Real-world efficacy and safety of upadacitinib in difficult-to-treat Crohn’s disease: a 24-week multicenter study from China
Year: 2026
Type: article
Abstract: Background/Aims: Real-world evidence for upadacitinib use in strictly defined difficult-to-treat Crohn's disease (DTT-CD), particularly in Asian populations, remains limited. Herein, we aimed to evaluate the efficacy and safety of upadacitinib in Chinese patients with DTT-CD. Methods: This multicenter, bidirectional cohort study was conducted at 8 Chinese inflammatory bowel disease centers. Patients received upadacitinib 45 mg once daily for 12 weeks induction, followed by 15 mg daily for maintenance. The coprimary endpoints were clinical remission at week 12 and week 24. Results: Among the 151 DTT-CD patients enrolled, the clinical remission rates were 47.0% at week 12 and 62.9% at week 24, with endoscopic remission achieved in 28.1% of patients at week 24. Adverse events occurred in 42 (27.8%) during induction and in 33 (21.9%) during maintenance, with 3 serious events (venous thrombosis, perforation, and hemorrhage) reported during the maintenance phase. Notably, 2 male reproductive system-related adverse events were observed, including blue semen in 2 patients and a suspected case of paternal teratogenicity with fetal anomalies and pregnancy loss. The drug persistence at week 24 was 93.4%. Conclusions: Upadacitinib demonstrated robust efficacy in Chinese patients with DTT-CD, with a manageable safety profile and high treatment persistence.
Source: Intestinal Research
Authors: Zile Zhang, Shuowen Zhang, Wensong Ge, Yue Li, Ruidong Chen, Wen Tang, Qunying Wang, Yihong Fan, Linyan Zhou, Feng Tian, Chunxiao Chen, Yubei Gu, Duowu Zou
Institutions: Shanghai Jiao Tong University, Ruijin Hospital, XinHua Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Peking Union Medical College Hospital, Second Affiliated Hospital of Soochow University, Jinhua Central Hospital, Zhejiang University, Zhejiang Chinese Medical University, Sheng Jing Hospital, China Medical University, First Affiliated Hospital Zhejiang University
Language: English
Topic: Inflammatory Bowel Disease
Subfield: Genetics
Domain: Life Sciences
Open Access status: diamond
OpenAlex ID: W7208756407