Final results of an investigator initiated, multicenter randomised controlled trial of the efficacy of Adalimumab in active uveitis refractoty to standard treatment (ADUR)

Purpose TNF alpha inhibitors have revolutionized the care of autoimmune diseases, among them severe cases of non‐infectious uveitis. Randomized clinical trials are lacking for this indication except for etanercept. We aimed to close this gap by initiating a randomized clinical trial testing Adalimumab (ADA) in severe forms of uveitis. Methods Local and federal authorities approval has been obtained. Patients with active uveitis despite 0,1mg/kg/bodyweight of prednisone and already one immunosuppressive medication were eligible. Patients were randomized into either a therapy with ADA 40 mg s.c. every other week and high dose corticosteroids in a tapering regime or to increase the corticosteroids only. At three months main outcome parameters are assessed and efficacy determined. In case of treatment failure switch to the other arm was possible. Results 25 patients were enrolled. The last patient will finish the trial in september 2012. 20 patients have been evaluated to date. The primary outcome criterion (Visual accuity improvement > 2 lines) was reached by 63.3% patients in the ADA group (mean improvement 0.29 logMar). In the control arm only 25% of patients improved > 2 lines. In parallel the control arm showed less reduction in inflammatory activity (reduction in activity score by a mean 2.89) as compared to the ADA group (mean reduction by 15.3 points). Conclusion The results oft he trial show clear superiority of ADA over control in the treatment of severe uveitis forms in termy of visual accuity and inflammatory activty.Commercial interest