Methotrexate in Crohn's disease: Results of a randomized, double-blind, placebo-controlled trial

Sanjeev Arora, William Katkov, Jeffery Cooley, James Alan Kemp, David E. Johnston, Robert H. Schapiro, Daniel Podolsky

Research output: Contribution to journalArticle

124 Citations (Scopus)

Abstract

BACKGROUND/AIMS: Immunosuppression with methotrexate may be useful in the treatment of Crohn's disease. We tested the efficacy of methotrexate in refractory Crohn's disease in a randomized, controlled trial. METHODOLOGY: Randomized, double-blind placebo-controlled trial of methotrexate in 33 patients with steroid-dependent Crohn's disease, 33% of whom had previously failed therapy with 6-mercaptopurine. Patients were given placebo or oral methotrexate 15 mg/week, or adjusted up to 22.5 mg/week, for up to 1 year or until treatment failure. Outcome was assessed by reduction in prednisone dosage, Crohn's Disease Activity Index, hospital admission, and laboratory parameters. RESULTS: Four patients were dropped from the study for non-compliance and one because of intercurrent illness, and 28 patients could be evaluated. Fewer methotrexate-treated patients (6/13 or 46%) had flares of Crohn's disease as compared to placebo-treated patients (12/15 or 80%), but this did not achieve statistical significance (p < 0.1). There was a non-significant trend toward an increased number of significant side effects in the methotrexate-treated patients (3/13 or 23%) as compared to the placebo-treated patients (0/15 or 0%) (p < 0.2). Laboratory indices of inflammation did not differ between the two groups. CONCLUSIONS: The methotrexate-treated group showed a trend toward fewer Crohn's disease flares, balanced by an increased number of significant side effects.

Original languageEnglish (US)
Pages (from-to)1724-1729
Number of pages6
JournalHepato-Gastroenterology
Volume46
Issue number27
StatePublished - 1999

Fingerprint

Methotrexate
Crohn Disease
Placebos
6-Mercaptopurine
Hospital Laboratories
Prednisone
Treatment Failure
Immunosuppression
Randomized Controlled Trials
Steroids
Inflammation
Therapeutics

Keywords

  • Crohn's disease
  • Methotrexate

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Arora, S., Katkov, W., Cooley, J., Kemp, J. A., Johnston, D. E., Schapiro, R. H., & Podolsky, D. (1999). Methotrexate in Crohn's disease: Results of a randomized, double-blind, placebo-controlled trial. Hepato-Gastroenterology, 46(27), 1724-1729.

Methotrexate in Crohn's disease : Results of a randomized, double-blind, placebo-controlled trial. / Arora, Sanjeev; Katkov, William; Cooley, Jeffery; Kemp, James Alan; Johnston, David E.; Schapiro, Robert H.; Podolsky, Daniel.

In: Hepato-Gastroenterology, Vol. 46, No. 27, 1999, p. 1724-1729.

Research output: Contribution to journalArticle

Arora, S, Katkov, W, Cooley, J, Kemp, JA, Johnston, DE, Schapiro, RH & Podolsky, D 1999, 'Methotrexate in Crohn's disease: Results of a randomized, double-blind, placebo-controlled trial', Hepato-Gastroenterology, vol. 46, no. 27, pp. 1724-1729.
Arora S, Katkov W, Cooley J, Kemp JA, Johnston DE, Schapiro RH et al. Methotrexate in Crohn's disease: Results of a randomized, double-blind, placebo-controlled trial. Hepato-Gastroenterology. 1999;46(27):1724-1729.
Arora, Sanjeev ; Katkov, William ; Cooley, Jeffery ; Kemp, James Alan ; Johnston, David E. ; Schapiro, Robert H. ; Podolsky, Daniel. / Methotrexate in Crohn's disease : Results of a randomized, double-blind, placebo-controlled trial. In: Hepato-Gastroenterology. 1999 ; Vol. 46, No. 27. pp. 1724-1729.
@article{fe1c3f6eb6914fbd9213d732470640be,
title = "Methotrexate in Crohn's disease: Results of a randomized, double-blind, placebo-controlled trial",
abstract = "BACKGROUND/AIMS: Immunosuppression with methotrexate may be useful in the treatment of Crohn's disease. We tested the efficacy of methotrexate in refractory Crohn's disease in a randomized, controlled trial. METHODOLOGY: Randomized, double-blind placebo-controlled trial of methotrexate in 33 patients with steroid-dependent Crohn's disease, 33{\%} of whom had previously failed therapy with 6-mercaptopurine. Patients were given placebo or oral methotrexate 15 mg/week, or adjusted up to 22.5 mg/week, for up to 1 year or until treatment failure. Outcome was assessed by reduction in prednisone dosage, Crohn's Disease Activity Index, hospital admission, and laboratory parameters. RESULTS: Four patients were dropped from the study for non-compliance and one because of intercurrent illness, and 28 patients could be evaluated. Fewer methotrexate-treated patients (6/13 or 46{\%}) had flares of Crohn's disease as compared to placebo-treated patients (12/15 or 80{\%}), but this did not achieve statistical significance (p < 0.1). There was a non-significant trend toward an increased number of significant side effects in the methotrexate-treated patients (3/13 or 23{\%}) as compared to the placebo-treated patients (0/15 or 0{\%}) (p < 0.2). Laboratory indices of inflammation did not differ between the two groups. CONCLUSIONS: The methotrexate-treated group showed a trend toward fewer Crohn's disease flares, balanced by an increased number of significant side effects.",
keywords = "Crohn's disease, Methotrexate",
author = "Sanjeev Arora and William Katkov and Jeffery Cooley and Kemp, {James Alan} and Johnston, {David E.} and Schapiro, {Robert H.} and Daniel Podolsky",
year = "1999",
language = "English (US)",
volume = "46",
pages = "1724--1729",
journal = "Acta hepato-splenologica",
issn = "0172-6390",
publisher = "H.G.E. Update Medical Publishing Ltd.",
number = "27",

