维多珠单抗治疗溃疡性结肠炎与克罗恩病的真实世界疗效及安全性：一项意大利多中心研究的结果

Real-world efficacy and safety of vedolizumab in managing ulcerative colitis versus Crohn's disease: results from an Italian multicenter study.

作者信息

Mocci Giammarco, Tursi Antonio, Maconi Giovanni, Cataletti Giovanni, Mantia Beatrice, Serio Mariaelena, Scarcelli Antonella, Pagnini Cristiano, Graziani Maria Giovanna, Di Paolo Maria Carla, Pranzo Giuseppe, Luppino Ileana, Paese Pietro, Elisei Walter, Monterubbianesi Rita, Faggiani Roberto, Ferronato Antonio, Perini Barbara, Savarino Edoardo, Onidi Francesca Maria, Binaghi Laura, Usai Satta Paolo, Schiavoni Elisa, Napolitano Daniele, Scaldaferri Franco, Pugliese Daniela, Pica Roberta, Cocco Andrea, Zippi Maddalena, Rodino Stefano, Sebkova Ladislava, Rocco Giulia, Sacchi Carlotta, Zampaletta Costantino, Gaiani Federica, De Angelis Gianluigi, Kayali Stefano, Fanigliulo Libera, Lorenzetti Roberto, Allegretta Leonardo, Scorza Stefano, Cuomo Antonio, Donnarumma Laura, Della Valle Nicola, Sacco Rodolfo, Forti Giacomo, Antonelli Elisabetta, Bassotti Gabrio, Iannelli Chiara, Luzza Francesco, Aragona Giovanni, Perazzo Patrizia, Lauria Angelo, Piergallini Simona, Colucci Raffaele, Bianco Maria Antonia, Meucci Costantino, Giorgetti Gianmarco, Clemente Valeria, Fiorella Serafina, Penna Antonio, De Medici Antonio, Picchio Marcello, Papa Alfredo

机构信息

Division of Gastroenterology, "Brotzu" Hospital, Cagliari, Italy.

Territorial Gastroenterology Service, ASL BAT, Andria, Italy.

出版信息

Expert Opin Biol Ther. 2023 Mar;23(3):293-304. doi: 10.1080/14712598.2023.2185510. Epub 2023 Mar 2.

DOI:10.1080/14712598.2023.2185510

PMID:36843568

Abstract

BACKGROUND

Vedolizumab (VDZ) can be used to treat refractory ulcerative colitis (UC) and Crohn's disease (CD). We assessed whether there are differences in treating UC vs CD with VDZ.

RESEARCH DESIGN AND METHODS

Mayo score in UC and the Harvey-Bradshaw Index (HBI) in CD scored the clinical activity. Achievement and maintenance of clinical remission during the follow-up, and safety were the primary endpoints.

RESULTS

729 patients (475 with UC and 254 with CD), median follow-up of 18 (IQR 6-36) months, were enrolled. Clinical remission at the 6 month of treatment was achieved in 488 (66.9%) patients (74.4% in CD vs 62.9% in UC, p<0.002) while, during the follow-up, no difference was found (81.5% in the UC group and 81.5% pts in the CD group; p=0.537). The clinical remission at the 6 month of treatment (p=0.001) and being naïve to biologics (p<0.0001) were significantly associated with prolonged clinical remission. The clinical response was significantly higher in UC (90.1%) vs CD (84.3%) (p=0.023), and surgery occurred more frequently in CD (1.9% in UC vs 5.1% in CD, p=0.016).

CONCLUSION

We found differences when using VDZ in UC vs CD in real life. These parameters can help the physician predict this drug's longterm efficacy.

摘要

背景

维多珠单抗（VDZ）可用于治疗难治性溃疡性结肠炎（UC）和克罗恩病（CD）。我们评估了使用VDZ治疗UC和CD是否存在差异。

研究设计与方法

用UC的梅奥评分和CD的哈维-布拉德肖指数（HBI）对临床活动进行评分。随访期间临床缓解的达成和维持以及安全性是主要终点。

结果

共纳入729例患者（475例UC患者和254例CD患者），中位随访时间为18（四分位间距6 - 36）个月。488例（66.9%）患者在治疗6个月时实现临床缓解（CD组为74.4%，UC组为62.9%，p<0.002），而在随访期间未发现差异（UC组为81.5%，CD组为81.5%；p = 0.537）。治疗6个月时的临床缓解（p = 0.001）和未使用过生物制剂（p<0.0001）与延长的临床缓解显著相关。UC的临床缓解率（90.1%）显著高于CD（84.3%）（p = 0.023），CD的手术发生率更高（UC为1.9%，CD为5.1%，p = 0.016）。