDA at Week 24
 * Proportion of patients with resolution of enthesitis (LEI=0) at Week 24 (for
   patients with baseline presence of enthesitis [LEI>0])
 * Proportion of patients with resolution of dactylitis (LDI=0) at Week 24 (for
   patients with baseline presence of dactylitis [LDI>0])

Additional Key Secondary Endpoints3

Upadacitinib vs placebo if not otherwise specified

 * Proportion of patients achieving ACR50/70 response at Week 12
 * Proportion of patients achieving ACR20 response at Week 2

Select Prespecified Nonranked Endpoints3

Additional efficacy analyses include the following endpoints at the scheduled
time points other than those specified for the primary and key secondary
variables:

 * Proportion of patients with no radiographic progression defined as:
   * Change from baseline in
     mTSS ≤0;
   * Change from baseline in
     mTSS ≤0.5;
 * Change from baseline in joint space narrowing score and joint erosion score
 * Change from baseline in Health Assessment Questionnaire – Disability Index
   (HAQ-DI)
 * Proportion of patients achieving ACR20/50/70 response
 * Proportion of patients achieving MDA

 * Proportion of patients with resolution of enthesitis defined as LEI=0 (for
   patients with baseline
   LEI>0)
 * Proportion of patients with resolution of dactylitis defined as LDI=0 (for
   patients with baseline
   LDI>0)
 * Proportion of patients achieving PASI75/90/100 response (for patients with
   ≥3% BSA-Psoriasis at baseline)

Data Limitations2

Prespecified nonranked endpoints were not controlled for multiplicity;
therefore, treatment differences could represent chance findings. No conclusions
regarding these comparisons can be made.

BASELINE CHARACTERISTICS3,6



*ULN=2.87 mg/L


ACR=American College of Rheumatology; ACR20=improvement of at least 20% in
tender joint count, swollen joint count, and at least 3 of the 5 other core
criteria, including patient and physician global assessments, health assessment
questionnaire — disability index (HAQ‑DI), pain assessment, and high‑sensitivity
C‑reactive protein (hs-CRP); ACR50=improvement of at least 50% in tender joint
count, swollen joint count, and at least 3 of the 5 other core criteria,
including patient and physician global assessments, health assessment
questionnaire — disability index (HAQ‑DI), pain assessment, and high‑sensitivity
C‑reactive protein (hs-CRP); ACR70=improvement of at least 70% in tender joint
count, swollen joint count, and at least 3 of the 5 other core criteria,
including patient and physician global assessments, health assessment
questionnaire — disability index (HAQ‑DI), pain assessment, and high‑sensitivity
C‑reactive protein (hs‑CRP); ADA=adalimumab; BMI=body mass index; BSA=body
surface area; DMARD=disease‑modifying antirheumatic drug; HAQ‑DI=health
assessment questionnaire — disability index; hs-CRP=high‑sensitivity C‑reactive
protein; IR=intolerance or inadequate response; LDI=Leeds dactylitis index;
LEI=Leeds enthesitis index; MDA=minimal disease activity; mTSS=modified total
Sharp/van der Heijde score; MTX=methotrexate; NRS=numerical rating scale;
NSAID=nonsteroidal anti-inflammatory drug; PASI=psoriasis area severity
index; PASI75/90/100=at least 75%/90%/100% reduction in psoriasis area severity
score from baseline; PsA=psoriatic arthritis; QD=once per day; SD=standard
deviation; SJC66=swollen joint count of 66 joints; TJC68=tender joint count of
68 joints; TNFi=tumor necrosis factor inhibitor; ULN=upper limit normal

REFERENCES

 1. RINVOQ [package insert]. North Chicago, IL: AbbVie Inc.
 2. McInnes IB, Anderson JK, Magrey M, et al. Supplement - Trial of Upadacitinib
    and Adalimumab for Psoriatic Arthritis. NEJM. 2021;384(13):1227-1239.
    doi:10.1056/nejmoa2022516
 3. Data on File. ABVRRTI71645.
 4. McInnes IB, Anderson JK, Magrey M, et al. Trial of Upadacitinib and
    Adalimumab for Psoriatic Arthritis. NEJM. 2021;384(13):1227-1239.
    doi:10.1056/nejmoa2022516
 5. Data on File. ABVRRTI71869.
 6. Data on File. ABVRRTI71868.

US-MULT-211444




STUDY DESIGN & BASELINE CHARACTERISTICS

modal-select-psa1-n


SELECT‑PSA 1

Adults with active PsA who had an inadequate response or intolerance to ≥1
non-biologic DMARDs.1
RINVOQ is indicated for TNFi-IR patients




Upadacitinib 30 mg is not an approved dose for PsA.

aAll patients will receive X‑rays of hands and feet.3
bStarting at Week 16, patients who did not achieve ≥20% improvement in tender
and/or swollen joint counts (TJC68/SJC66) compared to baseline at Weeks 12  and
16 had background DMARDs, NSAIDs, acetaminophen, low potency opioids, or
corticosteroids adjusted or initiated.4
cAfter Week 16, the use of concomitant treatments for psoriasis therapies were
permitted.2
dAt Week 24, all remaining placebo patients were switched to RINVOQ 15 mg QD or
upadacitinib 30 mg QD (1:1 ratio) regardless of response.1
eStarting at Week 36, patients who did not achieve ≥20% improvement in TJC68 and
SJC66 compared to baseline at 2 consecutive visits were discontinued from the
study.5

Primary Endpoint1

 * Proportion of patients achieving ACR20 response at Week 12 vs placebo

Select Ranked Key Secondary Endpoints3

Upadacitinib vs placebo if not otherwise specified

 * Change from baseline in HAQ-DI at Week 12
 * Proportion of patients achieving PASI75 response at Week 16 (for patients
   with ≥3% BSA-Psoriasis at baseline)
 * Change from baseline in mTSS at Week 24
 * Proportion of patients achieving MDA at Week 24
 * Proportion of patients with resolution of enthesitis (LEI=0) at Week 24 (for
   patients with baseline presence of enthesitis [LEI>0])
 * Proportion of patients with resolution of dactylitis (LDI=0) at Week 24 (for
   patients with baseline presence of dactylitis [LDI>0])

Additional Key Secondary Endpoints3

Upadacitinib vs placebo if not otherwise specified

 * Proportion of patients achieving ACR50/70 response at Week 12
 * Proportion of patients achieving ACR20 response at Week 2

Select Prespecified Nonranked Endpoints3

Additional efficacy analyses include the following endpoints at the scheduled
time points other than those specified for the primary and key secondary
variables:

 * Proportion of patients with no radiographic progression defined as:
   * Change from baseline in
     mTSS ≤0;
   * Change from baseline in
     mTSS ≤0.5;
 * Change from baseline in joint space narrowing score and joint erosion score
 * Change from baseline in Health Assessment Questionnaire – Disability Index
   (HAQ-DI)
 * Proportion of patients achieving ACR20/50/70 response
 * Proportion of patients achieving MDA

 * Proportion of patients with resolution of enthesitis defined as LEI=0 (for
   patients with baseline
   LEI>0)
 * Proportion of patients with resolution of dactylitis defined as LDI=0 (for
   patients with baseline
   LDI>0)
 * Proportion of patients achieving PASI75/90/100 response (for patients with
   ≥3% BSA-Psoriasis at baseline)

Data Limitations2

Prespecified nonranked endpoints were not controlled for multiplicity;
therefore, treatment differences could represent chance findings. No conclusions
regarding these comparisons can be made.

