OBJECTIVE: To study the effect of folates on discontinuation of @entity1499 ( @entity1500 ) as single-drug antirheumatic treatment due to @entity137 , to determine which type of adverse events are reduced, to study the effects on the efficacy of @entity1500 , and to compare folic with @entity4181 supplementation in a 48-week, randomized, double-blind, placebo-controlled trial. METHODS: @entity1 with active RA (n = 434) were randomly assigned to receive @entity1500 plus either placebo, @entity1501 (1 mg/day), or @entity4181 (2.5 mg/week). The initial @entity1500 dosage was 7.5 mg/week; dosage increases were allowed up to a maximum of 25 mg/week for insufficient responses. @entity1501 dosages were doubled once the dosage of @entity1500 reached 15 mg/week. The primary end point was @entity1500 withdrawal because of adverse events. Secondary end points were the @entity1500 dosage and parameters of efficacy and @entity137 of @entity1500 . RESULTS: @entity137 -related discontinuation of @entity1500 occurred in 38% of the placebo group, 17% of the @entity1501 group, and 12% of the @entity4181 group. These between-group differences were explained by a decreased incidence of elevated liver enzyme levels in the @entity1501 supplementation groups. No between-group differences were found in the frequency of other adverse events or in the duration of adverse events. Parameters of disease activity improved equally in all groups. Mean dosages of @entity1500 at the end of the study were lower in the placebo group (14.5 mg/week) than in the folic and @entity4181 groups (18.0 and 16.4 mg/week, respectively). CONCLUSION: Both @entity1501 supplementation regimens reduced the incidence of elevated liver enzyme levels during @entity1500 therapy, and as a consequence, @entity1500 was discontinued less frequently in these @entity1 . Folates seem to have no effect on the incidence, severity, and duration of other adverse events, including gastrointestinal and mucosal side effects. Slightly higher dosages of @entity1500 were prescribed to obtain similar improvement in disease activity in the @entity1501 supplementation groups.

Effect of folic or @entity4181 supplementation on the XXXX and efficacy of @entity1499 in rheumatoid arthritis: a forty-eight week, multicenter, randomized, double-blind, placebo-controlled study.

@entity4181 :: ('MESH:D002955', 'Chemical') :: ['folinic acid'] @entity1 :: ('9606', 'Species') :: ['Patients', 'patients'] @entity1501 :: ('MESH:D005492', 'Chemical') :: ['Folate', 'folic acid', 'folate'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity', 'Toxicity'] @entity1500 :: ('CHEBI:44185', 'Chemical') :: ['MTX'] @entity1499 :: ('MESH:D008727', 'Chemical') :: ['methotrexate']
@entity137 :: (MESH:D064420,Disease) :: ['toxicity']
