Methotrexate in combination with infliximab is no more effective than infliximab alone in patients with Crohn's disease

Brian G. Feagan; John W.D. McDonald; Remo Panaccione; Robert A. Enns; Charles N. Bernstein; Terry P. Ponich; Raymond Bourdages; Donald G. Macintosh; Chrystian Dallaire; Albert Cohen; Richard N. Fedorak; Pierre Paré; Alain Bitton; Fred Saibil; Frank Anderson; Allan Donner; Cindy J. Wong; Guangyong Zou; Margaret K. Vandervoort; Marybeth Hopkins; Gordon R. Greenberg

doi:10.1053/j.gastro.2013.11.024

Methotrexate in combination with infliximab is no more effective than infliximab alone in patients with Crohn's disease

Brian G. Feagan, John W.D. McDonald, Remo Panaccione, Robert A. Enns, Charles N. Bernstein, Terry P. Ponich, Raymond Bourdages, Donald G. Macintosh, Chrystian Dallaire, Albert Cohen, Richard N. Fedorak, Pierre Paré, Alain Bitton, Fred Saibil, Frank Anderson, Allan Donner, Cindy J. Wong, Guangyong Zou, Margaret K. Vandervoort, Marybeth HopkinsGordon R. Greenberg

Medicine

Research output: Contribution to journal › Article › peer-review

320 Citations (Scopus)

Abstract

Background & Aims Methotrexate and infliximab are effective therapies for Crohn's disease (CD). In the combination of maintenance methotrexate- infliximab trial, we evaluated the potential superiority of combination therapy over infliximab alone. Methods In a 50-week, double-blind, placebo-controlled trial, we compared methotrexate and infliximab with infliximab alone in 126 patients with CD who had initiated prednisone induction therapy (15-40 mg/day) within the preceding 6 weeks. Patients were assigned randomly to groups given methotrexate at an initial weekly dose of 10 mg, escalating to 25 mg/week (n = 63), or placebo (n = 63). Both groups received infliximab (5 mg/kg of body weight) at weeks 1, 3, 7, and 14, and every 8 weeks thereafter. Prednisone was tapered, beginning at week 1, and discontinued no later than week 14. The primary outcome was time to treatment failure, defined as a lack of prednisone-free remission (CD Activity Index, <150) at week 14 or failure to maintain remission through week 50. Results Patients' baseline characteristics were similar between groups. By week 50, the actuarial rate of treatment failure was 30.6% in the combination therapy group compared with 29.8% in the infliximab monotherapy group (P =.63; hazard ratio, 1.16; 95% confidence interval, 0.62-2.17). Prespecified subgroup analyses failed to show a benefit in patients with short disease duration or an increased level of C-reactive protein. No clinically meaningful differences were observed in secondary outcomes. Combination therapy was well tolerated. Conclusions The combination of infliximab and methotrexate, although safe, was no more effective than infliximab alone in patients with CD receiving treatment with prednisone. ClincialTrials.gov number, NCT00132899.

Original language	English
Pages (from-to)	681-688.e1
Journal	Gastroenterology
Volume	146
Issue number	3
DOIs	https://doi.org/10.1053/j.gastro.2013.11.024
Publication status	Published - Mar 2014

