Specialist doctor in Gastroenterology, Department of Gastroenterology, Ankara City Hospital, Ankara, Turkey.
Professor of Gastroenterology, Department of Gastroenterology, Ankara City Hospital, Ankara, Turkey.
Scott Med J. 2021 Aug;66(3):152-157. doi: 10.1177/00369330211008587. Epub 2021 Apr 9.
The aim of this study was to present one-year real-life data of our patients with CD who showed unresponsiveness and/or intolerance to biological agents and then received ustekinumab treatment through an early access program.
The retrospective study reviewed the 52-week clinical data of 10 patients with moderate or severe CD who underwent ustekinumab therapy.
The 10 patients comprised 7 (70%) men and 3 (30%) women with a mean age of 38 ± 11.3 years. Mean disease duration was 13.5 ± 8.5 years. Mean pretreatment CDAI score was 273.5 ± 92 and mean pretreatment HBI score was 11.6 ± 3.8. At the end of the 8-week intravenous induction treatment, 5 (55%) patients showed clinical remission according to the CDAI and HBI scores. Additionally, 62.5% of the patients were in clinical remission at the end of week 52 according to the CDAI and HBI scores. No drug-related side effects were observed in any patient throughout the treatment.
Ustekinumab appears to be effective and safe in the treatment of moderate and severe CD, particularly in cases of unresponsiveness and intolerance to biological agents such as anti-TNF, and in the achievement of clinical remission.
本研究旨在报告我们的一组对生物制剂无应答和/或不耐受的中重度 CD 患者的一年真实世界数据，这些患者随后通过早期准入计划接受乌司奴单抗治疗。
这项回顾性研究回顾了 10 例接受乌司奴单抗治疗的中重度 CD 患者的 52 周临床数据。
10 例患者中包括 7 例（70%）男性和 3 例（30%）女性，平均年龄为 38±11.3 岁。平均疾病病程为 13.5±8.5 年。治疗前 CDAI 评分的平均值为 273.5±92，HBI 评分为 11.6±3.8。在 8 周静脉诱导治疗结束时，根据 CDAI 和 HBI 评分，5 例（55%）患者达到临床缓解。此外，根据 CDAI 和 HBI 评分，52 周结束时 62.5%的患者达到临床缓解。在整个治疗过程中，没有观察到任何与药物相关的不良反应。
乌司奴单抗在治疗中重度 CD 中显示出有效性和安全性，尤其是在对 TNF 拮抗剂等生物制剂无应答和不耐受的情况下，以及实现临床缓解方面。
