阿达木单抗针对九种不同疾病的临床试验中炎症性肠病不良事件的低发生率。
Low Incidence of Inflammatory Bowel Disease Adverse Events in Adalimumab Clinical Trials Across Nine Different Diseases.
作者信息
Elewaut Dirk, Braun Jürgen, Anderson Jaclyn K, Arikan Dilek, Chen Su, Hojnik Maja, De Craemer Ann-Sophie, Curtis Jeffrey R
机构信息
Ghent University Hospital and Ghent University, Ghent, Belgium.
Rheumazentrum Ruhrgebiet, Herne, and Ruhr Universität Bochum, Bochum, Germany.
出版信息
Arthritis Care Res (Hoboken). 2021 Feb;73(2):289-295. doi: 10.1002/acr.24175.
OBJECTIVE
Adalimumab is approved for treatment of Crohn's disease and ulcerative colitis. Thus, we postulated that exacerbation or new-onset of inflammatory bowel disease (IBD) would be rare events in patients treated with adalimumab for non-IBD indications. The objective was to evaluate the incidence of IBD adverse events (AEs) across adalimumab trials.
METHODS
IBD AE rates in 75 adalimumab clinical trials in rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, pediatric enthesitis-related arthritis, uveitis, hidradenitis suppurativa, adult and pediatric psoriasis, psoriatic arthritis, nonpsoriatic arthritis peripheral spondyloarthritis (SpA), axial SpA, including nonradiographic axial SpA, and ankylosing spondylitis, were analyzed. Search terms for IBD AEs (new onset or worsening/flare) included IBD, ulcerative colitis, Crohn's disease, and ulcerative proctitis.
RESULTS
This analysis included 24,114 patients, representing 36,508 patient-years of adalimumab exposure. The overall rate of IBD AEs in adalimumab-treated patients was 0.1 (95% confidence interval [95% CI] 0.1-0.2)/100 patient-years (41 events), ranging from no events (psoriatic arthritis, uveitis, and pediatric trials) to 0.8 (95% CI 0.2-2.2)/100 patient-years in peripheral SpA. The rate of IBD in axial SpA was 0.6 (95% CI 0.4-1.0)/100 patient-years. During placebo-controlled trials, the overall IBD rate was 0.1 (95% CI 0.0-0.3)/100 patient-years for adalimumab groups (3 events in 6,781 patients; 2,752 patient-years of exposure) and 0.1 (95% CI 0.0-0.4)/100 patient-years for placebo groups (1 event in 3,493 patients; 1,246 patient-years of exposure). IBD rates in axial SpA were 0.5 (95% CI 0.1-1.4)/100 patient-years for adalimumab and 0.6 (95% CI 0.0-3.1)/100 patient-years for placebo.
CONCLUSION
The rates of IBD AEs in adalimumab clinical trials were generally low across the evaluated diseases, including axial SpA; all events occurred in adult patients.
目的
阿达木单抗已被批准用于治疗克罗恩病和溃疡性结肠炎。因此，我们推测，在接受阿达木单抗治疗非IBD适应症的患者中，炎症性肠病（IBD）的加重或新发将是罕见事件。目的是评估阿达木单抗各试验中IBD不良事件（AE）的发生率。
方法
分析了75项阿达木单抗治疗类风湿性关节炎、多关节型幼年特发性关节炎、儿童附着点炎相关关节炎、葡萄膜炎、化脓性汗腺炎、成人和儿童银屑病、银屑病关节炎、非银屑病关节炎外周型脊柱关节炎（SpA）、中轴型SpA（包括非放射学中轴型SpA）和强直性脊柱炎的临床试验中的IBD AE发生率。IBD AE（新发或恶化/发作）的检索词包括IBD、溃疡性结肠炎、克罗恩病和溃疡性直肠炎。
结果
该分析纳入了24114例患者，相当于36508患者年的阿达木单抗暴露量。接受阿达木单抗治疗的患者中IBD AE的总体发生率为0.1（95%置信区间[95%CI]0.1 - 0.2）/100患者年（41例事件），范围从无事件（银屑病关节炎、葡萄膜炎和儿童试验）到外周型SpA中的0.8（95%CI 0.2 - 2.2）/100患者年。中轴型SpA中IBD的发生率为0.
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