Efficacy and safety of Infliximab biosimilar, REMSIMA® in treatment of chronic plaque psoriasis.

Abstract

Objective: To assess the efficacy and safety of REMSIMA®, a biosimilar of infliximab in treatment of chronic plaque psoriasis. Study Design: Non-randomized Clinical Trial. Setting: Departments of Dermatology, GTTH and SIMS Lahore. Period: April, 2022 to July, 2023. Methods: A multi-centered study conducted in Dermatology Departments of GTTH and SIMS Lahore after permission from IRB (Ref. No. LM&DC/ 5366-67/2022 dated 14.4.2022). Informed consent obtained for treatment with REMSIMA 120mg S/C given at 0,1,2,3,4,6,8,10 and 12 weeks. PASI was calculated at 0,4,8 and 12 weeks. Efficacy was measured as achievement of PASI-75 at 12 weeks. Relapse was checked on monthly regular follow ups till 24 weeks. Results: A total of 51 diagnosed patients of chronic plaque psoriasis were enrolled (1 was lost to follow-up, 1 had continuous fever, 1 discontinued due to elevated LFT’s) 48 continued the treatment (72.9% males, 27.1% females) with age 18-59 years. Disease duration was >10 years in 20 patients and <10 years in 28 patients. Prior systemic treatment was taken by 75% patients. Average PASI was 22.50 at baseline. Results at 12 weeks post-treatment showed that PASI-75 was achieved by 93.75% patients with average PASI being 1.24 (p<0.001). Adverse events were noted in 4 (8.3%) patients i.e 3 had recurrent upper respiratory tract infections and 1 patient had dizziness and sweating post 1^st dose. Relapse was observed in 5 patients. Conclusion: Remsima is efficacious and safe, although expensive but the patient can be shifted to cost-effective therapy once the disease is controlled.