A Phase Iii, Randomized, Two-Armed, Double-Blind, Parallel, Active Controlled, and Non-Inferiority Clinical Trial to Compare Efficacy and Safety of Biosimilar Adalimumab (Cinnora®) to the Reference Product (Humira®) in Patients With Active Rheumatoid Arthritis Publisher Pubmed



Jamshidi A¹ ; Gharibdoost F¹ ; Vojdanian M¹ ; Soroosh SG² ; Soroush M³ ; Ahmadzadeh A⁴ ; Nazarinia MA⁵ ; Mousavi M⁶ ; Karimzadeh H⁷ ; Shakibi MR⁸ ; Rezaieyazdi Z⁹ ; Sahebari M⁹ ; Hajiabbasi A¹⁰ ; Ebrahimi AA¹¹ Show All Authors
Source: Arthritis Research and Therapy Published:2017

Abstract

Background: This study aimed to compare efficacy and safety of test-adalimumab (CinnoRA®, CinnaGen, Iran) to the innovator product (Humira®, AbbVie, USA) in adult patients with active rheumatoid arthritis (RA). Methods: In this randomized, double-blind, active-controlled, non-inferiority trial, a total of 136 patients with active RA were randomized to receive 40 mg subcutaneous injections of either CinnoRA® or Humira® every other week, while receiving methotrexate (15 mg/week), folic acid (1 mg/day), and prednisolone (7.5 mg/day) over a period of 24 weeks. Physical examinations, vital sign evaluations, and laboratory tests were conducted in patients at baseline and at 12-week and 24-week visits. The primary endpoint in this study was the proportion of patients achieving moderate and good disease activity score in 28 joints-erythrocyte sedimentation rate (DAS28-ESR)-based European League Against Rheumatism (EULAR) response. The secondary endpoints were the proportion of patients achieving American College of Rheumatology (ACR) criteria for 20% (ACR20), 50% (ACR50), and 70% (ACR70) responses along with the disability index of health assessment questionnaire (HAQ), and safety. Results: Patients who were randomized to CinnoRA® or Humira® arms had comparable demographic information, laboratory results, and disease characteristics at baseline. The proportion of patients achieving good and moderate EULAR responses in the CinnoRA® group was non-inferior to the Humira® group at 12 and 24 weeks based on both intention-to-treat (ITT) and per-protocol (PP) populations (all p values >0.05). No significant difference was noted in the proportion of patients attaining ACR20, ACR50, and ACR70 responses in the CinnoRA® and Humira® groups (all p values >0.05). Further, the difference in HAQ scores and safety outcome measures between treatment arms was not statistically significant. Conclusion: CinnoRA® was shown to be non-inferior to Humira® in terms of efficacy at week 24 with a comparable safety profile to the reference product. Trial registration: IRCT.ir, IRCT2015030321315N1. Registered on 5 April 2015. © 2017 The Author(s).