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E. B. Suhler, C. Y. Lowder, D. A. Goldstein, T. R. Giles, H. H. Tessler, A. K. Lauer, J. R. Smith, J. T. Rosenbaum; Adalimumab (Humira) for the Treatment of Refractory Sight-Threatening Non-Infectious Uveitis: Interim Results of an Open-Label Prospective Multicenter Study. Invest. Ophthalmol. Vis. Sci. 2010;51(13):2918.
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to report the ongoing safety and effectiveness of adalimumab (Humira, Abbott), a fully human monoclonal antibody against TNF-alpha, for the treatment of refractory non-infectious uveitis.
Three centers received IRB approval to participate in an open-label, prospective clinical trial utilizing 40 mg subcutaneous injections of adalimumab administered every two weeks for the treatment of non-infectious uveitis refractory to corticosteroids and at least one immunosuppressive. Treatment outcome was ascertained at 10 weeks by a composite clinical endpoint comprised of visual acuity, intraocular inflammation, ability to taper corticosteroids or immunosuppressives, and posterior segment imaging with fluorescein angiography and ocular coherence tomography. Patients who met one or more study endpoints without decrement in any were allowed to continue adalimumab therapy for a total of 50 weeks, when outcome assessments were repeated.
Enrollment in the study concluded at 31 patients in September 2009. Seventeen of 26 patients reaching the 10 week assessment endpoint (65%) were characterized as clinical responders and allowed to continue in the study. All but two initial responders remain in the study, with three completing 50 weeks successfully, and the remainder still in follow-up. Reasons for study discontinuation after 10 weeks included unintended pregnancy (1) and primary loss of efficacy (1, at week 23). One significant adverse effect, in which a patient was hospitalized in a hypoglycemic coma, required study discontinuation, but was not clearly related to adalimumab. Minor adverse effects included mild infections that required delaying therapy with adalimumab but that did not require study discontinuation.
Adalimumab was effective in the treatment of 65% of enrolled patients with refractory uveitis at 10 weeks after study enrollment. Although toxicity was uncommon, careful surveillance for serious potential side effects remains important. Ongoing study is required to further classify subsets of patients in whom TNF-alpha blockers in general, and adalimumab specifically, will be safe and effective.
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