Spondyloarthritis & psoriatic arthritis

Low uveitis rates in patients with axial spondyloarthritis treated with bimekizumab: pooled results from phase 2b/3 trials

Ann Rheum DisPublished Pooled analysis of phase 2b/3 randomised trials

Authors' conclusion

Bimekizumab, a dual-IL-17A/F inhibitor, may confer protective effects for uveitis in patients with axSpA.

Study context

Population
Patients with axial spondyloarthritis (axSpA) (nr-axSpA and r-axSpA) in the BE MOBILE 1 and 2 and BE AGILE trials and their open-label extension (OLEs)phase 2b/3 pool N=848
Participants
349 vs 237
Comparison
Bimekizumab 160 mg vs placebo
  • Bimekizumab (BKZ)n = 349
  • Placebon = 237reference
Outcome
Uveitis rates and EAIR/100 PYs
Follow-up
Double-blind treatment period
Methodological detailsdouble-blind treatment period, placebo-controlled, open-label extension pool
  • Double-blind treatment period
  • Placebo-controlled
  • Open-label extension pool

Pooled result

As reported in the abstract

Uveitis, BE MOBILE 1 and 2 double-blind period
GroupValueExposure-adjusted incidence rates (EAIR)/100 patient-years (PYs) (95% CI)
BKZ0.6%1.8 (0.2 to 6.7)
Placebo4.6%15.4 (7.7 to 27.5)

Value

BKZ0.6%
Placebo4.6%

Exposure-adjusted incidence rates (EAIR)/100 patient-years (PYs) (95% CI)

BKZ1.8 (0.2 to 6.7)
Placebo15.4 (7.7 to 27.5)
  • BKZ vs Placebo: nominal p=0.001

Further pooled results

Uveitis in patients with history of uveitis (subgroup) · double-blind treatment period

nominal p=0.004

EAIR/100 PYs (95% CI) BKZ 6.2 (0.2 to 34.8) · Placebo 70.4 (32.2 to 133.7)

Uveitis EAIR, phase 2b/3 pool (≥1 BKZ dose, incl. OLEs)
1.2 · EAIR · 95% CI 0.8–1.8 · /100 PYs
  • Uveitis EAIR, phase 2b/3 pool (≥1 BKZ dose, incl. OLEs): N=848

Original publication

Low uveitis rates in patients with axial spondyloarthritis treated with bimekizumab: pooled results from phase 2b/3 trials. Ann Rheum Dis. Published 14 November 2024. doi:10.1136/ard-2024-225933

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