Burbage Sabree, Knight Hannah, Godwin Bridget, Meadows Rachael, Jones William, Zhao Ruizhi, Kachroo Sumesh
Janssen Scientific Affairs, LLC, Horsham, PA, USA.
Adelphi Real World, Bollington, United Kingdom.
Curr Med Res Opin. 2025 Apr;41(4):683-689. doi: 10.1080/03007995.2025.2494642. Epub 2025 May 6.
Ustekinumab was approved for use in the treatment of moderate/severe ulcerative colitis (UC) in 2019. Though it has proven effective in clinical trials, evidence of its effectiveness in clinical practice is limited to the published reports of use in clinical practice. This study assessed ustekinumab effectiveness in patients with UC presenting in real-world clinical practice.
Data were drawn from the Adelphi Real World Inflammatory Bowel Disease (IBD) Disease Specific Programme, a cross-sectional survey of physicians and their IBD patients in the USA from December 2022 to January 2024. Physicians provided demographics and clinical characteristics, treatment patterns, symptoms, and remission status for UC patients aged ≥18 years old who were prescribed ustekinumab for >1 day. Analyses were descriptive; McNemar's test was used to compare symptoms and disease severity before and after ustekinumab prescription.
Overall, 56 physicians reported on 185 patients. Mean (standard deviation) patient age was 39.7 (12.9) years and 53.0% were female. Most patients were advanced therapy-naïve at ustekinumab initiation (65.9%) and had taken ustekinumab for ≥3 months (84.6%). At survey, 53.0% were in remission defined by Mayo score, and 61.9% were in physician-stated clinical remission. Reports of abdominal pain, bowel urgency, nighttime urgency, and bloody diarrhea were more than halved at survey compared to pre-ustekinumab, with reductions in fatigue and non-bloody diarrhea also seen (all < 0.0001).
Overall, ustekinumab is an effective treatment for UC in real-world clinical practice capable of inducing and maintaining long-term remission. Future work should assess how ustekinumab impacts quality of life.
乌司奴单抗于2019年被批准用于治疗中度/重度溃疡性结肠炎（UC）。尽管它在临床试验中已被证明有效，但其在临床实践中的有效性证据仅限于已发表的临床实践使用报告。本研究评估了乌司奴单抗在真实世界临床实践中治疗UC患者的有效性。
数据来自阿德尔菲真实世界炎症性肠病（IBD）特定疾病项目，这是一项于2022年12月至2024年1月在美国对医生及其IBD患者进行的横断面调查。医生提供了年龄≥18岁且接受乌司奴单抗治疗超过1天的UC患者的人口统计学和临床特征、治疗模式、症状及缓解状态。分析为描述性分析；使用McNemar检验比较乌司奴单抗处方前后的症状和疾病严重程度。
总体而言，56名医生报告了185例患者。患者平均（标准差）年龄为39.7（12.9）岁，53.０%为女性。大多数患者在开始使用乌司奴单抗时未接受过进阶治疗（65.9%），且使用乌司奴单抗≥3个月（84.6%）。在调查时，根据梅奥评分，53.0%的患者处于缓解期，61.9%的患者处于医生认定临床缓解期。与使用乌司奴单抗前相比，调查时腹痛、排便急迫感、夜间急迫感和血性腹泻的报告减少了一半以上，疲劳和非血性腹泻也有所减少（均P＜0.0001）。
总体而言，在真实世界临床实践中，乌司奴单抗是治疗UC的有效药物，能够诱导并维持长期缓解。未来的工作应评估乌司奴单抗对生活质量的影响。
