MedElevator
Войти в исследования Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2026
Efficacy and Safety of Guselkumab in Patients with Crohn's Disease and Ulcerative Colitis: A Prospective Real-World Study.
СтатьяНазвание и аннотация: Перевод пока не подготовлен
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.
Shafrir Asher, Choi David, Capucci Lauren C, Hannett Alexandra, Tanouye Jessica, Mathew Alex J, Natt Navneet, Dalal Sushila, McDonald Benjamin D, Cleveland Noa Krugliak, Pekow Joel, Choden Tenzin, Cohen Russell D, Rubin David T
Аннотация
BACKGROUND AND AIMS: Guselkumab (GUS), selective IL-23p19 inhibitor that also binds to CD64+ cells, is approved for the treatment of moderately-to-severely active Crohn's disease (CD) and ulcerative colitis (UC). Real-world evidence of effectiveness and safety is needed.
METHODS: We prospectively enrolled adult patients with IBD initiating GUS at our tertiary center between 9/2024 and 1/2026. Patients were followed for up to 52 weeks. Clinical and biochemical data were collected at designated time points on patients' activity indices and adverse events (AEs). Clinical remission was defined as a Harvey-Bradshaw Index (HBI) <5 for CD or Simple Clinical Colitis Activity Index (SCCAI) ≤2 for UC.
RESULTS: We followed 234 patients who initiated GUS (142 CD, 92 UC). Week 12 clinical remission was achieved in 76.8% of patients with CD (HBI<5) and 80.7% of patients with UC (SCCAI≤2). Among patients with active disease at baseline, week 12 remission rates were 24/41 (58.5%) in CD and 35/48 (72.9%) in UC. Remission was maintained at month 6 in 88.4% in CD. In UC, remission rates at 6 months were maintained in 85.4% of patients. Normal CRP at week 12 was observed in 72.9% patients with CD and 90.0% in UC. Disease location, extent, or behavior were not associated with different response rates. AEs occurred in 15 patients (6.4%) and were mostly mild; 7 patients discontinued GUS due to AEs.
CONCLUSION: In this large real-world prospective experience of GUS for IBD, we describe high rates of remission and an overall safety profile that is similar to that seen in the pivotal trials.
METHODS: We prospectively enrolled adult patients with IBD initiating GUS at our tertiary center between 9/2024 and 1/2026. Patients were followed for up to 52 weeks. Clinical and biochemical data were collected at designated time points on patients' activity indices and adverse events (AEs). Clinical remission was defined as a Harvey-Bradshaw Index (HBI) <5 for CD or Simple Clinical Colitis Activity Index (SCCAI) ≤2 for UC.
RESULTS: We followed 234 patients who initiated GUS (142 CD, 92 UC). Week 12 clinical remission was achieved in 76.8% of patients with CD (HBI<5) and 80.7% of patients with UC (SCCAI≤2). Among patients with active disease at baseline, week 12 remission rates were 24/41 (58.5%) in CD and 35/48 (72.9%) in UC. Remission was maintained at month 6 in 88.4% in CD. In UC, remission rates at 6 months were maintained in 85.4% of patients. Normal CRP at week 12 was observed in 72.9% patients with CD and 90.0% in UC. Disease location, extent, or behavior were not associated with different response rates. AEs occurred in 15 patients (6.4%) and were mostly mild; 7 patients discontinued GUS due to AEs.
CONCLUSION: In this large real-world prospective experience of GUS for IBD, we describe high rates of remission and an overall safety profile that is similar to that seen in the pivotal trials.