Treatment of noninfectious intermediate and posterior uveitis with the humanized anti-Tac mAb: A phase I/II clinical trial

To evaluate the safety and potential therapeutic activity of humanized anti -IL-2 receptor mAb (Daclizumab) therapy in the treatment of patients with s e cere, sight-threatening, intermediate and posterior noninfectious uveitis , a nonrandomized, open-label, pilot study was performed, Patients with uve itis were treated with a minimum of 20 mg of prednisone, cyclosporine, anti metabolites, or any combination of these agents were eligible. Patients wer e weaned off their systemic immunosuppressive agents according to a standar dized schedule, while ultimately receiving Daclizumab infusions every 4 wee ks. Anti-IL-2 receptor antibody therapy, given intravenously with intervals of up to 4 weeks in lieu of standard immunosuppressive therapy, appeared t o prevent the expression of severe sight-threatening intraocular inflammato ry disease in 8 of 10 patients treated over a 12-month period, with noted i mprovements in visual acuity. One patient met a primary endpoint with a los s of vision of 10 letters or more from baseline in one eye and another pati ent discontinued therapy because of evidence of increased ocular inflammati on. hll patients were able to tolerate the study medications,without the ne ed for dose reduction. We report effective long-term use of anti-IL-2 thera py for an autoimmune indication. These initial findings would suggest that anti-IL-2? receptor therapy ma be an effective therapeutic approach for uve itis and, by implication, other disorders with a predominant Th1 profile.