Efficacy and Safety of Golimumab in Patients With Ankylosing Spondylitis Results of a Randomized, Double-Blind, Placebo-Controlled, Phase III Trial
Efficacy and Safety of Golimumab in Patients With Ankylosing Spondylitis Results of a Randomized, Double-Blind, Placebo-Controlled, Phase III Trial
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DOI：
10.1002/art.23969
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发表时间：
2008-11-01
影响因子：
--
通讯作者：
Braun, Juergen
中科院分区：
文献类型：
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作者：
Inman, Robert D.;Davis, John C., Jr.;Braun, Juergen
Objective.在GO-RAISE研究中评价戈利木单抗治疗强直性脊柱炎（AS）患者的疗效和安全性。活动性AS、巴斯AS疾病活动指数（BASDAI）评分>= 4且背痛评分>= 4的患者以1.8：1.8：1的比例随机分配，每4周接受一次皮下注射戈利木单抗（50 mg或100 mg）或安慰剂。主要终点为治疗14周时AS评估（ASAS 20）标准至少改善20%的患者比例。在随机分组时，138、140和78例患者分别被分配到50 mg、100 mg和安慰剂组。14周后，分别有59.4%、60.0%和21.8%的患者为ASAS 20应答者（P < 0.001）。第24周时ASAS标准改善40%的患者分别为43.5%、54.3%和15.4%。接受戈利木单抗治疗的患者在简明健康调查表36中的身体和精神成分总分、Jenkins睡眠评估问卷评分、BASDAI评分和Bath AS功能指数评分方面也显示出显著改善，但Bath AS计量指数评分没有改善。到第24周，85.6%的戈利木单抗治疗患者和76.6%的安慰剂组患者发生≥ 1起不良事件，分别有5.4%和6.5%的患者发生≥ 1起严重不良事件。8例接受戈利木单抗治疗的患者和1例接受安慰剂治疗的患者出现明显异常的肝酶值（较基线增加>= 100%和值>150 IU/L），这些值是一过性的。在一项为期24周的研究期间，戈利木单抗在一个大型AS患者队列中有效且耐受性良好。
Objective. To evaluate the efficacy and safety of golimumab in patients with ankylosing spondylitis (AS) in the GO-RAISE study.Methods. Patients with active AS, a Bath AS Disease Activity Index (BASDAI) score >= 4, and a back pain score of >= 4 were randomly assigned in a 1.8:1.8:1 ratio to receive subcutaneous injections of golimumab (50 mg or 100 mg) or placebo every 4 weeks. The primary end point was the proportion of patients with at least 20% improvement in the Assessment in AS (ASAS20) criteria at week 14.Results. At randomization, 138, 140, and 78 patients were assigned to the 50-mg, 100-mg, and placebo groups, respectively. After 14 weeks, 59.4%, 60.0%, and 21.8% of patients, respectively, were ASAS20 responders (P < 0.001). A 40% improvement in the ASAS criteria at week 24 occurred in 43.5%, 54.3%, and 15.4% of patients, respectively. Patients receiving golimumab also showed significant improvement in the physical and mental component summary scores of the Short Form 36 Health Survey, the Jenkins Sleep Evaluation Questionnaire score, the BASDAI score, and the Bath AS Functional Index score, but not the Bath AS Metrology Index score. Through week 24, 85.6% of golimumab-treated patients and 76.6% of patients in the placebo group had >= 1 adverse event, and 5.4% and 6.5% of patients, respectively, had >= 1 serious adverse event. Eight golimumab-treated patients and 1 placebo-treated patient had markedly abnormal liver enzyme values (>= 100% increase from baseline and a value >150 IU/liter), which were transient.Conclusion. Golimumab was effective and well tolerated in a large cohort of patients with AS during a 24-week study period.