比美吉珠单抗对银屑病关节炎患者报告结局和工作生产力的影响：两项III期研究的1年结果
Effect of Bimekizumab on Patient-Reported Outcomes and Work Productivity in Patients With Psoriatic Arthritis: 1-Year Results From 2 Phase III Studies.
作者信息
Gladman Dafna D, Mease Philip J, Gossec Laure, Husni M Elaine, Gottlieb Alice B, Ink Barbara, Bajracharya Rajan, Coarse Jason, Lyris Nikos, Lambert Jérémy, Tillett William
机构信息
D.D. Gladman, MD, Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, University Health Network, University of Toronto, Toronto, Ontario, Canada;
P.J. Mease, MD, Swedish Medical Center and Providence St. Joseph Health and University of Washington, Seattle, Washington, USA.
出版信息
J Rheumatol. 2025 May 1;52(5):466-478. doi: 10.3899/jrheum.2024-0923.
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.
目的
评估在长达1年的时间里，比美吉珠单抗对初治生物性改善病情抗风湿药物（bDMARD）或对肿瘤坏死因子抑制剂反应不足/不耐受（TNFi-IR）的活动性银屑病关节炎（PsA）患者报告的症状、健康相关生活质量（HRQOL）和工作效率的长期影响。
方法
BE OPTIMAL（ClinicalTrials.gov：NCT03895203；初治bDMARD患者）和BE COMPLETE（NCT03896581；TNFi-IR患者）是皮下注射比美吉珠单抗160mg每4周一次的III期研究。两项研究均为双盲且安慰剂对照至16周。完成BE OPTIMAL第52周或BE COMPLETE第16周的患者有资格参加开放标签扩展研究BE VITAL（NCT04009499），在此期间所有患者均接受比美吉珠单抗治疗。使用比美吉珠单抗和安慰剂治疗组的个体研究数据，报告患者报告的疼痛、疲劳、身体功能、HRQOL和工作效率至第52周或第40周（52/40）。
结果
随机接受比美吉珠单抗治疗的患者在患者报告的结局方面，从基线到第52/40周均表现出持续的平均改善，包括疼痛（视觉模拟量表[0-100mm]：初治bDMARD患者-30.5；TNFi-IR患者-31.8）、疲劳（慢性病治疗功能评估-疲劳量表[0-52]：初治bDMARD患者5.3；TNFi-IR患者6.0）、身体功能（健康评估问卷-残疾指数[0-3]：初治bDMARD患者-0.34；TNFi-IR患者-0.39）和HRQOL（36项简明健康调查，身体成分总结：初治bDMARD患者8.1；TNFi-IR患者8.4）；在第16周改用比美吉珠单抗的安慰剂患者在第16周至第52/40周表现出相当的改善水平。随机接受比美吉珠单抗治疗的患者在总体工作障碍方面的改善持续至第52周。在缺勤、出勤障碍和活动障碍方面也观察到类似趋势。
结论
在初治bDMARD和TNFi-IR的活动性PsA患者中，比美吉珠单抗治疗可使患者报告的症状、HRQOL和工作效率在长达1年的时间里持续改善。
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