BASELINE CHARACTERISTICS3,6



*ULN=2.87 mg/L


ACR=American College of Rheumatology; ACR20=improvement of at least 20% in
tender joint count, swollen joint count, and at least 3 of the 5 other core
criteria, including patient and physician global assessments, health assessment
questionnaire — disability index (HAQ‑DI), pain assessment, and high‑sensitivity
C‑reactive protein (hs-CRP); ACR50=improvement of at least 50% in tender joint
count, swollen joint count, and at least 3 of the 5 other core criteria,
including patient and physician global assessments, health assessment
questionnaire — disability index (HAQ‑DI), pain assessment, and high‑sensitivity
C‑reactive protein (hs-CRP); ACR70=improvement of at least 70% in tender joint
count, swollen joint count, and at least 3 of the 5 other core criteria,
including patient and physician global assessments, health assessment
questionnaire — disability index (HAQ‑DI), pain assessment, and high‑sensitivity
C‑reactive protein (hs‑CRP); ADA=adalimumab; BMI=body mass index; BSA=body
surface area; DMARD=disease‑modifying antirheumatic drug; HAQ‑DI=health
assessment questionnaire — disability index; hs-CRP=high‑sensitivity C‑reactive
protein; IR=intolerance or inadequate response; LDI=Leeds dactylitis index;
LEI=Leeds enthesitis index; MDA=minimal disease activity; mTSS=modified total
Sharp/van der Heijde score; MTX=methotrexate; NRS=numerical rating scale;
NSAID=nonsteroidal anti-inflammatory drug; PASI=psoriasis area severity
index; PASI75/90/100=at least 75%/90%/100% reduction in psoriasis area severity
score from baseline; PsA=psoriatic arthritis; QD=once per day; SD=standard
deviation; SJC66=swollen joint count of 66 joints; TJC68=tender joint count of
68 joints; TNFi=tumor necrosis factor inhibitor; ULN=upper limit normal

REFERENCES

 1. RINVOQ [package insert]. North Chicago, IL: AbbVie Inc.
 2. McInnes IB, Anderson JK, Magrey M, et al. Supplement - Trial of Upadacitinib
    and Adalimumab for Psoriatic Arthritis. NEJM. 2021;384(13):1227-1239.
    doi:10.1056/nejmoa2022516
 3. Data on File. ABVRRTI71645.
 4. McInnes IB, Anderson JK, Magrey M, et al. Trial of Upadacitinib and
    Adalimumab for Psoriatic Arthritis. NEJM. 2021;384(13):1227-1239.
    doi:10.1056/nejmoa2022516
 5. Data on File. ABVRRTI71869.
 6. Data on File. ABVRRTI71868.

US-MULT-211444




STUDY DESIGN & BASELINE CHARACTERISTICS

modal-select-psa2


SELECT‑PSA 2

Adults with active PsA who had an inadequate response or intolerance to
≥1 biologic DMARDs.1
RINVOQ is indicated for TNFi-IR patients




Upadacitinib 30 mg is not an approved dose for PsA.

aStarting at Week 16, patients who did not achieve ≥20% improvement in tender
and/or swollen joint counts (TJC68/SJC66) compared to baseline at Weeks 12 and
16 had background medications, adjusted or initiated.3
bAt Week 24, all remaining placebo patients were switched to RINVOQ 15 mg QD or
upadacitinib 30 mg QD.2
cAfter Week 16, the use of concomitant treatments for psoriasis therapies were
permitted.2
dStarting at Week 36, patients who did not achieve ≥20% improvement in TJC68 and
SJC66 compared to baseline at 2 consecutive visits were discontinued from the
study.3

Primary Endpoint1

 * Proportion of patients achieving ACR20 response at Week 12 vs placebo

Select Ranked Key Secondary Endpoints3

 * Change from baseline in HAQ‑DI at Week 12
 * Proportion of patients achieving PASI75 response at Week 16 (for patients
   with ≥3% BSA‑Psoriasis at baseline)
 * Proportion of patients achieving MDA at Week 24

Additional Key Secondary Endpoints3

 * Proportion of patients achieving ACR50/70 response at Week 12
 * Proportion of patients achieving ACR20 response at Week 2

Select Prespecified Nonranked Endpoints3

 * Proportion of patients achieving PASI90/100 response
 * Proportion of patients with resolution of enthesitis defined as LEI=0 (for
   patients with baseline LEI>0)
 * Proportion of patients with resolution of dactylitis defined as LDI=0 (for
   patients with baseline LDI>0)
 * Change from baseline in individual components of ACR response

Data Limitations3

Prespecified nonranked endpoints were not controlled for multiplicity;
therefore, treatment differences could represent chance findings. No conclusions
regarding these comparisons can be made.

BASELINE CHARACTERISTICS3,4



*Patients with intolerance but not inadequate response to a biologic DMARD.
†ULN=2.87 mg/L

ACR=American College of Rheumatology; ACR20=improvement of at least 20% in
tender joint count, swollen joint count, and at least 3 of the 5 other core
criteria, including patient and physician global assessments, health assessment
questionnaire — disability index (HAQ‑DI), pain assessment, and high‑sensitivity
C‑reactive protein (hs‑CRP); ACR50=improvement of at least 50% in tender joint
count, swollen joint count, and at least 3 of the 5 other core criteria,
including patient and physician global assessments, health assessment
questionnaire — disability index (HAQ‑DI), pain assessment, and high‑sensitivity
C‑reactive protein (hs‑CRP); ACR70=improvement of at least 70% in tender joint
count, swollen joint count, and at least 3 of the 5 other core criteria,
including patient and physician global assessments, health assessment
questionnaire — disability index (HAQ‑DI), pain assessment, and high‑sensitivity
C‑reactive protein (hs‑CRP); BSA=body surface area; CCP=cyclic citrullinated
peptide; DMARD=disease‑modifying antirheumatic drug; HAQ-DI=health assessment
questionnaire — disability index; hs-CRP=high-sensitivity C-reactive protein;
IR=intolerance or inadequate response; LDI=Leeds dactylitis index; LEI=Leeds
enthesitis index; MDA=minimal disease activity; MTX=methotrexate; NRS=numerical
rating scale; NSAID=nonsteroidal anti‑inflammatory drug; PASI=psoriasis area
severity index; PASI75/90/100=at least 75%/90%/100% improvement in psoriasis
area severity score from baseline; PsA=psoriatic arthritis; QD=once per day;
RF=rheumatoid factor; SD=standard deviation; SJC66=swollen joint count using 66
joints; TJC68=tender joint count using 68 joints; TNFi=tumor necrosis factor
inhibitor; ULN=upper limit normal

REFERENCES

 1. RINVOQ [package insert]. North Chicago, IL: AbbVie Inc.
 2. Mease PJ, Lertratanakul A, Anderson JK, et al. Supplement - Upadacitinib for
    psoriatic arthritis refractory to biologics: SELECT-PsA 2. Ann Rheum Dis.
    2021;80(3):312-320. doi:10.1136/annrheumdis-2020-218870.
 3. Mease PJ, Lertratanakul A, Anderson JK, et al. Upadacitinib for psoriatic
    arthritis refractory to biologics: SELECT-PsA 2. Ann Rheum Dis.
    2021;80(3):312-320. doi:10.1136/annrheumdis-2020-218870.
    
