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AstraZeneca Announces Top-Line Results From OSKIRA-1 Phase 3 Study of Fostamatinib in Rheumatoid Arthritis
Date:4/4/2013

nd, 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. Patients on fostamatinib remained on treatment in OSKIRA-1 for 12 months. 

The OSKIRA-2 and OSKIRA-3 results are expected later in the second quarter of 2013.

About ACR20 and mTSSThe American College of Rheumatology (ACR) score represents a percentage improvement in symptoms (tenderness and swelling in the joints). 28 joints are evaluated for tenderness and swelling respectively (prior to taking any required analgesic that day if possible). To qualify for an ACR20 score, a person with RA must have at least 20% fewer tender joints and at least 20% fewer swollen joints. He or she must also show a 20% improvement in at least three of the following five areas: 1) the person's overall (global) assessment of his or her own RA, 2) the physician's global assessment of the person's RA, 3) the person's assessment of his or her own pain, 4) the person's assessment of his or her own physical functioning, and 5) the results of an erythrocyte sedimentation rate or C-reactive protein blood test (both of which test for inflammation).

Radiographic mTSS is measured in the hands and feet using X-rays. mTSS is a measure of bone erosion and joint space narrowing on X-rays. In each hand, 16 areas are measured for erosions and 15 areas are measured for joint space narrowing. In each foot, six areas are measured for erosions and six areas are measured for joint space narrowing.  A smaller change in mTSS over a given time period, given in percentage change of mTSS score, reflects less progression of joint damage.

About the OSKIRA programThe ongoing (Oral SYK Inhibition in Rheumatoid Arthritis) OSKIRA program, has been designed to investigate fostamatinib as a potential new oral treatment option for
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SOURCE Rigel Pharmaceuticals, Inc.
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