September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
Mycophenolate sodium significantly reduces the relapse rate in patients with non-infectious intermediate uveitis
Author Affiliations & Notes
  • Christoph M E Deuter
    Centre for Ophthalmology, University of Tuebingen, Tuebingen, Germany
  • Katrin Engelmann
    Eye Clinic, Klinikum Chemnitz gGmbH, Chemnitz, Germany
  • Arnd Heiligenhaus
    Department of Ophthalmology, St. Franziskus Hospital, Muenster, Germany
  • Ines Lanzl
    Department of Ophthalmology, Technical University of Munich, Munich, Germany
  • Friederike Mackensen
    Interdisciplinary Uveitis Center, University of Heidelberg, Heidelberg, Germany
  • Thomas Ness
    University Eye Center, University of Freiburg, Freiburg, Germany
  • Uwe Pleyer
    Department of Ophthalmology, Charite University Medicine, Berlin, Georgia
  • Nicole Stuebiger
    Department of Ophthalmology, Charite University Medicine, Berlin, Georgia
  • Manfred Zierhut
    Centre for Ophthalmology, University of Tuebingen, Tuebingen, Germany
  • Deshka Doycheva
    Centre for Ophthalmology, University of Tuebingen, Tuebingen, Germany
  • Footnotes
    Commercial Relationships   Christoph Deuter, Novartis Pharma (F); Katrin Engelmann, Novartis Pharma (F); Arnd Heiligenhaus, Novartis Pharma (F); Ines Lanzl, Novartis Pharma (F); Friederike Mackensen, None; Thomas Ness, Novartis Pharma (F); Uwe Pleyer, Novartis Pharma (F); Nicole Stuebiger, Novartis Pharma (F); Manfred Zierhut, Novartis Pharma (F); Deshka Doycheva, Novartis Pharma (F)
  • Footnotes
    Support  Research Grant by Novartis Pharma GmbH
Investigative Ophthalmology & Visual Science September 2016, Vol.57, No Pagination Specified. doi:
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      Christoph M E Deuter, Katrin Engelmann, Arnd Heiligenhaus, Ines Lanzl, Friederike Mackensen, Thomas Ness, Uwe Pleyer, Nicole Stuebiger, Manfred Zierhut, Deshka Doycheva; Mycophenolate sodium significantly reduces the relapse rate in patients with non-infectious intermediate uveitis. Invest. Ophthalmol. Vis. Sci. 201657(12):.

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      © 2017 Association for Research in Vision and Ophthalmology.

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Abstract

Purpose : To evaluate whether a mycophenolate sodium-based treatment regimen is able to reduce the probability of a relapse compared to corticosteroid therapy alone in patients with non-infectious intermediate uveitis.

Methods : Investigator-initiated, phase 3 open, prospective, controlled, randomized national multicenter trial (protocol MYCUV-IIT02). To be eligible, patients had to suffer from a documented at least 6 months history of unilateral or bilateral intermediate uveitis, either idiopathic or due to non-infectious systemic disease, that was active at study entry. All patients received initial treatment with oral prednisolone 1 mg/kg, followed by a slow tapering over 3 months. For maintenance therapy, subjects were randomized in a 1:1 ratio to either mycophenolic sodium 1440 mg/day (Myfortic®, Novartis Pharma) plus prednisolone 5 mg/day (treatment arm) or prednisolone 5mg/day alone (control arm). Maximum treatment duration was 15 months. The primary endpoint was defined as the time from study entry to the first relapse defined as a deterioration of best corrected visual acuity ≥ 3 lines and/or an at least 2-step increase of vitreous haze and/or an at least 2-step increase of anterior chamber cells and/or a new onset or worsening of preexisting cystoid macular edema, proven by optical coherence tomography, and/or a new onset or worsening of retinal vasculitis, proven by fluorescein angiography.

Results : Fourty-four subjects at 8 sites were included. Of these, 41 patients (16 males, 25 females; median age 41.5 years, 18.6 – 82.7 years) were eligible for further analysis. Twenty-two patients (53.7 %) were randomized to treatment arm, 19 patients (46.3%) to control arm. In a first analysis using the Kaplan-Meier method, the proportion of relapse-free patients was estimated as 58.2 % in the treatment arm and 26.3 % in the control arm at 9 months after study entry, and as 52.9 % in the treatment arm and 19.7 % in the control arm at 15 months after study entry. The difference between treatment arm and control arm regarding relapse-free survival was statistically significant (log-rank test p = 0.011).

Conclusions : During an observation period of 15 months, a combination of mycophenolate sodium plus low-dose corticosteroids resulted in a significant reduction of relapse rate compared to treatment with low-dose corticosteroids alone in patients with non-infectious intermediate uveitis.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.

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