β-Cell Function and Diabetes Outcomes 1 Year After Stopping Oral Baricitinib Immunotherapy for Type 1 Diabetes
OBJECTIVE: The Baricitinib in New-Onset Type 1 Diabetes (BANDIT) trial showed that baricitinib treatment for 48 weeks preserved β-cell function and lowered insulin requirements and glucose in recent-onset type 1 diabetes. We aimed to determine the durability of these effects following treatment cessation. RESEARCH DESIGN AND METHODS: The following posttreatment outcomes of the randomized, double-blind, placebo-controlled BANDIT trial were analyzed: C-peptide and glucagon responses to a mixed meal, HbA1c, continuous glucose monitoring (CGM) measures, CD8+ T-cell phenotype and function, and adverse events. RESULTS: Of 91 randomized participants, 88 (58 baricitinib and 30 placebo) completed the week 96 follow-up. Mean ± SEM C-peptide was significantly greater in baricitinib-treated participants at week 72 (0.54 ± 0.05 vs. 0.38 ± 0.06 pmol/mL; P = 0.015) but not at week 96 (0.43 ± 0.05 vs. 0.35 ± 0.06 nmol/L; P = 0.336). No significant between-group differences in insulin dose, HbA1c, or CGM measures were observed during follow-up. Post hoc comparisons showed that when the study drug was ceased at week 48, baricitinib-treated adults (n = 28) experienced full preservation of β-cell function whereas C-peptide decreased relative to baseline by 0.09 pmol/mL in baricitinib-treated children (n = 32; P = 0.022). Baricitinib did not resolve paradoxical glucagon increase after a mixed meal. Decreased frequency and cytokine signaling of effector memory CD8+ T cells observed at week 48 resolved by week 96. CONCLUSIONS: The benefits of oral baricitinib in type 1 diabetes wane over 48 weeks following treatment cessation. Durable benefit is likely to require continuous treatment.
Authors
- Thomas W. H. Kay (ORCID: https://orcid.org/0000-0002-7273-2556)
- Alexandra Gorelik (ORCID: https://orcid.org/0000-0003-1032-0457)
- Jessica E. Harbison (ORCID: https://orcid.org/0000-0002-1438-598X)
- Felicity Healy
- Gabby Atlas (ORCID: https://orcid.org/0000-0001-7705-7425)
- Tom Brodnicki
- Jennifer Couper
- Renee Kludas
- Jane Keenan
- Maria Craig
- John M. Wentworth (ORCID: https://orcid.org/0000-0002-5197-3529)
- Len Harrison
- Bala Krishnamurthy
- Michelle So (ORCID: https://orcid.org/0000-0001-5411-3711)
- Kirsty Herewane
- Candice Hall
- Laura Sanz‐Villanueva (ORCID: https://orcid.org/0000-0003-3318-4224)
- Balasubramanian Krishnamurthy (ORCID: https://orcid.org/0000-0003-4735-2540)
- Stephan Mynhardt
- Sarah Lee (ORCID: https://orcid.org/0000-0002-7681-3441)
- Wing Fai Nip
- John Wentworth
- Fergus Cameron
- Kate Murphy
- Peter Colman
- Moses Mwangi
- Thomas Kay
- Tara Catterall
- Richard MacIsaac
- Joe Sasadeusz
- Dao Hoa Anh Huynh
- Rebecca Gebert
- Jessica Harbison
- Peter G. Colman
- Madeleine Hall
- Vicky Gonzalez
- Richard J. MacIsaac
- Madeleine Masterton
- Anouk Koopman-Daemen
- Sara Vogrin
- Michaela Waibel
- Katherine Woods
- Leanne Redl
- Mandy Anderson
- Stuart Mannering
- Elizabeth Mulrooney
- Helen E. Thomas
- Baricitinib in New-Onset Type 1 Diabetes (BANDIT) Study Group:
- Lisa Kuspira
- Leonard C. Harrison
- Nicole Kruger
- Jennifer J. Couper
- Prerak Trivedi
- Madeleine Doyle
- Fergus J. Cameron
- Sara Litwak
Institutions
- The Royal Melbourne Hospital (AU)
- Royal Children's Hospital (AU)
- The University of Melbourne (AU)
- Walter and Eliza Hall Institute of Medical Research (AU)
- Women's and Children's Hospital (AU)
- UNSW Sydney (AU)
- St Vincent's Hospital Melbourne (AU)
- Murdoch Children's Research Institute (AU)
- Monash University (AU)
- The University of Adelaide (AU)
- St Vincents Institute of Medical Research (AU)
Publication Details
- Journal
- Diabetes Care
- Published
- 2026-08-21
- DOI
- https://doi.org/10.2337/dc26-1072
- Primary Topic
- Diabetes and associated disorders
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- Juvenile Diabetes Research Foundation Australia
- Department of Health and Aged Care, Australian Government
- Medical Research Future Fund