To evaluate the safety and efficacy of recombinant interferon-gamma (rIFN gamma) in patients with active rheumatoid arthritis (RA), using an induction and maintenance regimen.
A multicenter, randomized, double-blind trial of 197 patients with RA was conducted to compare the effects in a group receiving 50 micrograms of rIFN gamma, given subcutaneously in a decreasing regimen over 24 weeks, with those in a placebo group receiving injections of placebo at the same time frequency. Standard clinical assessments were performed.
Both rIFN gamma and placebo produced a significant improvement from baseline to end point visit for most measurements (except erythrocyte sedimentation rate, duration of morning stiffness, and grip strength), but no significant intergroup differences were seen. Regarding adverse effects, mild local skin reactions at the site of injection were observed, and among the cardiovascular events, mild edema and vasodilatation were reported.
IFN gamma proved no more effective than placebo in this group of patients with RA. IFN gamma was well tolerated in this group of patients, without increased toxicity compared with placebo.