Research in context
Evidence before this study
We searched PubMed on May 4, 2021, for previous studies that assessed the long-term safety and efficacy of dupilumab using multiple search terms including “dupilumab,” “anti-interleukin-4,” “anti-interleukin-13,” “safety,” “efficacy,” “open-label,” “asthma,” and “long-term.” No language or time restrictions were applied. Our searches revealed studies showing long-term safety and efficacy data for dupilumab in patients with atopic dermatitis, and long-term open-label extension studies of mepolizumab, benralizumab, omalizumab, and reslizumab in patients with asthma, lasting from approximately 1·0 year to 4·5 years. No long-term studies investigating the safety or efficacy of dupilumab in patients with asthma were identified.
Added value of this study
To our knowledge, this study is the first assessment of the long-term safety and efficacy of dupilumab in patients with asthma. To date, safety and efficacy data have been assessed in randomised controlled trials of up to 1 year in duration. The current study is an open-label extension that enrolled patients from phase 2A, phase 2B, and phase 3 studies assessing dupilumab in patients with both oral-corticosteroid-dependent and non-oral-corticosteroid-dependent asthma. We found that the safety profile was acceptable and consistent with that observed in the parent studies, and improvements in exacerbation rates, lung function, asthma control, and quality of life were sustained or improved further over the extended treatment period.
Implications of all the available evidence
This study provides a robust assessment of the safety and efficacy of dupilumab in 2282 patients with asthma up to 148 weeks, and complements the long-term safety profile of dupilumab previously reported in patients with atopic dermatitis. These findings support the long-term use of dupilumab in patients with uncontrolled moderate-to-severe asthma.