Methotrexate in chronic active ulcerative colitis: A double-blind, randomized, Israeli multicenter trial

Oren, Ran; Arber, Nadir; Odes, Shmuel; Moshkowitz, Menachem; Keter, Daniel; Pomeranz, I; Ron, Yishai; Reisfeld, I; Broide, E; Lavy, Alexandra; Fich, Alexander; Eliakim, R; Patz, Julian; Bardan, Eytan; Villa, Yael; Gilat, Tuvia

doi:10.1053/gast.1996.v110.pm8613046

Cited by 289 publications

(164 citation statements)

References 5 publications

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“…16 In contrast, low-dose oral methotrexate has been associated with low response rates. 16 The only randomized, placebo-controlled trial of methotrexate performed in UC tested oral methotrexate at a dosage of 12.5 mg weekly 11 No difference in efficacy was demonstrated between methotrexate and placebo. In CD, the bioavailability of oral methotrexate plateaus at approximately 15 mg/wk, and with subcutaneous administration, it increases linearly at higher dosages.…”

Section: Discussionmentioning

confidence: 99%

“…9,10 A Cochrane review concludes that there is insufficient evidence to support the use of methotrexate for induction or maintenance of remission in UC, although the only included controlled trial used an oral dosage of 12.5 mg/wk. 11,12 We therefore conducted a multicenter, controlled, randomized, double-blind study of parenteral methotrexate in patients with steroid-dependent UC.…”

mentioning

confidence: 99%

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Methotrexate Is Not Superior to Placebo for Inducing Steroid-Free Remission, but Induces Steroid-Free Clinical Remission in a Larger Proportion of Patients With Ulcerative Colitis

et al. 2016

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Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

Methotrexate Is Not Superior to Placebo for Inducing Steroid-Free Remission, but Induces Steroid-Free Clinical Remission in a Larger Proportion of Patients With Ulcerative Colitis

et al. 2016

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“…A North American group reported that this drug, given once a week as a 25 mg intramuscular injection, was superior to placebo in improving symptoms (remission rates at 16 weeks 40% and 20%, respectively) and reducing requirements for prednisone in steroid-dependent CD [32] . In chronic steroid-dependent UC, in contrast, a lower dose of methotrexate (12.5 mg), given orally once weekly, was no more effective than placebo in the induction of remission or its maintenance over a 9 month period [33] . Whether use of methotrexate in IBD becomes widespread will depend on the success of rival agents with fewer side-effects.…”

Section: Methotrexatementioning

confidence: 87%

New treatments for inflammatory bowel disease

S¹

1998

WJG

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“…[39][40][41][42][43][44][45][46][47][48][49][50][51][52][53][54][55][56][57][58] All 20 studies reported a mean age. The composite mean age was 38.5 years, with a mean range of 30.5 to 46.4 years.…”

Section: Immunosuppressant Age Summationmentioning

confidence: 99%

Treatment of Ulcerative Colitis in the Elderly: A Systematic Review

Baggenstos

Hanson²,

Shaukat

2013

Clinical Medicine Insights: Geriatrics

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Ulcerative colitis (UC) is increasingly recognized as a disease affecting the elderly. Approximately 10%-30% of the UC population is over the age of 60 years. Additionally, younger patients with UC are aging and thus comprise a second group of elderly IBD patients. To date, there have been no clinical trials that have evaluated treatment efficacy of UC in the elderly population. The aim of our study was to conduct a systematic review of all randomized controlled trials (RCTs) addressing treatment outcome in UC; we also sought to identify the elderly population, defined as age 60 years or older, represented in these studies, to see if pooled data would lead to meaningful conclusions regarding treatment efficacy and safety profile in the elderly. A search of the MEDLINE database via PubMed and the EMBASE database via Scopus was performed to identify all RCTs evaluating medical therapy for UC in humans, published within the English language through September 2012. Studies were grouped into three categories: biological agent (BA) therapy; immunosuppressant (IS) therapy; and 5-aminosalicylic acid (5-ASA) therapy. To estimate the number of elderly patients in each study, mean age plus 1 and 2 standard deviations (SD) was calculated to find the closest approximation to age 60. Of 876 studies, 112 RCTs were included in the final analysis-20 studies for BA, 20 for IS, and 72 for 5-ASA agents. While nearly all studies reported either a mean or median age, only 38% additionally reported the SD and age range. The mean composite age was 39.2 years for the BA studies, 38.5 years for the IS studies, and 42.8 years for the 5-ASA studies, consistent with a young middle-aged patient. We estimated that no more than 16% of patients per study would have qualified as elderly, and in most cases a much smaller percentage (,8%). Additionally, there were no BA or IS RCTs that reported results by age subgroup analysis. Four studies in the 5-ASA group report age-specific analyses and showed no difference in treatment efficacy by age. None of the 112 RCTs reported age sub-analyses of safety, tolerability, adverse events, or withdrawal rates. There is insufficient evidence to evaluate efficacy of treatment and adverse events from treatment for UC in the elderly. With the rising number of elderly patients with UC, there is a need for more clinical trials that specifically address UC treatment in this unique population.

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Methotrexate in chronic active ulcerative colitis: A double-blind, randomized, Israeli multicenter trial

Cited by 289 publications

References 5 publications

Methotrexate Is Not Superior to Placebo for Inducing Steroid-Free Remission, but Induces Steroid-Free Clinical Remission in a Larger Proportion of Patients With Ulcerative Colitis

Methotrexate Is Not Superior to Placebo for Inducing Steroid-Free Remission, but Induces Steroid-Free Clinical Remission in a Larger Proportion of Patients With Ulcerative Colitis

New treatments for inflammatory bowel disease

Treatment of Ulcerative Colitis in the Elderly: A Systematic Review

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