PMID- 21121872 OWN - NLM STAT- MEDLINE DCOM- 20110331 LR - 20161125 IS - 1744-764X (Electronic) IS - 1474-0338 (Linking) VI - 10 IP - 1 DP - 2011 Jan TI - Clinical safety of tocilizumab in rheumatoid arthritis. PG - 123-31 LID - 10.1517/14740338.2011.537256 [doi] AB - IMPORTANCE OF THE FIELD: Tocilizumab is a new biologic disease-modifying antirheumatic drug directed against the activity of IL-6, a key pro-inflammatory cytokine in the pathogenesis of rheumatoid arthritis (RA). This drug has proved highly effective in RA patients, including those who had previously not responded to anti-TNFs. As side effects are a major cause for discontinuing biologic therapy, the present article focuses on the tolerability profile of tocilizumab. AREAS COVERED IN THIS REVIEW: This review describes the adverse events (AEs) reported in RA patients treated with tocilizumab. Most data are derived from controlled clinical trials and their open-label extensions. WHAT THE READER WILL GAIN: The reader will gain a comprehensive review of treatment-emergent AEs associated with tocilizumab therapy. These AEs include infections, including opportunistic infections, infusion and hyper-sensitivity reactions, gastrointestinal perforation, and laboratory test abnormalities, especially hepatic transaminase elevations, altered lipid profile and neutropenia. TAKE HOME MESSAGE: Based on current data, tocilizumab appears to have an acceptable safety profile inasmuch as most AEs were manageable or controllable. However, results from large scale pharmacoepidemiological investigations and appropriate post-marketing surveillance are awaited to identify the full spectrum of AEs and define the true benefit:risk ratio of tocilizumab. FAU - Bannwarth, Bernard AU - Bannwarth B AD - University Hospital Pellegrin & Division of Therapeutics, Department of Rheumatology, University Victor Segalen, Bordeaux, France. bernard.bannwarth@u-bordeaux2.fr FAU - Richez, Christophe AU - Richez C LA - eng PT - Journal Article PT - Review DEP - 20101202 PL - England TA - Expert Opin Drug Saf JT - Expert opinion on drug safety JID - 101163027 RN - 0 (Antibodies, Monoclonal) RN - 0 (Antibodies, Monoclonal, Humanized) RN - 0 (Antirheumatic Agents) RN - 0 (Interleukin-6) RN - I031V2H011 (tocilizumab) SB - IM MH - Antibodies, Monoclonal/*adverse effects/therapeutic use MH - Antibodies, Monoclonal, Humanized MH - Antirheumatic Agents/*adverse effects/therapeutic use MH - Arthritis, Rheumatoid/*drug therapy MH - Drug-Related Side Effects and Adverse Reactions MH - Humans MH - Interleukin-6/antagonists & inhibitors MH - Randomized Controlled Trials as Topic EDAT- 2010/12/03 06:00 MHDA- 2011/04/01 06:00 CRDT- 2010/12/03 06:00 PHST- 2010/12/03 06:00 [entrez] PHST- 2010/12/03 06:00 [pubmed] PHST- 2011/04/01 06:00 [medline] AID - 10.1517/14740338.2011.537256 [doi] PST - ppublish SO - Expert Opin Drug Saf. 2011 Jan;10(1):123-31. doi: 10.1517/14740338.2011.537256. Epub 2010 Dec 2.