Tocilizumab A Review of Its Use in the Treatment

Authors: James E Frampton

Publish Date: 2013/10/24

Volume: 15, Issue: 6, Pages: 515-531

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Abstract

Tocilizumab RoActemra® Actemra® is a recombinant humanized monoclonal antibody that acts as an interleukin6 receptor antagonist Both in the US and EU tocilizumab has been approved for the treatment of two subtypes of juvenile idiopathic arthritis JIA namely systemic JIA sJIA and polyarticular JIA pJIA in patients aged ≥2 years These approvals are based on favorable results from two randomized doubleblind placebocontrolled multinational phase III trials in which patients aged 2–17 years with active sJIA TENDER or pJIA CHERISH received an intravenous dose of tocilizumab based on bodyweight every 2 or 4 weeks respectively Tocilizumab met the primary endpoint in both of these ongoing multipart studies That is in TENDER significantly more tocilizumab recipients than placebo recipients achieved a JIA American College of Rheumatology ACR 30 response plus absence of fever as assessed at the end of a 12week doubleblind treatment period while in CHERISH significantly fewer tocilizumab recipients than placebo recipients experienced a JIA ACR 30 flare during a 24week doubleblind withdrawal period all patients had previously received openlabel tocilizumab in a 16week leadin phase Tocilizumab was generally well tolerated in the TENDER trial Infections eg upper respiratory tract infection and pharyngitis or nasopharyngitis accounted for just over onethird of all reported adverse events in this trial tocilizumabtreated patients appeared to have an approximately 11  risk of a serious infection per year of treatment Clinical laboratory abnormalities included neutropenia and elevated aminotransferase levels The tolerability profile of tocilizumab in CHERISH was generally consistent with that of the drug in TENDERThe manuscript was reviewed by P Quartier Unité d’immunohématologie et rhumatologie pédiatriques université ParisDescartes centre de référence national maladies rares «arthrites juvéniles» hôpital NeckerEnfantsMalades Paris France S RoseJohn Institute of Biochemistry ChristianAlbrechtsUniversity of Kiel Kiel Germany S Yokota Department of Pediatrics Yokohama City University School of Medicine Yokohama JapanThe preparation of this review was not supported by any external funding During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on this article Changes resulting from comments received were made by the authors on the basis of scientific and editorial merit

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