Journal of Crohn's & colitis · 2025
Low Incidence of Macular Edema and Other Ocular Events in the Etrasimod Development Program.
СтатьяНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Dubinsky Marla C, Wu Joseph, McDonnell Aoibhinn, Lazin Krisztina, Goetsch Martina, Branquinho Diogo, Modesto Irene, Armuzzi Alessandro
Аннотация
BACKGROUND AND AIMS: Sphingosine 1-phosphate receptor modulators have been associated with an increased risk of macular edema. Etrasimod is an oral, once-daily, selective sphingosine 1-phosphate1,4,5 receptor modulator.
METHODS: We report the proportions and incidence rates (per 100 patient-years of exposure) of Macular edema and other ocular adverse events in the etrasimod clinical program, including patients with ulcerative colitis, Crohn's disease, eosinophilic esophagitis, alopecia areata, and atopic dermatitis. Ulcerative colitis data were analyzed in 2 cohorts: Placebo-controlled ulcerative colitis and All ulcerative colitis (comprising the Placebo-controlled ulcerative colitis cohort plus open-label extension studies).
RESULTS: In the Placebo-controlled ulcerative colitis cohort, Macular edema was reported in 2 patients receiving etrasimod (0.3%; incidence rate: 0.70) and 1 receiving placebo (0.3%; incidence rate: 0.84). In the All ulcerative colitis cohort, 1 patient (0.1%; incidence rate: 0.13) receiving etrasimod reported 2 events of Cystoid macular edema. All events were nonserious, and 1 led to treatment discontinuation. No events of Macular edema were reported in other conditions. Nine and 4 patients receiving etrasimod reported Vision blurred and Visual impairment adverse events, respectively. All events were nonserious and most did not require any intervention.
CONCLUSIONS: Macular edema and other ocular events were uncommon in patients treated with etrasimod across multiple conditions. Incidence of Macular edema was comparable with placebo.
CLINICAL TRIALS.GOV IDENTIFIERS: NCT02447302; NCT03945188; NCT03996369; NCT02536404; NCT03950232; NCT04176588; NCT04173273; NCT04682639; NCT04556734; NCT04162769.
METHODS: We report the proportions and incidence rates (per 100 patient-years of exposure) of Macular edema and other ocular adverse events in the etrasimod clinical program, including patients with ulcerative colitis, Crohn's disease, eosinophilic esophagitis, alopecia areata, and atopic dermatitis. Ulcerative colitis data were analyzed in 2 cohorts: Placebo-controlled ulcerative colitis and All ulcerative colitis (comprising the Placebo-controlled ulcerative colitis cohort plus open-label extension studies).
RESULTS: In the Placebo-controlled ulcerative colitis cohort, Macular edema was reported in 2 patients receiving etrasimod (0.3%; incidence rate: 0.70) and 1 receiving placebo (0.3%; incidence rate: 0.84). In the All ulcerative colitis cohort, 1 patient (0.1%; incidence rate: 0.13) receiving etrasimod reported 2 events of Cystoid macular edema. All events were nonserious, and 1 led to treatment discontinuation. No events of Macular edema were reported in other conditions. Nine and 4 patients receiving etrasimod reported Vision blurred and Visual impairment adverse events, respectively. All events were nonserious and most did not require any intervention.
CONCLUSIONS: Macular edema and other ocular events were uncommon in patients treated with etrasimod across multiple conditions. Incidence of Macular edema was comparable with placebo.
CLINICAL TRIALS.GOV IDENTIFIERS: NCT02447302; NCT03945188; NCT03996369; NCT02536404; NCT03950232; NCT04176588; NCT04173273; NCT04682639; NCT04556734; NCT04162769.