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Eric B. Suhler, Careen Y. Lowder, Debra A. Goldstein, Tracy R. Giles, Howard H. Tessler, Andreas K. Lauer, Justine R. Smith, James T. Rosenbaum; Adalimumab (humira) For The Treatment Of Refractory Sight-threatening Non-infectious Uveitis: One Year Outcomes Of An Open-label Prospective Multicenter Study. Invest. Ophthalmol. Vis. Sci. 2011;52(14):6565.
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to report one year safety and effectiveness outcomes 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 adalimumab injections given every two weeks for 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 for a total of 50 weeks, when final outcome assessments were obtained.
31 patients were enrolled from February 2008 to September 2009. Twenty-one of 31 patients (68%) were characterized as clinical responders at 10 weeks and allowed to continue in the study. Thirteen of 21 (62%) initial responders exhibited durable response to adalimumab therapy at the 50 week endpoint. Reasons for study discontinuation after 10 weeks were unintended pregnancy (1), loss to followup (1), and primary loss of efficacy (6). 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 adalimumab injections but that did not require study discontinuation.
Adalimumab was effective in 68% of enrolled patients with refractory uveitis 10 weeks after study enrollment, with 13 of 31 enrolled patients (42%) maintaining benefit after one year. Significant toxicity was uncommon. Ongoing study is required to determine the role of TNF-alpha blockers in general, and adalimumab specifically, in patients with refractory ocular inflammatory disease.
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