Persistence of Efficacy of 0.1% Cyclosporin A Cationic Emulsion in Subjects with Severe Keratitis Due to Dry Eye Disease: A Nonrandomized, Open-label Extension of the SANSIKA Study

Labétoulle, Marc; Leonardi, Andrea; Amrane, Mourad; Ismail, Dahlia; Garrigue, Jean-Sébastien; Garhöfer, Gerhard; Maza, Maite Sainz de la; Baudouin, Christophe

doi:10.1016/j.clinthera.2018.09.012

Cited by 18 publications

(27 citation statements)

References 18 publications

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“…Исходные результаты теста Ширмера достоверно различались между группами пациентов, что, безусловно, было связано с особенностями Лечение хронического воспаления глазной поверхности представляет собой длительный процесс, в котором важна непрерывность и влияние на ключевые патофизиологические механизмы. Эффективность местного применения 0,1% катионной эмульсии циклоспорина А (Икервис) в лечении БСГ средней и тяжелой степени при болезни Шегрена была доказана в ранее проведенных, в том числе рандомизированных международных, исследованиях [6,11].…”

Section: практикующему врачуunclassified

“…В последнее время в комплексном лечении БСГ применяют иммуносупрессанты (0,1% катионная эмульсия циклоспорина А). Циклоспорин А хорошо переносится пациентами, оказывает выраженное противовоспалительное действие при длительном лечении [6,10,11].…”

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Эффективность 0,1% Катионной Эмульсии Циклоспорина А (Икервис) В Лечении Хронического Воспаления Глазной Поверхности При Болезни Сухого Глаза (Исследование SACURA)

Ситник¹,

Лебедева²,

Чекина³

et al. 2021

Офтальмология. Восточная Европа

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Цель. Изучить эффективность использования 0,1% эмульсии циклоспорина (Икервис) в лечении болезни сухого глаза (БСГ). Материалы и методы. В проспективное когортное исследование SACURA (Save the ocular surface) были включены 79 пациентов (149 глаз) с клиническими проявлениями БСГ, средний возраст участников составил 52±16,8 года (от 18 до 84 лет). Мужчин было 30 (37,9%), женщин - 49 (62,1%). Пациенты были разделены на 4 группы: группу A составили пациенты c непереносимостью контактных линз после длительного их ношения на фоне БСГ, группу B - пациенты с БСГ и ассоциированным с ней кератитом на фоне системного заболевания (ревматологического, болезни Шегрена, синдрома Стивенса - Джонсона и т. п.), группу C - пациенты с БСГ после перенесенного инфекционного кератита, конъюнктивита, блефарита; группу D составили пациенты с БСГ после травм или хирургических операций на переднем отрезке глаза (пересадка роговицы, осложненная катаракта, птеригиум, антиглаукомные операции и прочее). Одним из критериев включения в исследование было согласие пациента на применение в комплексном местном лечении 0,1% катионной эмульсии циклоспорина А (Икервис) не менее 3 месяцев. Контрольные осмотры пациентов производились ежемесячно в течение периода исследования (6 месяцев). 0,1% катионную эмульсию циклоспорина А (Икервис) назначали закапывать 1 раз в сутки в вечернее время. Результаты. Местное использование ЦсА катионной эмульсии (Икервис) показало высокую эффективность в отношении субъективных и объективных симптомов БСГ и связанного с ней кератита, а именно улучшение индекса OSDI с 61,2 до 40,2, улучшение ВРСП с 4 (3-7) сек. в начале исследования до 9 (5-11) сек. через 6 месяцев наблюдения, уменьшение количества эпителиальных дефектов глазной поверхности по результатам окраски лиссаминовым зеленым и флюоресцеином. Выводы. Лечение хронического воспаления глазной поверхности представляет собой длительный процесс, в котором важна непрерывность и влияние на ключевые патофизиологические механизмы. Результаты исследования показали, что применение 0,1% катионной эмульсии циклоспорина А (Икервис) в лечении БСГ средней и тяжелой степени является эффективным, оказывает благоприятное воздействие на течение патологического процесса и позволяет значимо снизить степень тяжести БСГ благодаря уменьшению воспаления и восстановлению структурной целостности эпителия роговицы и конъюнктивы. Purpose. To study the efficiency of using 0.1% cyclosporin (Ikervis) emulsion in the treatment of dry eye disease (DED). Methods. A prospective cohort study SACURA (save the ocular surface) included 79 patients (149 eyes) with clinical manifestations of dry eye disease, the average age of participants was 52±16.8 years (18 to 84 years). There were 30 men (37.9%), 49 women (62.1%). Patients were divided into 4 groups: group A included patients with contact lens intolerance after long-term wearing on the background of DED, group B were patients with DED and associated keratitis on the background of systemic disease (rheumatological, Sjögren’s disease, Stevens-Johnson syndrome, etc.), group C - patients with DED after suffering infectious keratitis, conjunctivitis, blepharitis, group D were patients with DED after injuries or surgical operations in the anterior segment of the eye (corneal transplant, complicated cataract, pterygium, antiglaucoma surgery, etc.). One of the criteria for inclusion in the study was the patient’s consent to use 0.1% of the cationic emulsion of Cyclosporin A (Ikervis) in complex topical treatment for at least 3 months. Control examinations of patients were performed monthly during the study period (6 months). 0.1% cationic emulsion of Cyclosporin A (Ikervis) was prescribed to receive 1 time per day, in the evening. Results. Topical use of Cyclosporin A cationic emulsion (Ikervis) showed high efficacy in relation to subjective and objective symptoms of DED and associated keratitis, namely, improvement of OSDI index from 61.2 to 40.2, improvement of TBUT from 4 (3-7) sec at baseline to 9 (5-11) seconds after 6 months of observation, reduction of the number of epithelial defects of the eye surface based on the results of lissamine green and fluorescein coloration. Conclusions. Treatment of chronic inflammation of ocular surface is a long-term process in which continuity and influence on key pathophysiological mechanisms are important. The study showed that the use of 0.1% cationic emulsion Cyclosporin A (Ikervis) in the treatment of moderate to severe DED is effective, has a benefit influence on the course of the pathological process and allows to reduce significantly the severity of DED due to impact on inflammation and restoration of the structural integrity of the corneal and conjunctival epithelium.

