Effect of folic or folinic acid supplementation on the toxicity and efficacy of methotrexate in rheumatoid arthritis: a forty-eight week, multicenter, randomized, double-blind, placebo-controlled study.
- Ede, A.E. van
- Laan, R.F.J.M.
- Rood, M.J.
- Huizinga, T.W.J.
- Laar, M.A.F.J. van de
- Denderen, C.J. van
- Westgeest, T.A.
- Romme, T.C.
- Rooij, D.J.R.A.M. de
- Jacobs, M.J.
- Boo, T.M. de
- Wilt, G.J. van der
- Severens, J.L.
- Moret-Hartman, M.
- Krabbe, P.F.M.
- Dijkmans, B.A.C.
- Breedveld, F.C.
- Putte, L.B.A. van de
DOIAbstract
OBJECTIVE: To study the effect of folates on discontinuation of methotrexate (MTX) as single-drug antirheumatic treatment due to toxicity, to determine which type of adverse events are reduced, to study the effects on the efficacy of MTX, and to compare folic with folinic acid supplementation in a 48-week, randomized, double-blind, placebo-controlled trial. METHODS: Patients with active RA (n = 434) were randomly assigned to receive MTX plus either placebo, folic acid (1 mg/day), or folinic acid (2.5 mg/week). The initial MTX dosage was 7.5 mg/week; dosage increases were allowed up to a maximum of 25 mg/week for insufficient responses. Folate dosages were doubled once the dosage of MTX reached 15 mg/week. The primary end point was MTX withd...
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