CEMAD - IBD Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Dipartimento Universitario di Medicina e Chirurgia Traslazionale, Università Cattolica del Sacro Cuore, Rome, Italy.
United European Gastroenterol J. 2021 Feb;9(1):102-109. doi: 10.1177/2050640620974308. Epub 2021 Mar 1.
Few data exist regarding the long-term effectiveness of golimumab in ulcerative colitis. No data have been reported on real-world continuous clinical response.
This study aimed to describe the long-term outcomes in a large cohort of patients on golimumab who had ulcerative colitis.
Consecutive patients with active ulcerative colitis, started on golimumab, were enrolled and prospectively followed up. The primary end point was to evaluate the long-term persistence on golimumab therapy.
A total of 173 patients with ulcerative colitis were studied. Of these, 79.2% were steroid dependent, and 46.3% were naïve to anti-tumour necrosis factor alpha agents. The median duration of golimumab therapy was 52 weeks (range: 4-142 weeks). The cumulative probability of maintaining golimumab treatment was 47.3% and 22.5% at 54 and 108 weeks, respectively. Biological-naïve status (odds ratio [OR] = 3.02, 95% confidence interval [CI]: 1.44-6.29; p = 0.003) and being able to discontinue steroids at Week 8 (OR = 3.32, 95% CI: 1.34-8.30; p = 0.010) and Week 14 (OR = 2.94, 95% CI: 1.08-8.02; p = 0.036) were associated with longer persistence on therapy. At Week 54, 65/124 (52.4%) postinduction responders were in continuous clinical response. A continuous clinical response was associated with a lower likelihood of golimumab discontinuation throughout the subsequent year of therapy (p < 0.01). Overall, 40 (23.1%) patients were in clinical remission at the last follow-up visit. Twenty-six adverse events were recorded, leading to golimumab withdrawal in 9.2% of patients.
Biological-naïve status and not requiring steroids at Weeks 8 and 14 seem to be associated with a longer persistence on golimumab therapy in ulcerative colitis.
关于戈利木单抗治疗溃疡性结肠炎的长期疗效数据有限。尚未有关于真实世界连续临床应答的数据报告。
本研究旨在描述大量接受戈利木单抗治疗的溃疡性结肠炎患者的长期结局。
连续纳入接受戈利木单抗治疗的活动期溃疡性结肠炎患者，并前瞻性随访。主要终点是评估戈利木单抗治疗的长期持续时间。
共纳入 173 例溃疡性结肠炎患者。其中，79.2%为类固醇依赖型，46.3%为初次接受抗肿瘤坏死因子α治疗。戈利木单抗治疗的中位持续时间为 52 周（范围：4-142 周）。分别在 54 周和 108 周时，维持戈利木单抗治疗的累积概率分别为 47.3%和 22.5%。初次接受生物制剂治疗（比值比[OR] = 3.02，95%置信区间[CI]：1.44-6.29；p = 0.003）和第 8 周（OR = 3.32，95%CI：1.34-8.30；p = 0.008）及第 14 周（OR = 2.94，95%CI：1.08-8.02；p = 0.036）时停用类固醇与更长的治疗持续时间相关。第 54 周时，124 例诱导缓解者中有 65 例（52.4%）持续临床缓解。持续临床缓解与随后一年中戈利木单抗停药的可能性较低相关（p < 0.01）。总体而言，在最后一次随访时有 40 例（23.1%）患者处于临床缓解。记录了 26 例不良事件，导致 9.2%的患者停止使用戈利木单抗。
初次接受生物制剂治疗且第 8 周和第 14 周时不需要类固醇似乎与溃疡性结肠炎患者更长时间地使用戈利木单抗治疗相关。
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