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Rigel's R788 Significantly Improves Rheumatoid Arthritis in Phase 2b Clinical Trial
Date:7/9/2009

6%) 150 mg qd 152 87 (57%) 49 (32%) 21 (14%) 26 (17%) p<0.001 p=0.007 p=0.34 p=0.003 100 mg bid 152 101 (66%) 65 (43%) 43 (28%) 41 (27%) p<0.001 p<0.001 p<0.001 <0.001 p values compared to placebo Note: At 6 months. All patients were on stable doses of methotrexate throughout the clinical trial. * The results presented are based on an intention to treat analysis that includes all randomized patients, regardless of how long treatment lasted. Any patient who dropped out of the study for any reason, or for whom month 6 data were unavailable, was considered a treatment failure (ACR non-responder). Disease Activity Scores are based on a 28 joint count and CRP or an ESR at week 24 (depending on which was the qualifying biomarker).

Safety Results

The most common clinically meaningful drug-related adverse events noted in TASKi2 were diarrhea and hypertension. Dose reduction options were pre-specified in the trial protocol and in cases where doses were reduced, patients generally completed the clinical trial with minimal safety issues. The most common adverse events in the trial overall were related to infections, though these were generally evenly distributed among the placebo and active dose groups.

The mean increase in blood pressure from baseline at 6 months, using a last observation carry forward methodology, was less than 0.5 mmHg for the 150 mg qd dose group and approximately 1 mmHg for the 100 mg bid dose group. Approximately 18% and 23% of patients in the 150 mg qd and the 100 mg bid dose groups, respectively, had blood pressure medication adjusted or in some cases initiated during the course of the study, compared with 7% of the placebo patients. The blood pressure was successfully reduced in these patients, and
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SOURCE Rigel Pharmaceuticals, Inc.
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