Journal article
Methotrexate Is Not Superior to Placebo in Maintaining Steroid-Free Response or Remission in Ulcerative Colitis
Gastroenterology (New York, N.Y. 1943), Vol.155(4), pp.1098-1108.e9
10/01/2018
DOI: 10.1053/j.gastro.2018.06.046
PMCID: PMC6174092
PMID: 29964043
Abstract
BACKGROUND & AIMS: Parenteral methotrexate induces clinical remission but not endoscopic improvement of mucosal inflammation in patients with ulcerative colitis (UC). We performed a randomized, placebo-controlled trial to assess the efficacy of parenteral methotrexate in maintaining steroid-free response or remission in patients with UC after induction therapy with methotrexate and steroids. METHODS: We performed a 48-week trial, from February 2012 through May 2016, of 179 patients with active UC (Mayo score of 6-12 with endoscopy subscore >= 2) despite previous conventional or biological therapy. The study comprised a 16-week open label methotrexate induction period followed by a 32-week double-blind, placebo-controlled maintenance period. Patients were given subcutaneous methotrexate (25 mg/wk) and a 12-week steroid taper. At week 16, steroid-free responders were randomly assigned to groups that either continued methotrexate (25 mg/wk, n = 44) or were given placebo (n = 40) until week 48. We compared the efficacy of treatment by analyzing the proportion of patients who remained relapse free and were in remission at week 48 without use of steroids or other medications to control disease activity. RESULTS: Ninety-one patients (51%) achieved response at week 16, and 84 patients were included in the maintenance period study. During this period, 60% of patients in the placebo group (24/40) and 66% in the methotrexate group (29/44) had a relapse of UC (P = .75). At week 48, 30% of patients in the placebo group (12/40) and 27% of patients in the methotrexate group (12/44) were in steroid-free clinical remission without need for additional therapies (P = .86). No new safety signals for methotrexate were detected. CONCLUSIONS: Parenteral methotrexate (25 mg/wk) was not superior to placebo in preventing relapses of UC in patients who achieved steroid-free response during induction therapy. ClinicalTrials.gov, Number: NCT01393405.
Details
- Title: Subtitle
- Methotrexate Is Not Superior to Placebo in Maintaining Steroid-Free Response or Remission in Ulcerative Colitis
- Creators
- Hans Herfarth - University of North Carolina at Chapel HillEdward L. Barnes - University of North Carolina at Chapel HillJohn F. Valentine - University of UtahJohn Hanson - Atrium Health, Charlotte, North Carolina.Peter D. R. Higgins - University of Michigan–Ann ArborKim L. Isaacs - University of North Carolina at Chapel HillSusan Jackson - University of North Carolina at Chapel HillMark T. Osterman - University of PennsylvaniaKristen Anton - University of North Carolina at Chapel HillAnastasia Ivanova - University of North Carolina at Chapel HillMillie D. Long - University of North Carolina at Chapel HillChristopher Martin - University of North Carolina at Chapel HillRobert S. Sandler - University of North Carolina at Chapel HillBincy Abraham - Methodist HospitalRaymond K. Cross - University of Maryland, BaltimoreGerald Dryden - University of LouisvilleMonika Fischer - Indiana University – Purdue University IndianapolisWilliam Harlan - Asheville Cardiology AssociatesCampbell Levy - Dartmouth–Hitchcock Medical CenterRobert McCabe - Minnesota GastroenterologySteven Polyak - University of IowaSumona Saha - University of Wisconsin–MadisonEmmanuelle Williams - Penn State Milton S. Hershey Medical CenterVijay Yajnik - Massachusetts General HospitalJose Serrano - National Institute of Diabetes and Digestive and Kidney DiseasesBruce E. Sands - Icahn School of Medicine at Mount SinaiJames D. Lewis - University of PennsylvaniaClinical Research Alliance of the Crohn’s and Colitis Foundation
- Resource Type
- Journal article
- Publication Details
- Gastroenterology (New York, N.Y. 1943), Vol.155(4), pp.1098-1108.e9
- Publisher
- Elsevier
- DOI
- 10.1053/j.gastro.2018.06.046
- PMID
- 29964043
- PMCID
- PMC6174092
- ISSN
- 0016-5085
- eISSN
- 1528-0012
- Number of pages
- 20
- Grant note
- P30 DK034987 / Crohn's and Colitis Foundation P30 DK034987 / National Institutes of Health; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA U01DK092239 / NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK) U01DK092239 / National Institute of Diabetes and Digestive Kidney Diseases; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK)
- Language
- English
- Date published
- 10/01/2018
- Academic Unit
- Internal Medicine
- Record Identifier
- 9984359958502771
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