}

TY - JOUR

T1 - Methotrexate in Crohn's disease

T2 - Results of a randomized, double-blind, placebo-controlled trial

AU - Arora, Sanjeev

AU - Katkov, William

AU - Cooley, Jeffery

AU - Kemp, James Alan

AU - Johnston, David E.

AU - Schapiro, Robert H.

AU - Podolsky, Daniel

PY - 1999

Y1 - 1999

N2 - BACKGROUND/AIMS: Immunosuppression with methotrexate may be useful in the treatment of Crohn's disease. We tested the efficacy of methotrexate in refractory Crohn's disease in a randomized, controlled trial. METHODOLOGY: Randomized, double-blind placebo-controlled trial of methotrexate in 33 patients with steroid-dependent Crohn's disease, 33% of whom had previously failed therapy with 6-mercaptopurine. Patients were given placebo or oral methotrexate 15 mg/week, or adjusted up to 22.5 mg/week, for up to 1 year or until treatment failure. Outcome was assessed by reduction in prednisone dosage, Crohn's Disease Activity Index, hospital admission, and laboratory parameters. RESULTS: Four patients were dropped from the study for non-compliance and one because of intercurrent illness, and 28 patients could be evaluated. Fewer methotrexate-treated patients (6/13 or 46%) had flares of Crohn's disease as compared to placebo-treated patients (12/15 or 80%), but this did not achieve statistical significance (p < 0.1). There was a non-significant trend toward an increased number of significant side effects in the methotrexate-treated patients (3/13 or 23%) as compared to the placebo-treated patients (0/15 or 0%) (p < 0.2). Laboratory indices of inflammation did not differ between the two groups. CONCLUSIONS: The methotrexate-treated group showed a trend toward fewer Crohn's disease flares, balanced by an increased number of significant side effects.

AB - BACKGROUND/AIMS: Immunosuppression with methotrexate may be useful in the treatment of Crohn's disease. We tested the efficacy of methotrexate in refractory Crohn's disease in a randomized, controlled trial. METHODOLOGY: Randomized, double-blind placebo-controlled trial of methotrexate in 33 patients with steroid-dependent Crohn's disease, 33% of whom had previously failed therapy with 6-mercaptopurine. Patients were given placebo or oral methotrexate 15 mg/week, or adjusted up to 22.5 mg/week, for up to 1 year or until treatment failure. Outcome was assessed by reduction in prednisone dosage, Crohn's Disease Activity Index, hospital admission, and laboratory parameters. RESULTS: Four patients were dropped from the study for non-compliance and one because of intercurrent illness, and 28 patients could be evaluated. Fewer methotrexate-treated patients (6/13 or 46%) had flares of Crohn's disease as compared to placebo-treated patients (12/15 or 80%), but this did not achieve statistical significance (p < 0.1). There was a non-significant trend toward an increased number of significant side effects in the methotrexate-treated patients (3/13 or 23%) as compared to the placebo-treated patients (0/15 or 0%) (p < 0.2). Laboratory indices of inflammation did not differ between the two groups. CONCLUSIONS: The methotrexate-treated group showed a trend toward fewer Crohn's disease flares, balanced by an increased number of significant side effects.

KW - Crohn's disease

KW - Methotrexate

UR - http://www.scopus.com/inward/record.url?scp=0009447497&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0009447497&partnerID=8YFLogxK

M3 - Article

C2 - 10430331

AN - SCOPUS:0009447497

VL - 46

SP - 1724

EP - 1729

JO - Acta hepato-splenologica

JF - Acta hepato-splenologica

SN - 0172-6390

IS - 27

ER -