Bibliographical note

Funding Information:
Conflicts of interest These authors disclose the following: Brian Feagan has received grant/research support from Millennium Pharmaceuticals, Merck, Tillotts Pharma AG, Abbott Labs, 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, Abbott Labs, Astra Zeneca, Serono, Genentech, Tillotts Pharma AG, Unity Pharmaceuticals, Albireo Pharma, Given Imaging, Inc, Salix Pharmaceuticals, Novonordisk, GlaxoSmithKline, Actogenix, Prometheus Therapeutics and Diagnostics, Athersys, Axcan, Gilead, Pfizer, Shire, Wyeth, Zealand Pharma, Zyngenia, GiCare Pharma, Inc, Sigmoid Pharma; and has served as a member of the speakers bureau for UCB, Abbott, and J&J/Janssen; John McDonald, Allan Donner, Cindy Wong, Guangyong Zou, Margaret Vandervoort, and Marybeth Hopkins are employees of Robarts Clinical Trials, which was the research organization that conducted this study; Remo Panaccione has received consultant and/or lecture fees from Abbott Laboratories, Amgen, AstraZeneca, Axcan Pharma (now Aptalis), Biogen Idec, Bristol-Myers Squibb, Centocor, ChemoCentryx, Eisai Medical Research, Inc, Elan Pharmaceuticals, Ferring, Genentech, GlaxoSmithKline, Janssen, Merck Sharp and Dohme Corp, Millennium Pharmaceuticals, Inc (now Takeda), Ocera Therapeutics, Inc, Otsuka America Pharmaceutical, Pfizer, Shire Pharmaceuticals, Prometheus Laboratories, Schering-Plough, Synta Pharmaceuticals Corp, Teva, UCB Pharma, and Warner Chilcott; Robert Enns has received research/grant support from Abbvie Canada, Aptalis Pharma, AstraZeneca, Boston Scientific, Bristol Myers Squibb, Cook Canada, Ferring, Janssen Canada Olympus, Pentax, Shire Pharmaceuticals, Takeda, UCB Pharma, Vertex, and Warner-Chilcott; Charles Bernstein has received consultant fees from Abbott Canada, Abbvie Canada, Janssen Canada, Bristol Myers Squibb, and Vertex Pharmaceuticals; and has received research grants from Abbott Canada and Abbvie Canada, and an unrestricted educational grant from Aptalis; Raymond Bourdages has received consultant and/or lecture fees from Abbott Laboratories, Aptalis, Janssen, Shire, Takeda, and Warner-Chilcott; Donald MacIntosh has received consultant and/or lecture feels from Abbott Laboratories, Centocor, and Janssen; Chrystian Dallaire has received consultant and/or lecture fees from Abbott Laboratories, Aptalis, Janssen, Shire, Merck, and Roche; Albert Cohen has received consultant and/or lecture fees from Abbvie, Janssen, and Shire, and educational grants from Abbvie and Janssen; Richard Fedorak has received consultant fees from Abbvie, Centocor, Ferring, Janssen, Shire, and VSL Pharmaceuticals; unrestricted clinical/basic research grants from Abbvie, Alba, Bristol Myers Squibb, Centocor, GlaxoSmithKline, Genentech, Janssen, Merck, Millennium, Novartis, Pfizer, Proctor & Gamble, Roche, and VSL Pharmaceuticals; and is an owner and shareholder in Metablolomic Technologies, Inc; Pierre Paré has received consultant or lecture fees from Abbott Laboratories, Forest Laboratories, Janssen, Novartis, Shire, and Warner-Chilcott; research grants from Abbott Laboratories, Glaxo, Santarus, and Shire; and advisory fees from Abbott Laboratories and Janssen; Alain Bitton has received consultant and/or lecture fees from Abbott Laboratories, Aptalis, Janssen, Shire, Takeda, and Warner-Chilcott; Fred Saibil has received consultancy and/or educational grant support from Abbott Laboratories, Aptalis, Ferring, Inc, Janssen, Shire, and Warner-Chilcott; and Gordon Greenberg has received grant/research support from UCB Pharma, Centocor, Inc, and Millennium Pharmaceuticals; and lecture/consultant fees from Janssen Canada, Merck, Prometheus Laboratories, and Abbott Laboratories.

Funding Information:
Funding Supported by the Crohn's and Colitis Foundation of America, Merck/Schering-Plough Canada, and Prometheus Laboratories, Inc.

ASJC Scopus Subject Areas

Hepatology
Gastroenterology

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10.1053/j.gastro.2013.11.024

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Feagan, B. G., McDonald, J. W. D., Panaccione, R., Enns, R. A., Bernstein, C. N., Ponich, T. P., Bourdages, R., Macintosh, D. G., Dallaire, C., Cohen, A., Fedorak, R. N., Paré, P., Bitton, A., Saibil, F., Anderson, F., Donner, A., Wong, C. J., Zou, G., Vandervoort, M. K., ... Greenberg, G. R. (2014). Methotrexate in combination with infliximab is no more effective than infliximab alone in patients with Crohn's disease. Gastroenterology, 146(3), 681-688.e1. https://doi.org/10.1053/j.gastro.2013.11.024

