Dupilumab Shows Safety, Efficacy for 3 years in Moderate-to-Severe Asthma

By Jeff Craven /alert Contributor
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Results from the phase 3 open-label extension study LIBERTY ASTHMA TRAVERSE show dupilumab remains safe and effective for up to 3 years in patients with moderate-to-severe asthma, according to recent research presented at the virtual 2020 European Respiratory Society (ERS) International Congress.

“These data suggest Dupixent may slow the progressive decline in lung function that many patients with moderate-to-severe asthma experience, as shown by the sustained improvement in lung function for up to three years. Further, patients on Dupixent maintained asthma control and reduced rates of severe asthma attacks that may result in hospitalizations,” Michael Wechsler, MD, MMSc, principal investigator of LIBERTY ASTHMA TRAVERSE and director of the National Jewish Cohen Family Asthma Institute in Denver, Colorado, said in a press release. “This reinforces the importance of Dupixent as a continuous, long-term treatment option to improve patients’ ability to breathe and maintain control of their asthma, particularly in those with higher markers of underlying type 2 inflammation.” 

Dr. Wechsler and colleagues evaluated 2,282 adolescents and adults with moderate-to-severe asthma who had participated in a prior trial of dupilumab. These participants received 300 mg of dupilumab every 2 weeks for up to 96 weeks, which represented up to 3 years of dupilumab use when combined with treatment in previous trials. The investigators analyzed adverse events, annual exacerbation rate, and mean change in forced expiratory volume in 1 second (FEV1) compared with baseline measurements in previous trials. 

Overall, 2,039 patients completed the open-label extension study and had follow-up data for analysis. The results at 96 weeks showed a range of lung function improvement between 13% and 22% compared with baseline measurements of FEV1. There was also a sustained level of reduced asthma exacerbations averaging between 0.31 and 0.35 events annually compared with measurements of 2.07 to 2.17 events annually in the year prior to enrolling in dupilumab trials. Participants with elevated baseline blood eosinophils or fractional exhaled nitric oxide (FeNO) at baseline were more likely to see greater improvements in lung function and reduced number of exacerbations. 

The investigators noted dupilumab had a similar safety signal in the open-label extension study compared with other asthma dupilumab trials. The rate of adverse events ranged between 76% and 88% over 96 weeks, with participants most commonly experiencing nasopharyngitis (18- 26%) and injection-site erythema (2- 23%). The number of participants who experienced serious adverse events during the open-label extension study ranged between 9% and 13%.

 

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