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Original ArticleFree Preview


BARICITINIB AND Β-CELL FUNCTION IN PATIENTS WITH NEW-ONSET TYPE 1 DIABETES

List of authors.
 * Michaela Waibel, Ph.D.,
 * John M. Wentworth, M.B., B.S., Ph.D.,
 * Michelle So, M.B., B.S., Ph.D.,
 * Jennifer J. Couper, M.D.,
 * Fergus J. Cameron, M.D.,
 * Richard J. MacIsaac, M.B., B.S., Ph.D.,
 * Gabby Atlas, M.B., B.S.,
 * Alexandra Gorelik, M.Sc.,
 * Sara Litwak, Ph.D.,
 * Laura Sanz-Villanueva, B.Sc.,
 * Prerak Trivedi, Ph.D.,
 * Simi Ahmed, Ph.D.,
 * Francis J. Martin, Ph.D.,
 * Madeleine E. Doyle, D.M.,
 * Jessica E. Harbison, M.B., B.S., Ph.D.,
 * Candice Hall, B.Sc.,
 * Balasubramanian Krishnamurthy, M.D.,
 * Peter G. Colman, M.D.,
 * Leonard C. Harrison, M.D., D.Sc.,
 * Helen E. Thomas, Ph.D.,
 * and Thomas W.H. Kay, M.B., B.S., Ph.D.
 * et al.,
 * for the BANDIT Study Group*

A list of investigators in the BANDIT Study Group is provided in the
Supplementary Appendix, available at NEJM.org.



Drs. Waibel, Wentworth, and So and Profs. Thomas and Kay contributed equally to
this article.



December 7, 2023
N Engl J Med 2023; 389:2140-2150
DOI: 10.1056/NEJMoa2306691


 * Related Articles


ABSTRACT


BACKGROUND

Janus kinase (JAK) inhibitors, including baricitinib, block cytokine signaling
and are effective disease-modifying treatments for several autoimmune diseases.
Whether baricitinib preserves β-cell function in type 1 diabetes is unclear.


METHODS

Download a PDF of the Research Summary.

In this phase 2, double-blind, randomized, placebo-controlled trial, we assigned
patients with type 1 diabetes diagnosed during the previous 100 days to receive
baricitinib (4 mg once per day) or matched placebo orally for 48 weeks. The
primary outcome was the mean C-peptide level, determined from the area under the
concentration–time curve, during a 2-hour mixed-meal tolerance test at week 48.
Secondary outcomes included the change from baseline in the glycated hemoglobin
level, the daily insulin dose, and measures of glycemic control assessed with
the use of continuous glucose monitoring.


RESULTS

A total of 91 patients received baricitinib (60 patients) or placebo (31
patients). The median of the mixed-meal–stimulated mean C-peptide level at week
48 was 0.65 nmol per liter per minute (interquartile range, 0.31 to 0.82) in the
baricitinib group and 0.43 nmol per liter per minute (interquartile range, 0.13
to 0.63) in the placebo group (P=0.001). The mean daily insulin dose at 48 weeks
was 0.41 U per kilogram of body weight per day (95% confidence interval [CI],
0.35 to 0.48) in the baricitinib group and 0.52 U per kilogram per day (95% CI,
0.44 to 0.60) in the placebo group. The levels of glycated hemoglobin were
similar in the two trial groups. However, the mean coefficient of variation of
the glucose level at 48 weeks, as measured by continuous glucose monitoring, was
29.6% (95% CI, 27.8 to 31.3) in the baricitinib group and 33.8% (95% CI, 31.5 to
36.2) in the placebo group. The frequency and severity of adverse events were
similar in the two trial groups, and no serious adverse events were attributed
to baricitinib or placebo.


CONCLUSIONS

In patients with type 1 diabetes of recent onset, daily treatment with
baricitinib over 48 weeks appeared to preserve β-cell function as estimated by
the mixed-meal–stimulated mean C-peptide level. (Funded by JDRF International
and others; BANDIT Australian New Zealand Clinical Trials Registry number,
ACTRN12620000239965. opens in new tab.)