Feagan, BG, McDonald, JWD, Panaccione, R, Enns, RA, Bernstein, CN, Ponich, TP, Bourdages, R, Macintosh, DG, Dallaire, C, Cohen, A, Fedorak, RN, Paré, P, Bitton, A, Saibil, F, Anderson, F, Donner, A, Wong, CJ, Zou, G, Vandervoort, MK, Hopkins, M & Greenberg, GR 2014, 'Methotrexate in combination with infliximab is no more effective than infliximab alone in patients with Crohn's disease', Gastroenterology, vol. 146, no. 3, pp. 681-688.e1. https://doi.org/10.1053/j.gastro.2013.11.024

@article{1c0836adddfe402d85f703621bd43b41,

title = "Methotrexate in combination with infliximab is no more effective than infliximab alone in patients with Crohn's disease",

abstract = "Background & Aims Methotrexate and infliximab are effective therapies for Crohn's disease (CD). In the combination of maintenance methotrexate- infliximab trial, we evaluated the potential superiority of combination therapy over infliximab alone. Methods In a 50-week, double-blind, placebo-controlled trial, we compared methotrexate and infliximab with infliximab alone in 126 patients with CD who had initiated prednisone induction therapy (15-40 mg/day) within the preceding 6 weeks. Patients were assigned randomly to groups given methotrexate at an initial weekly dose of 10 mg, escalating to 25 mg/week (n = 63), or placebo (n = 63). Both groups received infliximab (5 mg/kg of body weight) at weeks 1, 3, 7, and 14, and every 8 weeks thereafter. Prednisone was tapered, beginning at week 1, and discontinued no later than week 14. The primary outcome was time to treatment failure, defined as a lack of prednisone-free remission (CD Activity Index, <150) at week 14 or failure to maintain remission through week 50. Results Patients' baseline characteristics were similar between groups. By week 50, the actuarial rate of treatment failure was 30.6% in the combination therapy group compared with 29.8% in the infliximab monotherapy group (P =.63; hazard ratio, 1.16; 95% confidence interval, 0.62-2.17). Prespecified subgroup analyses failed to show a benefit in patients with short disease duration or an increased level of C-reactive protein. No clinically meaningful differences were observed in secondary outcomes. Combination therapy was well tolerated. Conclusions The combination of infliximab and methotrexate, although safe, was no more effective than infliximab alone in patients with CD receiving treatment with prednisone. ClincialTrials.gov number, NCT00132899.",

author = "Feagan, {Brian G.} and McDonald, {John W.D.} and Remo Panaccione and Enns, {Robert A.} and Bernstein, {Charles N.} and Ponich, {Terry P.} and Raymond Bourdages and Macintosh, {Donald G.} and Chrystian Dallaire and Albert Cohen and Fedorak, {Richard N.} and Pierre Par{\'e} and Alain Bitton and Fred Saibil and Frank Anderson and Allan Donner and Wong, {Cindy J.} and Guangyong Zou and Vandervoort, {Margaret K.} and Marybeth Hopkins and Greenberg, {Gordon R.}",

