Efficacy and safety of dual-targeted therapy for inflammatory bowel disease: a retrospective multicenter study in China

Xiuxiu Jin; Kefang Sun; Liying Wang; Haiyan Shen; Dan Ma; Tejia Shen; Chunxiao Chen; Lan Li

doi:10.1177/17562848241307598

Efficacy and safety of dual-targeted therapy for inflammatory bowel disease: a retrospective multicenter study in China

Therap Adv Gastroenterol. 2025 Jan 2:18:17562848241307598. doi: 10.1177/17562848241307598. eCollection 2025.

Authors

Xiuxiu Jin^{1

2}, Kefang Sun¹, Liying Wang³, Haiyan Shen⁴, Dan Ma¹, Tejia Shen¹, Chunxiao Chen⁵, Lan Li⁵

Affiliations

¹ Department of Gastroenterology, The First Affiliated Hospital, Zhejiang University School of Medicine, Zhejiang University, Hangzhou, China.
² Department of Gastroenterology, Taizhou Hospital of Zhejiang Province Affiliated to Wenzhou Medical University, Linhai, Zhejiang, China.
³ Department of Gastroenterology, Shangyu People's Hospital of Shaoxing, Shangyu, Zhejiang, China.
⁴ Department of Gastroenterology, The Second Hospital of Jiaxing, Jiaxing, Zhejiang, China.
⁵ Department of Gastroenterology, The First Affiliated Hospital, Zhejiang University School of Medicine, Zhejiang University, 79 Qingchun Road, Hangzhou 310003, China.

Abstract

Background: Treatment options for patients with refractory inflammatory bowel disease (IBD) or concomitant IBD and extraintestinal manifestations (EIM) are often limited.

Objective: This study aimed to examine the efficacy and safety of combining biologics or small molecules in patients with refractory IBD, active EIM, or active immune-mediated inflammatory disease (IMID).

Design: This was a retrospective and multicenter study.

Methods: We retrospectively collected demographics and disease characteristics from 47 patients with IBD who received dual-targeted therapy in 3 hospitals from January 2022 to June 2024. The primary endpoint was clinical remission based on the Harvey-Bradshaw index or patient-reported outcome 2 after at least 4 months of combination therapy. The secondary endpoints included clinical response, endoscopic response, and endoscopic remission, as well as all adverse events that occurred within the period of combination therapy.

Results: In total, 47 IBD patients including 37 with refractory IBD, 5 with active EIM, and 5 with active IMID received dual-targeted therapy, of which 37 achieved clinical response (78.7%) and 27 achieved clinical remission (57.4%) at a median follow-up time of 13.0 months. Among these 47 patients, 29 patients underwent endoscopic follow-up, of which 15 (51.7%) achieved endoscopic response and 8 (27.6%) achieved endoscopic remission at a median follow-up time of 9.0 months. Mild and moderate adverse events were reported in 17 (36.2%) patients within the period of combination therapy, and serious adverse events requiring hospitalization occurred in 1 patient (2.1%).

Conclusion: The combination therapy of biologics and small molecules for refractory IBD or those with concomitant EIM/IMID is effective and safe.

Keywords: biologics; combination; inflammatory bowel disease; small molecules.

Plain language summary

Efficacy and safety of dual targeted therapy for inflammatory bowel disease This present study examined the efficacy and safety of the combination of biologics and small molecules in patients with refractory inflammatory bowel disease (IBD), active extraintestinal manifestations (EIM) or active immune-mediated inflammatory disease (IMID). Among these 47 patients, the rates of clinical response, clinical remission, endoscopic response, and endoscopic remission were 78.7%, 57.4%, 51.7%, and 27.6%, respectively. The rates of adverse events and serious adverse events were 38.3% and 2.1%, respectively. In conclusion, dual targeted therapy for refractory IBD or those with concomitant EIM/IMID is effective and safe.