Mocci Giammarco, Tursi Antonio, Scaldaferri Franco, Napolitano Daniele, Pugliese Daniela, Capobianco Ivan, Bartocci Bianca, Blasi Valentina, Savarino Edoardo V, Maniero Daria, Redavid Carlo, Lorenzon Greta, Cuomo Antonio, Donnarumma Laura, Gravina Antonietta Gerarda, Pellegrino Raffaele, Bodini Giorgia, Pasta Andrea, Marzo Manuela, Serio Mariaelena, Scarcelli Antonella, Rodinò Stefano, Sebkova Ladislava, Maconi Giovanni, Cataletti Giovanni, Luppino Ileana, Checchin Davide, Ferronato Antonio, Gaiani Federica, Kayali Stefano, Felice Carla, Pranzo Giuseppe, Catarella Domenico, D'Agostino Dario, Di Bartolo Elisabetta, Lombardi Giovanni, Patturelli Marta, Bendia Emanuele, Bolognini Laura, Balducci Daniele, Quatraccioni Claudia, Martini Francesco, Mucherino Caterina, D'Antonio Elvira, Montesano Laura, Vespere Giuliana, Sedda Silvia, D'Onofrio Vittorio, De Luca Leonardo, Spagnuolo Rocco, Luzza Francesco, Fanigliulo Libera, Rocco Giulia, Sacchi Carlotta, Zampaletta Costantino, Grossi Laurino, Lorenzetti Roberto, Aragona Giovanni, Perazzo Patrizia, Forti Giacomo, Allegretta Leonardo, Cazzato Alessia Immacolata, Scorza Stefano, Cortellini Fabio, Capone Pietro, Villani Guido Daniele, Di Fonzo Michela, Iacopini Federico, Tonti Paolo, Neve Viviana, Colucci Raffaele, Elisei Walter, Monterubbianesi Rita, Faggiani Roberto, Pica Roberta, Pagnini Cristiano, Graziani Maria Giovanna, Di Paolo Maria Carla, Onidi Francesca Maria, Saba Francesco, Dore Maria Pina, Usai-Satta Paolo, Picchio Marcello, Papa Alfredo
Division of Gastroenterology, AORN "Brotzu" Hospital, 09124 Cagliari, Italy.
Territorial Gastroenterology Service, ASL BAT, 76123 Andria, Italy.
J Clin Med. 2024 Nov 27;13(23):7192. doi: 10.3390/jcm13237192.
Ustekinumab (UST) is an interleukin-12/interleukin-23 receptor antagonist approved for the treatment of Crohn's disease (CD). Only limited real-life data on the long-term outcomes of CD patients treated with UST are available. This study assessed UST's long-term effectiveness and safety in a large population-based cohort of moderate to severe CD patients. This was a multicenter, retrospective, observational cohort study that included both naïve and biologic-experienced patients treated with UST who achieved clinical remission or clinical response after at least one year of treatment. Clinical activity was scored according to the Harvey-Bradshaw Index (HBI). The primary endpoints were the maintenance or achievement of clinical remission after a further 12-month period of treatment, defined as an HBI of ≤5, and safety. Other endpoints included steroid-free remission, mucosal healing (MH), steroid discontinuation, and the need for treatment optimization during the follow-up. Out of 562 CD patients, after an overall 24-month follow-up, clinical remission was present in 450 (80.0%) patients, and at 12 months, clinical remission was observed in 417/437 (95.4%) patients; 33/125 (26.4%) showed clinical response at 12 months ( = 0.000). A total of 38/103 (36.9%) patients achieved MH. Only 2.1% (12/562), 3% (17/562), and 1.1% (6/562) of patients required surgery, optimization, and re-induction, respectively. Adverse events occurred in eight patients (1.42%). According to a multivariate analysis, the only predictor of long-term remission was the presence of remission at the 12-month follow-up ( = 0.000). : Long-term treatment with UST presents good efficacy and safety profiles in CD patients, especially for patients who achieve remission after one year.
优特克单抗（UST）是一种已被批准用于治疗克罗恩病（CD）的白细胞介素-12/白细胞介素-23受体拮抗剂。关于接受UST治疗的CD患者长期预后的真实生活数据有限。本研究评估了UST在一个基于人群的大型中重度CD患者队列中的长期有效性和安全性。这是一项多中心、回顾性、观察性队列研究，纳入了初治和有生物制剂治疗经验且在至少一年治疗后达到临床缓解或临床反应的接受UST治疗的患者。根据哈维-布拉德肖指数（HBI）对临床活动进行评分。主要终点是在进一步12个月的治疗期后维持或实现临床缓解（定义为HBI≤5）以及安全性。其他终点包括无激素缓解、黏膜愈合（MH）、停用激素以及随访期间优化治疗的需求。在562例CD患者中，经过总共24个月的随访，450例（80.0%）患者出现临床缓解，在12个月时，417/437例（95.4%）患者观察到临床缓解；33/125例（26.4%）在12个月时出现临床反应（P = 0.000）。共有38/103例（36.9%）患者实现MH。分别只有2.1%（12/562）、3%（17/562）和1.1%（6/562）的患者需要手术、优化治疗和再次诱导治疗。8例患者（1.42%）发生不良事件。根据多变量分析，长期缓解的唯一预测因素是在12个月随访时出现缓解（P = 0.000）。结论：UST长期治疗在CD患者中呈现出良好的疗效和安全性，尤其是对于在一年后实现缓解的患者。
