Lebrikizumab: Phase IIb data

Pooled data from 463 patients with severe asthma uncontrolled on inhaled corticosteroids and a second controller in the identical, double-blind, U.S. and Australian Phase IIb LUTE and VERSE trials showed that subcutaneous lebrikizumab every 4 weeks as an add-on therapy reduced the rate of exacerbations per year from baseline, the primary endpoint, by 36% across all doses compared to placebo. Specifically, lebrikizumab reduced the rate of exacerbations by 62% at the 37.5 mg dose, 35% at the 125 mg dose and 11% at the 250 mg dose compared to placebo. In January 2013, Roche stopped the dosing in the trial after identifying a process-related impurity that required changes to the lebrikizumab manufacturing process. Patients had received a median of 6 doses. The pharma said the primary endpoint of exacerbation rate during the placebo-controlled period was based on a variable observation period and were pre-specified to be analyzed separately in patients with high serum periostin (POSTN) levels, defined as >=50 ng/mL, and patients with low periostin levels <50 ng/mL.

In patients with high periostin levels, lebrikizumab reduced the rate of exacerbations from baseline by 60% compared to placebo (p=0.01 for all doses combined). Specifically in patients with high periostin levels, lebrikizumab reduced asthma attacks by 81% in the low-dose arm, 77% in the mid-dose arm and 22% in the high-dose arm vs. placebo. In patients with low periostin levels, lebrikizumab reduced the rate of exacerbations by 5% from baseline vs. placebo (p=0.87 for all doses combined). Specifically, in patients with low periostin levels, lebrikizumab reduced asthma attacks by 33% in the low-dose arm, increased asthma attacks by 17% in the mid-dose arm and reduced asthma attacks by 5% in the high-dose arm. ...