 4. Mease PJ, Lertratanakul A, Strober B et al. Efficacy of upadacitinib in
    patients with psoriatic arthritis stratified by number of prior biologic
    disease-modifying anti rheumatic drugs. Poster presented at: The American
    College of Rheumatology Convergence, 5-9 November 2020, E-Congress.



US-MULT-211444


YOU ARE ABOUT TO ENTER A SITE THAT IS FOR US HEALTHCARE PROFESSIONALS ONLY.

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that you wish to proceed to the Healthcare Professionals Only section on the
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or any further links from such site. AbbVie is providing these links to you only
as a convenience and the inclusion of any link does not imply the endorsement of
the linked site by AbbVie. You should also be aware that the linked site may be
governed by its own set of terms and conditions and privacy policy for which
AbbVie has no responsibility.

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US-RNQR-200716


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By selecting "Yes" below, you certify that you are a Healthcare Professional and
that you wish to proceed to the Healthcare Professionals Only section on the
AbbVie Medical Information site. Products or treatments described on this site
are available in the U.S. but may not be available in all other countries. I am
a licensed Healthcare Professional and wish to proceed to the Healthcare
Professionals Only AbbVie Medical Information Site.

Conversely, the presence of this link does not imply the linked
site's endorsement of rinvoqhcp.com or AbbVie.

Do you wish to leave this site?

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No

US-RNQR-200716


YOU ARE ABOUT TO ENTER A SITE THAT IS FOR US HEALTHCARE PROFESSIONALS ONLY.

By selecting "Yes" below, you certify that you are a Healthcare Professional and
that you wish to proceed to the Healthcare Professionals Only section on the
AbbVie Medical Information site. Products or treatments described on this site
are available in the U.S. but may not be available in all other countries. I am
a licensed Healthcare Professional and wish to proceed to the Healthcare
Professionals Only AbbVie Medical Information Site.

Conversely, the presence of this link does not imply the linked
site's endorsement of rinvoqhcp.com or AbbVie.

Do you wish to leave this site?

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US-RNQR-200716



LABEL UPDATE

Click here for FDA updates to Indication, Boxed Warning, Contraindication and
Warnings & Precautions


IMPORTANT UPDATES TO THE PRESCRIBING INFORMATION FOR
RINVOQ® (UPADACITINIB) EXTENDED-RELEASE TABLETS, FOR ORAL USE

On January 14, 2022, the Prescribing Information and Medication Guide for RINVOQ
(upadacitinib) was updated to include a new Indication, Recommended Dosage
information and added a Contraindication related to Hypersensitivity and a new
Warning and Precaution for Hypersensitivity Reactions.

The relevant sections of the Prescribing Information read as follows:

1 INDICATION AND USAGE

Section 1.3 Atopic Dermatitis


RINVOQ is indicated for the treatment of adults and pediatric patients 12 years
of age and older with refractory, moderate to severe atopic dermatitis whose
disease is not adequately controlled with other systemic drug products,
including biologics, or when use of those therapies are inadvisable.

Limitations of Use: RINVOQ is not recommended for use in combination with other
JAK inhibitors, biologic immunomodulators, or with other immunosuppressants.

2 DOSAGE AND ADMINISTRATION

2.5 Recommended Dosage in Atopic Dermatitis

Pediatric Patients 12 Years of Age and Older Weighing at Least 40 kg and Adults
Less Than 65 Years of Age
Initiate treatment with 15 mg once daily. If an adequate response is not
achieved, consider increasing the dosage to 30 mg once daily. Discontinue RINVOQ
if an adequate response is not achieved with the 30 mg dose. Use the lowest
effective dose needed to maintain response.

Adults 65 Years of Age and Older

The recommended dosage is 15 mg once daily.

2.6 Recommended Dosage in Patients with Renal Impairment or Severe Hepatic
Impairment

Renal Impairment
Atopic Dermatitis:

 * For patients with severe renal impairment [creatinine clearance (CrCL) < 30
   mL/min] the recommended dosage is 15 mg once daily.
 * No dosage adjustment is needed for patients with mild or moderate renal
   impairment [(CrCL) > 30 mL/min)].

Hepatic Impairment
RINVOQ is not recommended for use in patients with severe hepatic impairment.

4 CONTRAINDICATIONS

RINVOQ is contraindicated in patients with known hypersensitivity to
upadacitinib or any of its excipients.

5 WARNINGS AND PRECAUTIONS

Section 5.6 Hypersensitivity Reactions
Serious hypersensitivity reactions such as anaphylaxis and angioedema were
reported in patients receiving RINVOQ in clinical trials. If a clinically
significant hypersensitivity reaction occurs, discontinue RINVOQ and institute
appropriate therapy.

17 PATIENT COUNSELING INFORMATION

Hypersensitivity Reactions
Advise patients to discontinue RINVOQ and seek immediate medical attention if
they develop any signs and symptoms of allergic reactions.

On December 2, 2021, the Prescribing Information and Medication Guide for
RINVOQ® (upadacitinib) was updated as a result of discussions with the U.S. Food
and Drug Administration (FDA). This follows a Drug Safety Communication (DSC)
issued on September 1, 2021, by the FDA based upon its review of a large,
randomized, post-marketing safety study in rheumatoid arthritis (RA) patients 50
years of age and older with at least one cardiovascular risk factor comparing
another Janus kinase (JAK) inhibitor to tumor necrosis factor (TNF) blockers.

The indication has been updated to the following:


1 INDICATION AND USAGE
Section 1.1 Rheumatoid Arthritis
RINVOQ (upadacitinib) is indicated for the treatment of adults with moderately
to severely active rheumatoid arthritis who have had an inadequate response or
intolerance to one or more TNF blockers.

Limitation of Use: Use of RINVOQ in combination with other JAK inhibitors,
biologic DMARDs, or with potent immunosuppressants such as azathioprine and
cyclosporine is not recommended.

