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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

Background/Aims Data on the efficacy and safety of the adalimumab biosimilar Exemptia are limited. Methods Patients with moderate-to-severe active steroid-refractory ulcerative colitis (UC) treated at Dayanand Medical College and Hospital, India were offered cyclosporine A, biologicals or biosimilars, or surgery. A retrospective analysis was conducted on patients who were treated with the adalimumab biosimilar, Exemptia. These patients were administered an induction dosing schedule of 160 mg Exemptia at week 0, 80 mg at week 2, and then 40 mg every other week from week 4 to 8. The clinical response and remission were assessed at week 8 using Mayo score. Results A total of 29 patients (62.1% male; mean age, 34.9 ± 9.7 years) with moderate-to-severe steroid-refractory active UC (mean disease duration, 6.3±5.1 years; pancolitis in 9 patients [31.1%]; left-sided colitis in 20 patients [68.9%]) were treated with the Exemptia induction dosing schedule. The mean Mayo score at presentation was 8.2±1.4. At week 8, clinical response was observed in 7 patients (24.1%), whereas clinical remission was observed only in 1 patient (3.5%). Among the non-responders (n=21), 4 patients required colectomy, 1 died, 1 was lost to follow-up, 10 were offered fecal microbiota transplant, 3 were administered infliximab, and 2 patients were administered cyclosporine and tacrolimus, respectively. Four patients (13.8%) developed extrapulmonary tuberculosis. Conclusions The adalimumab biosimilar Exemptia has limited efficacy for the attainment of clinical response and remission in moderate-to-severe steroid-refractory UC, with a significant risk of acquisition or reactivation of tuberculosis in developing countries such as India.

Aim In this study, efficacy, tolerability and safety of biosimilar adalimumab (Exemptia; Zydus Cadila) was compared with reference adalimumab (Humira; AbbVie) in patients with moderate to severe rheumatoid arthritis (RA). Method In this multicentre, prospective, randomized, double‐blind, active controlled parallel arm study, 120 patients with moderate to severe RA were given 40 mg of either test adalimumab (Exemptia) or reference adalimumab (Humira) by subcutaneous route every other week for 12 weeks. The primary endpoint was proportion of responders in two tretament groups by American College of Rheumatology 20 (ACR20) at week 12. The secondary endpoints were change in Disease Activity Score of 28 joints – C‐reactive protein (DAS28‐CRP) and proportion of patients with an ACR50 and ACR70 response in two treatment groups at week 12. Safety outcomes were also assessed. Results After 12 weeks, patients treated every other week with test adalimumab (Zydus Cadila) had statistically similar response rates as compared to reference adalimumab (AbbVie): ACR20 (82% vs. 79.2%; P > 0.7); ACR50 (46%, vs. 43.4%; P > 0.7); ACR70 (14% vs. 15.1%; P > 0.8). The change in DAS28‐CRP score was −2.1 ± 1.09 and −2.1 ± 1.21, in test and reference products, respectively. It was statistically significant compared to baseline, but not significantly different between the two products. Three serious adverse events and no death was reported during the study. Both adalimumab preparations were safe and well tolerated in this study. Conclusion The results demonstrated biosimilarity with respect to efficacy, tolerability and safety of test adalimumab (Exemptia) and reference adalimumab (Humira) in patients with moderate to severe RA.