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. 2024 Sep 23;10(3):e004464. doi: 10.1136/rmdopen-2024-004464.

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.

Keywords: arthritis, psoriatic; biological therapy; health-related quality of life; patient reported outcome measures.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial

MeSH terms

  • Adalimumab / administration & dosage
  • Adalimumab / therapeutic use
  • Adult
  • Antibodies, Monoclonal, Humanized* / administration & dosage
  • Antibodies, Monoclonal, Humanized* / therapeutic use
  • Antirheumatic Agents / administration & dosage
  • Antirheumatic Agents / therapeutic use
  • Arthritis, Psoriatic* / drug therapy
  • Double-Blind Method
  • Fatigue / etiology
  • Female
  • Humans
  • Male
  • Middle Aged
  • Patient Reported Outcome Measures*
  • Quality of Life*
  • Severity of Illness Index
  • Treatment Outcome

Substances

  • bimekizumab
  • Antibodies, Monoclonal, Humanized
  • Antirheumatic Agents
  • Adalimumab

Associated data

  • ClinicalTrials.gov/NCT03896581
  • ClinicalTrials.gov/NCT03895203