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ARTICLE | Clinical News

Blisibimod: Additional Phase IIb data

December 10, 2012 8:00 AM UTC

Anthera reported additional response data from the double-blind, placebo-controlled, international Phase IIb PEARL-SC trial of subcutaneous blisibimod in 546 patients with active SLE. Specifically, SRI-5 response rates, the primary endpoint, at week 24 were 32.3% for once-weekly 100 mg blisibimod (p=0.603), 43.5% for once-weekly 200 mg blisibimod (p=0.154) and 35.9% for once-monthly 200 mg blisibimod (p=0.925) vs. 35.3% for the pooled placebo group. On secondary endpoints, SRI-6 response rates at week 24 were 32.3% for once-weekly 100 mg blisibimod (p=0.695), 41.3% for once-weekly 200 mg blisibimod (p=0.237) and 31.5% for once-monthly 200 mg blisibimod (p=0.588) vs. 34.6% for the pooled placebo group. SRI-7 and SRI-8 response rates at week 24 were 18.3% for once-weekly 100 mg blisibimod (p=0.887 and p=0.692), 25% for once-weekly 200 mg blisibimod (p=0.119 and p=0.069) and 16.3% for once-monthly 200 mg blisibimod (p=0.711 and p=0.925) vs. 17.8% and 16.7%, respectively, for the pooled placebo groups. Data were presented at the American College of Rheumatology meeting in Washington. ...