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罗氏RA药物Actemra获加拿大批准用于儿童多关节幼年特发性关节炎

  1. Actemra
  2. tocilizumab
  3. 单抗
  4. 多关节幼年特发性关节炎
  5. 罗氏

来源:生物谷 2013-10-23 14:47

2013年10月22日讯 /生物谷BIOON/ --罗氏(Roche)旗下基因泰克(Genentech)10月21日宣布,类风湿性关节炎(RA)药物Actemra(tocilizumab)获得加拿大卫生部批准,用于对既往疾病修饰性RA药物(DMARDs)和系统性类固醇疗法反应不足的2岁及以上儿童多关节幼年特发性关节炎(polyJIA)患者的治疗。

2013年10月22日讯 /生物谷BIOON/ --罗氏(Roche)旗下基因泰克(Genentech)10月21日宣布,类风湿性关节炎(RA)药物Actemra(tocilizumab)获得加拿大卫生部批准,用于对既往疾病修饰性RA药物(DMARDs)和系统性类固醇疗法反应不足的2岁及以上儿童多关节幼年特发性关节炎(polyJIA)患者的治疗。Actemra可单独用药(对氨甲喋呤MTX不耐受或不适合MTX治疗的情况下)或与氨甲喋呤(MTX)联合用药。

多关节幼年特发性关节炎(polyJIA)是一种罕见、慢性致衰性儿童关节炎,为幼年特发性关节炎(JIA)的一种。JIA的发病率约为千分之一,polyJIA则占到了JIA的30%,其特征为5个或更多关节出现炎症,受影响部位常见于体内大小关节,包括膝盖、手腕、手、脚关节。

此前,Actemra曾于2012年1月获加拿大卫生部批准,用于全身型幼年特发性关节炎(sJIA),这是另一种形式的JIA。

Actemra新适应症的获批,是基于III期CHERISH研究的数据。研究结果表明,Actemra治疗组经历了临床意义的症状和体征改善。此外,迄今为止收集到的有关Actemra治疗polyJIA患者的安全性数据与既往的研究一致。

关于Actemra(tocilizumab):

Actemra是首个人源化的白细胞介素6(IL-6)受体拮抗剂,由罗氏和中外制药(Chugai)合作开发,已获批用于对疾病修饰性RA药物(DMARDs)治疗反应不足的中度至重度活动性RA成人患者的治疗。

此外,该药也已获批用于2岁及以上全身型幼年特发性关节炎(sJIA)和多关节幼年特发性关节炎(PolyJIA)的治疗。

英文原文:Health Canada Approves Treatment for Children with Rare Form of Arthritis

ACTEMRA® (tocilizumab) Now Approved to Treat Canadian Children with Polyarticular Juvenile Idiopathic Arthritis (polyJIA)
MISSISSAUGA, ON, Oct. 21, 2013 /CNW/ - ACTEMRA® (tocilizumab) was recently approved by Health Canada to treat children with polyarticular-course juvenile idiopathic arthritis (polyJIA), a rare, chronic and debilitating form of childhood arthritis. The medicine can be used for the treatment of signs and symptoms of active polyarticular juvenile idiopathic arthritis in patients two years of age and older who have not responded adequately to previous therapy with disease modifying anti-rheumatic drugs (DMARDs) and systemic corticosteroids. ACTEMRA can be used alone (in cases of intolerance to MTX or where treatment with MTX is not appropriate) or in combination with MTX.

PolyJIA, or polyarticular-course juvenile idiopathic arthritis, is a form of juvenile idiopathic arthritis (JIA).1 JIA affects approximately 1 in every 1,000 children2, with polyJIA accounting for approximately 30 per cent of cases.3 PolyJIA is characterized by inflammation in five or more joints and most commonly affects both the large and small joints in the body, including knees, wrist and joints of the hands and feet.  In January 2012 ACTEMRA received its first pediatric indication when Health Canada approved it for systemic juvenile idiopathic arthritis (sJIA), another form of juvenile idiopathic arthritis.

"The effects of polyarticular-course juvenile idiopathic arthritis on children are quite significant because it not only decreases their mobility, but interferes with all aspects of their life including schooling and interactions with their family and friends," said Dr. Earl Silverman, Pediatric Rheumatologist, The Hospital for Sick Children.  "The approval of ACTEMRA for this form of juvenile arthritis represents another treatment option to help relieve the symptoms of this disease. As a physician, my goal is to aim for remission in order to allow children to enjoy a more active and enjoyable life."

The expanded approval for ACTEMRA is based on phase III CHERISH study data that showed patients treated with ACTEMRA experienced clinically meaningful improvement in signs and symptoms of polyJIA.4 In addition, safety data collected to date for ACTEMRA in polyJIA patients is consistent with that observed in previous studies in ACTEMRA-treated patients.4, 5

About the CHERISH Study

CHERISH is a 104-week, phase III study in patients aged 2-17 years with active polyJIA for ≥6 months who have failed treatment with methotrexate (MTX).4 Treatment with ACTEMRA was efficacious, with sustained clinically meaningful improvement in signs and symptoms of polyJIA, using a monthly regimen at doses of 8 mg/kg if body weight ≥30 kg and 10 mg/kg if body weight 30 kg.4 The study met the primary endpoint with ACTEMRA-treated patients experiencing significantly fewer disease flares compared to placebo-treated patients (25.6 percent versus 48.1 percent, respectively).4

In the CHERISH study, infections were the most common adverse events (AEs) and serious adverse events (SAEs) over 40-weeks.4 Laboratory abnormalities known to occur with ACTEMRA were also observed in this study, including decreases in white blood cell counts and platelet counts, and elevation in ALT and AST liver enzyme levels.4

About ACTEMRA (tocilizumab)

ACTEMRA, is the first humanized interleukin-6 (IL-6) receptor antagonist approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs).6 The extensive ACTEMRA clinical development programme included five phase III clinical studies and enrolled more than 4,000 people with RA in 41 countries, including Canada.

ACTEMRA is also approved for the treatment of active systemic juvenile idiopathic arthritis (SJIA) and polyarticular-course juvenile idiopathic arthritis (PolyJIA) in patients two years of age and older.

ACTEMRA is part of a co-development agreement with Chugai Pharmaceutical Co. It has been approved in Japan since April 2005 for Castleman's disease, followed by approvals for RA, SJIA and PolyJIA in 2008. ACTEMRA is approved Canada, and several other countries, including the United States, the European Union, China, India, Brazil, Switzerland and Australia.

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