Topical ocular 0.1% cyclosporine A cationic emulsion in dry eye disease patients with severe keratitis: experience through the French early-access program

Pierre-Jean Pisella,1 Marc Labetoulle,2 Serge Doan,3 Beatrice Cochener-Lamard,4 Mourad Amrane,5 Dahlia Ismail,5 Catherine Creuzot-Garcher,6,7 Christophe Baudouin8–10 1Department of Ophthalmology, Tours University Hospital, University François Rabelais, Bretonneau Hospi...

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Autores principales:	Pisella P, Labetoulle M, Doan S, Cochener-Lamard B, Amrane M, Ismail D, Creuzot-Garcher C, Baudouin C
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2018
Materias:	dry eye keratoconjunctivitis sicca cyclosporine A Sjögren’s syndrome inflammation cationic emulsion severe keratitis Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/7917160755934ce599f4781aeb0d92d4
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spelling	oai:doaj.org-article:7917160755934ce599f4781aeb0d92d42021-12-02T06:01:58ZTopical ocular 0.1% cyclosporine A cationic emulsion in dry eye disease patients with severe keratitis: experience through the French early-access program1177-5483https://doaj.org/article/7917160755934ce599f4781aeb0d92d42018-02-01T00:00:00Zhttps://www.dovepress.com/topical-ocular-01-cyclosporine-a-cationic-emulsion-in-dry-eye-disease--peer-reviewed-article-OPTHhttps://doaj.org/toc/1177-5483Pierre-Jean Pisella,1 Marc Labetoulle,2 Serge Doan,3 Beatrice Cochener-Lamard,4 Mourad Amrane,5 Dahlia Ismail,5 Catherine Creuzot-Garcher,6,7 Christophe Baudouin8–10 1Department of Ophthalmology, Tours University Hospital, University François Rabelais, Bretonneau Hospital, Tours, 2Department of Ophthalmology, Bicêtre Hospital, APHP, Paris-Sud University, Le Kremlin-Bicêtre, 3Department of Ophthalmology, Bichat Hospital and Fondation A de Rothschild, Paris, 4Brest University Medical School, Morvan Hospital, Brest, 5Santen SAS, Evry, 6Department of Ophthalmology, University Hospital, 7Department of Ophthalmology III, Eye and Nutrition Research Group, Burgundy, Dijon, 8Research Team S12, Quinze-Vingts National Ophthalmology Hospital, 9Department of Ophthalmology, Ambroise-Paré Hospital, APHP, UPMC University, Paris 6, Vision Institute, INSERM UMRS968, CNRS UMR7210, Paris, 10University of Versailles Saint-Quentin en Yvelines, Versailles, France Purpose: The objective of this study was to report the evaluation of efficacy and safety of cyclosporine A cationic emulsion (CsA CE) 0.1% for the treatment of severe keratitis in adults with dry eye disease (DED) in a French early-access program. Methods: Patients with DED and severe keratitis (corneal fluorescein staining [CFS] score of 3–5 on the Oxford scale and/or the presence of corneal lesions [filaments or ulcers]) were enrolled in a compassionate use program (Authorization for Temporary Use [ATU]) for once-daily CsA CE, which was approved by French health authorities prior to its registration. Efficacy and safety at 1, 3, 6, and 12-month follow-up visits were evaluated. Results: The ATU cohort (n=1,212; mean age =60.5 years; 79.5% female; 98.1% with severe keratitis; 74.5% with corneal lesions) consisted of 601 CsA-naïve patients and 611 patients treated previously with other CsA formulations. The primary DED etiology was Sjögren’s syndrome (48.7%). Clinical benefit could be discerned among 548 evaluable patients from months 1 to 12: keratitis improvement, 44.8% at month 1 and 42.1% at month 12; keratitis stabilization, 47.2% and 45.7%, respectively; symptom improvement, 47.2% and 48.6%; and symptom stabilization, 44.8% and 45.0%. Corneal clearing (CFS score =0) increased from 4.8% (month 1) to 11.4% (month 12). No unexpected safety concerns were identified; instillation site pain (10.2%) and eye irritation (7.8%) were the most common adverse events. Conclusion: The French ATU cohort provides supportive data on the clinical benefit of CsA CE in improving/stabilizing symptoms and corneal damage in DED patients with severe keratitis in real-world clinical practice. Keywords: dry eye, keratoconjunctivitis sicca, cyclosporine A, Sjögren’s syndrome, inflammation, cationic emulsion, severe keratitis, IkervisPisella PLabetoulle MDoan SCochener-Lamard BAmrane MIsmail DCreuzot-Garcher CBaudouin CDove Medical Pressarticledry eyekeratoconjunctivitis siccacyclosporine ASjögren’s syndromeinflammationcationic emulsionsevere keratitisOphthalmologyRE1-994ENClinical Ophthalmology, Vol Volume 12, Pp 289-299 (2018)
institution	DOAJ
collection	DOAJ
language	EN
topic	dry eye keratoconjunctivitis sicca cyclosporine A Sjögren’s syndrome inflammation cationic emulsion severe keratitis Ophthalmology RE1-994
