April 2009
Volume 50, Issue 13
ARVO Annual Meeting Abstract  |   April 2009
Everolimus for the Treatment of Uveitis Unresponsive to Cyclosporine A
Author Affiliations & Notes
  • A. Heiligenhaus
    Ophthalmology, St Franziskus Hosp, Muenster, Germany
  • B. Zurek-Imhoff
    Ophthalmology, St Franziskus Hosp, Muenster, Germany
  • H. Maren
    Ophthalmology, St Franziskus Hosp, Muenster, Germany
  • M. Roesel
    Ophthalmology, St Franziskus Hosp, Muenster, Germany
  • C. Heinz
    Ophthalmology, St Franziskus Hosp, Muenster, Germany
  • Footnotes
    Commercial Relationships  A. Heiligenhaus, Novartis Germany, F; B. Zurek-Imhoff, None; H. Maren, None; M. Roesel, None; C. Heinz, None.
  • Footnotes
    Support  Novartis Germany
Investigative Ophthalmology & Visual Science April 2009, Vol.50, 2700. doi:
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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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      © ARVO (1962-2015); The Authors (2016-present)

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Purpose: : This study investigated the efficacy of systemic everolimus in noninfectious uveitis.

Methods: : 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.

Results: : 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.

Conclusions: : 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

Keywords: inflammation • uveitis-clinical/animal model • drug toxicity/drug effects 

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