The full Prescribing Information now includes new information about the risks of
Mortality and Major Adverse Cardiovascular Events and updated information about
the risks of Malignancies and Thrombosis within the Boxed Warning and Warnings
and Precautions sections.

The Boxed Warning has been updated to the following:

WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR
EVENTS, AND THROMBOSIS

SERIOUS INFECTIONS

Patients treated with RINVOQ are at increased risk for developing serious
infections that may lead to hospitalization or death. Most patients who
developed these infections were taking concomitant immunosuppressants such as
methotrexate or corticosteroids.

If a serious infection develops, interrupt RINVOQ until the infection is
controlled.

Reported infections include:

 * Active tuberculosis, which may present with pulmonary or extrapulmonary
   disease. Patients should be tested for latent tuberculosis before RINVOQ use
   and during therapy. Treatment for latent infection should be considered prior
   to RINVOQ use.
 * Invasive fungal infections, including cryptococcosis and pneumocystosis.
 * Bacterial, viral, including herpes zoster, and other infections due to
   opportunistic pathogens.

The risks and benefits of treatment with RINVOQ should be carefully considered
prior to initiating therapy in patients with chronic or recurrent infection.

Patients should be closely monitored for the development of signs and symptoms
of infection during and after treatment with RINVOQ, including the possible
development of tuberculosis in patients who tested negative for latent
tuberculosis infection prior to initiating therapy.

MORTALITY

In a large, randomized, postmarketing safety study in rheumatoid arthritis (RA)
patients 50 years of age and older with at least one cardiovascular risk factor
comparing another Janus kinase (JAK) inhibitor to tumor necrosis factor (TNF)
blockers, a higher rate of all-cause mortality, including sudden cardiovascular
death, was observed with the JAK inhibitor.

MALIGNANCIES

Lymphoma and other malignancies have been observed in patients treated with
RINVOQ. In RA patients treated with another JAK inhibitor, a higher rate of
malignancies (excluding non-melanoma skin cancer [NMSC]) was observed when
compared with TNF blockers. Patients who are current or past smokers are at
additional increased risk.

MAJOR ADVERSE CARDIOVASCULAR EVENTS

In RA patients 50 years of age and older with at least one cardiovascular risk
factor treated with another JAK inhibitor, a higher rate of major adverse
cardiovascular events (MACE) (defined as cardiovascular death, myocardial
infarction, and stroke) was observed when compared with TNF blockers. Patients
who are current or past smokers are at additional increased risk. Discontinue
RINVOQ in patients that have experienced a myocardial infarction or stroke.

THROMBOSIS

Thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial
thrombosis have occurred in patients treated with JAK inhibitors used to treat
inflammatory conditions. Many of these adverse events were serious and some
resulted in death. In RA patients 50 years of age and older with at least one
cardiovascular risk factor treated with another JAK inhibitor, a higher rate of
thrombosis was observed when compared with TNF blockers. Avoid RINVOQ in
patients at risk. Patients with symptoms of thrombosis should discontinue RINVOQ
and be promptly evaluated.

The following sub-sections in the Warnings and Precautions have been updated to
the following:

5 WARNINGS AND PRECAUTIONS

Section 5.2 Mortality

In a large, randomized, postmarketing safety study of another JAK inhibitor in
RA patients 50 years of age and older with at least one cardiovascular risk
factor, a higher rate of all-cause mortality, including sudden cardiovascular
death, was observed in patients treated with the JAK inhibitor compared with TNF
blockers.

Consider the benefits and risks for the individual patient prior to initiating
or continuing therapy with RINVOQ.

Section 5.3 Malignancy and Lymphoproliferative Disorders
Malignancies were observed in clinical studies of RINVOQ.

In a large, randomized, postmarketing safety study of another JAK inhibitor in
RA patients, a higher rate of malignancies (excluding non-melanoma skin cancer
[NMSC]) was observed in patients treated with the JAK inhibitor compared to
those treated with TNF blockers. A higher rate of lymphomas was observed in
patients treated with the JAK inhibitor compared to those treated with TNF
blockers. A higher rate of lung cancers was observed in current or past smokers
treated with the JAK inhibitor compared to those treated with TNF blockers. In
this study, current or past smokers had an additional increased risk of overall
malignancies.

Consider the benefits and risks for the individual patient prior to initiating
or continuing therapy with RINVOQ, particularly in patients with a known
malignancy (other than a successfully treated NMSC), patients who develop a
malignancy when on treatment, and patients who are current or past smokers.


Non-Melanoma Skin Cancer
NMSCs have been reported in patients treated with RINVOQ. Periodic skin
examination is recommended for patients who are at increased risk for skin
cancer.

Section 5.4 Major Adverse Cardiovascular Events

In a large, randomized, postmarketing safety study of another JAK inhibitor in
RA patients 50 years of age and older with at least one cardiovascular risk
factor, a higher rate of major adverse cardiovascular events (MACE) defined as
cardiovascular death, non-fatal myocardial infarction (MI), and non-fatal stroke
was observed with the JAK inhibitor compared to those treated with TNF blockers.
Patients who are current or past smokers are at additional increased risk.

Consider the benefits and risks for the individual patient prior to initiating
or continuing therapy with RINVOQ, particularly in patients who are current or
past smokers and patients with other cardiovascular risk factors. Patients
should be informed about the symptoms of serious cardiovascular events and the
steps to take if they occur. Discontinue RINVOQ in patients that have
experienced a myocardial infarction or stroke.

Section 5.5 Thrombosis

Thrombosis, including deep venous thrombosis (DVT), pulmonary embolism (PE), and
arterial thrombosis, have occurred in patients treated for inflammatory
conditions with JAK inhibitors, including RINVOQ. Many of these adverse events
were serious and some resulted in death.

In a large, randomized, postmarketing safety study of another JAK inhibitor in
RA patients 50 years of age and older with at least one cardiovascular risk
factor, higher rates of overall thrombosis, DVT, and PE were observed compared
to those treated with TNF blockers.

If symptoms of thrombosis occur, patients should discontinue RINVOQ and be
evaluated promptly and treated appropriately. Avoid RINVOQ in patients that may
be at increased risk of thrombosis.

This information was added to the following section:

17 PATIENT COUNSELING INFORMATION

Major Adverse Cardiovascular Events

Inform patients that RINVOQ may increase their risk of major adverse
cardiovascular events (MACE) including myocardial infarction, stroke, and
cardiovascular death. Instruct all patients, especially current or past smokers
or patients with other cardiovascular risk factors, to be alert for the
development of signs and symptoms of cardiovascular events.

The following information on important labeling revisions does not include all
changes; please refer to the RINVOQ full Prescribing Information.

Indications and Important Safety Information for RINVOQ (upadacitinib)1

Use


IMPORTANT SAFETY INFORMATION & INDICATIONS1


INDICATIONS1

RINVOQ is indicated for the treatment of:

 * Moderately to severely active rheumatoid arthritis in adults who have had an
   inadequate response or intolerance to one or more TNF blockers.
 * Active psoriatic arthritis in adults who have had an inadequate response or
   intolerance to one or more TNF blockers.

