Itepekimab Bests Placebo for Moderate-to-Severe Asthma
Incidence of events indicating loss of asthma control lower with itepekimab monotherapy in phase 2, proof-of-concept trial
THURSDAY, Oct. 28, 2021 (HealthDay News) -- For adults with moderate-to-severe asthma, itepekimab monotherapy is associated with a reduction in events indicating loss of asthma control, according to a study published in the Oct. 28 issue of the New England Journal of Medicine.
Michael E. Wechsler, M.D., from National Jewish Health in Denver, and colleagues conducted a phase 2 trial involving adults with moderate-to-severe asthma receiving inhaled glucocorticoids plus long-acting beta-agonists. A total of 296 participants were randomly assigned in a 1:1:1:1 ratio to receive subcutaneous itepekimab, itepekimab plus dupilumab, dupilumab, or placebo every two weeks for 12 weeks.
The researchers found that an event indicating loss of asthma control occurred in 22, 27, 19, and 41 percent of those in the itepekimab, itepekimab plus dupilumab, dupilumab, and placebo groups, respectively, by 12 weeks; the corresponding odds ratios were 0.42 (95 percent confidence interval, 0.20 to 0.88; P = 0.02), 0.52 (95 percent confidence interval, 0.26 to 1.06; P = 0.07), and 0.33 (95 percent confidence interval, 0.15 to 0.70) for itepekimab, itepekimab plus dupilumab, and dupilumab compared with placebo. The forced expiratory volume in one second before bronchodilator use increased with itepekimab and dupilumab monotherapies compared with placebo, but not with itepekimab plus dupilumab. Compared with placebo, itepekimab treatment improved asthma control and quality of life and led to a greater reduction in the mean blood eosinophil count.
"Both the itepekimab and dupilumab monotherapies led to a lower incidence of events indicating loss of asthma control and to improved lung function," write the authors of an accompanying editorial. "However, the combination of itepekimab and dupilumab was not superior to either treatment alone."
Several authors disclosed financial ties to Sanofi and Regeneron, which manufacture itepekimab and funded the study.