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<0.001. Greater proportions of bimekizumab-treated patients achieved minimal clinically important differences for patient-reported symptoms vs placebo, including FACIT-Fatigue (bimekizumab: 53.1%; placebo: 36.3%) and HAQ-DI (bimekizumab: 53.0%; placebo: 28.7%); both nominal p<0.001.
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.
| Original language | English |
|---|---|
| Article number | e004464. |
| Number of pages | 11 |
| Journal | RMD Open |
| Volume | 10 |
| Issue number | 3 |
| Early online date | 23 Sept 2024 |
| DOIs | |
| Publication status | Published - 23 Sept 2024 |
Data Availability Statement
Data are available upon reasonable request. Data from this manuscript may be requested by qualified researchers 6 months after product approval in the USA and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymised individual patient data and redacted study documents, which may include raw datasets, analysis-ready datasets, study protocols, blank case report forms, annotated case report forms, statistical analysis plans, dataset specifications and clinical study reports. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password-protected portal.Keywords
- Humans
- Quality of Life
- Patient Reported Outcome Measures
- Male
- Female
- Arthritis, Psoriatic/drug therapy
- Middle Aged
- Treatment Outcome
- Double-Blind Method
- Antibodies, Monoclonal, Humanized/therapeutic use
- Adult
- Antirheumatic Agents/therapeutic use
- Severity of Illness Index
- Adalimumab/therapeutic use
- Fatigue/etiology