The following article is a part of conference coverage from the American College of Allergy, Asthma & Immunology 2021 Annual Scientific Meeting, being held virtually from November 4 to 8, 2021. The team at Pulmonology Advisor will be reporting on the latest news and research conducted by leading experts in the field. Check back for more from the ACAAI 2021 Annual Scientific Meeting.
Lebrikizumab, a humanized monoclonal antibody that targets interleukin-13, appears to improve lung function in patients with severe eosinophilic asthma, according to study findings presented at the 2021 American College of Allergy, Asthma and Immunology (ACAAI) Annual Scientific Meeting, held in New Orleans, LA, from November 4 to 8.
The study investigators noted that recent research into biologic medications for severe asthma has shown that outcomes are affected by patients’ exacerbation history and baseline eosinophilia.
For the study, investigators conducted post-hoc analyses of the LAVOLTA (L) I and II studies (ClinicalTrials.gov Identifiers: NCT01867125 and NCT01868061, respectively) — randomized, double-blind, phase 3 trials of lebrikizumab in adults with uncontrolled asthma who are on inhaled corticosteroids and a second controller medication.
The team evaluated the absolute change in pre-bronchodilator forced expiratory volume in 1 second (FEV1) from baseline for lebrikizumab vs placebo from the results of LI, LII, and pooled data from these 2 trials. They also conducted a subgroup analysis of patients who had blood eosinophil counts of 300 µL or higher at baseline and had experienced at least 1 exacerbation during the previous 12 months, criteria similar to those of recent studies of biologic medications in asthma.
A total of 1081 and 1067 patients were enrolled in LI and LII, respectively. In both studies, patients received subcutaneous lebrikizumab (at a dose of 125 mg or 37.5 mg) or placebo every 4 weeks, for 52 weeks.
In all analyses, patients in the lebrikizumab group showed improvement in FEV1 compared with the placebo group. In the pooled analysis, patients who received lebrikizumab at 37.5 mg (least squares [LS] mean, 0.152) or 125 mg (LS mean, 0.171) showed improvement in FEV1 compared with patients who received placebo (LS mean, 0.081; LS mean difference for the 37.5-mg dose, 0.071 and P =.0007; and LS mean difference for the 125-mg dose, 0.090 and P <.0001).
The subgroup analysis (of patients with eosinophil counts of 300 or higher and at least 1 exacerbation) yielded similar results; patients who received lebrikizumab at 37.5 mg (LS mean, 0.221) and 125 mg (LS mean, 0.255) showed improvement in FEV1 compared with those who received placebo (LS mean, 0.087; LS mean difference for the 37.5-mg dose, 0.134 and P =.0011; and LS mean difference for the 125-mg dose, 0.168 and P <.0001).
According to the investigators, “A phase 2b study with lebrikizumab in atopic dermatitis (ClinicalTrials.gov Identifier: NCT03443024) [that] used higher doses with loading doses showed a clearer dose-response curve.” They concluded, “These asthma patients in the LAVOLTA program may have been under dosed.”
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Korenblat P, Sher E, Berman G, et al. Effect of lebrikizumab on lung function in patients with severe eosinophilic asthma. Presented at: American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting; November 4-8, 2021; New Orleans, LA. Abstract P069.