BACKGROUND & AIMS With several options available for patients with moderate-severe ulcerative colitis (UC), rapidity of symptom resolution could be an important differentiator. We compared the efficacy and speed of onset of action of infliximab vs golimumab induction therapy using patient-level data from phase 3 trials (ACT-1, ACT-2, and PURSUIT-SC). METHODS We compared differences in proportions of patients who achieved the composite outcome of a rectal bleeding score=0 and stool frequency score ≤1 (patient-reported outcome 2 remission) at weeks 2 and 6 of treatment with standard-dose infliximab vs golimumab using logistic generalized estimating equation. Overall efficacy for inducing clinical remission (Mayo clinic score <3) was compared using logistic regression. Analyses were adjusted for sex, disease extent, baseline clinical and endoscopic severity, C-reactive protein, albumin, body weight and concomitant medications (immunomosuppressives, corticosteroids, and 5-aminsalicylates). RESULTS Trial populations were similar and no differences were observed among the placebo groups in the studies. A significantly higher proportion patients treated with infliximab than golimumab achieved patient-reported outcome 2 remission at week 2 (35% vs 30%; adjusted odds ratio [OR], 1.71; 95% CI, 1.15-2.55) and at week 6 (50.0% vs 38.9%; adjusted OR, 2.0; 95% CI, 1.40-2.94). Infliximab-treated patients were also significantly more likely to achieve clinical remission than golimumab-treated patients (adjusted OR, 3.01; 95% CI, 1.95-4.70), with consistent findings in patients with moderate or severe UC. CONCLUSIONS Based on a patient-level analysis of data from phase 3 trials, infliximab resolves symptoms more rapidly and has greater efficacy for inducing remission than golimumab in patients with moderate-to-severe UC.

中文翻译：

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英夫利昔单抗与戈利木单抗在溃疡性结肠炎中的疗效和起效速度的比较。

背景和目的 中重度溃疡性结肠炎 (UC) 患者有多种选择，症状消退的速度可能是一个重要的区分因素。我们使用 3 期试验（ACT-1、ACT-2 和 PURSUIT-SC）的患者水平数据比较了英夫利昔单抗与戈利木单抗诱导治疗的疗效和起效速度。方法 我们比较了在标准剂量英夫利昔单抗和戈利木单抗治疗的第 2 周和第 6 周达到直肠出血评分 = 0 和大便频率评分≤1（患者报告的结果 2 缓解）复合结果的患者比例差异广义估计方程。使用逻辑回归比较诱导临床缓解（梅奥诊所评分 <3）的总体疗效。分析根据性别、疾病程度、基线临床和内窥镜严重程度、C 反应蛋白、白蛋白、体重和伴随药物（免疫抑制剂、皮质类固醇和 5-氨基水杨酸盐​​）。结果 试验人群相似，研究中的安慰剂组之间没有观察到差异。在第 2 周（35% 对 30%；调整优势比 [OR]，1.71；95% CI，1.15-2.55）和第 6 周（50.0 % 与 38.9%；调整后的 OR，2.0；95% CI，1.40-2.94）。与戈利木单抗治疗的患者相比，英夫利昔单抗治疗的患者实现临床缓解的可能性也显着更高（调整后的 OR，3.01；95% CI，1.95-4.70），在中度或重度 UC 患者中的结果一致。