June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
Efficacy and Safety Results From the SAKURA Program: Two Phase III Studies of Intravitreal Sirolimus Every Other Month for Non-infectious Uveitis of the Posterior Segment
Author Affiliations & Notes
  • Quan Dong Nguyen
    Byers Eye Institute, Stanford University, Palo Alto, California, United States
  • Pauline Merrill
    Ophthalmology, Rush University Medical Center, Chicago, Illinois, United States
  • W. Lloyd Clark
    Palmetto Retina Center, West Columbia, South Carolina, United States
  • Footnotes
    Commercial Relationships   Quan Dong Nguyen, Abbvie (F), Abbvie (S), AbbVie (C), Genentech (R), Genentech (F), Genentech (C), Regeneron (R), Regeneron (F), Regeneron (C), Santen (R), Santen (F), Santen (C), Santen (S), Xoma (F), Xoma (C), Xoma (S); Pauline Merrill, AbbVie (F), AbbVie (R), Santen (F), Santen (R); W. Lloyd Clark, Allergan (F), Bayer (C), Genentech/Roche (C), Genentech/Roche (F), Regeneron (C), Regeneron (F), Santen (C), Santen (F)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2017, Vol.58, 517. doi:
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      Quan Dong Nguyen, Pauline Merrill, W. Lloyd Clark; Efficacy and Safety Results From the SAKURA Program: Two Phase III Studies of Intravitreal Sirolimus Every Other Month for Non-infectious Uveitis of the Posterior Segment. Invest. Ophthalmol. Vis. Sci. 2017;58(8):517.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : The SAKURA Program – two Phase III, multinational, multicenter, randomized, double-masked studies – assessed the safety and efficacy of every-other-month intravitreal (IVT) sirolimus for treating active non-infectious uveitis of the posterior segment (NIU-PS).

Methods : SAKURA Study 1 enrolled subjects through March 31, 2013 (N=347) and SAKURA Study 2 enrolled subjects on/after April 1, 2013 (N=245). All subjects had vitreous haze (VH) ≥1.5+ at baseline. Subjects from both studies comprised the integrated Intent-to-Treat (ITT) population evaluating sirolimus 440 μg vs 44 μg active control, n=208 for each group. 81% of subjects in the SAKURA Program (n=171, 440 μg; n=163, 44 μg) were considered to have more severe disease at baseline, defined as VH ≥1.5+ and ≥1 markers of disease: systemic corticosteroids at an overall prednisone-equivalent dose >5 mg/day, best-corrected visual acuity ≤75 ETDRS letters, macular edema (central retinal thickness ≥300 µm on optical coherence tomography). VH was analyzed at Month 5 and safety at Month 6.

Results : Study 1 demonstrated the efficacy of every-other-month IVT injections of 440 μg sirolimus over 44 µg. Although the results of Study 2 were not statistically significant (Figure), in the integrated ITT population, 21.2% and 13.5% of subjects (in 440 µg and 44 µg, p=0.0381) achieved the primary endpoint of VH=0 and 50% and 40.4% (in 440 µg and 44 µg, p=0.0488) achieved the pre-specified key secondary endpoint of VH score of 0 or 0.5+. In the integrated subpopulation of subjects with more severe disease, 21.1% and 8% of subjects (in 440 µg and 44 µg, p=0.0007) achieved VH=0 and 48% and 37.4% (in 440 µg and 44 µg, p=0.0519) achieved VH 0 or 0.5+. Occurrences of serious adverse events were similar among treatment groups in both the integrated ITT population and more severe disease subpopulation.

Conclusions : The integrated analysis of the SAKURA Program demonstrated the efficacy and safety of the 440 μg dose of every-other-month IVT sirolimus in NIU-PS, including in those subjects with more severe disease.

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: Primary endpoint of vitreous haze (VH)=0 at Month 5 and key secondary endpoint of VH = 0/0.5+ at Month 5 in Study 1, Study 2, and Integrated Intent-to-Treat populations

Efficacy results from the SAKURA Program: Primary endpoint of vitreous haze (VH)=0 at Month 5 and key secondary endpoint of VH = 0/0.5+ at Month 5 in Study 1, Study 2, and Integrated Intent-to-Treat populations

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