Abatacept (Orencia®): A Comprehensive Monograph on its Pharmacology, Clinical Efficacy, and Therapeutic Positioning

Executive Summary

Abatacept represents a first-in-class biologic therapeutic agent, classified as a selective T-cell costimulation modulator. Its introduction marked a significant evolution in the management of autoimmune diseases, shifting the therapeutic paradigm from broad immunosuppression or the blockade of downstream inflammatory cytokines to a more targeted, upstream intervention in the adaptive immune response. As a recombinant fusion protein, abatacept uniquely inhibits the activation of T-lymphocytes, a critical event in the pathogenesis of numerous autoimmune conditions. The drug is principally indicated for the treatment of adult patients with moderate-to-severe rheumatoid arthritis (RA), patients two years of age and older with active psoriatic arthritis (PsA), and patients two years of age and older with moderate-to-severe polyarticular juvenile idiopathic arthritis (pJIA).[1] In a distinct and specialized application, abatacept is also approved for the prophylaxis of acute graft-versus-host disease (aGVHD) in adults and children undergoing hematopoietic stem cell transplantation (HSCT) from specific donor types.[1]