RESEARCH - Do patients with RA established on MTX and folic acid 5 mg daily need to continue FA supplements long term

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Rheumatology (Oxford). 2000 Oct;39(10):1102-9.

Do patients with rheumatoid arthritis established on methotrexate and

folic acid 5 mg daily need to continue folic acid supplements long term?

Griffith SM, Fisher J, e S, Montgomery B, PW, Saklatvala J,

Dawes PT, Shadforth MF, Hothersall TE, Hassell AB, Hay EM.

Department of Rheumatology, East Surrey Hospital, Surrey, UK.

BACKGROUND: It is postulated that some aspects of methotrexate toxicity

may be related to its action as an anti-folate. Folic acid (FA) is often

given as an adjunct to methotrexate therapy, but there is no conclusive

proof that it decreases the toxicity of methotrexate and there is a

theoretical risk that it may decrease the efficacy of methotrexate.

OBJECTIVES: To look at the effect of stopping FA supplementation in UK

rheumatoid arthritis (RA) patients established on methotrexate <20 mg

weekly and FA 5 mg daily, to report all toxicity (including absolute

changes in haematological and liver enzyme indices) and to report

changes in the efficacy of methotrexate. METHODS: In a prospective,

randomized, double-blind, placebo-controlled study, 75 patients who were

established on methotrexate <20 mg weekly and FA 5 mg daily were asked

to stop their FA and were randomized to one of two groups: placebo or FA

5 mg daily. Patients were evaluated for treatment toxicity and efficacy

before entry and then at intervals of 3 months for 1 yr. RESULTS:

Overall, 25 (33%) patients concluded the study early, eight (21%) in the

group remaining on FA and 17 (46%) in the placebo group (P = 0.02). Two

patients in the placebo group discontinued because of neutropenia. At 9

months there was an increased incidence of nausea in the placebo group

(45 vs. 7%, P = 0.001). The placebo group had significantly lower

disease activity on a few of the variables measured, but these were

probably not of clinical significance.

CONCLUSIONS: It is important to continue FA supplementation over the

long term in patients on methotrexate and FA in order to prevent them

discontinuing treatment because of mouth ulcers or nausea and vomiting.

Our data suggest that FA supplementation is also helpful in preventing

neutropenia, with very little loss of efficacy of methotrexate.

PMID: 11035130

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=PubMed & list_uids=1\

1035130 & dopt=Abstract

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