Efficacy And Safety Of Adalimumab Biosimilar (Exemptia) In Moderate-To-Severe Steroid-Refractory Ulcerative Colitis Patients: Real-Life Outcomes In Resource-Constrained Setting At 24-Weeks Follow-Up

Alok Chandra, Ravi Kanth, Sandeep Thareja Department of Gastroenterology, Base Hospital, New Delhi, IndiaCorrespondence: Ravi KanthDepartment of Gastroenterology, Base Hospital, New Delhi, IndiaEmail ravikanthf2@gmail.comBackground: Adalimumab (ADA) is approved for the management of lcerative colitis (UC) not responding to conventional therapy. Use of biologics in resource-constrained settings is very challenging. Currently, real-life data on the safety and efficacy of ADA biosimilar (Exemptia) in steroid-refractory UC patients are limited.Aim and objectives: To assess the efficacy and safety of ADA biosimilar (Exemptia) to treat steroid-refractory difficult-to-treat UC patients in a resource-constrained Indian setting at 24-weeks follow-up.Materials and methods: This was a retrospective single-center study to evaluate the efficacy and safety of ADA biosimilar (Exemptia) in steroid-refractory UC patients. All the eligible patients who received induction dose of 160 mg at week 0, 80 mg at week 2 and 40 mg at week 4 and 40 mg every 4 weeks as maintenance regimen from 01 September 2017 to 31 Jan 2019 were retrospectively included in this single-center analysis. Those patients who had shown sub-optimal response at 12 weeks received 40 mg every 2 weeks as maintenance therapy. Outcomes in terms of clinical remission, clinical response and mucosal healing were evaluated in the short term at 12 weeks and 24 weeks.Results: Twenty-five patients were retrospectively included between the time period of 1 September 2017 to 31 July 2018 with a mean age of 35 years. ADA biosimilar was effective in inducing clinical remission in 16% patients at 12 and 24 weeks, clinical response was seen in 48% at week 12 and 44% at week 24. The mean baseline total Mayo score (TMS) for all patients was 10.16 which decreased to a mean score of 5.72 at 12 weeks and 5.52 at 24 weeks with therapy with the decrease of the score being statistically significant both at 12 and 24 weeks (p