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A. Heiligenhaus, B. Zurek-Imhoff, H. Maren, M. Roesel, C. Heinz; Everolimus for the Treatment of Uveitis Unresponsive to Cyclosporine A. Invest. Ophthalmol. Vis. Sci. 2009;50(13):2700.
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This study investigated the efficacy of systemic everolimus in noninfectious uveitis.
Mono-center non-randomized prospective pilot-study with patients (mean age 40 years) with chronic intermediate (n=9) or posterior (n=1) uveitis or panuveitis (n=2) unresponsive to cyclosporine A. Prevalent uveitis complications were cystoid macular edema (n=8), cataract (n=7) and epiretinal membrane formation (n=9). Everolimus was added at 1.0 - 2.5 mg oral daily dosage. The primary outcome evaluated was inactivity of uveitis at 3 months. Secondary outcome measures were uveitis recurrence (two step increase of anterior chamber / vitreous cells) during 12 months of follow up, best-corrected visual acuity (BCVA), cystoid macular edema by means of optical coherence tomography (OCT), and the ability to taper concomitant immunosuppression. CD4+CD25+FoxP3+ cells in peripheral blood were studied by flow-cytometry.
At 3 months with everolimus, 11 of 12 patients demonstrated uveitis inactivity. Uveitis recurrence was noted during the follow up in 3 patients, either after CsA tapering (n=2) or - withdrawing (n=1). BCVA remained stable in all participants during the course of the study. Mean foveal thickness was reduced from 308 µm at baseline to 291 µm and 251 µm at 3 and 6 months, respectively. Patients receiving everolimus experienced a 50% dose reduction of prednisone (2 of 3) or cyclosporine A (9 of 12). During prolonged therapy, peripheral blood CD4+CD25+FoxP3+ T cells increased.
This is the first study demonstrating that everolimus can improve uveitis. Additive everolimus was effective in severe uveitis not responding to cyclosporine A, and permitted the generation of CD4+FoxP3+ TREG cells.
Clinical Trial: :
www.clinicaltrials.gov NCT00792726 EudraCT number 2006-004876-10
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