LONDON -- May 31, 2011 -- Rheumatoid arthritis patients failing to respond to the disease-modifying agent methotrexate appear to achieve a reduction in symptoms when treated with the investigational interleukin-6 inhibitor sirukumab, researchers said here at the 2011 Annual Meeting of the European League Against Rheumatism (EULAR).
“Not all patients respond to initial treatment, and in my experience a proportion of patients receiving currently available therapies will either have an inadequate response or lose response over time,” said Josef Smolen, MD, Medical University of Vienna, Vienna, Austria.
“There continues to be a need for additional therapeutic options for the treatment of rheumatoid arthritis -- a serious, progressive autoimmune disease. The results we have seen to date with sirukumab are promising, and we look forward to seeing future data from the ongoing clinical studies,” he said.
Results from the phase 2 multicentre, randomised, double-blind, dose-finding study showed that patients treated with sirukumab achieved a significantly greater reduction in Disease Activity Score 28 (DAS28 CRP) at week 12, the primary endpoint of the study, researchers reported on May 27.
At week 12, in this proof-of-concept trial, the 19 patients on methotrexate plus placebo achieved a score reduction 0.65 while the 17 patients on methotrexate and sirukumab showed a reduction of 1.66 (P =.001).
All patients remained on their background medication of methotrexate and were randomised to receive subcutaneous injections of sirukumab 100 mg or placebo once every 2 weeks from week 0 to week 10. At week 12, an interim analysis showed that 82% of patients in the sirukumab group achieved good or moderate DAS28 C-reactive protein (CRP) response compared with 32% of patients receiving placebo plus methotrexate (P =.015).
By week 12, at least a 20% improvement in American College of Rheumatology scores (ACR20) was seen in 75% of sirukumab-treated patients compared with 21% of patients receiving placebo plus methotrexate patients (P =.002).
Treatment with sirukumab was generally well tolerated through 10 weeks of treatment. Three patients discontinued the study before week 12 due to an adverse event -- one being a serious case of staphylococcal cellulitis. The infection resolved. Another patient was withdrawn after developing pneumonia and the third patient -- in the placebo group -- quit the study due to worsening rheumatoid arthritis. No deaths, cardiovascular events, or gastrointestinal perforations were reported.
The study was funded by Centocor Ortho Biotech Inc.
By Alex Morrisson
Presented at EULAR
[Presentation title: Proof-of-Concept for CNTO 136, a Human Anti-Interleukin-6 Monoclonal Antibody, in a Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy. Abstract FRI0345]
Thank you All !!!
