Kết quả và tính an toàn của thuốc sinh học trong điều trị bệnh viêm ruột mạn tính tại Bệnh viện Trung ương Quân đội 108

Abstract

Objective: Biologic agents have been evaluated for their efficacy and safety in patients with moderate to severe inflammatory bowel disease (IBD). However, clinical data in Vietnam remain limited. Therefore, this study aims to assess the safety and treatment response of IBD patients receiving three biologic agents available in Vietnam: infliximab, adalimumab, and ustekinumab. Subject and method: This retrospective study collected data from 91 IBD patients who received biologic therapy at the Department of Gastrointestinal Diseases, 108 Military Central Hospital, from January 2020 to August 2024. Clinical response, clinical remission, and endoscopic remission were assessed at weeks 2 and 14, and at months 6, 12, 18, 24, 36, and 45. Tolerance and adverse effects of biologic agents were also evaluated. Result: Among the 91 patients studied, 71.4% had Crohn’s disease and 28.6% had ulcerative colitis, with a male predominance in both groups. Infliximab was used in 83.5% of patients, adalimumab in 7.7%, and ustekinumab in 8.8%. Most patients achieved clinical remission at weeks 2 and 14 (85–100%). At 12 months, 94% of patients maintained a clinical response to infliximab, with 69% achieving clinical remission and 62.2% achieving endoscopic remission. Five patients experienced grade I/II anaphylaxis during infliximab infusion, four cases of tuberculosis reactivation were observed, three cases of other infection, and one case of Strongyloides infection was recorded. No secondary infections were noted in the eight patients treated with ustekinumab. Conclusion: Infliximab remains the most commonly used biologic therapy for IBD patients, demonstrating rapid symptom improvement and high rates of clinical and endoscopic remission. Preliminary data suggest that ustekinumab is also effective and safe in this patient population.