TY - JOUR
T1 - Comparative Efficacy and Speed of Onset of Action of Infliximab vs Golimumab in Ulcerative Colitis
AU - Singh, Siddharth
AU - Proudfoot, James A.
AU - Dulai, Parambir S.
AU - Xu, Ronghui
AU - Feagan, Brian G.
AU - Sandborn, William J.
AU - Jairath, Vipul
N1 - Funding Information:
Funding Siddharth Singh is supported by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health under award number K23DK117058, the American College of Gastroenterology Junior Faculty Development Award, and the Crohn's and Colitis Foundation Career Development Award (#404614). The project was also partially supported by National Institutes of Health Grant UL1TR001442 (R.X., J.P.). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Conflicts of interest These authors declare the following: Siddharth Singh has received research support from AbbVie; and consulting fees from AbbVie, Takeda, and AMAG Pharmaceuticals, outside the submitted work. Parambir Dulai has received grant support from Pfizer, Janssen, and Takeda; advisory board/consulting fees from Takeda and Janssen; and speaker honorarium from Takeda, outside the submitted work. Vipul Jairath has received consulting fees from AbbVie, Sandoz, Takeda, Janssen, and Robarts Clinical Trials; and speakers fees from Takeda, Janssen, Shire, and Ferring. Brian Feagan has received grant/research support from Millennium Pharmaceuticals, Merck, Tillotts Pharma AG, AbbVie, Novartis Pharmaceuticals, Centocor Inc, Elan/Biogen, UCB Pharma, Bristol-Myers Squibb, Genentech, ActoGenix, and Wyeth Pharmaceuticals Inc; consulting fees from Millennium Pharmaceuticals, Merck, Centocor Inc, Elan/Biogen, Janssen-Ortho, Teva Pharmaceuticals, Bristol-Myers Squibb, Celgene, UCB Pharma, AbbVie, AstraZeneca, Serono, Genentech, Tillotts Pharma AG, Unity Pharmaceuticals, Albireo Pharma, Given Imaging Inc, Salix Pharmaceuticals, Novo Nordisk, GSK, Actogenix, Prometheus Therapeutics and Diagnostics, Athersys, Axcan, Gilead, Pfizer, Shire, Wyeth, Zealand Pharma, Zyngenia, GiCare Pharma Inc, and Sigmoid Pharma; and speakers bureau fees from UCB, AbbVie, and J&J/Janssen. William Sandborn has received consulting fees from AbbVie, Akros Pharma, Allergan, Ambrx Inc, Amgen, Ardelyx, Arena Pharmaceuticals, Atlantic Pharmaceuticals, Avaxia, Biogen, Boehringer Ingelheim, Bristol-Meyers Squibb, Celgene, Conatus, Cosmo Technologies, Escalier Biosciences, Ferring, Ferring Research Institute, Forward Pharma, Galapagos, Genentech, Gilead Sciences, Immune Pharmaceuticals, Index Pharmaceuticals, Janssen, Kyowa Hakko Kirin Pharma, Lilly, Medimmune, Mesoblast, Miraca Life Sciences, Nivalis Therapeutics, Novartis, Nutrition Science Partners, Oppilan Pharma, Otsuka, Palatin, Paul Hastings, Pfizer, Precision IBD, Progenity, Prometheus Laboratories, Qu Biologics, Regeneron, Ritter Pharmaceuticals, Robarts Clinical Trials (owned by Health Academic Research Trust [HART]), Salix, Seattle Genetics, Seres Therapeutics, Shire, Sigmoid Biotechnologies, Takeda, Theradiag, Theravance, Tigenix, Tillotts Pharma, UCB Pharma, Vascular Biogenics, and Vivelix; has received research grants from Atlantic Healthcare Limited, Amgen, Genentech, Gilead Sciences, AbbVie, Janssen, Takeda, Lilly, and Celgene/Receptos; has received payments for lectures/speakers bureau from AbbVie, Janssen, Takeda; and holds stock/stock options in Escalier Biosciences, Oppilan Pharma, Precision IBD, Progenity, and Ritter Pharmaceuticals. The remaining authors disclose no conflicts.
Publisher Copyright:
© 2020 AGA Institute
PY - 2020/2
Y1 - 2020/2
N2 - 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.
AB - 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.
KW - Comparative Efficacy
KW - Inflammatory Bowel Diseases
KW - Open Science
KW - Patient-Reported Outcomes
UR - http://www.scopus.com/inward/record.url?scp=85077700431&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85077700431&partnerID=8YFLogxK
U2 - 10.1016/j.cgh.2019.05.019
DO - 10.1016/j.cgh.2019.05.019
M3 - Article
C2 - 31108227
AN - SCOPUS:85077700431
VL - 18
SP - 424-431.e7
JO - Clinical Gastroenterology and Hepatology
JF - Clinical Gastroenterology and Hepatology
SN - 1542-3565
IS - 2
ER -