医学
银屑病性关节炎
安慰剂
物理疗法
生活质量(医疗保健)
随机对照试验
内科学
工作效率
关节炎
生产力
宏观经济学
经济
替代医学
护理部
病理
作者
Dafna D. Gladman,Philip J. Mease,Laure Gossec,M. Elaine Husni,Alice B. Gottlieb,Barbara Ink,Rajan Bajracharya,Jason Coarse,Nikos Lyris,Jérémy Lambert,William Tillett
标识
DOI:10.3899/jrheum.2024-0923
摘要
Objective 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. Methods 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. Results 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. 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.
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