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Section: практикующему врачуunclassified

unclassified

Эффективность 0,1% Катионной Эмульсии Циклоспорина А (Икервис) В Лечении Хронического Воспаления Глазной Поверхности При Болезни Сухого Глаза (Исследование SACURA)

Ситник¹,

Лебедева²,

Чекина³

et al. 2021

Офтальмология. Восточная Европа

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“…ocular hypertension, cataracts and opportunistic infections) [ 4 , 29 ]. Multicenter, randomized controlled trials (RCTs) have demonstrated efficacy and safety outcomes with CsA 0.05% anionic solutions or 0.1% cationic emulsion (CE) treatment, with significant improvement observed concerning the signs and symptoms of DED [ 20 – 24 , 27 ]. In Europe, only CsA 0.1% CE is licensed for prescription and reimbursement [ 31 ].…”

Section: Introductionmentioning

confidence: 99%

“…It is approved for the treatment of severe keratitis in adult patients with DED that has not improved despite treatment with tear substitutes [ 31 ]. Two double-masked, randomized, parallel-group, vehicle-controlled phase III studies, SICCANOVE and SANSIKA, examined treatment outcomes with CsA 0.1% CE in people with moderate-to-severe and severe DED, respectively [ 21 – 24 ]. In both studies, CsA 0.1% CE was well tolerated, reduced corneal surface damage and lowered ocular surface inflammation [ 21 – 24 ].…”

Section: Introductionmentioning

confidence: 99%

“…Two double-masked, randomized, parallel-group, vehicle-controlled phase III studies, SICCANOVE and SANSIKA, examined treatment outcomes with CsA 0.1% CE in people with moderate-to-severe and severe DED, respectively [ 21 – 24 ]. In both studies, CsA 0.1% CE was well tolerated, reduced corneal surface damage and lowered ocular surface inflammation [ 21 – 24 ]. Pooled analysis of SICCANOVE and SANSIKA outcomes confirmed that CsA 0.1% CE improved the signs and symptoms of DED, with a particular benefit to those with severe keratitis [ 20 ].…”

Section: Introductionmentioning

confidence: 99%

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Real-World Effectiveness, Tolerability and Safety of Cyclosporine A 0.1% Cationic Emulsion in Severe Keratitis and Dry Eye Treatment

