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Clin Gastroenterol Hepatol. 2019 May 17. pii: S1542-3565(19)30529-4. doi: 10.1016/j.cgh.2019.05.019. [Epub ahead of print]

Efficacy and Speed of Induction of Remission of Infliximab vs Golimumab for Patients With Ulcerative Colitis, Based on Data From Clinical Trials.

Author information

1
Division of Gastroenterology, University of California San Diego, La Jolla, California; Division of Biomedical Informatics, University of California San Diego, La Jolla, California. Electronic address: sis040@ucsd.edu.
2
Biostatistics Unit, Altman Clinical and Translational Research Institute, University of California San Diego, La Jolla, California.
3
Division of Gastroenterology, University of California San Diego, La Jolla, California.
4
Biostatistics Unit, Altman Clinical and Translational Research Institute, University of California San Diego, La Jolla, California; Department of Family Medicine and Public Health and Department of Mathematics, University of California San Diego, La Jolla, California.
5
Division of Epidemiology and Biostatistics, Western University, London, Ontario, Canada; Department of Medicine, Division of Gastroenterology, University Hospital, Ontario, Canada.
6
Division of Epidemiology and Biostatistics, Western University, London, Ontario, Canada; Department of Medicine, Division of Gastroenterology, University Hospital, Ontario, Canada. Electronic address: vjairath@uwo.ca.

Abstract

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-severe UC.

KEYWORDS:

Comparative efficacy; inflammatory bowel diseases; open science; patient-reported outcomes

PMID:
31108227
DOI:
10.1016/j.cgh.2019.05.019

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