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Subgroup analysis of two phase III studies of 0.1% cyclosporine A cationic emulsion (CsA CE) in patients with dry eye disease
Author(s) -
Leonardi A.,
Garhöfer G.,
Amrane M.,
Garrigue J.S.,
Ismail D.,
Sainz de la Maza M.,
Labetoulle M.
Publication year - 2016
Publication title -
acta ophthalmologica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.534
H-Index - 87
eISSN - 1755-3768
pISSN - 1755-375X
DOI - 10.1111/j.1755-3768.2016.0552
Subject(s) - medicine , gastroenterology , keratitis , disease , confidence interval , surgery , ophthalmology
Purpose Dry eye disease (DED) increases the risk of ocular surface damage, severe keratitis, vision loss and impaired quality of life. In two randomized phase III studies (SANSIKA and SICCANOVE), the cationic emulsion formulation containing 0.1% (1 mg/ml) cyclosporine A (CsA CE) improved ocular damage and inflammation in patients with moderate to [AS1] severe DED. This analysis evaluated the efficacy of CsA CE in improving signs of DED in specific patient subgroups. Methods Analysis was performed based on efficacy data from the SANSIKA study ( n = 215) and pooled efficacy data from the SANSIKA and SICCANOVE studies ( n = 629); change from baseline in corneal fluorescein staining (CFS) at Month 6 was analyzed in subgroups of DED patients defined by age, sex, menopausal status, DED duration (ranging from <4 to ≥12 years) and the presence of Sjögren disease. Results Of the patients included in the pooled analysis, 65% were <65 years old, 83% were female (72% in menopause) and 38% had Sjögren disease. The overall change in CFS score from baseline to Month 6 favored CsA CE over vehicle (treatment difference −0.303; 95% confidence interval, −0.464 to −0.142). In the SANSIKA study and in the pooled analysis, the effect of CsA CE on CFS score was comparable in patients regardless of age, sex, menopausal status, DED duration and Sjögren disease status. In the subset of patients with severe keratitis, the effect of CsA CE on CFS was also comparable across all subgroups. CsA CE was well tolerated, with a safety profile consistent with ophthalmic CsA use. Conclusions These data suggest that CsA CE is well tolerated and comparably efficacious in improving signs of DED across multiple DED patient subpopulations.