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AstraZeneca PLC Announces Top-Line Results From OSKIRA-1 Phase 3 Study Of Fostamatinib In Rheumatoid Arthritis

Friday, 5 Apr 2013 02:01am EDT 

AstraZeneca PLC announced top-line results of OSKIRA-1, a Phase 3 study to assess efficacy and safety of fostamatinib, the first oral spleen tyrosine kinase (SYK) inhibitor in development for rheumatoid arthritis (RA). OSKIRA-1 had two primary endpoints assessing signs and symptoms of RA as measured by ACR20 response rates, and an X-ray endpoint known as mTSS (modified Total Sharp Score). In the OSKIRA-1 study, fostamatinib achieved statisticall improvement in ACR20 response rate at 24 weeks in both 100 mg twice daily group and group that received 100 mg twice daily for four weeks followed by 150 mg once daily (49%, p <0.001 and 44%, p=0.006 respectively) compared to placebo (34%). Fostamatinib did not demonstrate a statisticall difference in mTSS compared to placebo at 24 weeks for either dose (p=0.252 and p=0.170, respectively). The safety and tolerability findings for fostamatinib observed in OSKIRA-1 study were generally consistent with those previously reported for the TASKi Phase 2 program. OSKIRA-1 randomized 923 patients who had experienced an inadequate response to methotrexate (MTX) and, over a 24-week period, evaluated the effectiveness of two dosing regimens of fostamatinib (100 mg twice daily or fostamatinib 100 mg twice daily for four weeks followed by 150 mg once daily) in combination with MTX versus placebo in combination with MTX. 

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