Literature DB >> 31150157

Low-Dose Methotrexate and Mucocutaneous Adverse Events: Results of a Systematic Literature Review and Meta-Analysis of Randomized Controlled Trials.

Riyana Lalani1, Houchen Lyu2, Kathleen Vanni3, Daniel H Solomon3.   

Abstract

OBJECTIVE: Methotrexate (MTX) increases the risk of alopecia and stomatitis, but the prevalence of these adverse events among rheumatic patients taking MTX is poorly defined. We conducted a systematic literature review and meta-analysis to estimate the prevalence of alopecia and stomatitis with MTX in rheumatic diseases.
METHODS: We searched PubMed, The Cochrane Library, and CINAHL databases for double-blind randomized controlled trials (RCTs) with an MTX monotherapy arm. Alopecia, stomatitis, and oral/mouth ulcers data were extracted. The quality of trials was assessed by 2 authors. We included trials published since 1990 that used at least 10 mg of MTX weekly, coadministered with folic or folinic acid. We estimated the prevalence using random-effects models because heterogeneity was anticipated. Two estimates of prevalence were included; the lower bound estimate included all trials (assuming no alopecia and stomatitis if not mentioned), and the upper bound estimate included only those that specifically described prevalence estimates of alopecia or stomatitis.
RESULTS: Of 3,954 studies identified, 20 RCTs were included, with a total of 24 MTX monotherapy arms, of which 10 reported the prevalence of alopecia (n = 1,113), and 21 reported stomatitis or mouth/oral ulcers (n = 2,056). The prevalence of alopecia was between 1.0% and 4.9%. The prevalence of stomatitis was between 5.7% and 8.0%.
CONCLUSION: This meta-analysis gives more precise estimates of mucocutaneous adverse events that occur in rheumatic disease patients taking MTX. These estimates will help inform patient decision-making regarding MTX.
© 2019, American College of Rheumatology.

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Year:  2020        PMID: 31150157      PMCID: PMC6885092          DOI: 10.1002/acr.23999

Source DB:  PubMed          Journal:  Arthritis Care Res (Hoboken)        ISSN: 2151-464X            Impact factor:   4.794


  28 in total

1.  A comparison of etanercept and methotrexate in patients with early rheumatoid arthritis.

Authors:  J M Bathon; R W Martin; R M Fleischmann; J R Tesser; M H Schiff; E C Keystone; M C Genovese; M C Wasko; L W Moreland; A L Weaver; J Markenson; B K Finck
Journal:  N Engl J Med       Date:  2000-11-30       Impact factor: 91.245

2.  A 48-week, randomized, double-blind, double-observer, placebo-controlled multicenter trial of combination methotrexate and intramuscular gold therapy in rheumatoid arthritis: results of the METGO study.

Authors:  Allen J Lehman; John M Esdaile; Alice V Klinkhoff; Eric Grant; Avril Fitzgerald; Janice Canvin
Journal:  Arthritis Rheum       Date:  2005-05

3.  A randomized, double-blind, parallel, single-site pilot trial to compare two different starting doses of methotrexate in methotrexate-naïve adult patients with rheumatoid arthritis.

Authors:  Eva-Luise Hobl; Robert M Mader; Bernd Jilma; Bernhard Duhm; Monika Mustak; Hans Bröll; Petra Högger; Ludwig Erlacher
Journal:  Clin Ther       Date:  2012-04-18       Impact factor: 3.393

4.  Comparison of the clinical efficacy and safety of subcutaneous versus oral administration of methotrexate in patients with active rheumatoid arthritis: results of a six-month, multicenter, randomized, double-blind, controlled, phase IV trial.

Authors:  J Braun; P Kästner; P Flaxenberg; J Währisch; P Hanke; W Demary; U von Hinüber; K Rockwitz; W Heitz; U Pichlmeier; C Guimbal-Schmolck; A Brandt
Journal:  Arthritis Rheum       Date:  2008-01

5.  A comparison study of a recombinant tumor necrosis factor receptor:Fc fusion protein (rhTNFR:Fc) and methotrexate in treatment of patients with active rheumatoid arthritis in China.

Authors:  Dawei Hu; Chunde Bao; Shunle Chen; Jieruo Gu; Zhanguo Li; Lingyun Sun; Xinghai Han; Liqing Ni
Journal:  Rheumatol Int       Date:  2008-08-15       Impact factor: 2.631

6.  The safety and efficacy of the use of methotrexate in long-term therapy for rheumatoid arthritis.

Authors:  J M Kremer; J K Lee
Journal:  Arthritis Rheum       Date:  1986-07

7.  A randomized, double-blind, multicenter, controlled clinical trial of chicken type II collagen in patients with rheumatoid arthritis.

Authors:  Ling-Ling Zhang; Wei Wei; Feng Xiao; Jian-Hua Xu; Chun-De Bao; Li-Qing Ni; Xing-Fu Li
Journal:  Arthritis Rheum       Date:  2008-07-15

Review 8.  Folate supplementation and methotrexate treatment in rheumatoid arthritis: a review.

Authors:  S L Whittle; R A Hughes
Journal:  Rheumatology (Oxford)       Date:  2004-01-06       Impact factor: 7.580

9.  A trial of etanercept, a recombinant tumor necrosis factor receptor:Fc fusion protein, in patients with rheumatoid arthritis receiving methotrexate.

Authors:  M E Weinblatt; J M Kremer; A D Bankhurst; K J Bulpitt; R M Fleischmann; R I Fox; C G Jackson; M Lange; D J Burge
Journal:  N Engl J Med       Date:  1999-01-28       Impact factor: 91.245

10.  Low-dose methotrexate with leucovorin (folinic acid) in the management of rheumatoid arthritis. Results of a multicenter randomized, double-blind, placebo-controlled trial.

Authors:  J B Shiroky; C Neville; J M Esdaile; D Choquette; M Zummer; M Hazeltine; V Bykerk; M Kanji; A St-Pierre; L Robidoux
Journal:  Arthritis Rheum       Date:  1993-06
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