Decelle Kendra, Horton Evan R
Baystate Medical Center, Springfield, MA, USA.
Ann Pharmacother. 2012 Jun;46(6):822-9. doi: 10.1345/aph.1Q756. Epub 2012 May 15.
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 www.clinicaltrials.gov.
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.
评估托珠单抗治疗幼年特发性关节炎的药理作用、临床疗效、安全性及作用。
通过PubMed对MEDLINE（1970年 - 2011年12月）和国际药学文摘（1970年 - 2011年12月）进行文献检索，以识别临床试验和综述文章。使用了关键检索词托珠单抗、抗白细胞介素6和幼年特发性关节炎，并进行了多种检索词组合。检查所选文章的参考文献以识别其他参考文献，并通过浏览www.clinicaltrials.gov识别正在进行的试验。
文章仅限于英文发表的文章及人体研究。纳入综述的研究考察了全身型和多关节型幼年特发性关节炎的儿科数据。背景信息通过对成人和儿科人群多种自身免疫性疾病状态的文献综述获得。
托珠单抗已获美国食品药品监督管理局批准用于治疗2岁及以上的全身型幼年特发性关节炎患者。在2期和3期临床试验中，托珠单抗在引发症状性反应方面优于安慰剂。托珠单抗被确定为安全的，研究中仅发生少量严重药物不良事件。
托珠单抗为全身型幼年特发性关节炎的治疗提供了更多选择，特别是对于那些对传统疗法无反应的患者。托珠单抗耐受性相对良好，已证明其疗效可持续长达52周。有必要进一步研究以确定其作为全身型幼年特发性关节炎一线治疗选择的效用及其在多关节型幼年特发性关节炎治疗中的作用。
