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Late-Breaking Abstract Session

Session: Late-Breaking Abstracts (L15–L20)

L16: Withdrawal of Immunosuppressant and Low-dose Steroids in IgG4-RD Patients with Stable Disease (WInS IgG4-RD): An Investigator-initiated, Multi-center, Open-label, Randomized Controlled Trial

Wednesday, November 15, 2023
7:45 AM – 8:00 AM PT
Location: Room 6A-B
In Person Livestreamed On Demand

    Presenting Author(s)

  • LP

    Linyi Peng, n/a (she/her/hers)

    Peking Union Medical College Hospital，Department of Rheumatology and Clinical Immunology, National Clinical Research Center for Dermatologic and Immunologic Diseases, State Key Laboratory of Complex Severe and Rare Diseases
    Beijing, Beijing, China (People's Republic)

    Disclosure information not submitted.

Linyi Peng1, Yuxue nie1, Jiaxin Zhou1, Lijun Wu2, Fang Wang3, Xiaomei Chen4, Jieqiong Li1, Yu Peng1, Hui Lu1, Lidan Zhao1, Mengtao Li1, Yan Zhao1, Xiaofeng Zeng5, Yunyun Fei1 and Wen Zhang1, 1Peking Union Medical College Hospital，Department of Rheumatology and Clinical Immunology, National Clinical Research Center for Dermatologic and Immunologic Diseases, State Key Laboratory of Complex Severe and Rare Diseases, Beijing, China, 2Xinjiang Uygur Autonomous Region People's Hospital, XinJiang, China, 3Beijing Hospital, Beijing, China, 4Xinjiang Uygur Autonomous Region People's Hospital, Wulumuqi, China, 5Peking Union Medical College Hospital, Chinese Academy of Medical Science & Peking Union Medical College, Beijing, China

Background/Purpose: IgG4-related disease (IgG4-RD) is a fibroinflammatory disease. Remission induction treatment with glucocorticoid (GC) is usually effective, but its tendency of relapse makes the strategy for maintenance treatment a challenge. TheWInS IgG4-RD (withdraw immunosuppressants and steroid in stable IgG4-RD) trial tested whether discontinuation of GC and immunosuppressive agent (IM) were feasible in stable IgG4-RD.

Methods: The WInS IgG4-RD trial was a multicentre, open-label, randomised controlled trial. IgG4-RD patients receiving GC+IM as maintenance treatment with clinically quiescent disease for at least 12 months were randomised (1:1:1) into three groups: (1) Group 1: withdraw GC+IM; (2) Group 2: withdraw GC but maintain IM; (3) Group 3: maintain GC+IM. The primary endpoint was the relapse rate of disease within 18 months. The secondary endpoints include the changes of responder index (RI), physician's global assessment (PGA), serum IgG4 and IgG, as well as adverse events.

Results: One hundred and forty-six patients were randomised, with 48 patients in Group 1, and 49 patients in Group 2 and Group 3 respectively. Within the 18-month follow-up period, disease relapse occurred in 25/48 (52.1%) patients in Group 1 versus 7/49 (14.2%) in Group 2 and 6/49 (12.2%) in Group 3 (p< 0.001). The changes in RI and PGA were significantly higher in Group 1 than Group 2 (p< 0.001) or Group 3 (p< 0.001).

Conclusion: The 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.


Flowchart of WInS IgG4-RD study


The occurrence of relapse during follow-up is presented as a Kaplan-Meier curve of cumulative probability (Figure 2), where there were significant differences among the three groups by both ITT and PP analysis (both overall p<0.001).


Changes of IgG4(a), IgG (b), IgG4-RD RI (3c), PGA (figure 3d) at baseline of the study and the endpoints by intention-to-treat analysis. RI, Responder index; PGA, physician’s global assessment.


Withdrawal of Immunosuppressant and Low-dose Steroids in IgG4-RD Patients with Stable Disease (WInS IgG4-RD): An Investigator-initiated, Multi-center, Open-label, Randomized Controlled Trial

L. Peng: None; Y. nie: None; J. Zhou: None; L. Wu: None; F. Wang: None; X. Chen: None; J. Li: None; Y. Peng: None; H. Lu: None; L. Zhao: None; M. Li: None; Y. Zhao: None; X. Zeng: None; Y. Fei: None; W. Zhang: None.