Three-year experience in treating patients with severe ulcerative colitis with biosimilar Infliximab (RemsimaTM)

Abstract

Introduction: The biosimilar version of Infliximab (Remsima TM ) showed clinical efficiency and immunogenicity similar to Infliximab in the treatment of ulcerative colitis. In Bulgaria the treatment with biosimilar Infliximab (Remsima TM ) has been approved since July 2014. Aim: We have set ourselves the goal of study to investigate the efficacy and safety of biosimilar Infliximab (Remsima TM ) in patients with severe ulcerative colitis. Patients and Methods: Over of a period of three years in the Clinic of Gastroenterology, St. Marina University Hospital, Varna, Bulgaria, fifteen patients with severe ulcerative colitis were treated with Infliximab (Remsima TM ) including patients who received at least one infusion: both anti-TNF naïve and patients who switched from another anti-TNF. Efficiency criteria: clinical response, clinical remission, mucosal healing, serum C-reactive protein (CRP) levels were observed on week 6, 24 and 52. Results and Discussion: All patients had an early clinical response at week 6 and very good improvement at week 24. The total Mayo Score was reduced to 9 points at week 24. The CRP level decreased in all patients. Twelve patients had clinical remission at week 24 (80%). After the treatment, the patients had improved quality of life. Conclusion: Our primary results with biosimilar Infliximab (Remsima TM ) showed a very good efficiency in terms of achieving clinical remission in the induction period in the treatment of patients with severe ulcerative colitis.