note = "Funding Information: Conflicts of interest These authors disclose the following: Brian Feagan has received grant/research support from Millennium Pharmaceuticals, Merck, Tillotts Pharma AG, Abbott Labs, 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, Abbott Labs, Astra Zeneca, Serono, Genentech, Tillotts Pharma AG, Unity Pharmaceuticals, Albireo Pharma, Given Imaging, Inc, Salix Pharmaceuticals, Novonordisk, GlaxoSmithKline, Actogenix, Prometheus Therapeutics and Diagnostics, Athersys, Axcan, Gilead, Pfizer, Shire, Wyeth, Zealand Pharma, Zyngenia, GiCare Pharma, Inc, Sigmoid Pharma; and has served as a member of the speakers bureau for UCB, Abbott, and J&J/Janssen; John McDonald, Allan Donner, Cindy Wong, Guangyong Zou, Margaret Vandervoort, and Marybeth Hopkins are employees of Robarts Clinical Trials, which was the research organization that conducted this study; Remo Panaccione has received consultant and/or lecture fees from Abbott Laboratories, Amgen, AstraZeneca, Axcan Pharma (now Aptalis), Biogen Idec, Bristol-Myers Squibb, Centocor, ChemoCentryx, Eisai Medical Research, Inc, Elan Pharmaceuticals, Ferring, Genentech, GlaxoSmithKline, Janssen, Merck Sharp and Dohme Corp, Millennium Pharmaceuticals, Inc (now Takeda), Ocera Therapeutics, Inc, Otsuka America Pharmaceutical, Pfizer, Shire Pharmaceuticals, Prometheus Laboratories, Schering-Plough, Synta Pharmaceuticals Corp, Teva, UCB Pharma, and Warner Chilcott; Robert Enns has received research/grant support from Abbvie Canada, Aptalis Pharma, AstraZeneca, Boston Scientific, Bristol Myers Squibb, Cook Canada, Ferring, Janssen Canada Olympus, Pentax, Shire Pharmaceuticals, Takeda, UCB Pharma, Vertex, and Warner-Chilcott; Charles Bernstein has received consultant fees from Abbott Canada, Abbvie Canada, Janssen Canada, Bristol Myers Squibb, and Vertex Pharmaceuticals; and has received research grants from Abbott Canada and Abbvie Canada, and an unrestricted educational grant from Aptalis; Raymond Bourdages has received consultant and/or lecture fees from Abbott Laboratories, Aptalis, Janssen, Shire, Takeda, and Warner-Chilcott; Donald MacIntosh has received consultant and/or lecture feels from Abbott Laboratories, Centocor, and Janssen; Chrystian Dallaire has received consultant and/or lecture fees from Abbott Laboratories, Aptalis, Janssen, Shire, Merck, and Roche; Albert Cohen has received consultant and/or lecture fees from Abbvie, Janssen, and Shire, and educational grants from Abbvie and Janssen; Richard Fedorak has received consultant fees from Abbvie, Centocor, Ferring, Janssen, Shire, and VSL Pharmaceuticals; unrestricted clinical/basic research grants from Abbvie, Alba, Bristol Myers Squibb, Centocor, GlaxoSmithKline, Genentech, Janssen, Merck, Millennium, Novartis, Pfizer, Proctor & Gamble, Roche, and VSL Pharmaceuticals; and is an owner and shareholder in Metablolomic Technologies, Inc; Pierre Par{\'e} has received consultant or lecture fees from Abbott Laboratories, Forest Laboratories, Janssen, Novartis, Shire, and Warner-Chilcott; research grants from Abbott Laboratories, Glaxo, Santarus, and Shire; and advisory fees from Abbott Laboratories and Janssen; Alain Bitton has received consultant and/or lecture fees from Abbott Laboratories, Aptalis, Janssen, Shire, Takeda, and Warner-Chilcott; Fred Saibil has received consultancy and/or educational grant support from Abbott Laboratories, Aptalis, Ferring, Inc, Janssen, Shire, and Warner-Chilcott; and Gordon Greenberg has received grant/research support from UCB Pharma, Centocor, Inc, and Millennium Pharmaceuticals; and lecture/consultant fees from Janssen Canada, Merck, Prometheus Laboratories, and Abbott Laboratories. Funding Information: Funding Supported by the Crohn's and Colitis Foundation of America, Merck/Schering-Plough Canada, and Prometheus Laboratories, Inc. ",

year = "2014",

month = mar,

doi = "10.1053/j.gastro.2013.11.024",

language = "English",

volume = "146",

pages = "681--688.e1",

journal = "Gastroenterology",

issn = "0016-5085",

publisher = "W.B. Saunders Ltd",

number = "3",

}

TY - JOUR

T1 - Methotrexate in combination with infliximab is no more effective than infliximab alone in patients with Crohn's disease

AU - Feagan, Brian G.

AU - McDonald, John W.D.

AU - Panaccione, Remo

AU - Enns, Robert A.

AU - Bernstein, Charles N.

AU - Ponich, Terry P.

