Spondyloarthritis & psoriatic arthritis

Bimekizumab provided rapid improvements in patient-reported symptoms and health-related quality of life in patients with active psoriatic arthritis: pooled 16-week results from two phase 3 studies

RMD OpenPublished Pooled analysis of two phase 3 randomised controlled trials

Authors' conclusion

Bimekizumab treatment demonstrated rapid and greater improvements in patient-reported pain, fatigue, physical function and HRQoL to week 16 vs placebo in bDMARD-naïve and TNFi-IR patients.

Study context

Population
Patients with active psoriatic arthritis (PsA), biologic disease-modifying antirheumatic drug (bDMARD)-naïve (BE OPTIMAL) or TNFi inadequate response/intolerance (BE COMPLETE)1,073 completed week 16
Participants
1,112 patients
Comparison
Subcutaneous bimekizumab 160 mg Q4W vs placebo
  • Bimekizumabn = 698
  • Placebon = 414reference
Outcome
Pain Visual Analogue Scale (VAS), mean change from baseline
Follow-up
Week 16
Methodological detailsBE OPTIMAL and BE COMPLETE, double-blind, placebo-controlled to 16 weeks, pooled and individual study data
  • BE OPTIMAL and BE COMPLETE
  • Double-blind
  • Placebo-controlled to 16 weeks
  • Pooled and individual study data

Pooled result

As reported in the abstract

Bimekizumab

-‍25.2

mean · 95% CI −27.2–-23.1

Placebo

-‍5.7

mean · 95% CI −8.2–-3.3

Nominal p<0.001

Further pooled results

FACIT-Fatigue MCID achieved · week 16

nominal p<0.001

HAQ-DI MCID achieved · week 16

nominal p<0.001

Mean

OutcomeBimekizumabPlaceboP value
FACIT-Fatigue, mean change from baseline · week 164.5 (95% CI 3.9–5.1)1.1 (95% CI 0.3–2.0)nominal p<0.001

Pain, fatigue, physical function and health-related quality of life (HRQoL) after a single dose · week 4

Rapid improvements with bimekizumab vs placebo

Original publication

Bimekizumab provided rapid improvements in patient-reported symptoms and health-related quality of life in patients with active psoriatic arthritis: pooled 16-week results from two phase 3 studies. RMD Open. Published 23 September 2024. doi:10.1136/rmdopen-2024-004464

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