Second-line agents in myositis: 1-year factorial trial of additional immunosuppression in patients who have partially responded to steroids.

ABSTRACT:

Objective

Ciclosporin and MTX are used in idiopathic inflammatory myopathies (DM and PM) when patients incompletely respond to glucocorticoids. Their effectiveness is unproved in randomized controlled trials (RCTs). We evaluated their benefits in a placebo-controlled factorial RCT.

Methods

A 56-week multicentre factorial-design double-blind placebo-controlled RCT compared steroids alone, MTX (15-25 mg weekly) plus steroids, ciclosporin (1-5 mg/kg/day) plus steroids and all three treatments. It enrolled adults with myositis (by Bohan and Peter criteria) with active disease receiving corticosteroids.

Results

A total of 359 patients were screened and 58 randomized. Of the latter, 37 patients completed 12 months of treatment, 7 were lost to follow-up and 14 discontinued t

SUBMITTER: Ibrahim F 

PROVIDER: S-EPMC4476843 | biostudies-literature | 2015 Jun

REPOSITORIES: biostudies-literature