Patients with uncontrolled, moderate-to-severe asthma treated with dupilumab demonstrated significant improvement in asthma control regardless of exacerbation history, according to data presented at the American College of Allergy, Asthma and Immunology Annual Scientific Meeting.
“Dupilumab, a fully human anti-interleukin (IL)-4 receptor a monoclonal antibody, inhibiting IL-4/IL-13 signaling pathways, key drivers of type 2 inflammation, is approved for treatment of adults with inadequately controlled moderate-to-severe atopic dermatitis,” Jonathan Corren, MD, from David Geffen School of Medicine at the University of California, Los Angeles, and colleagues wrote.
Corren and colleagues conducted a post hoc analysis of the phase 3 Liberty Asthma Quest study to evaluate how dupilumab (Dupixent; Sanofi, Regeneron) affects asthma control in patients aged 12 years or older with persistent asthma for 1 year or longer receiving medium-to-high dose inhaled corticosteroids and up to two additional controllers. Asthma control was assessed using the five-item Asthma Control Questionnaire (ACQ-5).
Participants were categorized into three subgroups based on prior exacerbations. The first group had one or more prior severe exacerbation events, the second group had two or more and the third group had three or more. During a 52-week treatment period, participants received either 1.14 mL of placebo every 2 weeks, 200 mg of dupilumab every 2 weeks, 2 mL of placebo every 2 weeks or 300 mg of dupilumab every 2 weeks.
Compared with placebo, both doses of dupilumab significantly reduced annual severe exacerbation rates by about 47%.
At week 12, there was an improvement in forced expiratory volume in 1 second (FEV1) with dupilumab by 0.32 L/0.34 L (least squares mean difference vs. placebo = 0.14 L/0.13 L) which was maintained throughout the remainder of the treatment period.
In all subgroups of patients, both doses of dupilumab significantly reduced ACQ-5 scores compared with placebo at week 2, indicating improved asthma control. These improvements were sustained through week 52.
The most common adverse event was injection-site reactions in the dupilumab vs. placebo groups.
“Dupilumab significantly improved asthma control, as measured by the ACQ-5, regardless of prior severe exacerbation history and was generally well tolerated,” Corren and colleagues concluded. – by Alaina Tedesco
Corren J, et al. Abstract P216. Presented at: American College of Allergy, Asthma and Immunology Annual Scientific Meeting; Nov. 15-19, 2018; Seattle.
Disclosures: Corren reports receiving research funding from Sanofi. Please see the poster for all other authors’ relevant financial disclosures.