SAN ANTONIO – For adolescents with asthma, treatment with the biologic agent dupilumab provided benefits that were at least comparable with what was seen in adults, results from a retrospective analysis of a randomized, phase 3 study suggest.
Andrew Bowser/MDedge News
Dr. Neil M.H. Graham
Adolescents had reduced asthma exacerbations in line with what was seen in adults and had improvements in lung function that were at a greater magnitude than adults, according to study coauthor Neil M.H. Graham, MD, of Regeneron Pharmaceuticals, Tarrytown, N.Y.
“We think, overall, it’s a very good treatment response from this drug in this high-risk population, and it is generally well tolerated, as we’ve seen in other studies,” Dr. Graham said in a podium presentation at the annual meeting of the American College of Chest Physicians.
Dr. Graham presented results of an analysis of the 1,902-patient, phase 3 Liberty Asthma QUEST trial, published in May 2018 in the New England Journal of Medicine.
Top-line results of QUEST showed that treatment with dupilumab, a fully human anti–IL-4Ra monoclonal antibody, resulted in significantly lower rates of severe asthma exacerbation, along with improved lung function, in patients aged 12 years and older with moderate to severe asthma.
Now, this retrospective analysis shows that, in adolescents, improvements from baseline to week 12 in forced expiratory volume in 1 second (FEV1) were significant and at a greater magnitude than in adults, according to Dr. Graham and his coinvestigators.
The improvement over 12 weeks in FEV1 for adolescents was 0.36 L and 0.27 L, respectively, for the 200- and 300-mg doses of dupilumab (P less than .05 vs. placebo for both), Dr. Graham and his coinvestigators reported. In adults, the improvement was 0.12 L.
The annualized exacerbation rate dropped by 46.4% for those adolescents who received 200 mg dupilumab, though there was no treatment effect versus placebo for dupilumab 300 mg; the investigators said the lack of effect in this retrospective analysis could have been caused by imbalances in prior event rates or the small sample size.
A total of 107 out of 1,902 patients in QUEST were adolescents, and of those, 68 were randomly assigned to dupilumab, according to the report. Injection site reaction was the most common adverse event in adolescents in both dosing groups.
Dr. Graham reported disclosures related to his employment with Regeneron. Study coauthors reported disclosures related to Regeneron, AstraZeneca, Sanofi, Teva Pharmaceutical, GlaxoSmithKline, Boehringer Ingelheim, Merck, Genentech, and others.
SOURCE: Graham NMH et al. CHEST. 2018 Oct. doi: 10.1016/j.chest.2018.08.022.