Vasculitis & polymyalgia rheumatica
Efficacy and safety of infliximab or adalimumab in severe mucocutaneous Behçet's syndrome refractory to traditional immunosuppressants: a 6-month, multicentre, randomised controlled, prospective, parallel group, single-blind trial
Authors' conclusion
The overall results of this study confirm the effectiveness of both IFX and ADA in achieving remission in patients with BS affected by mucocutaneous involvement.
Study context
- Population
- Adults with BD with active mucocutaneous manifestations while on azathioprine or cyclosporine for at least 3 months42 screened
- Participants
- 40 adults
- Comparison
- Infliximab (IFX) vs ADA for 6 months
- IFXn = 22
- ADAn = 18reference
- Primary endpoint
- Time to response of manifestations over 6-month anti-TNF treatment
- Follow-up
- 6 months
Methodological detailsphase 3, multicentre, prospective, active-controlled, parallel-group, single-blind
- Phase 3
- Multicentre
- Prospective
- Active-controlled
- Parallel-group
- Single-blind
Primary result
As reported in the abstract
Responders
Further findings
Retention on treatment
Quality of life and Behçet's Disease Current Activity Form
- Significantly improved from baseline in both groups
Safety
Events
| Outcome | IFX | ADA |
|---|---|---|
| Adverse eventsADA: one serious · IFX: all non-serious | 3 | 2 |
Original publication
Efficacy and safety of infliximab or adalimumab in severe mucocutaneous Behçet's syndrome refractory to traditional immunosuppressants: a 6-month, multicentre, randomised controlled, prospective, parallel group, single-blind trial. Ann Rheum Dis. Published 17 October 2024. doi:10.
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