Melotti Laura, Dussias Nikolas Konstantine, Salice Marco, Calabrese Carlo, Baldoni Monia, Scaioli Eleonora, Belluzzi Andrea, Mazzotta Elena, Gionchetti Paolo, Rizzello Fernando
IBD Unit, IRCCS, Azienda Ospedaliero-Universitaria di Bologna, Italy; Alma Mater Studiorum, Università di Bologna, Italy.
IBD Unit, IRCCS, Azienda Ospedaliero-Universitaria di Bologna, Italy.
Dig Liver Dis. 2023 Feb;55(2):230-234. doi: 10.1016/j.dld.2022.06.029. Epub 2022 Jul 22.
Ustekinumab (UST) and vedolizumab (VDZ) are biologic therapies for moderate-to-severe Crohn's disease (CD) in patients who failed or had contraindication to anti-TNF treatment.
To evaluate ustekinumab efficacy as third-line treatment after swapping from VDZ for failure.
We conducted a monocentric, retrospective, observational study where CD patients were followed for 12 months from the beginning of UST therapy. We assessed clinical activity (HBI) and laboratory markers (CRP) at the initiation of UST therapy (T0) and after 2(T2), 6(T6) and 12(T12) months. Endoscopic activity was recorded at T0 and T12. We registered data regarding their clinical history and previous biologic treatments. Steroid-free clinical remission was defined as HBI ≤ 4 without need for steroids. Clinical response was defined as HBI reduction of at least three points or the suspension of steroids.
27 CD patients treated with UST after VDZ failure had a minimum follow up of 12 months and were included. All patients had previously been treated with anti-TNF agents. After 12 months, steroid-free clinical remission was evident in 15 (55.5%) patients, 5 (18.5%) had clinical response, while 7 (26%) had suspended for failure or persisted on treatment after optimization.
Ustekinumab should be considered as third-line biologic treatment in multi-refractory CD patients.
乌司奴单抗（UST）和维多珠单抗（VDZ）是用于对抗TNF治疗失败或有禁忌的中度至重度克罗恩病（CD）患者的生物疗法。
评估在因治疗失败从VDZ换药后，乌司奴单抗作为三线治疗的疗效。
我们进行了一项单中心、回顾性、观察性研究，对CD患者从UST治疗开始起随访12个月。我们在UST治疗开始时（T0）以及2个月（T2）、6个月（T6）和12个月（T12）后评估临床活动度（HBI）和实验室指标（CRP）。在T0和T12记录内镜活动度。我们记录了有关他们临床病史和既往生物治疗的数据。无类固醇临床缓解定义为HBI≤4且无需使用类固醇。临床反应定义为HBI至少降低3分或停用类固醇。
27例VDZ治疗失败后接受UST治疗的CD患者至少随访了12个月并被纳入研究。所有患者此前均接受过抗TNF药物治疗。12个月后，15例（55.5%）患者出现无类固醇临床缓解，5例（18.5%）有临床反应，而7例（26%）因治疗失败停药或在优化治疗后仍持续治疗。
对于多重难治性CD患者，应将乌司奴单抗视为三线生物治疗药物。
