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E.B. Suhler, J.R. Smith, T.D. Pickard, A.K. Lauer, D.E. Kurz, L.L. Lim, F. Mackensen, M.S. Wertheim, J.T. Rosenbaum; A Prospective Trial of Infliximab Therapy in Patients With Refractory Uveitis: Trials and Tribulations, Successes and Setbacks . Invest. Ophthalmol. Vis. Sci. 2005;46(13):2387.
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Purpose: The tumor necrosis factor–alpha blocking agent infliximab (Remicade) has been approved for the treatment of numerous inflammatory diseases and has gained increasing recognition as a potentially beneficial treatment for inflammatory eye diseases. We report safety and efficacy data from our ongoing prospective, open–label, Phase II clinical trial of infliximab therapy for the treatment of refractory uveitis. Methods: 31 subjects with refractory uveitis have been enrolled from our tertiary care referral uveitis clinic and treated with infliximab via a standard protocol. Response to treatment was ascertained via a composite clinical endpoint comprised of visual acuity, control of intraocular inflammation, ability to taper corticosteroids or other immunosuppressives, and angiographic/OCT criteria. Patients were loaded with infliximab infusions at 0, 2, and 6 weeks and assessed at ten weeks using the above endpoint. Subjects with demonstrated efficacy at 10 weeks received study infusions every eight weeks with dose escalation allowed for breakthrough inflammation. Repeated demonstration of benefit at 50 weeks allowed subjects to remain in the protocol for the full study duration of two years. Results: Of 31 enrolled subjects, 28 have reached 10 weeks in the study, the initial endpoint for assessing efficacy, 18 have reached one year, and five have had opportunity to reach the two year endpoint. At these time points, 22/28, 9/18, and 1/5 have been characterized as treatment successes. Only one post–10 week study termination occurred due to lack of efficacy and three patients were terminated due to noncompliance with study protocol. Other subjects terminated from the study were due to the occurrence of adverse events, including three cases of drug–related lupus, one neoplasm, three thromboembolic side effects, one case of congestive heart failure, and one infectious complication. 13 of the 18 patients who reached one year in the study developed positive antinuclear antibodies; however the development of ANAs did not clearly correlate with treatment efficacy or toxicity. Conclusions: Infliximab is a promising agent for the treatment of refractory uveitis and very effective in selected patients who tolerate it well. This study has had a much higher rate of toxicity than expected, although a causal relationship to infliximab was not certain in many cases. Ongoing study is required to determine the role of infliximab in the treatment of intraocular inflammatory diseases.
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