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.
Publication Title
RMD Open
Document Type
Article
Publication Date
9-23-2024
Keywords
Humans; Quality of Life; Patient Reported Outcome Measures; Male; Female; Arthritis, Psoriatic; Middle Aged; Treatment Outcome; Double-Blind Method; Antibodies, Monoclonal, Humanized; Adult; Antirheumatic Agents; Severity of Illness Index; Adalimumab; Fatigue; arthritis, psoriatic; biological therapy; health-related quality of life; patient reported outcome measures.; washington; swedish
Abstract
OBJECTIVES: To assess impact of bimekizumab treatment on patient-reported outcomes and health-related quality of life (HRQoL) in patients with active psoriatic arthritis (PsA), using 16-week data from two phase 3 studies.
METHODS: BE OPTIMAL (NCT03895203; biologic disease-modifying antirheumatic drug (bDMARD)-naïve) and BE COMPLETE (NCT03896581; tumour necrosis factor inhibitor inadequate response/intolerance (TNFi-IR)) are phase 3 studies of subcutaneous bimekizumab 160 mg Q4W; both were double-blind and placebo-controlled to 16 weeks. Patients were randomised 3:2:1 to bimekizumab, placebo or reference (subcutaneous adalimumab 40 mg Q2W) in BE OPTIMAL; 2:1 to bimekizumab or placebo in BE COMPLETE. Patient-reported outcomes for pain, fatigue, physical function and HRQoL are reported to week 16 using pooled and individual study data for bimekizumab and placebo patients.
RESULTS: 1073/1112 (96.5%) patients completed week 16 (bimekizumab: 677/698 [97.0%]; placebo: 396/414 [95.7%]). Bimekizumab-treated patients achieved rapid improvements vs placebo in pain, fatigue, physical function and HRQoL by week 4, after a single dose. Improvements continued to week 16 for all patient-reported outcomes, including Pain Visual Analogue Scale (VAS; mean (95% CI) change from baseline: bimekizumab: -25.2 [-27.2, -23.1]; placebo: -5.7 [-8.2, -3.3]) and FACIT-Fatigue (bimekizumab: 4.5 [3.9, 5.1]; placebo: 1.1 [0.3, 2.0]); both nominal p
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.
TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: NCT03895203; NCT03896581.
Area of Special Interest
Orthopedics & Sports Medicine
Specialty/Research Institute
Orthopedics
Specialty/Research Institute
Rheumatology
Specialty/Research Institute
Pharmacy
DOI
10.1136/rmdopen-2024-004464