Limitations of Use: Use of RINVOQ in combination with other JAK inhibitors,
biologic DMARDs, or with potent immunosuppressants, such as azathioprine and
cyclosporine, is not recommended.

 * Refractory, moderate to severe atopic dermatitis in adults and pediatric
   patients 12 years of age and older whose disease is not adequately controlled
   with other systemic drug products, including biologics, or when use of those
   therapies are inadvisable.

Limitations of Use: RINVOQ is not recommended for use in combination with other
JAK inhibitors, biologic immunomodulators, or with other immunosuppressants.


IMPORTANT SAFETY INFORMATION


SERIOUS INFECTIONS

Patients treated with RINVOQ are at increased risk for developing serious
infections that may lead to hospitalization or death. Most patients who
developed these infections were taking concomitant immunosuppressants, such as
methotrexate or corticosteroids. If a serious infection develops, interrupt
RINVOQ until the infection is controlled.

Reported infections include:

 * Active tuberculosis (TB), which may present with pulmonary or extrapulmonary
   disease. Test patients for latent TB before RINVOQ use and during therapy.
   Consider treatment for latent TB infection prior to RINVOQ use.
 * Invasive fungal infections, including cryptococcosis and pneumocystosis.
 * Bacterial, viral, including herpes zoster, and other infections due to
   opportunistic pathogens.

Carefully consider the risks and benefits of treatment with RINVOQ prior to
initiating therapy in patients with chronic or recurrent infection. Monitor
patients closely for the development of signs and symptoms of infection during
and after treatment with RINVOQ, including the possible development of TB in
patients who tested negative for latent TB infection prior to initiating
therapy.


MORTALITY

In a large, randomized, postmarketing safety study comparing another Janus
kinase (JAK) inhibitor with tumor necrosis factor (TNF) blockers in rheumatoid
arthritis (RA) patients ≥50 years old with at least one cardiovascular (CV) risk
factor, a higher rate of all-cause mortality, including sudden CV death, was
observed with the JAK inhibitor. Consider the benefits and risks for the
individual patient prior to initiating or continuing therapy with RINVOQ.


MALIGNANCIES

Lymphoma and other malignancies have been observed in patients treated with
RINVOQ.

In a large, randomized, postmarketing safety study comparing another JAK
inhibitor with TNF blockers in RA patients, a higher rate of malignancies
(excluding non-melanoma skin cancer [NMSC]), lymphomas, and lung cancer (in
current or past smokers) was observed with the JAK inhibitor. Patients who are
current or past smokers are at additional increased risk.

With RINVOQ, consider the benefits and risks for the individual patient prior to
initiating or continuing therapy, particularly in patients with a known
malignancy (other than a successfully treated NMSC), patients who develop a
malignancy when on treatment, and patients who are current or past smokers.
NMSCs have been reported in patients treated with RINVOQ. Periodic skin
examination is recommended for patients who are at increased risk for skin
cancer. Advise patients to limit sunlight exposure by wearing protective
clothing and using sunscreen.


MAJOR ADVERSE CARDIOVASCULAR EVENTS

In a large, randomized, postmarketing study comparing another JAK inhibitor with
TNF blockers in RA patients ≥50 years old with at least one CV risk factor, a
higher rate of major adverse cardiovascular events (MACE) (defined as
cardiovascular death, myocardial infarction, and stroke) was observed with the
JAK inhibitor. Patients who are current or past smokers are at additional
increased risk. Discontinue RINVOQ in patients that have experienced a
myocardial infarction or stroke.

Consider the benefits and risks for the individual patient prior to initiating
or continuing therapy with RINVOQ, particularly in patients who are current or
past smokers and patients with other CV risk factors. Patients should be
informed about the symptoms of serious CV events and the steps to take if they
occur.


THROMBOSIS

Thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial
thrombosis have occurred in patients treated with JAK inhibitors used to treat
inflammatory conditions. Many of these adverse events were serious and some
resulted in death.

In a large, randomized, postmarketing study comparing another JAK inhibitor to
TNF blockers in RA patients ≥50 years old with at least one CV risk factor, a
higher rate of thrombosis was observed with the JAK inhibitor. Avoid RINVOQ in
patients at risk. Patients with symptoms of thrombosis should discontinue RINVOQ
and be promptly evaluated.


HYPERSENSITIVITY

RINVOQ is contraindicated in patients with known hypersensitivity to
upadacitinib or any of its excipients. Serious hypersensitivity reactions, such
as anaphylaxis and angioedema, were reported in patients receiving RINVOQ in
clinical trials. If a clinically significant hypersensitivity reaction occurs,
discontinue RINVOQ and institute appropriate therapy.


GASTROINTESTINAL PERFORATIONS

Gastrointestinal (GI) perforations have been reported in clinical trials with
RINVOQ. In these trials, many patients with RA were receiving background therapy
with nonsteroidal anti-inflammatory drugs (NSAIDs). Monitor RINVOQ-treated
patients who may be at risk for gastrointestinal perforation (e.g., patients
with a history of diverticulitis or taking NSAIDs). Promptly evaluate patients
presenting with new onset abdominal pain for early identification of GI
perforation.


LABORATORY ABNORMALITIES

Neutropenia

Treatment with RINVOQ was associated with an increased incidence of neutropenia
(absolute neutrophil count [ANC] <1000 cells/mm3). Treatment with RINVOQ is not
recommended in patients with an ANC <1000 cells/mm3. Evaluate neutrophil counts
at baseline and thereafter according to routine patient management.

Lymphopenia

Absolute lymphocyte counts (ALC) <500 cells/mm3 were reported in RINVOQ clinical
studies. Treatment with RINVOQ is not recommended in patients with an ALC <500
cells/mm3. Evaluate at baseline and thereafter according to routine patient
management.

Anemia

Decreases in hemoglobin levels to <8 g/dL were reported in RINVOQ clinical
studies. Treatment should not be initiated or should be interrupted in patients
with hemoglobin levels <8 g/dL. Evaluate at baseline and thereafter according to
routine patient management.

Lipids

Treatment with RINVOQ was associated with increases in lipid parameters,
including total cholesterol, low-density lipoprotein (LDL) cholesterol, and
high-density lipoprotein (HDL) cholesterol. Manage patients according to
clinical guidelines for the management of hyperlipidemia. Evaluate patients 12
weeks after initiation of treatment and thereafter according to the clinical
guidelines for hyperlipidemia.

Liver enzyme elevations

Treatment with RINVOQ was associated with increased incidence of liver enzyme
elevation compared to placebo. Evaluate at baseline and thereafter according to
routine patient management. Prompt investigation of the cause of liver enzyme
elevation is recommended to identify potential cases of drug-induced liver
injury. If increases in aspartate aminotransferase (AST) or alanine
aminotransferase (ALT) are observed during routine patient management and
drug-induced liver injury is suspected, RINVOQ should be interrupted until this
diagnosis is excluded.


