Dupilumab lowers nighttime symptoms, exacerbation rate in type 2 asthma

Key takeaways:

• Receiving dupilumab vs. placebo for 52 weeks led to improvement in several clinical and sleep-related outcomes.
• Factors that improved included nighttime symptoms, asthma control and exacerbation rate.

Patients with moderate to severe type 2 asthma, poor asthma control and high sleep disturbance experienced fewer nighttime symptoms and exacerbations with dupilumab, according to results published in Respiratory Medicine.

“This post-hoc analysis ... showed that dupilumab treatment significantly reduced nighttime symptoms, exacerbations, and [short-acting beta agonist] use, and improved lung function, asthma control, and health-related [quality of life],” Jorge F. Maspero, MD, FCCP, FAAAAI, director for allergy and respiratory medicine at Fundación Cidea, and colleagues wrote.

In a post-hoc analysis of the phase 3 QUEST study, Maspero and colleagues assessed 364 patients with moderate to severe type 2 asthma, a 5-item Asthma Control Questionnaire (ACQ) score of 2.5 or more and high sleep disturbance to determine the impact of dupilumab (Dupixent; Regeneron Pharmaceuticals, Sanofi) for 52 weeks on nighttime symptoms, ACQ-5 score, annualized severe exacerbation rates, lung function and SABA use.

Researchers classified a patient as having high sleep disturbance if they had impairment in one sleep-related item on the ACQ-5, Asthma-Related Quality-of-Life Questionnaire (AQLQ), Rhino-Conjunctivitis Quality-of-Life Questionnaire or Sinonasal Outcome Test-22.

Of the total cohort, 235 patients received dupilumab (mean age, 46.5 years; 66% female), whereas 129 received placebo (mean age, 48.1 years; 67.4% female).

From baseline to week 52, researchers found a larger reduction in high sleep disturbance prevalence among those receiving dupilumab (81% to 30%) vs. those receiving placebo (84% to 49%).

Taking dupilumab for 52 weeks also resulted in a lower nighttime symptom score (least squares mean difference, –0.31 points; 95% CI, –0.47 to –0.14), a lower ACQ-5 score (least squares mean difference, –0.56 points; 95% CI, –0.81 to –0.32) and a higher AQLQ score (least squares mean difference, 0.48; 95% CI, 0.23-0.73) compared with placebo, all of which signaled significant improvement, according to researchers.

Further, data from QUEST revealed that yearly severe exacerbation rates of patients receiving dupilumab vs. placebo decreased by 66% at week 52. These patients also had better pre-bronchodilator FEV₁ (+0.34 L) at this timepoint.

In terms of SABA use, the dupilumab group had more patients who said they “no longer need SABA” at week 52 in relation to baseline (37.6% vs. 1.3%) compared with the placebo group (24.5% vs. 5.4%).

The reduction in the number of patients who needed five or more puffs/inhalations of SABA daily was also greater in the group that received dupilumab (baseline, 35.7% to week 52, 10.7%) vs. the group that received placebo (baseline, 36.4% to week 52, 21.4%).

“These results suggest a potential association between reported [high sleep disturbance] and poor asthma control as measured by the ACQ-5, supporting the sleep-related items of the asthma [patient reported outcomes] as a useful tool to identify [high sleep disturbance] among the asthma population,” Maspero and colleagues wrote. “Future research is needed to further explore and validate this hypothesis.”