Abstract
To assess the longer-term impact of bimekizumab 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) up to 1 year. BE OPTIMAL (NCT03895203; bDMARD-naïve) and BE COMPLETE (NCT03896581; TNFi-IR) are phase 3 studies of subcutaneous bimekizumab 160 mg every 4 weeks; both 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 52/40 using individual study data for bimekizumab and placebo treatment arms. Bimekizumab-randomized patients demonstrated sustained mean improvements from baseline in patient-reported outcomes to Week 52/40, including pain (Pain VAS [0-100]: bDMARD-naïve -30.5; TNFi-IR -31.8), fatigue (FACIT-Fatigue [0-52]: bDMARD-naïve 5.3; TNFi-IR 6.0), physical function (HAQ-DI [0-3]: bDMARD-naïve -0.34; TNFi-IR -0.39), and HRQoL (SF-36 PCS: 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 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. 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.
Published Version
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