Tocilizumab for the Treatment of Juvenile Idiopathic Arthritis

Baystate Medical Center, Springfield, MA, USA.
Annals of Pharmacotherapy (Impact Factor: 2.06). 05/2012; 46(6):822-9. DOI: 10.1345/aph.1Q756
Source: PubMed


To evaluate the pharmacology, clinical efficacy, safety, and role of tocilizumab for the treatment of juvenile idiopathic arthritis.
A literature search via MEDLINE through PubMed (1970-December 2011) and International Pharmaceutical Abstracts (1970-December 2011) was performed to identify clinical trials and review articles. The key search terms tocilizumab, anti-interleukin 6, and juvenile idiopathic arthritis were used, with several combinations of terms. Bibliographies of selected articles were examined to identify additional references, and ongoing trials were identified through a review of
Articles were limited to those published in English and studies in humans. Studies included in the review examined pediatric data in systemic and polyarticular juvenile idiopathic arthritis. Background information was obtained through reviews of literature on a wide variety of autoimmune disease states in both adult and pediatric populations.
Tocilizumab is Food and Drug Administration-approved for use in patients aged 2 years and older with systemic juvenile idiopathic arthritis. Tocilizumab was superior to placebo in triggering a symptomatic response during Phase 2 and 3 clinical trials. Tocilizumab was determined to be safe, with only a small number of serious adverse drug events occurring within studies.
Tocilizumab provides expansion of the available options for the treatment of systemic juvenile idiopathic arthritis, specifically in patients who have not responded to conventional therapies. Tocilizumab is relatively well tolerated and has proven efficacy for up to 52 weeks. Further studies are warranted to determine its utility as a first-line option for systemic juvenile idiopathic arthritis as well as its role within the treatment of polyarticular juvenile idiopathic arthritis.

Download full-text


Available from: Evan R Horton, Nov 21, 2014
41 Reads
  • [Show abstract] [Hide abstract]
    ABSTRACT: Tocilizumab (RoActemra(®); Actemra(®)) is a recombinant humanized monoclonal antibody that acts as an interleukin-6 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, double-blind, placebo-controlled, 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, multi-part 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 12-week double-blind treatment period, while in CHERISH, significantly fewer tocilizumab recipients than placebo recipients experienced a JIA ACR 30 flare during a 24-week double-blind withdrawal period (all patients had previously received open-label tocilizumab in a 16-week lead-in phase). Tocilizumab was generally well tolerated in the TENDER trial. Infections (e.g. upper respiratory tract infection and pharyngitis or nasopharyngitis) accounted for just over one-third of all reported adverse events in this trial; tocilizumab-treated 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 TENDER.
    Paediatric Drugs 10/2013; 15(6). DOI:10.1007/s40272-013-0053-1 · 1.98 Impact Factor