Primary Endpoints Not Met in Phase II/III Atacicept Trial
MedPage Today reports that atacicept did not meet primary endpoints in the Phase II/III trial. Flare rates were not significantly less in the group of patients treated at a lower 75 mg dose; while the rate was significantly lower for patients receiving a higher 150 mg dose, two deaths due to infections might have been associated with the drug.
The time to first flare (length of time person was in the study before experiencing a flare) was significantly longer among those treated with the 150 mg dose but not those who received the lower dose. Enrollment in the 150 mg dose arm was terminated prematurely due to the two deaths. Investigators feel the drug at the higher dose may still have benefit but further study is needed to determine if there is a role for atacicept in treating lupus.
Atacicept is a biologic agent that targets two B-cell factors being studied in patients with moderate-to-severe lupus. The study was reported on in Annals of the Rheumatic Diseases.