Purchase this article with an account.
Raj Maturi; Corticosteroid Tapering Success With Every-Other-Month Intravitreal Sirolimus for Non-infectious Uveitis of the Posterior Segment: Results of the SAKURA Program. Invest. Ophthalmol. Vis. Sci. 2017;58(8):520.
Download citation file:
© ARVO (1962-2015); The Authors (2016-present)
The SAKURA Program was designed to be a monotherapy study assessing the efficacy and safety of every-other-month intravitreal (IVT) sirolimus in subjects with active non-infectious uveitis of the posterior segment (NIU-PS). The proportion of subjects in whom systemic corticosteroids (CSTs) were successfully tapered alongside improvements in vitreous haze (VH) was examined.
The SAKURA Program comprised two Phase III, multinational, multicenter, randomized, double-masked studies. Study 1 included subjects enrolled through March 31, 2013 (N=347) and Study 2 enrolled subjects on/after April 1, 2013 (N = 245). Subjects from both comprised the integrated Intent-to-Treat (ITT) population evaluating sirolimus 440 μg vs 44 μg active control, n=208 for each group. VH was assessed at Month 5. Non-CST systemic immunosuppressants and topical CSTs were discontinued before baseline. 46 subjects from the 440 µg group and 32 from the 44 µg group in the integrated ITT population formed the Intent-to-Taper population (overall prednisone-equivalent dose >5 mg/day at baseline). Subjects achieving an overall prednisone-equivalent dose ≤5 mg/day at Month 5 without any rescue therapy were classified as CST tapering successes. Tapering success with VH reduction (prednisone equivalent dose ≤5 mg/day plus VH 0 or 0.5+ at Month 5) was also assessed.
21.2% and 13.5% of subjects (in 440 μg and 44 µg, p=0.0381) in the integrated ITT population achieved the primary endpoint of VH=0. Tapering success with VH reduction was higher in 440 μg vs 44 μg (43.5% vs 28.1%). Difference among treatment groups did not reach statistical significance due to small sample size (p=0.1676).
Efficacy results from the integrated analysis of the SAKURA Program demonstrated that IVT sirolimus 440 μg every other month achieved statistically significant improvements in VH at Month 5 in subjects with active NIU-PS. CST tapering success results demonstrated that subjects on oral CSTs can achieve tapering success with VH reduction by Month 5. Numerically higher results were observed with 440 μg vs 44 μg, confirming results seen in SAKURA Study 1.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.
Efficacy results from the SAKURA Program: corticosteroid tapering success with vitreous haze reduction at month 5 in Study 1, Study 2, and Integrated intent-to-taper populations
This PDF is available to Subscribers Only