A supplemental biologics license application was recently submitted.
Investigators in a poster presentation from the 2022 American Academy of Dermatology Annual Meeting created an observational, real practice study, to analyze real world data on the efficacy and safety of dupilumab (Dupixent; Sanofi and Regeneron Pharmaceuticals) in atopic dermatitis (AD) patients 16 years and older.1
Dupilumab is a fully human IgG4 monoclonal antibody against interleukin (IL)-4 receptor IL-13 pathways and is not an immunosuppressant.
This study was conducted from January 2020 to August of 2021 and included patients that had moderate to severe AD, were 16 years or older, had an Eczema Area and Severity index (EASI) score of greater than or equal to 21, a physician global assessment (PGA) score of greater than or equal to 3, total effected body surface area (BSA) of 10% or more, and a failure to respond to both topical treatment and cyclosporine.
In total 14 patients were included in the study, 8 of which were male, the mean age of the group was 30.5 years with patients being anywhere being between the ages of 16 and 57. The group also had a mean basal EASI score of 31.4 +/- 8.3 before treatment had begun. After 16 weeks of treatment, this score dropped significantly, with the mean EASI score being 6.4 +/- 3.5, with an overall mean improvement of 76.3%. When broken down further, the data demonstrated that there was an EASI 50 improvement in all the patients, EASI 75 improvement in 64% of patients, and EASI 90 in 21% of them.
At 24 weeks of dupilumab treatment, the mean EASI improvement increased from 16 weeks to 89.6% and the patients who experience EASI 50, EASI 75, and EASI 90 were 100%, 100%, and 60% respectively. The researchers stated that they observed a rapid reduction in pruritus mean during this time also.
When it comes to adverse events (AEs), the most common were conjunctivitis and facial erythema—both occurring in 14% of patients. The poster stated that they were limited by being a, “small monocentric observational study with different evaluators measuring scores.”
Dupilumab recently had its supplemental biologics license application (sBLA) as an add-on maintenance treatment for children aged 6 months to 5 years with moderate to severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable, accepted by the FDA.2 The target action sate for this investigational use is June 9, 2022.