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Drug Safety Evaluation

Safety of tocilizumab in the treatment of juvenile idiopathic arthritis

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Pages 493-500 | Received 24 Nov 2016, Accepted 03 Mar 2017, Published online: 22 Mar 2017
 

ABSTRACT

Introduction: Tocilizumab (TCZ) is a recombinant humanized monoclonal antibody and IL-6 receptor antagonist, currently approved for the treatment of systemic juvenile idiopathic arthritis (sJIA) and polyarticular juvenile idiopathic arthritis (pJIA) in children aged 2 years or older refractory to conventional treatment. The most common adverse events in patients treated with TCZ were infections, especially in the respiratory tract. The most frequent laboratory abnormalities were altered liver function, neutropenia and elevated cholesterol levels.

Areas covered: The safety of TCZ in the treatment of children with JIA was determined based on a review of published clinical trials, including two multicenter studies of patients with sJIA and pJIA (the TENDER and CHERISH trials, respectively). The frequency of adverse events (AEs), serious adverse events (SAEs) and deaths reported in these studies was analyzed and discussed.

Expert opinion: TCZ was effective and well tolerated in the treatment of severe forms of sJIA and pJIA, and can be considered a treatment of choice for these conditions. The risk of infections and laboratory abnormalities, such as neutropenia, should be constantly monitored. There is still a need for comparative studies of the risks and benefits of biological agents in patients with refractory JIA.

Declaration of interest

RM Xavier has previously been a speaker for Roche (Tocilizumab and adult rheumatoid arthritis), Janssen Abbvie and Pfizer. RM Xavier has also received research grants from Roche. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. SH Machado has no conflict of interest.

Additional information

Funding

This study received financial support from the National Council for Scientific and Technological Development (CNPq).

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