EMBRYO-FETAL TOXICITY

Based on findings in animal studies, RINVOQ may cause fetal harm when
administered to a pregnant woman. Advise pregnant women of the potential risk to
a fetus. Advise females of reproductive potential to use effective contraception
during treatment with RINVOQ and for 4 weeks after the final dose. Verify
pregnancy status of females of reproductive potential prior to starting
treatment with RINVOQ.


VACCINATION

Avoid use of live vaccines during, or immediately prior to, RINVOQ therapy.
Prior to initiating RINVOQ, patients should be brought up to date on all
immunizations, including varicella zoster or prophylactic herpes zoster
vaccinations, in agreement with current immunization guidelines.


LACTATION

There are no data on the presence of RINVOQ in human milk, the effects on the
breastfed infant, or the effects on milk production. Available data in animals
have shown the excretion of RINVOQ in milk. Advise patients that breastfeeding
is not recommended during treatment with RINVOQ and for 6 days after the last
dose.


HEPATIC IMPAIRMENT

RINVOQ is not recommended for use in patients with severe hepatic impairment.


ADVERSE REACTIONS

The most common adverse reactions in RINVOQ clinical trials (≥1%) were upper
respiratory tract infections, herpes zoster, herpes simplex, bronchitis, nausea,
cough, pyrexia, acne, headache, blood creatine phosphokinase increased,
hypersensitivity, folliculitis, abdominal pain, increased weight, influenza,
fatigue, neutropenia, myalgia, and influenza-like illness.

Inform patients that retinal detachment has been reported in clinical trials
with RINVOQ. Advise patients to immediately inform their healthcare provider if
they develop any sudden changes in vision while receiving RINVOQ.

Dosage Forms and Strengths: RINVOQ is available in 15 mg and 30 mg
extended-release tablets.

US-RNQ-210031

Please see full Prescribing Information.

Reference: 1. RINVOQ [package insert]. North Chicago, IL: AbbVie Inc.

US-RNQD-210561




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or any further links from such site. AbbVie is providing these links to you only
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US-RNQR-200716

IMPORTANT SAFETY INFORMATION & INDICATIONS FOR HUMIRA® (ADALIMUMAB)1

INDICATIONS1

Rheumatoid Arthritis: HUMIRA is indicated, alone or in combination with
methotrexate or other non-biologic DMARDs, for reducing signs and symptoms,
inducing major clinical response, inhibiting the progression of structural
damage, and improving physical function in adult patients with moderately to
severely active rheumatoid arthritis.

Psoriatic Arthritis: HUMIRA is indicated, alone or in combination with
non-biologic DMARDs, for reducing signs and symptoms, inhibiting the progression
of structural damage, and improving physical function in adult patients with
active psoriatic arthritis.

IMPORTANT SAFETY INFORMATION1

SERIOUS INFECTIONS

Patients treated with HUMIRA are at increased risk for developing serious
infections that may lead to hospitalization or death. Most patients who
developed these infections were taking concomitant immunosuppressants such as
methotrexate or corticosteroids.

Discontinue HUMIRA if a patient develops a serious infection or sepsis.

Reported infections include:

 * Active tuberculosis (TB), including reactivation of latent TB. Patients with
   TB have frequently presented with disseminated or extrapulmonary disease.
   Test patients for latent TB before HUMIRA use and during therapy. Initiate
   treatment for latent TB prior to HUMIRA use.
 * Invasive fungal infections, including histoplasmosis, coccidioidomycosis,
   candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with
   histoplasmosis or other invasive fungal infections may present with
   disseminated, rather than localized, disease. Antigen and antibody testing
   for histoplasmosis may be negative in some patients with active infection.
   Consider empiric anti-fungal therapy in patients at risk for invasive fungal
   infections who develop severe systemic illness.
 * Bacterial, viral, and other infections due to opportunistic pathogens,
   including Legionella and Listeria.

Carefully consider the risks and benefits of treatment with HUMIRA prior to
initiating therapy in patients: 1. with chronic or recurrent infection, 2. who
have been exposed to TB, 3. with a history of opportunistic infection, 4. who
resided in or traveled in regions where mycoses are endemic, 5. with underlying
conditions that may predispose them to infection. Monitor patients closely for
the development of signs and symptoms of infection during and after treatment
with HUMIRA, including the possible development of TB in patients who tested
negative for latent TB infection prior to initiating therapy.

 * Do not start HUMIRA during an active infection, including localized
   infections.
 * Patients older than 65 years, patients with co-morbid conditions, and/or
   patients taking concomitant immunosuppressants may be at greater risk of
   infection.
 * If an infection develops, monitor carefully and initiate appropriate therapy.
 * Drug interactions with biologic products: A higher rate of serious infections
   has been observed in RA patients treated with rituximab who received
   subsequent treatment with a TNF blocker. An increased risk of serious
   infections has been seen with the combination of TNF blockers with anakinra
   or abatacept, with no demonstrated added benefit in patients with RA.
   Concomitant administration of HUMIRA with other biologic DMARDs (e.g.,
   anakinra or abatacept) or other TNF blockers is not recommended based on the
   possible increased risk for infections and other potential pharmacological
   interactions.

MALIGNANCY

Lymphoma and other malignancies, some fatal, have been reported in children and
adolescent patients treated with TNF blockers, including HUMIRA. Postmarketing
cases of hepatosplenic T‑cell lymphoma (HSTCL), a rare type of T‑cell lymphoma,
have been reported in patients treated with TNF blockers, including HUMIRA.
These cases have had a very aggressive disease course and have been fatal. The
majority of reported TNF blocker cases have occurred in patients with Crohn's
disease or ulcerative colitis and the majority were in adolescent and young
adult males. Almost all of these patients had received treatment with
azathioprine or 6‑mercaptopurine concomitantly with a TNF blocker at or prior to
diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of
a TNF blocker or a TNF blocker in combination with these other
immunosuppressants.

 * Consider the risks and benefits of HUMIRA treatment prior to initiating or
   continuing therapy in a patient with known malignancy.
 * In clinical trials, more cases of malignancies were observed among
   HUMIRA-treated patients compared to control patients.
 * Non-melanoma skin cancer (NMSC) was reported during clinical trials for
   HUMIRA-treated patients. Examine all patients, particularly those with a
   history of prolonged immunosuppressant or PUVA therapy, for the presence of
   NMSC prior to and during treatment with HUMIRA.
 * In HUMIRA clinical trials, there was an approximate 3-fold higher rate of
   lymphoma than expected in the general U.S. population. Patients with chronic
   inflammatory diseases, particularly those with highly active disease and/or
   chronic exposure to immunosuppressant therapies, may be at higher risk of
   lymphoma than the general population, even in the absence of TNF blockers.
 * Postmarketing cases of acute and chronic leukemia were reported with TNF
   blocker use. Approximately half of the postmarketing cases of malignancies in
   children, adolescents, and young adults receiving TNF blockers were
   lymphomas; other cases included rare malignancies associated with
   immunosuppression and malignancies not usually observed in children and
   adolescents.

