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NLM AIDSLINE
Treatment of noninfectious intermediate and posterior uveitis with the humanized anti-Tac mAb: a phase I/II clinical trial.
Nussenblatt RB; Fortin E; Schiffman R; Rizzo L; Smith J; Van Veldhuisen
September 30, 1999
Proc Natl Acad Sci U S A. 1999 Jun 22;96(13):7462-6. Unique Identifier :

To evaluate the safety and potential therapeutic activity of humanized anti-IL-2 receptor mAb (Daclizumab) therapy in the treatment of patients with severe, sight-threatening, intermediate and posterior noninfectious uveitis, a nonrandomized, open-label, pilot study was performed. Patients with uveitis were treated with a minimum of 20 mg of prednisone, cyclosporine, antimetabolites, or any combination of these agents were eligible. Patients were weaned off their systemic immunosuppressive agents according to a standardized schedule, while ultimately receiving Daclizumab infusions every 4 weeks. Anti-IL-2 receptor antibody therapy, given intravenously with intervals of up to 4 weeks in lieu of standard immunosuppressive therapy, appeared to prevent the expression of severe sight-threatening intraocular inflammatory disease in 8 of 10 patients treated over a 12-month period, with noted improvements in visual acuity. One patient met a primary endpoint with a loss of vision of 10 letters or more from baseline in one eye and another patient discontinued therapy because of evidence of increased ocular inflammation. All patients were able to tolerate the study medications without the need for dose reduction. We report effective long-term use of anti-IL-2 therapy for an autoimmune indication. These initial findings would suggest that anti-IL-2 receptor therapy may be an effective therapeutic approach for uveitis and, by implication, other disorders with a predominant Th1 profile.

CLINICAL TRIAL CLINICAL TRIAL, PHASE I CLINICAL TRIAL, PHASE II JOURNAL ARTICLE Adult Antibodies, Monoclonal/*ADMINISTRATION & DOSAGE Cyclosporine/ADMINISTRATION & DOSAGE Drug Therapy, Combination Female Human IgG/*ADMINISTRATION & DOSAGE Immunosuppressive Agents/*ADMINISTRATION & DOSAGE Immunotherapy Infusions, Intravenous Male Middle Age Pilot Projects Prednisone/ADMINISTRATION & DOSAGE Th1 Cells/IMMUNOLOGY Treatment Outcome Uveitis/*DRUG THERAPY/IMMUNOLOGY

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