AU - Bourdages, Raymond

AU - Macintosh, Donald G.

AU - Dallaire, Chrystian

AU - Cohen, Albert

AU - Fedorak, Richard N.

AU - Paré, Pierre

AU - Bitton, Alain

AU - Saibil, Fred

AU - Anderson, Frank

AU - Donner, Allan

AU - Wong, Cindy J.

AU - Zou, Guangyong

AU - Vandervoort, Margaret K.

AU - Hopkins, Marybeth

AU - Greenberg, Gordon R.

N1 - Funding Information: Conflicts of interest These authors disclose the following: Brian Feagan has received grant/research support from Millennium Pharmaceuticals, Merck, Tillotts Pharma AG, Abbott Labs, 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, Abbott Labs, Astra Zeneca, Serono, Genentech, Tillotts Pharma AG, Unity Pharmaceuticals, Albireo Pharma, Given Imaging, Inc, Salix Pharmaceuticals, Novonordisk, GlaxoSmithKline, Actogenix, Prometheus Therapeutics and Diagnostics, Athersys, Axcan, Gilead, Pfizer, Shire, Wyeth, Zealand Pharma, Zyngenia, GiCare Pharma, Inc, Sigmoid Pharma; and has served as a member of the speakers bureau for UCB, Abbott, and J&J/Janssen; John McDonald, Allan Donner, Cindy Wong, Guangyong Zou, Margaret Vandervoort, and Marybeth Hopkins are employees of Robarts Clinical Trials, which was the research organization that conducted this study; Remo Panaccione has received consultant and/or lecture fees from Abbott Laboratories, Amgen, AstraZeneca, Axcan Pharma (now Aptalis), Biogen Idec, Bristol-Myers Squibb, Centocor, ChemoCentryx, Eisai Medical Research, Inc, Elan Pharmaceuticals, Ferring, Genentech, GlaxoSmithKline, Janssen, Merck Sharp and Dohme Corp, Millennium Pharmaceuticals, Inc (now Takeda), Ocera Therapeutics, Inc, Otsuka America Pharmaceutical, Pfizer, Shire Pharmaceuticals, Prometheus Laboratories, Schering-Plough, Synta Pharmaceuticals Corp, Teva, UCB Pharma, and Warner Chilcott; Robert Enns has received research/grant support from Abbvie Canada, Aptalis Pharma, AstraZeneca, Boston Scientific, Bristol Myers Squibb, Cook Canada, Ferring, Janssen Canada Olympus, Pentax, Shire Pharmaceuticals, Takeda, UCB Pharma, Vertex, and Warner-Chilcott; Charles Bernstein has received consultant fees from Abbott Canada, Abbvie Canada, Janssen Canada, Bristol Myers Squibb, and Vertex Pharmaceuticals; and has received research grants from Abbott Canada and Abbvie Canada, and an unrestricted educational grant from Aptalis; Raymond Bourdages has received consultant and/or lecture fees from Abbott Laboratories, Aptalis, Janssen, Shire, Takeda, and Warner-Chilcott; Donald MacIntosh has received consultant and/or lecture feels from Abbott Laboratories, Centocor, and Janssen; Chrystian Dallaire has received consultant and/or lecture fees from Abbott Laboratories, Aptalis, Janssen, Shire, Merck, and Roche; Albert Cohen has received consultant and/or lecture fees from Abbvie, Janssen, and Shire, and educational grants from Abbvie and Janssen; Richard Fedorak has received consultant fees from Abbvie, Centocor, Ferring, Janssen, Shire, and VSL Pharmaceuticals; unrestricted clinical/basic research grants from Abbvie, Alba, Bristol Myers Squibb, Centocor, GlaxoSmithKline, Genentech, Janssen, Merck, Millennium, Novartis, Pfizer, Proctor & Gamble, Roche, and VSL Pharmaceuticals; and is an owner and shareholder in Metablolomic Technologies, Inc; Pierre Paré has received consultant or lecture fees from Abbott Laboratories, Forest Laboratories, Janssen, Novartis, Shire, and Warner-Chilcott; research grants from Abbott Laboratories, Glaxo, Santarus, and Shire; and advisory fees from Abbott Laboratories and Janssen; Alain Bitton has received consultant and/or lecture fees from Abbott Laboratories, Aptalis, Janssen, Shire, Takeda, and Warner-Chilcott; Fred Saibil has received consultancy and/or educational grant support from Abbott Laboratories, Aptalis, Ferring, Inc, Janssen, Shire, and Warner-Chilcott; and Gordon Greenberg has received grant/research support from UCB Pharma, Centocor, Inc, and Millennium Pharmaceuticals; and lecture/consultant fees from Janssen Canada, Merck, Prometheus Laboratories, and Abbott Laboratories. Funding Information: Funding Supported by the Crohn's and Colitis Foundation of America, Merck/Schering-Plough Canada, and Prometheus Laboratories, Inc.

