Autoinflammatory & rare systemic diseases
Withdrawal of immunosuppressants and low-dose steroids in patients with stable igG4-related disease (IgG4-RD) (WInS IgG4-RD): an investigator-initiated, multicentre, open-label, randomised controlled trial
Authors' 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.
Study context
- Population
- Patients with IgG4-RD receiving glucocorticoid (GC)+IM as maintenance treatment with clinically quiescent disease for at least 12 months
- Participants
- 146 patients
- Comparison
- Withdraw GC+IM vs withdraw GC but maintain IM vs maintain GC+IM
- Group 1n = 48
- Group 2n = 49
- Group 3n = 49reference
- Primary endpoint
- Relapse rate of disease
- Follow-up
- 18 months
Methodological detailsinvestigator-initiated, multicentre, open-label
- Investigator-initiated
- Multicentre
- Open-label
Primary result
As reported in the abstract
Disease relapse
P < 0.001
Secondary outcomes
| Outcome | P value |
|---|---|
| Changes in IgG4-RD Responder Index (RI) and PGAGroup 1 vs Group 2 · significantly higher in group 1 | P < 0.001 |
| Changes in IgG4-RD Responder Index (RI) and PGAGroup 1 vs Group 3 · significantly higher in group 1 | P < 0.001 |
Original publication
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. Ann Rheum Dis. Published 11 April 2024. doi:10.
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