Integrated safety profile of atacicept: an analysis of pooled data from the atacicept clinical trial programme.

ABSTRACT:

Objective

To characterize the overall safety profile of atacicept, we conducted an integrated analysis of pooled safety data from all 17 clinical studies to date.

Methods

Three data sets were used to investigate safety endpoints: a double-blind placebo-controlled set (n = 1568), an SLE set (n = 761) and a full analysis set (n = 1845; including all 17 studies).

Results

Of 1568 patients in the double-blind placebo-controlled-set, 30.8% received placebo, and 8.2, 24.5 and 36.5% received atacicept 25, 75 and 150 mg, respectively. Treatment-emergent adverse event (TEAE) rates (adjusted by treatment-exposure) were generally higher with atacicept vs placebo, but no consistent association was found between atacicept dose and specific TEAEs or morta

SUBMITTER: Gordon C 

PROVIDER: S-EPMC6735746 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature