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E.B. Suhler, J.R. Smith, A.K. Lauer, M.S. Wertheim, D.E. Kurz, L.L. Lim, F. Mackensen, T.D. Pickard, J.T. Rosenbaum; Infliximab Therapy for Refractory Uveitis: One and Two Year Results of a Prospective Study . Invest. Ophthalmol. Vis. Sci. 2006;47(13):1524.
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© ARVO (1962-2015); The Authors (2016-present)
Our group has previously presented results from a prospective trial of infliximab, a monoclonal antibody that inhibits tumor necrosis factor (TNF), for the treatment of refractory uveitis, demonstrating both effectiveness and unexpected toxicity compared to other reported anti–TNF trials in the medical literature. We report updated safety and efficacy data from this study.
32 subjects with refractory uveitis were enrolled from our tertiary care referral uveitis clinic, of whom 31 received at least one infliximab infusion. Response to treatment was ascertained via a composite clinical endpoint of visual acuity, intraocular inflammation control, ability to taper immunosuppressive medications, and angiography/OCT grading. Subjects received 3 standard loading infusions with outcome assessment at week 10. Successes at week 10 were extended to 50 weeks, and those demonstrating benefit at this point were allowed to continue to week 102. Patients were assessed every four weeks in the first year and every eight weeks in the second year for safety and efficacy, with infusions given every eight weeks. Dose escalation was permitted for breakthrough inflammation.
Study enrollment ceased in December 2004. Of 32 enrolled subjects, 30 and 18 have had the opportunity to reach the 50 and 102 week endpoints, respectively. Fifteen of 30 patients met criteria for success at one year. Only two of 18 have successfully completed two years; however 6 of the remaining 12 patients remain active in the study, with a range of followup from 11–23 months, and another two remained on infliximab for a total of two years outside the study. Six study terminations occurred due to inefficacy, 8 due to toxicity, one due to inefficacy and toxicity, and 6 for non–medical reasons. The most concerning adverse events have included three cases each of drug–related lupus and thromboembolic side effects. Generation of positive antinuclear antibodies was nearly universal in patients receiving >3 infusions but did not correlate with inefficacy or toxicity.
Infliximab is an effective agent for the treatment of refractory uveitis in selected cases. Our study had a higher than expected early rate of toxicity but there have been no new episodes of significant toxicity since our last ARVO report one year ago. Despite limited retention rates, a subset of patients has experienced a durable response to infliximab therapy. Ongoing study is required to determine the optimal use of infliximab in the treatment of uveitis.
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