Lebrikizumab as safe as placebo among adults and adolescents with uncontrolled asthma
U.S.A: According to research findings presented at the American College of Allergy, Asthma & Immunology (ACAAI) 2022 Annual Scientific Meeting, held from November 10 to 14, 2022, in Louisville, Kentucky, lebrikizumab had a similar safety profile to placebo in adults and adolescents with uncontrolled asthma. The results were published in Annals of Allergy, Asthma & Immunology.
"Lebrikizumab phase 3 trials that were randomized, double-blinded, and administered to individuals with uncontrolled asthma did not consistently show statistically significant efficacy outcomes," asserted J. Corren and colleagues.
Asthma is a complicated illness with a clearly heterogeneous clinical history and therapeutic response. This variability may be caused by variations in the kind of airway inflammation. Many individuals still have uncontrolled asthma that necessitates more intense therapy even after receiving treatment with inhaled glucocorticoids.
In individuals with severe eosinophilic asthma, lebrikizumab, a humanized monoclonal antibody that targets interleukin-13, appears to enhance lung function.
Lebrikizumab was the subject of a pooled safety study during the 52-week placebo-controlled period from the clinical trials LAVOLTA I (LI), LAVOLTA II (LII), and ACOUSTICS.
Lebrikizumab 125mg or 37.5mg (n=1661) or placebo (n=883) were randomized in 1:1:1 ratio subcutaneously once every four weeks for 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. All patients who got at least 1 dose of the study medicine were subjected to safety studies, and participants were grouped according to their received treatment. adverse events served as a basis for safety (AEs).
Key findings of the trial:
- Lebrikizumab combined dosages (LEB), 1281 [77%] of 1661 participants vs. PBO, 650 [78%] of 883 patients; significant AEs (7.6% vs. 8.5%); and AEs resulting in study drug discontinuation (3.4% vs. 3.6%); were similar between LEB and PBO.
- In the PBO group, one person died.
- Similar rates of important safety incidents were observed, including conjunctivitis (LEB, 1.6%; PBO, 1.7%), infections and infestations (LEB, 51.6%; PBO, 50.7%), and eosinophil-related disorders (LEB, 0.2%; PBO, 0.2%); eosinophilia (>500 eosinophils/mm3) was reported at a higher rate (LEB, 1.1%; PBO, 0%).
The researchers came to the following conclusion: "In adults and adolescents with uncontrolled asthma, the safety profile was comparable between lebrikizumab and placebo."
REFERENCE
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
