Bimekizumab Improves Pain, Fatigue, and More in Active Psoriatic Arthritis Over Placebo

M. Elaine Husni, MD, MPH

Credit: Cleveland Clinic

Tumor necrosis factor inhibitor inadequate response/intolerance (TNFi-IR) and biologic disease-modifying antirheumatic drug (bDMARD)-naïve patients treated with bimekizumab for active psoriatic arthritis (PsA) experienced rapid and greater improvements in patient-reported pain, fatigue, physical function and health-related quality of life (HRQoL) by week 16 than those that received placebo.¹

“The European Alliance of Associations for Rheumatology (EULAR) treatment recommendations for PsA state that the main goal is to maximize quality of life through control of symptoms, prevention of structural damage and normalization of physical and social function.² Patient-reported symptom measures are a key component of assessing treatments for a condition with heterogeneous clinical presentation such as PsA,” lead investigator M. Elaine Husni, MD, MPH, Vice Chair of Rheumatology, and Director, Arthritis and Musculoskeletal Center, and Staff Physician, Orthopedic and Rheumatologic Institute, Cleveland Clinic, and Assistant Professor, Cleveland Clinic Lerner College of Medicine, Case Western Reserve University, and colleagues wrote.¹

Husni and colleagues collected patient-reported outcome pooled and individual study data from the phase 3 BE OPTIMAL (NCT03895203) and BE COMPLETE (NCT03896581) studies of bimekizumab in patients with PsA that were bDMARD-naive (BE OPTIMAL) and TNFi-IR (BE COMPLETE). Both studies were double-blind and placebo-controlled for 16 weeks and evaluated subcutaneous bimekizumab 160 mg every 4 weeks (Q4W). In BE OPTIMAL, patients were randomized 3:2:1 to bimekizumab, placebo or reference subcutaneous adalimumab (40 mg Q2W). In BE COMPLETE, patients were randomized 2:1 to bimekizumab or placebo.¹

There were 1073 (out of 1112; 96.5%) patients included in the analysis that completed week 16 in the studies, 677 (out of 698; 97.0%) received bimekizumab and 396 (out of 414; 95.7%) received placebo. Patients treated with bimekizumab achieved rapid improvements vs placebo in pain, fatigue, physical function and HRQoL after a single dose by week 4. These improvements continued until week 16, reaching a mean 25.2-point reduction in Pain Visual Analogue Scale (VAS) (95% CI, -27.2 to -23.1) and a 4.5-point change in Functional Assessment of Chronic Illness Therapy – Fatigue Scale (FACIT-Fatigue; 95% CI, 3.9-5.1) from baseline. Comparably, patients receiving place had a mean 5.7-point reduction in VAS (95% CI, -8.2 to -3.3; nominal P <.001) and a mean 1.1-point change in FACIT-Fatigue (95% CI, 0.3-2.0; nominal P <.001).

Additionally, a greater proportion of patients treated with bimekizumab achieved minimal clinically important differences for patient-reported symptoms as compared to those treated with placebo, including FACIT-Fatigue (bimekizumab, 53.1%; placebo, 36.3%) and HAQ-DI (bimekizumab, 53.0%; placebo, 28.7%; both nominal P <.001).

Overall, treatment of active PsA with subcutaneous bimekizumab during two phase 3 studies demonstrated rapid improvements in the patient-reported symptoms and HRQoL of bDMARD-naïve and TNFi-IR patients up to 16 weeks. The patient-reported improvements in pain, fatigue, HRQoL and impact of disease in this study provide further evidence of the efficacy of bimekizumab in patients with PsA alongside improvements in clinical measures previously reported; future studies will evaluate these outcomes using longer-term data,” Husni and colleagues concluded.¹

REFERENCES

1. Husni ME, Mease PJ, Merola JF, et al. 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;10:e004464. doi: 10.1136/rmdopen-2024-004464

2. Gossec L, Baraliakos X, Kerschbaumer A, et al. EULAR recommendations for the management of psoriatic arthritis with pharmacological therapies: 2019 update. Ann Rheum Dis 2020;79:700–12.