Withdrawal of immunosuppressants and low-dose steroids in patients with stable IgG4-RD (WInS IgG4-RD): an investigator-initiated, multicentre, open-label, randomised controlled trial
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Published:2024-01-12
Issue:
Volume:
Page:ard-2023-224487
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ISSN:0003-4967
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Container-title:Annals of the Rheumatic Diseases
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language:en
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Short-container-title:Ann Rheum Dis
Author:
Peng LinyiORCID,
Nie YuxueORCID,
Zhou Jiaxin,
Wu Lijun,
Chen Xiaomei,
Wang Fang,
Li Jieqiong,
Peng Yu,
Lu Hui,
Zhao Lidan,
Li MengtaoORCID,
Zhao Yan,
Zeng Xiaofeng,
Fei YunyunORCID,
Zhang WenORCID
Abstract
ObjectivesIgG4-related disease (IgG4-RD) is an immune-mediated, fibroinflammatory disease. Induction treatment with glucocorticoid (GC) is usually effective, but its tendency of relapse makes the strategy for maintenance treatment a challenge. The WInS IgG4-RD (withdraw immunosuppressants (IMs) and steroid in stable IgG4-RD) trial tested whether discontinuation of GC and IM was feasible in stable IgG4-RD.MethodsThe WInS IgG4-RD trial was a multicentre, open-label, randomised controlled trial. Patients with IgG4-RD receiving GC+IM as maintenance treatment with clinically quiescent disease for at least 12 months were randomised (1:1:1) into three groups: group 1: withdraw GC+IM; group 2: withdraw GC but maintain IM; group 3: maintain GC+IM. The primary outcome was the relapse rate of disease within 18 months. The secondary outcomes included the changes of IgG4-RD Responder Index (RI), Physician’s Global Assessment (PGA), serum IgG4 and IgG, as well as adverse events.ResultsOne hundred and forty-six patients were randomised, with 48 patients in group 1, 49 patients in group 2 and group 3, respectively. Within the 18-month follow-up period, disease relapse occurred in 25 out of 48 (52.1%) patients in group 1 vs 7 out of 49 (14.2%) in group 2 and 6 out of 49 (12.2%) in group 3 (p<0.001). The changes in RI and PGA were significantly higher in group 1 than in group 2 (p<0.001) or group 3 (p<0.001).ConclusionsThe maintenance of IMs, with or without low-dose GC, was found to be superior to withdraw GC+IM in preventing relapse for long-time stable IgG4-RD.Trial registration numberNCT04124861.
Funder
CAMS Innovation Fund for Medical Sciences
Research and Development Program of China
Beijing Municipal Science & Technology Commission
Capital’s Funds for Health Improvement and Research
National Natural Science Foundation of China
National High Level Hospital
Subject
General Biochemistry, Genetics and Molecular Biology,Immunology,Immunology and Allergy,Rheumatology