et al. 2022

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Introduction The PERSPECTIVE study evaluated, in routine clinical practice, the effectiveness, tolerability and safety of cyclosporine A (CsA) 0.1% cationic emulsion (CE) in controlling severe keratitis in adults with dry eye who remained insufficiently controlled despite artificial tear (AT) use. Methods A prospective, multicenter, observational study was conducted at 44 ophthalmology clinics across Finland, Germany, Norway, Sweden and the UK . Adults treated with ATs for severe keratitis and dry eye received CsA 0.1% CE therapy (1 drop in both eyes at bedtime) and were followed up at weeks 4, 12 and 24 and at month 12. Primary endpoint was mean [standard deviation (SD)] change from baseline in corneal fluorescein staining (CFS; Oxford Grade Scale) at month 12 following CsA 0.1% CE initiation. Secondary endpoints examined ocular sign and symptom severity and adverse events (AEs). Results The full analysis set included 472 adults (75.9% female). Mean (SD) age was 61.9 (15.41) years. Mean (SD) CFS score was significantly reduced from baseline [2.56 (1.10)] at month 12 [1.10 (SD 1.13); P < 0.0001]. CFS score reductions were statistically significant from week 4, with further incremental decreases reported at study visits through month 12 ( P < 0.0001). Severity of eyelid and conjunctival erythema was significantly reduced from baseline at week 4 and maintained through month 12 ( P < 0.001). Tear film breakup time increased significantly from baseline at all study visits through month 12 ( P < 0.001). Ocular symptom severity was significantly reduced from baseline at all study visits through month 12 ( P < 0.001). Overall, 101 treatment-related AEs were reported. Most were mild/moderate (83.6%) and resolved by month 12 (73.3%). Conclusions In routine clinical practice, CsA 0.1% CE provided statistically significant reductions in dry eye signs and symptoms. Improvements were seen at week 4 and maintained over 12 months. Treatment tolerability was good and consistent with previous CsA 0.1% CE clinical studies. Trial registration EU PAS register number: EUPAS 22376. Supplementary Information The online version contains supplementary material available at 10.1007/s40123-022-00487-x.

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Real-world insights and outcomes related to ciclosporin A 0.1% cationic emulsion for the long-term treatment of dry eye disease in Germany: Country-level sub-analysis of the PERSPECTIVE study

Lanzl,

Deuter,

Lorenz

et al. 2024

Graefes Arch Clin Exp Ophthalmol

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Purpose The PERSPECTIVE study was a real-world European, non-interventional, multicenter, observational study that evaluated the effectiveness, tolerability, and safety of ciclosporin A (CsA) 0.1% cationic emulsion (CE) in routine clinical practice as a treatment for adults with severe keratitis and dry eye disease (DED) that remained insufficiently controlled with artificial tears. This sub-analysis examined data from ophthalmology clinics in Germany to provide more precise insights into treatment patterns, outcomes, and clinical decision-making related to CsA 0.1% CE. Methods Study data were collected from adults starting CsA 0.1% CE (one drop in both eyes at bedtime) and followed up at Week 4, 12, and 24, and Month 12. The primary endpoint was mean change from baseline in corneal fluorescein staining (CFS) score (Oxford Grade Scale) at Month 12. Secondary endpoints examined the severity of ocular signs and symptoms, and adverse events (AEs). Results A total of 236 patients from 20 ophthalmology clinics in Germany participated in the PERSPECTIVE study (69.9% female; mean age 60.8 years). Following treatment with CsA 0.1% CE, patients experienced significant reductions in CFS score from Week 4, which were maintained through to Month 12 (P < 0.0001). From baseline, 81.6% of patients experienced an improvement in CFS score at Month 12. CsA 0.1% CE provided significant reductions in the severity of eyelid and conjunctival erythema at Month 12 compared with baseline (P < 0.001), as well as significant reductions in the severity of subjective ocular symptoms (all P ≤ 0.015). Safety data were consistent with the known safety profile of CsA 0.1% CE. Tolerability was rated as “satisfactory,” “good,” or “very good” by 97.2% of physicians and 95.7% of patients. Conclusion Outcomes in Germany were similar to those reported for the overall European study population and are indicative of the treatment results that ophthalmologists may expect to see with CsA 0.1% CE treatment in real-life clinical practice. Treatment with CsA 0.1% CE provided long-term improvements over 12 months and was generally well tolerated.

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Persistence of Efficacy of 0.1% Cyclosporin A Cationic Emulsion in Subjects with Severe Keratitis Due to Dry Eye Disease: A Nonrandomized, Open-label Extension of the SANSIKA Study

Cited by 18 publications

References 18 publications

Эффективность 0,1% Катионной Эмульсии Циклоспорина А (Икервис) В Лечении Хронического Воспаления Глазной Поверхности При Болезни Сухого Глаза (Исследование SACURA)

Эффективность 0,1% Катионной Эмульсии Циклоспорина А (Икервис) В Лечении Хронического Воспаления Глазной Поверхности При Болезни Сухого Глаза (Исследование SACURA)

Real-World Effectiveness, Tolerability and Safety of Cyclosporine A 0.1% Cationic Emulsion in Severe Keratitis and Dry Eye Treatment

Real-world insights and outcomes related to ciclosporin A 0.1% cationic emulsion for the long-term treatment of dry eye disease in Germany: Country-level sub-analysis of the PERSPECTIVE study

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