4.7 Article

Comparative Efficacy and Speed of Onset of Action of Infliximab vs Golimumab in Ulcerative Colitis

期刊

CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
卷 18, 期 2, 页码 424-+

出版社

ELSEVIER SCIENCE INC
DOI: 10.1016/j.cgh.2019.05.019

关键词

Comparative Efficacy; Patient-Reported Outcomes; Open Science; Inflammatory Bowel Diseases

资金

  1. NCATS NIH HHS [UL1 TR001442] Funding Source: Medline
  2. NIDDK NIH HHS [K23 DK117058] Funding Source: Medline

向作者/读者索取更多资源

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.

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