Friday, December 9, 2011

Sarilumab for the treatment of rheumatoid arthritis

Marc C. Genovese and colleagues presented a study on sarilumab. Sarilumab is a human monoclonal antibody directed against the alpha subunit of the IL-6 receptor complex. This phase 2 study looked at different dosages against placebo, both verum and placebo plus MTX. Patients had active rheumatoid arthritis and study duration was 12 weeks. Sarilumab demonstrated a significant and meaningful improvement. Adverse events werde similar to other IL-6 inhibitors. The study will be continued as part B for 52 weeks to assess long term efficacy and safety.

[TUE] L2
Sarilumab for the Treatment of Moderate-to-Severe Rheumatoid Arthritis: Results of a Phase 2, Randomized, Double-Blind, Placebo-Controlled, International Study
Mark C. Genovese, Stanford University Medical Center, Palo Alto, CA, Alan J. Kivitz, Altoona Center for Clinical Research, Duncansville, PA, J. Abraham Simon Campos, Centro De Especialidades Médicas, Merida, Mexico, Maria Rell-Bakalarska, Rheumatology and Osteoporosis Outpatient Clinic, Warsaw, Poland, Roy M. Fleischmann, Metroplex Clinical Research Center, Dallas, TX, Martine Jasson, Sanofi, Paris, France, Allen R. Radin, Regeneron Pharmaceuticals Inc, Tarrytown, NY, Xiaohong Huang, Sanofi, Bridgewater, NJ and Tom W. J. Huizinga, Leiden University Medical Centre, Leiden, NetherlandsConclusions: In this phase 2 study, sarilumab in combination with methotrexate demonstrated efficacy in patients with active, moderate-to-severe rheumatoid arthritis. The types and incidence of adverse events were consistent with those previously reported with IL-6 inhibition. Part B, the phase 3 portion of the MOBILITY seamless study, will assess long-term efficacy of sarilumab in rheumatoid arthritis.

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