HYPERSENSITIVITY

 * Anaphylaxis and angioneurotic edema have been reported following HUMIRA
   administration. If a serious allergic reaction occurs, stop HUMIRA and
   institute appropriate therapy.

HEPATITIS B VIRUS REACTIVATION

 * Use of TNF blockers, including HUMIRA, may increase the risk of reactivation
   of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases
   have been fatal.
 * Evaluate patients at risk for HBV infection for prior evidence of HBV
   infection before initiating TNF blocker therapy.
 * Exercise caution in patients who are carriers of HBV and monitor them during
   and after HUMIRA treatment.
 * Discontinue HUMIRA and begin antiviral therapy in patients who develop HBV
   reactivation. Exercise caution when resuming HUMIRA after HBV treatment.

NEUROLOGIC REACTIONS

 * TNF blockers, including HUMIRA, have been associated with rare cases of new
   onset or exacerbation of central nervous system and peripheral demyelinating
   diseases, including multiple sclerosis, optic neuritis, and Guillain‑Barré
   syndrome.
 * Exercise caution when considering HUMIRA for patients with these disorders;
   discontinuation of HUMIRA should be considered if any of these disorders
   develop.
 * There is a known association between intermediate uveitis and central
   demyelinating disorders.

HEMATOLOGIC REACTIONS

 * Rare reports of pancytopenia, including aplastic anemia, have been reported
   with TNF blockers. Medically significant cytopenia has been infrequently
   reported with HUMIRA.
 * Consider stopping HUMIRA if significant hematologic abnormalities occur.

CONGESTIVE HEART FAILURE

 * Worsening and new onset congestive heart failure (CHF) has been reported with
   TNF blockers. Cases of worsening CHF have been observed with HUMIRA; exercise
   caution and monitor carefully.

AUTOIMMUNITY

 * Treatment with HUMIRA may result in the formation of autoantibodies and,
   rarely, in development of a lupus-like syndrome. Discontinue treatment if
   symptoms of a lupus-like syndrome develop.

IMMUNIZATIONS

 * Patients on HUMIRA should not receive live vaccines.
 * Pediatric patients, if possible, should be brought up to date with all
   immunizations before initiating HUMIRA therapy.
 * Adalimumab is actively transferred across the placenta during the third
   trimester of pregnancy and may affect immune response in the in utero exposed
   infant. The safety of administering live or live-attenuated vaccines in
   infants exposed to HUMIRA in utero is unknown. Risks and benefits should be
   considered prior to vaccinating (live or live‑attenuated) exposed infants.

ADVERSE REACTIONS

 * The most common adverse reactions in HUMIRA clinical trials (>10%) were:
   infections (e.g., upper respiratory, sinusitis), injection site reactions,
   headache, and rash.

Please see full

Prescribing Information.

Reference: 1. HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc.

US-MULT-211444




INDICATIONS & LIMITATION OF USE1

RINVOQ is indicated for the treatment of:

 * Moderately to severely active rheumatoid arthritis in adults who have had an
   inadequate response or intolerance to one or more
   TNF blockers.
 * Active psoriatic arthritis in adults who have had an inadequate response or
   intolerance to one or more TNF blockers.


IMPORTANT SAFETY INFORMATION1

WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCIES, MAJOR ADVERSE
CARDIOVASCULAR EVENTS, AND THROMBOSIS

SERIOUS INFECTIONS

Patients treated with RINVOQ are at increased risk for developing serious
infections that may lead to hospitalization or death. Most patients who
developed these infections were taking concomitant


IMPORTANT SAFETY INFORMATION1

WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCIES, MAJOR ADVERSE
CARDIOVASCULAR EVENTS, AND THROMBOSIS

SERIOUS INFECTIONS

Patients treated with RINVOQ are at increased risk for developing serious
infections that may lead to hospitalization or death. Most patients who
developed these infections were taking concomitant


INDICATIONS & LIMITATION OF USE1

RINVOQ is indicated for the treatment of:

 * Moderately to severely active rheumatoid arthritis in adults who have had an
   inadequate response or intolerance to one or more
   TNF blockers.
 * Active psoriatic arthritis in adults who have had an inadequate response or
   intolerance to one or more TNF blockers.


IMPORTANT SAFETY INFORMATION1

WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCIES, MAJOR ADVERSE
CARDIOVASCULAR EVENTS, AND THROMBOSIS

SERIOUS INFECTIONS

Patients treated with RINVOQ are at increased risk for developing serious
infections that may lead to hospitalization or death. Most patients who
developed these infections were taking concomitant


IMPORTANT SAFETY INFORMATION1

WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCIES, MAJOR ADVERSE
CARDIOVASCULAR EVENTS, AND THROMBOSIS

SERIOUS INFECTIONS

Patients treated with RINVOQ are at increased risk for developing serious
infections that may lead to hospitalization or death. Most patients who
developed these infections were taking concomitant


IMPORTANT SAFETY INFORMATION & INDICATIONS1


INDICATIONS1

RINVOQ is indicated for the treatment of:

 * Moderately to severely active rheumatoid arthritis in adults who have had an
   inadequate response or intolerance to one or more TNF blockers.
 * Active psoriatic arthritis in adults who have had an inadequate response or
   intolerance to one or more TNF blockers.

Limitation of Use: Use of RINVOQ in combination with other JAK inhibitors,
biologic DMARDs, or with potent immunosuppressants, such as azathioprine and
cyclosporine, is not recommended.


IMPORTANT SAFETY INFORMATION


SERIOUS INFECTIONS

Patients treated with RINVOQ are at increased risk for developing serious
infections that may lead to hospitalization or death. Most patients who
developed these infections were taking concomitant immunosuppressants, such as
methotrexate or corticosteroids. If a serious infection develops, interrupt
RINVOQ until the infection is controlled.

Reported infections include:

 * Active tuberculosis (TB), which may present with pulmonary or extrapulmonary
   disease. Test patients for latent TB before RINVOQ use and during therapy.
   Consider treatment for latent TB infection prior to RINVOQ use.
 * Invasive fungal infections, including cryptococcosis and pneumocystosis.
 * Bacterial, viral, including herpes zoster, and other infections due to
   opportunistic pathogens.

Carefully consider the risks and benefits of treatment with RINVOQ prior to
initiating therapy in patients with chronic or recurrent infection. Monitor
patients closely for the development of signs and symptoms of infection during
and after treatment with RINVOQ, including the possible development of TB in
patients who tested negative for latent TB infection prior to initiating
therapy.


