Siddharth Singh1, James A Proudfoot2, Parambir S Dulai3, Ronghui Xu4, Brian G Feagan5, William J Sandborn3, Vipul Jairath6. 1. Division of Gastroenterology, UC San Diego School of Medicine, University of California, San Diego, La Jolla, California; Division of Biomedical Informatics, UC San Diego School of Medicine, University of California, San Diego, La Jolla, California. Electronic address: sis040@ucsd.edu. 2. Biostatistics Unit, Altman Clinical and Translational Research Institute, UC San Diego School of Medicine, University of California, San Diego, La Jolla, California. 3. Division of Gastroenterology, UC San Diego School of Medicine, University of California, San Diego, La Jolla, California. 4. Biostatistics Unit, Altman Clinical and Translational Research Institute, UC San Diego School of Medicine, University of California, San Diego, La Jolla, California; Department of Family Medicine and Public Health, University of California, San Diego, La Jolla, California; Department of Mathematics, University of California, San Diego, La Jolla, California. 5. Division of Epidemiology and Biostatistics, Western University, London, Ontario, Canada; Division of Gastroenterology, Department of Medicine, University Hospital, London Health Sciences Centre, Western University, London, Ontario, Canada. 6. Division of Epidemiology and Biostatistics, Western University, London, Ontario, Canada; Division of Gastroenterology, Department of Medicine, University Hospital, London Health Sciences Centre, Western University, London, 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-to-severe UC.
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.
Authors: Michael D Mandel; Anita Balint; Petra A Golovics; Zsuzsanna Vegh; Anna Mohas; Blanka Szilagyi; Agnes Szabo; Zsuzsanna Kurti; Lajos S Kiss; Barbara D Lovasz; Krisztina B Gecse; Klaudia Farkas; Tamas Molnar; Peter L Lakatos Journal: Dig Liver Dis Date: 2014-08-22 Impact factor: 4.088
Authors: V Jairath; R Khanna; G Y Zou; L Stitt; M Mosli; M K Vandervoort; G D'Haens; W J Sandborn; B G Feagan; B G Levesque Journal: Aliment Pharmacol Ther Date: 2015-09-21 Impact factor: 8.171
Authors: Omoniyi J Adedokun; Zhenhua Xu; Colleen W Marano; Richard Strauss; Hongyan Zhang; Jewel Johanns; Honghui Zhou; Hugh M Davis; Walter Reinisch; Brian G Feagan; Paul Rutgeerts; William J Sandborn Journal: J Crohns Colitis Date: 2016-07-20 Impact factor: 9.071