HS626, a newly approved infliximab biosimilar in China (2021), initially lacked approval for treating inflammatory bowel disease (IBD). This study aimed to evaluate the short-term efficacy and safety of HS626 in IBD inducing remission. A retrospective study (Jan 2022–Apr 2024) evaluated HS626 in Crohn’s disease (CD) and ulcerative colitis (UC). Disease activity was assessed using the Crohn’s disease activity index and simplified endoscopic score for Crohn’s disease (SES-CD) in CD patients, and the ulcerative colitis endoscopic index of severity, Mayo score, and endoscopic severity in UC patients. Blood samples were collected at weeks 0, 2, 6, and 14 to measure hemoglobin, leukocytes, platelets, albumin, C-reactive protein, and red blood cell count. Paired t -tests/Wilcoxon tests were used. Adverse reactions were assessed. In this study, 24 patients (11 UC, 13 CD) were enrolled, 21 patients (10 UC, 11 CD) with endoscopy data at weeks 0, 14 were enrolled. Clinical response rates were 81.8%(9/11) in UC and 69.2%(9/13) in CD. Clinical remission rates were 9.1%(1/11) in UC and 76.9% (10/13) in CD. Atopic dermatitis occurred in 1 patient (sole adverse reaction). HS626 effectively induces remission in IBD patients with a favorable short-term safety profile.
Yun-si et al. (Fri,) studied this question.