Effect of Bimekizumab on Patient-Reported Outcomes and Work Productivity in Patients With Psoriatic Arthritis: 1-Year Results From 2 Phase III Studies.

Abstract

Objective: To assess the longer-term effect of bimekizumab up to 1 year on patient-reported symptoms, health-related quality of life (HRQOL), and work productivity in patients with active PsA who were biologic disease-modifying antirheumatic drug (bDMARD)-naïve or had inadequate response/intolerance to tumor necrosis factor inhibitors (TNFi-IR).

Methods: BE OPTIMAL (ClinicalTrials.gov: NCT03895203; bDMARD-naïve patients) and BE COMPLETE (NCT03896581; TNFi-IR patients) are phase III studies of subcutaneous bimekizumab 160 mg every 4 weeks. Both studies were double-blind and placebo-controlled to 16 weeks. Patients who completed week 52 of BE OPTIMAL or week 16 of BE COMPLETE were eligible for the open-label extension, BE VITAL (NCT04009499), during which all patients received bimekizumab. Patient-reported pain, fatigue, physical function, HRQOL, and work productivity are reported to week 52 or 40 (52/40) using individual study data for bimekizumab and placebo treatment arms.

Results: Bimekizumab-randomized patients demonstrated sustained mean improvements from baseline in patient-reported outcomes to week 52/40, including pain (visual analog scale [0-100 mm]: bDMARD-naïve -30.5; TNFi-IR -31.8), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue scale [0-52]: bDMARD-naïve 5.3; TNFi-IR 6.0), physical function (Health Assessment Questionnaire-Disability Index [0-3]: bDMARD-naïve -0.34; TNFi-IR -0.39), and HRQOL (36-item Short Form Health Survey, physical component summary: bDMARD-naïve 8.1; TNFi-IR 8.4); placebo patients who switched to bimekizumab at week 16 demonstrated comparable levels of improvement from week 16 to week 52/40. Improvements in overall work impairment were sustained among bimekizumab-randomized patients to week 52. Similar trends were observed for absenteeism, presenteeism, and activity impairment.

Conclusion: Bimekizumab treatment resulted in sustained improvements in patient-reported symptoms, HRQOL, and work productivity up to 1 year in bDMARD-naïve and TNFi-IR patients with active PsA.