If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Interim Analysis Indicates Tocilizumab Safe, Effective for Patients With Treatment-Refractory RA: Presented at ACR/ARHP By Liz Meszaros PHILADELPHIA -- October 19, 2009 -- Tocilizumab, an IL-6 receptor antagonist, is a safe and effective treatment option in patients with rheumatoid arthritis (RA) who are intolerant to or who inadequately respond to conventional disease modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF)-blocker therapy, according to data presented here at the 2009 Annual Scientific Meeting of the American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP). The Tocilizumab and DMARDs: Achievements in Rheumatoid Arthritis (TAMARA) trial is a multicentre, open-label, non-controlled, phase 3b study. German researchers conducted the study to assess the effectiveness and safety of tocilizumab, the first IL-6 receptor antagonist developed for the treatment of RA, in a setting close to real-life medical care. IL-6 has been identified as having a fundamental role in the inflammation process in RA. TAMARA was conducted over 24 weeks and involved 293 adult patients with RA enrolled at 70 sites. All patients had had an inadequate response to conventional agents typically used in the treatment of RA and or/biological DMARD therapy. Patients were treated with once-monthly tocilizumab 8 mg/kg administered intravenously. The study’s primary endpoint is the proportion of patients who achieve a Disease Activity Score (DAS) 28 (<=3.2) at week 24. For this week-4 interim analysis, data from 218 patients were included. After 4 weeks of treatment, tocilizumab reduced disease activity, improved patient quality of life, and relieved fatigue. The mean decrease in DAS-28 from baseline was 2.6 points. CRP normalised completely by week 1, with a mean drop from baseline of 18.5 mg/L by week 4. Mean scores on the Health Assessment Questionnaire Disability Index (HAQ-DI) decreased by a mean 0.33 from baseline. In addition, the Functional Assessment of Chronic Illness Therapy (FACIT) fatigue scores improved by 6.2 points compared with mean baseline scores. A total of 49 serious adverse events were reported in 40 patients, with the most frequent being respiratory tract infection (n = 11), followed by increased liver enzymes (n = 6). “The interim results of this study are consistent with the favourable results of the pivotal phase 2 trials from the clinical development program in a diversified patient population,” said study author Andrea Rubbert-Roth, MD, University of Cologne, Germany. “The known favourable safety profile of tocilizumab is therefore confirmed by this ongoing study in a setting close to standard clinical conditions.” Support for this study was provided by Roche Pharmaceuticals. [Presentation title: Interim Results of the TAMARA Study -- Effectiveness and Safety of the Interluekin-6 (IL-6) Receptor Antagonist Tocilizumab After 4 and 24 Weeks in Patients With Active Rheumatoid Arthritis (RA). Abstract 412]
|