PY - 2014/3

Y1 - 2014/3

N2 - Background & Aims Methotrexate and infliximab are effective therapies for Crohn's disease (CD). In the combination of maintenance methotrexate- infliximab trial, we evaluated the potential superiority of combination therapy over infliximab alone. Methods In a 50-week, double-blind, placebo-controlled trial, we compared methotrexate and infliximab with infliximab alone in 126 patients with CD who had initiated prednisone induction therapy (15-40 mg/day) within the preceding 6 weeks. Patients were assigned randomly to groups given methotrexate at an initial weekly dose of 10 mg, escalating to 25 mg/week (n = 63), or placebo (n = 63). Both groups received infliximab (5 mg/kg of body weight) at weeks 1, 3, 7, and 14, and every 8 weeks thereafter. Prednisone was tapered, beginning at week 1, and discontinued no later than week 14. The primary outcome was time to treatment failure, defined as a lack of prednisone-free remission (CD Activity Index, <150) at week 14 or failure to maintain remission through week 50. Results Patients' baseline characteristics were similar between groups. By week 50, the actuarial rate of treatment failure was 30.6% in the combination therapy group compared with 29.8% in the infliximab monotherapy group (P =.63; hazard ratio, 1.16; 95% confidence interval, 0.62-2.17). Prespecified subgroup analyses failed to show a benefit in patients with short disease duration or an increased level of C-reactive protein. No clinically meaningful differences were observed in secondary outcomes. Combination therapy was well tolerated. Conclusions The combination of infliximab and methotrexate, although safe, was no more effective than infliximab alone in patients with CD receiving treatment with prednisone. ClincialTrials.gov number, NCT00132899.

AB - Background & Aims Methotrexate and infliximab are effective therapies for Crohn's disease (CD). In the combination of maintenance methotrexate- infliximab trial, we evaluated the potential superiority of combination therapy over infliximab alone. Methods In a 50-week, double-blind, placebo-controlled trial, we compared methotrexate and infliximab with infliximab alone in 126 patients with CD who had initiated prednisone induction therapy (15-40 mg/day) within the preceding 6 weeks. Patients were assigned randomly to groups given methotrexate at an initial weekly dose of 10 mg, escalating to 25 mg/week (n = 63), or placebo (n = 63). Both groups received infliximab (5 mg/kg of body weight) at weeks 1, 3, 7, and 14, and every 8 weeks thereafter. Prednisone was tapered, beginning at week 1, and discontinued no later than week 14. The primary outcome was time to treatment failure, defined as a lack of prednisone-free remission (CD Activity Index, <150) at week 14 or failure to maintain remission through week 50. Results Patients' baseline characteristics were similar between groups. By week 50, the actuarial rate of treatment failure was 30.6% in the combination therapy group compared with 29.8% in the infliximab monotherapy group (P =.63; hazard ratio, 1.16; 95% confidence interval, 0.62-2.17). Prespecified subgroup analyses failed to show a benefit in patients with short disease duration or an increased level of C-reactive protein. No clinically meaningful differences were observed in secondary outcomes. Combination therapy was well tolerated. Conclusions The combination of infliximab and methotrexate, although safe, was no more effective than infliximab alone in patients with CD receiving treatment with prednisone. ClincialTrials.gov number, NCT00132899.

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Methotrexate in combination with infliximab is no more effective than infliximab alone in patients with Crohn's disease

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