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Baseline characteristics of SAKURA- a phase III, multicenter, randomized, double-masked study of intravitreal injections of DE-109 for the treatment of active, non-infectious uveitis of the posterior segment

Session Details

Session Title: Miscellaneous

Session Date/Time: Saturday 13/09/2014 | 11:00-13:00

Paper Time: 12:52

Venue: Boulevard E

First Author: : Q.Nguyen USA

Co Author(s): :    L. Wilson   J. Naor   W. Liu   M.E. Valentine   N. Shams  

Abstract Details

Purpose:

Sirolimus is an mTOR inhibitor with immunoregulatory and anti-inflammatory properties. DE-109 is a proprietary formulation of sirolimus (intravitreal injection) being evaluated for the management of non-infectious uveitis of the posterior segment. The SAKURA studies are 2 randomized, double-masked, phase III studies evaluating 3 doses (44, 440, and 880 µg) of DE-109. Baseline characteristics of study subjects are important as noninfectious uveitis of the posterior segment encompasses a group of inflammatory conditions with diverse etiologies and anatomic locations. The index presentation describes the baseline characteristics of subjects in SAKURA as of March 31, 2013 by treatment group.

Setting:

The SAKURA study protocol has enrolled subjects at approximately 150 sites in the United States, India, Europe, Latin America, and Japan. The majority of sites are clinics that specialize in the treatment of uveitis or retinal diseases.

Methods:

The baseline characteristics of the 347 subjects enrolled as of March 31, 2013 (n=117 [44 µg], n=114 [440 µg], n=116 [880 µg]) are summarized in this analysis. Demographic characteristics were reported by the subjects and recorded on case report forms. Disease characteristics were determined based on the investigators’ ocular and physical examinations, the subjects’ medical histories, and any relevant laboratory evaluations. Vitreous haze (VH) was assessed using a modified Standardization of Uveitis Nomenclature (SUN) Working Group Scale (0-4+ units). All subjects were required to have active NI-PSU, defined as a VH score of >1+ (excluding 1+). Best corrected visual acuity was recorded using the ETDRS chart, with the total number of letters at 4 meters reported.

Results:

Baseline VH score in the study eye was well balanced across treatment groups, with an overall mean (SD) of 1.9 (0.48). The VH scores indicated moderate inflammation across treatment groups (44 µg: 1.9 [0.50]; 440 µg: 1.9 [0.44]; 880 µg: 2.0 [0.48]). The mean age was 46 years among the treatment groups. The majority of subjects were female (56% [44 µg], 60% [440 µg], 65% [880 µg]). Approximately 47% were Caucasians and 77% were not Hispanic or Latino. The anatomic location of uveitis (i.e., posterior, intermediate, or panuveitis) was evenly distributed among subjects. The etiology of the uveitis was idiopathic in the majority of subjects; however, the underlying etiology was identified for approximately 22% of subjects in each treatment group. Sarcoidosis and Vogt-Koyanagi-Harada Syndrome accounted for approximately 8% and 5% of diagnoses, respectively, in each group. The mean (SD) duration of uveitis in the study eye was 53.6 (74.44), 36.3 (45.36), and 43.4 (61.11) months, respectively, for the 44, 440, and 880 µg groups. Among subjects who were receiving oral corticosteroids at baseline, the mean (SD) prednisone-equivalent dosages were 23.9 (14.47), 23.0 (13.77), and 18.9 (10.36) mg/d, respectively, for the 44, 440, and 880 µg groups.

Conclusions:

The mean age, racial and gender distributions, as well as duration and etiology of uveitis were well balanced among the treatment groups and similar to the general population of patients with noninfectious uveitis of the posterior segment. The mean VH score and mean prednisone-equivalent dosage in each treatment group at baseline indicate that subjects in SAKURA represent a population of patients with moderate noninfectious uveitis of the posterior segment. The outcomes of the SAKURA study are thus expected to be representative of the general population of patients with ocular inflammation and vision loss.

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