MORTALITY

In a large, randomized, postmarketing safety study comparing another Janus
kinase (JAK) inhibitor with tumor necrosis factor (TNF) blockers in rheumatoid
arthritis (RA) patients ≥50 years old with at least one cardiovascular (CV) risk
factor, a higher rate of all-cause mortality, including sudden CV death, was
observed with the JAK inhibitor. Consider the benefits and risks for the
individual patient prior to initiating or continuing therapy with RINVOQ.


MALIGNANCIES

Lymphoma and other malignancies have been observed in patients treated with
RINVOQ.

In a large, randomized, postmarketing safety study comparing another JAK
inhibitor with TNF blockers in RA patients, a higher rate of malignancies
(excluding non-melanoma skin cancer [NMSC]), lymphomas, and lung cancer (in
current or past smokers) was observed with the JAK inhibitor. Patients who are
current or past smokers are at additional increased risk.

With RINVOQ, consider the benefits and risks for the individual patient prior to
initiating or continuing therapy, particularly in patients with a known
malignancy (other than a successfully treated NMSC), patients who develop a
malignancy when on treatment, and patients who are current or past smokers.
NMSCs have been reported in patients treated with RINVOQ. Periodic skin
examination is recommended for patients who are at increased risk for skin
cancer. Advise patients to limit sunlight exposure by wearing protective
clothing and using sunscreen.


MAJOR ADVERSE CARDIOVASCULAR EVENTS

In a large, randomized, postmarketing study comparing another JAK inhibitor with
TNF blockers in RA patients ≥50 years old with at least one CV risk factor, a
higher rate of major adverse cardiovascular events (MACE) (defined as
cardiovascular death, myocardial infarction, and stroke) was observed with the
JAK inhibitor. Patients who are current or past smokers are at additional
increased risk. Discontinue RINVOQ in patients that have experienced a
myocardial infarction or stroke.

Consider the benefits and risks for the individual patient prior to initiating
or continuing therapy with RINVOQ, particularly in patients who are current or
past smokers and patients with other CV risk factors. Patients should be
informed about the symptoms of serious CV events and the steps to take if they
occur.


THROMBOSIS

Thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial
thrombosis have occurred in patients treated with JAK inhibitors used to treat
inflammatory conditions. Many of these adverse events were serious and some
resulted in death.

In a large, randomized, postmarketing study comparing another JAK inhibitor to
TNF blockers in RA patients ≥50 years old with at least one CV risk factor, a
higher rate of thrombosis was observed with the JAK inhibitor. Avoid RINVOQ in
patients at risk. Patients with symptoms of thrombosis should discontinue RINVOQ
and be promptly evaluated.


HYPERSENSITIVITY

RINVOQ is contraindicated in patients with known hypersensitivity to
upadacitinib or any of its excipients. Serious hypersensitivity reactions, such
as anaphylaxis and angioedema, were reported in patients receiving RINVOQ in
clinical trials. If a clinically significant hypersensitivity reaction occurs,
discontinue RINVOQ and institute appropriate therapy.


GASTROINTESTINAL PERFORATIONS

Gastrointestinal (GI) perforations have been reported in clinical trials with
RINVOQ. In these trials, many patients with RA were receiving background therapy
with nonsteroidal anti-inflammatory drugs (NSAIDs). Monitor RINVOQ-treated
patients who may be at risk for gastrointestinal perforation (e.g., patients
with a history of diverticulitis or taking NSAIDs). Promptly evaluate patients
presenting with new onset abdominal pain for early identification of GI
perforation.


LABORATORY ABNORMALITIES

Neutropenia

Treatment with RINVOQ was associated with an increased incidence of neutropenia
(absolute neutrophil count [ANC] <1000 cells/mm3). Treatment with RINVOQ is not
recommended in patients with an ANC <1000 cells/mm3. Evaluate neutrophil counts
at baseline and thereafter according to routine patient management.

Lymphopenia

Absolute lymphocyte counts (ALC) <500 cells/mm3 were reported in RINVOQ clinical
studies. Treatment with RINVOQ is not recommended in patients with an ALC <500
cells/mm3. Evaluate at baseline and thereafter according to routine patient
management.

Anemia

Decreases in hemoglobin levels to <8 g/dL were reported in RINVOQ clinical
studies. Treatment should not be initiated or should be interrupted in patients
with hemoglobin levels <8 g/dL. Evaluate at baseline and thereafter according to
routine patient management.

Lipids

Treatment with RINVOQ was associated with increases in lipid parameters,
including total cholesterol, low-density lipoprotein (LDL) cholesterol, and
high-density lipoprotein (HDL) cholesterol. Manage patients according to
clinical guidelines for the management of hyperlipidemia. Evaluate patients 12
weeks after initiation of treatment and thereafter according to the clinical
guidelines for hyperlipidemia.

Liver enzyme elevations

Treatment with RINVOQ was associated with increased incidence of liver enzyme
elevation compared to placebo. Evaluate at baseline and thereafter according to
routine patient management. Prompt investigation of the cause of liver enzyme
elevation is recommended to identify potential cases of drug-induced liver
injury. If increases in aspartate aminotransferase (AST) or alanine
aminotransferase (ALT) are observed during routine patient management and
drug-induced liver injury is suspected, RINVOQ should be interrupted until this
diagnosis is excluded.


EMBRYO-FETAL TOXICITY

Based on findings in animal studies, RINVOQ may cause fetal harm when
administered to a pregnant woman. Advise pregnant women of the potential risk to
a fetus. Advise females of reproductive potential to use effective contraception
during treatment with RINVOQ and for 4 weeks after the final dose. Verify
pregnancy status of females of reproductive potential prior to starting
treatment with RINVOQ.


VACCINATION

Avoid use of live vaccines during, or immediately prior to, RINVOQ therapy.
Prior to initiating RINVOQ, patients should be brought up to date on all
immunizations, including varicella zoster or prophylactic herpes zoster
vaccinations, in agreement with current immunization guidelines.


LACTATION

There are no data on the presence of RINVOQ in human milk, the effects on the
breastfed infant, or the effects on milk production. Available data in animals
have shown the excretion of RINVOQ in milk. Advise patients that breastfeeding
is not recommended during treatment with RINVOQ and for 6 days after the last
dose.


HEPATIC IMPAIRMENT

RINVOQ is not recommended for use in patients with severe hepatic impairment.


ADVERSE REACTIONS

The most common adverse reactions in RINVOQ clinical trials (≥1%) were upper
respiratory tract infections, herpes zoster, herpes simplex, bronchitis, nausea,
cough, pyrexia, acne, headache, blood creatine phosphokinase increased,
hypersensitivity, folliculitis, abdominal pain, increased weight, influenza,
fatigue, neutropenia, myalgia, and influenza-like illness.

Inform patients that retinal detachment has been reported in clinical trials
with RINVOQ. Advise patients to immediately inform their healthcare provider if
they develop any sudden changes in vision while receiving RINVOQ.

Dosage Forms and Strengths: RINVOQ is available in 15 mg and 30 mg
extended-release tablets.

US-RNQ-210031

Please see full Prescribing Information.