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Friederike Mackensen, Matthias D. Becker, ADUR study group, Eva Jakob, Bianca Dobner, Florian T. Kretz, Christoph M. Deuter, Arnd Heiligenhaus, Hans M. Lorenz, Regina Max; First Results Of A Randomized Controlled Clinical Trial Testing Adalimumab In Uveitis Refractive To Standard Therapy (ADUR). Invest. Ophthalmol. Vis. Sci. 2011;52(14):4255.
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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 (one trial (1)).
Local and federal authorities approval has been obtained. Patients with active uveitis despite 10 mgs of prednisone and already one immunosuppressive medication are eligible. Patients are randomized into either a therapy with Adalimumab (ADA) 40 mg s.c. every other week and high dose corticosteroids in a tapering regime or increase corticosteroids only. At three months main outcome parameters are assessed and efficacy determined. In case of treatment failure switch to the other arm is possible.
So far 14 patients (6 ADA, 8 controls) could be included. 11 patients reached three months, 9 patients the study end at 6 months. Treatment was determined successful for the primary outcome parameter visual acuity (VA) (increase> 2 lines) in 3 of 4 (75%) patients in the ADA group, with a mean increase in VA of 0.42 logMar in the responders. One patient decreased VA by 1,6 logMar due to vitreous hemorrhage. In the control group, only 2 of 7(29%) improved by > 2 lines in VA, although the whole group slightly improved by a mean 0.15 logMar. Still, even the improved patients showed inflammatory activity mirrored by a lesser reduction in the activity score (mean 7.14) as compared to the ADA group (score decreased by a mean 15 points). Three control patients were switched to ADA, the four remaining were subsequently treated with ADA outside the study, one because of joint activity, and 3 because of uveitis activity later on. 7 Patients that were eventually treated with ADA have been followed up for 1 year with a mean VA of 0.13 logMar, and no inflammatory activity in 5, and minor activity (e.g. trace cells or remaining macular edema) in 2 with a mean score of 1.43 points.
First results of the trial show superiority of ADA over controls in the treatment of severe uveitis. More patients have to be included to have the sufficient power to decide if this treatment effect is significant.ADUR study group:C Springer, D Doycheva, C Heinz and C Rösler(1) Smith JA et al. (2005) Arthritis Rheum. 53:18-23
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