Tocilizumab (DB06273): A Comprehensive Monograph on its Pharmacology, Clinical Utility, and Regulatory Landscape

Executive Summary

Tocilizumab is a cornerstone biologic therapy that has fundamentally altered the treatment landscape for a spectrum of inflammatory and autoimmune disorders. Identified by DrugBank ID DB06273 and CAS Number 375823-41-9, it is a recombinant humanized monoclonal antibody of the immunoglobulin IgG1 subclass.[1] Its primary mechanism of action is the targeted inhibition of the interleukin-6 receptor (IL-6R), thereby neutralizing the pleiotropic effects of the pro-inflammatory cytokine IL-6.[1] By binding to both membrane-bound and soluble forms of the IL-6R, Tocilizumab provides a comprehensive blockade of IL-6-mediated signaling, a key driver in the pathophysiology of numerous diseases.[2]

Initially developed for rheumatologic conditions, Tocilizumab's clinical utility has expanded dramatically since its first approvals. It holds regulatory authorization in major markets for moderately to severely active rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), and systemic juvenile idiopathic arthritis (sJIA).[5] Its therapeutic reach extends beyond chronic autoimmune diseases to acute, life-threatening hyperinflammatory states, with landmark approvals for the management of chimeric antigen receptor (CAR) T-cell-induced cytokine release syndrome (CRS) and, more recently, for severe COVID-19 in hospitalized patients.[1] It is also approved for slowing pulmonary function decline in systemic sclerosis-associated interstitial lung disease (SSc-ILD).[5]