Introduction: The biosimilar version of Infliximab (RemsimaTM) showed clinical efficiency and immunogenicity similar to Infliximab in the treatment of ulcerative colitis. In Bulgaria the treatment with biosimilar Infliximab (RemsimaTM) has been approved since July 2014.
Aim: We have set ourselves the goal of study to investigate the efficacy and safety of biosimilar Infliximab (RemsimaTM) 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 (RemsimaTM) 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 (RemsimaTM) showed a very good efficiency in terms of achieving clinical remission in the induction period in the treatment of patients with severe ulcerative colitis.
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