RoACTEMRA: New hope for children with systemic Juvenile Idiopathic Arthritis
The TENDER study is an international study, including approximately 70 centres in 20 countries. The study aimed to assess efficacy for signs and symptoms and short term safety of RoACTEMRA versus placebo in 112 patients with active sJIA. Additional aims were efficacy for the common systemic features of sJIA, steroid reduction, other concomitant drug reductions, safety with chronic administration and biomarkers. In this randomised study, patients received RoACTEMRA 8 mg/kg (if weight ≥ 30 kg) and 12 mg/kg (if weight < 30 kg), every 2 weeks versus placebo infusions for 12 weeks. Patients were also given the option to enroll for long-term, open label follow-up. The study was performed in close collaboration with the PRINTO (Paediatric Rheumatology International Trials Organisation) and PRCSG (Paediatric Rheumatology Collaborative Study) groups. About RoACTEMRA/ACTEMRA
RoACTEMRA/ACTEMRA is the result of research collaboration by Chugai and is also being co-developed globally with Chugai. RoACTEMRA/ACTEMRA is the first humanised interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody. An extensive clinical development programme of five Phase III trials was designed to evaluate clinical findings of RoACTEMRA/ACTEMRA, all of which met their primary endpoints. RoACTEMRA/ACTEMRA was first approved in Japan, and launched by Chugai in June 2005 as a therapy for Castleman's disease; in April 2008, additional indications for rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis and systemic-onset juvenile idiopathic arthritis were also approved in Japan. RoACTEMRA/ACTEMRA was approved in the European Union in January 2009 for the treatment of RA in patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) inhibitors. It is also approved for use in several other countries, including India, Brazil, Switzerland, and Australia. RoACTEMRA/ACTEMRA was most recently (January 2010) approved in the United States for the treatment of adult patients with moderately to severely active RA who have had an inadequate response to one or more TNF inhibitors. The overall safety profile of RoACTEMRA/ACTEMRA is consistent across all global clinical studies. The serious adverse events reported in RoACTEMRA/ACTEMRA clinical studies include serious infections, gastrointestinal perforations and hypersensitivity reactions including anaphylaxis. The most common adverse events reported in clinical studies were upper respiratory tract infection, nasopharyngitis, headache, hypertension and increased ALT. Increases in liver enzymes (ALT and AST) were seen in some patients; these increases were generally mild and reversible, with no evidence of hepatic injuries or any observed impact on liver function. Laboratory changes, including increases in lipids (total cholesterol, LDL, HDL, triglycerides) and decreases in neutrophils and platelets, were seen in some patients without association with clinical outcomes. Treatments that suppress the immune system, such as RoACTEMRA/ACTEMRA, may cause an increase in the risk of malignancies. About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2009, Roche had over 80’000 employees worldwide and invested almost 10 billion Swiss francs in R&D. The Group posted sales of 49.1 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com. *) JIA ACR30 response is defined as 3 of the 6 core components improving (from the Baseline assessments) by ≥ 30%, with no more than 1 of the remaining components worsening by > 30%. Core components include Physician global assessment of disease activity VAS; Parent/patient global assessment of overall well-being VAS; Number of joints with active arthritis; Number of joints with limitation of movement; Erythrocyte Sedimentation Rate (ESR); Functional ability – Childhood Health Assessment Questionnaire (CHAQ) 1. Efficacy and safety of tocilizumab in patients with systemic Juvenile Idiopathic Arthritis (sJIA): 12-week data from the phase 3 tender trial. Abstract presented on 18th June 2010 at EULAR
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