Vasculitis & polymyalgia rheumatica
Efficacy and safety of mufemilast in patients with Behçet’s syndrome: a phase 2 randomised clinical trial
Authors' conclusion
Among patients with oral ulcers associated with BS, mufemilast significantly reduced the number of oral ulcers, improved pain scores, and induced significantly more ulcer-free remissions compared with placebo, with an acceptable safety profile.
Study context
- Population
- Patients with BD (International Criteria for Behçet's Disease 2013) and active oral ulcers
- Participants
- 90 patients
- Comparison
- Mufemilast 45 mg or 60 mg orally twice daily for 12 weeks vs placebo
- Mufemilast 45 mgn = 29
- Mufemilast 60 mgn = 31
- Placebon = 30reference
- Primary endpoint
- AUC for the number of oral ulcers from baseline to week 12
- Follow-up
- Week 12
Methodological detailsplacebo-controlled, dose-ranging (45 mg or 60 mg)
- Placebo-controlled
- Dose-ranging (45 mg or 60 mg)
Primary result
As reported in the abstract
AUC0-12 for oral ulcers, least-squares mean difference vs placebo
Each group vs placeboLeast-squares mean difference (95% CI)P value
Mufemilast 45 mg
−104.8(−156.3 to −53.2)
P < 0.001Mufemilast 60 mg
−142.5(−192.4 to −92.7)
P < 0.001Further findings
VAS pain scores and time to ulcer-free remission
- Significantly improved with mufemilast
- P < 0.001
Safety
Discontinuation
- Discontinuation: PDE4-related side effects were transient and resolved spontaneously
Drug-related serious adverse events
- None reported
- 0
Original publication
Efficacy and safety of mufemilast in patients with Behçet’s syndrome: a phase 2 randomised clinical trial. Ann Rheum Dis. Published 25 February 2026. doi:10.
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