Real-World Study: Dupilumab for Atopic Dermatitis More Effective Than Clinical Trial Results

September 12, 2020
Laura Joszt, MA
Laura Joszt, MA
Laura Joszt, MA

Laura is the editorial director of The American Journal of Managed Care® (AJMC®) and all its brands, including The American Journal of Accountable Care®, Evidence-Based Oncology™, and The Center for Biosimilars®. She has been working on AJMC® since 2014 and has been with AJMC®'s parent company, MJH Life Sciences, since 2011. She has an MA in business and economic reporting from New York University.

The broadest real-life study of dupilumab in atopic dermatitis (AD) found significant improvements in adults with moderate to severe AD that were even greater than the results reported in clinical trials.

Despite clinical trial evidence for the use of dupilumab to treat moderate to severe atopic dermatitis (AD), real-world evidence has been limited in the broader population.

Research published in Journal of Investigational Allergology and Clinical Immunology on the broadest real-life study of dupilumab in AD found significant improvements in adults with moderate to severe AD that were even greater than the results reported in clinical trials.

“As limited data on dupilumab treatment are available in a daily practice setting, it is important to assess the performance of this treatment in real clinical practice and in a broader population,” the authors explained.

Researchers performed a multicenter retrospective chart review of 543 Italian adult patients with moderate to severe AD who were treated with dupilumab from September 2018 to April 2020 at 10 Italian academic allergological/dermatological centers. Patients had to have an Eczema Area Severity Index (EASI) score of 24 or higher in order to be considered as having moderate to severe AD. Patients received a 600-mg loading dose of dupilumab at baseline and 300 mg every other week.

The primary outcome was median percent change in EASI score from baseline and the proportion of patients achieving a 50% (EASI-50), 75% (EASI-75), and 90% (EASI-90) improvement in score from baseline to week 16.

The median (interquartile range [IQR]) EASI score was 28.0 (IQR, 9.5) points. Among the patients included, AD had developed in 366 patients (67.4%) before adulthood (early-onset AD) and in 177 patients (32.6%) during adulthood (adult-onset AD).

Only 2 patients discontinued treatment before week 16. One patient discontinued because of bilateral conjunctivitis and cicatricial ectropion, while the other patient discontinued because of fever and arthralgia.

The response rate was 98.1% for EASI-50, 81.5% for EASI-75, and 50.8% for EASI-90 at the end of the study period (P < .001). According to the researchers, this represents higher efficacy than was reported in the clinical trials (EASI-50, 65%-85%; EASI-75, 44%-69%; EASI-90, 30%-45%). The majority (63.2%) of patients treated “showed a clinically meaningful response for all the major outcome responses and were considered super-responders,” the authors wrote.

Conjunctivitis, headache, and arthralgia were the most common adverse events (AEs), and the overall incidence of AEs was 16.4% during the 16-week study period. Sixty-six patients (12.2%) received a diagnosis of dupilumab-associated conjunctivitis, and most of these cases had resolved or were resolving at the end of week 16.

“The value provided by this study lies in the need for broader real clinical practice data on dupilumab treatment in patients with moderate-to-severe AD,” the authors wrote. They added that additional studies “are needed to assess the long-term effectiveness and safety of the drug.”

Reference

Nettis E, Ferrucci SM, Ortoncelli M, et al. Use of dupilumab for 543 adult patients with moderate-to-severe atopic dermatitis: a multicenter, retrospective study. J Investig Allergol Clin Immunol. Published August 26, 2020. doi:10.18176/jiaci.0641