Table 1.
Current indications of tocilizumab.
Autoimmune/ inflammatory condition | U.S. Food and Drug Administration (FDA) | FDA administration route | European Medicines Agency (EMA) | EMA administration route |
---|---|---|---|---|
RA | Adults with active RA and inadequate response to DMARDs | IV or SC | Adults with severe RA and inadequate response to methotrexate, or with moderate to severe active RA not responding to DMARDs or TNF blockers |
IV or SC |
Systemic JIA | Patients ≥ 2 years with active disease | IV | Patients ≥ 1 year with poor response to NSAIDs and GC | IV |
Polyarticular JIA | Patients ≥ 2 years with active disease | IV | Patients ≥ 2 years with active disease, not responding to methotrexate | IV or SC |
GCA | Adult patients | SC | Adult patients | SC |
CRS due to CAR-T cell therapy | Adults and pediatric patients ≥2 years with CAR T cell-induced severe or life-threatening CRS |
IV | Adults and pediatric patients ≥2 years with CAR T cell-induced severe or life-threatening CRS |
IV |
Abbreviations: CAR = Chimeric antigen receptor; CRS = Cytokine release syndrome; DMARDs = Disease modifying anti-rheumatic drugs; GC = Glucocorticoids; GCA = Giant cell arteritis; IV = Intravenous; JIA = Juvenile idiopathic arthritis; NSAIDs = Non-steroidal anti-inflammatory drugs; RA = Rheumatoid arthritis; SC = Subcutaneous; TNF = Tumor necrosis factor.