Effect of Bimekizumab on Patient-Reported Disease Impact in Patients with Psoriatic Arthritis: 1-Year Results from Two Phase 3 Studies

Laure Gossec; Ana-Maria Orbai; Maarten de Wit; Laura C Coates; Alexis Ogdie; Barbara Ink; Jason Coarse; Jérémy Lambert; Vanessa Taieb; Dafna D Gladman

doi:10.1093/rheumatology/keae277

Effect of Bimekizumab on Patient-Reported Disease Impact in Patients with Psoriatic Arthritis: 1-Year Results from Two Phase 3 Studies

Rheumatology (Oxford). 2024 May 16:keae277. doi: 10.1093/rheumatology/keae277. Online ahead of print.

Authors

Laure Gossec^{1

2}, Ana-Maria Orbai³, Maarten de Wit⁴, Laura C Coates⁵, Alexis Ogdie⁶, Barbara Ink⁷, Jason Coarse⁸, Jérémy Lambert⁹, Vanessa Taieb⁹, Dafna D Gladman¹⁰

Affiliations

¹ Sorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Paris, France.
² Pitié-Salpêtrière hospital, Rheumatology department, Paris, AP-HP, France.
³ Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
⁴ Patient Research Partner, Stichting Tools, Amsterdam, The Netherlands.
⁵ Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Diseases, University of Oxford and Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford, UK.
⁶ Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
⁷ UCB Pharma, Slough, UK.
⁸ UCB Pharma, Morrisville, North Carolina, USA.
⁹ UCB Pharma, Colombes, France.
¹⁰ Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, University Health Network, University of Toronto, Ontario, Canada.

PMID: 38754125
DOI: 10.1093/rheumatology/keae277

Abstract

Objectives: To evaluate 1-year bimekizumab efficacy in psoriatic arthritis (PsA) from the patient perspective using the 12-item PsA Impact of Disease (PsAID-12) questionnaire.

Methods: BE OPTIMAL (NCT03895203; biologic disease-modifying antirheumatic drug [bDMARD]-naïve), BE COMPLETE (NCT03896581; inadequate response/intolerance to tumour necrosis factor inhibitors [TNFi-IR]) and BE VITAL (NCT04009499; open-label extension) assessed bimekizumab 160 mg every 4 weeks in patients with PsA. Post hoc analyses of patient-reported disease impact, assessed by the PsAID-12 questionnaire, are reported to 1 year (collected to week 40 in BE COMPLETE).

Results: Overall, 1,112 total patients were included (698 bimekizumab, 414 placebo). Rapid improvements observed with bimekizumab treatment at week 4 continued to week 16 and were sustained to 1 year. At 1 year, mean (standard error) change from baseline in PsAID-12 total score was comparable between bimekizumab-randomized patients and patients who switched to bimekizumab at week 16 (bDMARD-naïve bimekizumab -2.3 [0.1], placebo/bimekizumab -2.2 [0.1]; TNFi-IR bimekizumab -‍2.5 [0.1], placebo/bimekizumab -2.2 [0.2]). Proportions of bimekizumab-randomized patients achieving clinically meaningful within-patient improvement (≥3-point decrease from baseline) at week 16 were sustained to 1 year (bDMARD-naïve 49.0%; TNFi-IR 48.5%) and were similar for placebo/bimekizumab patients (bDMARD-naïve 44.4%; TNFi-IR 40.6%). Across studies and arms, 35.3% to 47.8% of patients had minimal or no symptom impact at 1 year. Improvements were observed to 1 year across all single-item domains, including pain, fatigue and skin problems.

Conclusion: Bimekizumab treatment resulted in rapid and sustained clinically meaningful improvements in disease impact up to 1 year in bDMARD-naïve and TNFi-IR patients with PsA.

Keywords: PROM; PsA; Severity of Illness Index; bimekizumab; health-related QoL; rheumatology.