spellingShingle	dry eye keratoconjunctivitis sicca cyclosporine A Sjögren’s syndrome inflammation cationic emulsion severe keratitis Ophthalmology RE1-994 Pisella P Labetoulle M Doan S Cochener-Lamard B Amrane M Ismail D Creuzot-Garcher C Baudouin C Topical ocular 0.1% cyclosporine A cationic emulsion in dry eye disease patients with severe keratitis: experience through the French early-access program
description	Pierre-Jean Pisella,1 Marc Labetoulle,2 Serge Doan,3 Beatrice Cochener-Lamard,4 Mourad Amrane,5 Dahlia Ismail,5 Catherine Creuzot-Garcher,6,7 Christophe Baudouin8–10 1Department of Ophthalmology, Tours University Hospital, University François Rabelais, Bretonneau Hospital, Tours, 2Department of Ophthalmology, Bicêtre Hospital, APHP, Paris-Sud University, Le Kremlin-Bicêtre, 3Department of Ophthalmology, Bichat Hospital and Fondation A de Rothschild, Paris, 4Brest University Medical School, Morvan Hospital, Brest, 5Santen SAS, Evry, 6Department of Ophthalmology, University Hospital, 7Department of Ophthalmology III, Eye and Nutrition Research Group, Burgundy, Dijon, 8Research Team S12, Quinze-Vingts National Ophthalmology Hospital, 9Department of Ophthalmology, Ambroise-Paré Hospital, APHP, UPMC University, Paris 6, Vision Institute, INSERM UMRS968, CNRS UMR7210, Paris, 10University of Versailles Saint-Quentin en Yvelines, Versailles, France Purpose: The objective of this study was to report the evaluation of efficacy and safety of cyclosporine A cationic emulsion (CsA CE) 0.1% for the treatment of severe keratitis in adults with dry eye disease (DED) in a French early-access program. Methods: Patients with DED and severe keratitis (corneal fluorescein staining [CFS] score of 3–5 on the Oxford scale and/or the presence of corneal lesions [filaments or ulcers]) were enrolled in a compassionate use program (Authorization for Temporary Use [ATU]) for once-daily CsA CE, which was approved by French health authorities prior to its registration. Efficacy and safety at 1, 3, 6, and 12-month follow-up visits were evaluated. Results: The ATU cohort (n=1,212; mean age =60.5 years; 79.5% female; 98.1% with severe keratitis; 74.5% with corneal lesions) consisted of 601 CsA-naïve patients and 611 patients treated previously with other CsA formulations. The primary DED etiology was Sjögren’s syndrome (48.7%). Clinical benefit could be discerned among 548 evaluable patients from months 1 to 12: keratitis improvement, 44.8% at month 1 and 42.1% at month 12; keratitis stabilization, 47.2% and 45.7%, respectively; symptom improvement, 47.2% and 48.6%; and symptom stabilization, 44.8% and 45.0%. Corneal clearing (CFS score =0) increased from 4.8% (month 1) to 11.4% (month 12). No unexpected safety concerns were identified; instillation site pain (10.2%) and eye irritation (7.8%) were the most common adverse events. Conclusion: The French ATU cohort provides supportive data on the clinical benefit of CsA CE in improving/stabilizing symptoms and corneal damage in DED patients with severe keratitis in real-world clinical practice. Keywords: dry eye, keratoconjunctivitis sicca, cyclosporine A, Sjögren’s syndrome, inflammation, cationic emulsion, severe keratitis, Ikervis
format	article
author	Pisella P Labetoulle M Doan S Cochener-Lamard B Amrane M Ismail D Creuzot-Garcher C Baudouin C
author_facet	Pisella P Labetoulle M Doan S Cochener-Lamard B Amrane M Ismail D Creuzot-Garcher C Baudouin C
author_sort	Pisella P
title	Topical ocular 0.1% cyclosporine A cationic emulsion in dry eye disease patients with severe keratitis: experience through the French early-access program
title_short	Topical ocular 0.1% cyclosporine A cationic emulsion in dry eye disease patients with severe keratitis: experience through the French early-access program
title_full	Topical ocular 0.1% cyclosporine A cationic emulsion in dry eye disease patients with severe keratitis: experience through the French early-access program
title_fullStr	Topical ocular 0.1% cyclosporine A cationic emulsion in dry eye disease patients with severe keratitis: experience through the French early-access program
title_full_unstemmed	Topical ocular 0.1% cyclosporine A cationic emulsion in dry eye disease patients with severe keratitis: experience through the French early-access program
title_sort	topical ocular 0.1% cyclosporine a cationic emulsion in dry eye disease patients with severe keratitis: experience through the french early-access program
publisher	Dove Medical Press
publishDate	2018
url	https://doaj.org/article/7917160755934ce599f4781aeb0d92d4
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Topical ocular 0.1% cyclosporine A cationic emulsion in dry eye disease patients with severe keratitis: experience through the French early-access program

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