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| |  Oral JAK Inhibitor CP-690,550 Improves Function, Quality of Life in Patients With RA: Presented at ACR/ARHP By Liz Meszaros PHILADELPHIA -- October 19, 2009 -- Patients with rheumatoid arthritis (RA) treated with CP-690,550 (CP), either in combination with methotrexate or as monotherapy, showed early and sustained improvement in pain, physical functioning, and overall health-related quality of life, according to data presented here at the 2009 Annual Scientific Meeting of the American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP). CP is an orally active, highly selective inhibitor of the Janus Kinase (JAK) family of kinases being developed as disease-modifying anti-rheumatic drugs (DMARD) for the treatment of RA. “We wanted to get a sense of some of the patient-recorded measures. We do a lot of endpoints that are clinical in nature, but here we wanted to hear the patients’ voice. We’re seeing statistically significant improvements in pain, physical functioning, in global measures of health status, and on general health-related quality of life with this compound as early as week 2,” said lead author Gene V. Wallenstein, MD, Pfizer Inc., New London, Connecticut. “These results seem to persist out to week 24. We’re optimistic and are now in phase 3 trials,” he added. Dr. Wallenstein and his colleagues presented findings October 18 from two 6-month, double-blind, placebo-controlled phase 2B studies, which included patients with 6 or more tender and 6 or more swollen joints and evidence of inflammation. All patients had had an inadequate response to stable background methotrexate therapy (study 1) or to at least 1 conventional DMARD (study 2). In the first study, 507 patients were randomised to receive either CP dosed at 1, 3, 5, 10, or 15 mg twice daily, or 20 mg once daily, or placebo, in combination with their background methotrexate therapy. There were significant improvements in physical functioning and bodily pain at weeks 12 or 24 in all of the CP dosing groups. Pain scores were also significantly improved in all CP dosing groups at weeks 12 or 24, and all CP dosing groups, but the 10-mg group, experienced significant improvements at weeks 12 and 24 in mental health. In the second study, 384 patients were randomised to receive CP at 1, 3, 5, 10 or 15 mg twice daily, or adalimumab 40 mg subcutaneously every other week for 12 weeks followed by CP 5 mg twice daily, or placebo. In these patients, both pain and physical functioning improved significantly by week 2 in several of the dosage groups. Patients treated with CP 10 or 15 mg also had significant improvements in several areas of the SF-36 at week 12 and/or week 24, including physical functioning, role physical, bodily pain, and vitality. Likewise, patients treated with the 10- and 15-mg dosages of CP showed significant improvement in fatigue by week 2 (P < .05) and at week 12. Funding for this study was provided by Pfizer Inc. [Presentation title: Effects of the Oral JAK Inhibitor CP-690,550 on Pain, Physical Functioning, Fatigue, and Health-Related Quality of Life in Patients With Active Rheumatoid Arthritis. Abstract 418]
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