Lebrikizumab has a similar safety profile to placebo in adults and adolescents with uncontrolled asthma, according to study results presented at the American College of Allergy, Asthma & Immunology (ACAAI) 2022 Annual Scientific Meeting, held from November 10 to 14, 2022, in Louisville, Kentucky.
Researchers conducted on a pooled safety analysis of lebrikizumab during the 52-week placebo-controlled period from the LAVOLTA I (LI), LAVOLTA II (LII), and ACOUSTICS clinical trials (ClinicalTrials.gov Identifiers: NCT01867125, NCT01868061, and NCT01875003, respectively). These randomized, double-blinded, phase 3 trials of lebrikizumab in patients with uncontrolled asthma had failed to provide consistently significant efficacy results.
Adult patients in LI and LII and adolescents aged 12 to 17 years in ACOUSTICS with uncontrolled asthma, prebronchodilator forced expiratory volume in 1 second (FEV1) 40% to 90% predicted, and stable background therapy were randomized 1:1:1 to lebrikizumab 125mg or 37.5mg (n=1661) or placebo (n=883) subcutaneously once every 4 weeks. The safety analyses were performed in all patients who received at least 1 dose of study drug, with the participants grouped by assigned treatment. Safety was based on adverse events (AEs).
Treatment-emergent AEs occurred in 77% of the combined group of patients taking lebrikizumab vs 78% of those taking placebo; likewise, in the lebrikizumab vs placebo groups, serious AEs occurred in 7.6% vs 8.5% of participants, respectively, and AEs leading to study drug discontinuation occurred in 3.4% vs 3.6% of participants, respectively. The placebo group had the 1 death that occurred during the studies.
In comparing the lebrikizumab vs placebo groups, the investigators found that a similar proportion of key safety events, including conjunctivitis (lebrikizumab, 1.6%; placebo, 1.7%), infections and infestations (lebrikizumab, 51.6%; placebo, 50.7%), and eosinophil-related disorders (lebrikizumab, 0.2%; placebo, 0.2%). In addition, an increased frequency of eosinophilia (>500 eosinophils/mm3) was reported (lebrikizumab, 1.1%; placebo, 0%).
The researchers concluded that, “The safety profile was similar between lebrikizumab and placebo in adults and adolescents with uncontrolled asthma.”
Corren J, Szefler S, Armstrong A, et al. Pooled safety analysis of lebrikizumab in patients with uncontrolled asthma from three randomized clinical trials. Ann Allergy Asthma Immunol. 2022;125(5):S34-S35. doi:10.1016/j.anai.2022.08.604
This article originally appeared on Pulmonology Advisor.