Vasculitis & polymyalgia rheumatica
Combinations of immunomodulatory agents for prevention of uveitis relapse in patients with severe Behçet's disease already on corticosteroid therapy: a randomised, open-label, head-to-head trial
Authors' conclusion
Adalimumab plus corticosteroids was superior to ciclosporin plus corticosteroids with respect to uveitis relapse rate in patients with severe Behçet's disease naive to anti-TNF therapy, and interferon alfa-2a plus corticosteroids was not found to be non-inferior to adalimumab plus corticosteroids or superior to ciclosporin plus corticosteroids.
Study context
- Population
- Adults (≥18 years) with severe Behçet's disease uveitis on corticosteroids and naive to anti-TNF therapy, specialised uveitis centre, Chongqing, China261 in full analysis set
- Participants
- 270 adults
- Comparison
- Ciclosporin vs interferon alfa-2a vs adalimumab, each combined with tapering corticosteroids
- Ciclosporinn = 90
- Interferon alfa-2an = 90
- Adalimumabn = 90reference
- Primary endpoint
- Annualised relapse rate of uveitis (full analysis set)
Methodological detailsopen-label, assessor-masked, head-to-head, single-centre, non-inferiority, Trial ongoing but closed to new participants, Individuals with lived experience of Behçet's disease uveitis were involved in trial design and implementation
- Open-label
- Assessor-masked
- Head-to-head
- Single-centre
- Non-inferiority
- Trial ongoing but closed to new participants
- Individuals with lived experience of Behçet's disease uveitis were involved in trial design and implementation
Primary result
As reported in the abstract
Annualised uveitis relapse rate, least-squares mean
Ciclosporin
1.84
least-squares mean · 95% CI 1.40–2.44
Interferon alfa-2a
1.44
least-squares mean · 95% CI 1.10–1.89
Adalimumab
0.95
least-squares mean · 95% CI 0.64–1.40
Least-squares mean difference (95% CI)P value
Ciclosporinvs Adalimumab
0.90(0.27–1.53)
P = 0.0054 for superiorityInterferon alfa-2avs Adalimumabdid not meet non-inferiority criteria
0.50(−0.04 to 1.04)
P = 0.034 for non-inferiorityInterferon alfa-2avs Ciclosporin
−0.40(−1.05 to 0.25)
P = 0.23 for superiorityFurther findings
- No treatment-related deaths
Safety
Serious adverse events
Original publication
Combinations of immunomodulatory agents for prevention of uveitis relapse in patients with severe Behçet's disease already on corticosteroid therapy: a randomised, open-label, head-to-head trial. Lancet Rheumatol. Published 2 September 2024. doi:10.
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