Fostamatinib

New data from the EULAR 2013 at: http://rheumatologe.blogspot.de/2013/06/fostamatinib-at-eular-2013.html



Fostamatinib is an oral spleen tyrosine kinase inhibitor, but there hadn’t been as much new data as there had been on Tofacitinib during the 2011 ACR Meeting in Chicago. There are ongoing phase 3 studies, but we have to wait for next year’s EULAR and ACR meetings for results that might lead to marketing and availability.


Effects Fostamatinib on Health-Related Quality of Life in Active Rheumatoid Arthritis

Michael E. Weinblatt and colleagues looked into effects of the oral SYK inhibitor, Fostamatinib, in patients with rheumatoid arthritis, who failed to respond to methotrexate The analysis of this phase II study assessed the impact of fostamatinib on health-related quality of life. Fostamatinib significantly improved health-related quality of life outcomes including physical function, pain, fatigue, and overall physical health status.
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Effects of the Oral SYK Inhibitor, Fostamatinib (R788), on Health-Related Quality of Life in a Phase II Study of Active Rheumatoid Arthritis.
Michael E. Weinblatt1, Arthur Kavanaugh2, Mark C. Genovese3, David A. Jones4, Theresa K. Musser5, Elliott B. Grossbard5 and Daniel B. Magilavy5.
1Brigham and Women’s Hospital, Boston, MA, 2University of California San Diego, San Diego, CA, 3Stanford University, Palo Alto, CA, 4AstraZeneca, Macclesfield, United Kingdom, 5Rigel Pharmaceuticals, South San Francisco, CAConclusion: In this phase II study, 100 mg bid fostamatinib significantly improved HRQL outcomes including physical function, pain, fatigue, and overall physical health status. Phase III clinical trials of fostamatinib in RA are in progress.


Safety of Fostamatinib (R788) in Patients with Rheumatoid Arthritis From up to 2 Years of Exposure

Arthur Kavanaugh and colleagues presented data on longer-term safety and tolerability for fostamatinib. Data came from randomized, placebo-controlled, fostamatinib phase II trials (TASKi1, 2, and 3), the TASKi1 extension study and from an ongoing open-label study (C-935788-012). Thie analysis included 803 patients with 1,038 patien-years of fostamatinib exposure (mean exposure 1.3 years).
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Longer-Term Safety of Fostamatinib (R788) in Patients with Rheumatoid Arthritis—Analysis of Clinical Trial Data From up to 2 Years of Exposure.
Arthur Kavanaugh1, Michael E. Weinblatt2, Mark C. Genovese3, Theresa K. Musser4, Elliott B. Grossbard4, Daniel B. Magilavy4, Sally Hollis5, Eveline Wesby van-Sway5 and David Millson5.
1University of California San Diego, San Diego, CA, 2Brigham and Women’s Hospital, Boston, MA, 3Stanford University, Palo Alto, CA, 4Rigel Pharmaceuticals, South San Francisco, CA, 5AstraZeneca, Macclesfield, United KingdomConclusion: No new significant safety signals were identified with longer-term dosing of fostamatinib. Biologic refractory patients on a background of mixed DMARDs had a higher incidence rate of AEs, SAEs, and SIEs compared to MTX inadequate responders on background MTX; further confounding factors may play a role. This will be explored in ongoing phase III studies.