QUICK TAKE VIDEO SUMMARY
Baricitinib and β-Cell Function in New-Onset Type 1 Diabetes
 02:13


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FUNDING AND DISCLOSURES

Supported by JDRF International and JDRF Australia; a grant (4-SRA-2020-912-M-B)
from the Australian Government Department of Health through the Emerging
Priorities and Consumer-Driven Research Initiative, part of the Medical Research
Future Fund; a grant (GNT1150425) from the National Health and Medical Research
Council of Australia; and St. Vincent’s Institute of Medical Research,
Australia. Philanthropic support was provided by the Romanes, Burgess, and
Yencken families. Dr. So is supported by the Djinda Foundation Rising Star
Fellowship. Infrastructure support has been provided to St. Vincent’s Institute
by the Victorian State Government Operational Infrastructure Support Program.

Disclosure forms provided by the authors are available with the full text of
this article at NEJM.org.

Drs. Waibel, Wentworth, and So and Profs. Thomas and Kay contributed equally to
this article.

This is the New England Journal of Medicine version of record, which includes
all Journal editing and enhancements. The Author Accepted Manuscript, which is
the author’s version after external peer review and before publication in the
Journal, is available at PubMed Central.

A data sharing statement provided by the authors is available with the full text
of this article at NEJM.org.

We thank the trial patients and their families; the study coordinators, nurses,
and support staff at the trial sites; AK Clinical Research for trial monitoring;
Resolutum Global for database set up and management; Tara Catterall, Evan
Pappas, and Katherine Woods for logistic activities and processing related to
mechanistic analyses and biobank samples; and Tom Brodnicki for administrative
support.


AUTHOR AFFILIATIONS

From St. Vincent’s Institute of Medical Research (M.W., M.S., S.L., L.S.-V.,
P.T., M.E.D., C.H., B.K., H.E.T., T.W.H.K.), St. Vincent’s Hospital Melbourne
(R.J.M., B.K., T.W.H.K.), and the Department of Medicine at St. Vincent’s
Hospital, University of Melbourne (R.J.M., L.S.-V., M.E.D., B.K., H.E.T.,
T.W.H.K.), Fitzroy, the Walter and Eliza Hall Institute of Medical Research
(J.M.W., P.G.C., L.C.H.), the Departments of Medical Biology (J.M.W., L.C.H.)
and Medicine (A.G.), University of Melbourne, the Royal Melbourne Hospital
(J.M.W., M.S., C.H., P.G.C., L.C.H.), the Royal Children’s Hospital (F.J.C.,
G.A.), and the Murdoch Children’s Research Institute (F.J.C.), Parkville, and
the School of Public Health and Preventive Medicine, Monash University,
Melbourne (A.G.), VIC, and Women’s and Children’s Hospital (J.J.C., J.E.H.) and
the University of Adelaide (J.J.C.), Adelaide, SA — all in Australia; the New
York Stem Cell Foundation, New York (S.A.); and Macromoltek, Austin, TX
(F.J.M.).

Prof. Kay can be contacted at tkay@svi.edu.au or at St. Vincent’s Institute of
Medical Research, 9 Princes St., Fitzroy VIC 3065, Australia.

A list of investigators in the BANDIT Study Group is provided in the
Supplementary Appendix, available at NEJM.org.



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December 7, 2023
N Engl J Med 2023; 389:2140-2150
DOI: 10.1056/NEJMoa2306691


Print Subscriber? Activate your online access.



Related Articles

 * EditorialDec 7, 2023
   Immune Interventions at Onset of Type 1 Diabetes — Finally, a Bit of Hope
   J. Ludvigsson
 * Original ArticleDec 7, 2023
   Teplizumab and β-Cell Function in Newly Diagnosed Type 1 Diabetes
   E.L. Ramos and Others

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CREATE NEW PASSWORD

We've sent an email with instructions to create a new password. Your existing
password has not been changed.

CLOSE

To reset your password, enter a new password twice and click the 'Reset
Password' button.

{* #changePasswordFormNoAuth *} {* newPassword *} {* newPasswordConfirm *}

{* /changePasswordFormNoAuth *}

Your password has been reset. You will need to sign in again using your new
password to access site content and features.



{* #resetPasswordForm *}
The link that you followed to reset your password has expired.

Enter the email address associated with your account then click Continue. We
will email you a link to a page where you can easily create a new password.

{* signInEmailAddress *}

{* /resetPasswordForm *}

If the address matches an existing account, you will receive an email with
instructions to reset your password.







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