Results for Regeneron Pharmaceutical/Sanofi’s pivotal 16 week Phase III trial testing the safety and efficacy of Dupixent (dupilumab) in adolescent patients (ages 12–17 years) with moderate-severe atopic dermatitis were presented at the 27th European Academy of Dermatology and Venerology (EADV) Congress in Paris, France.

The results were positive, with 38.1% of patients receiving dupilumab once every four weeks achieving a skin improvement of 75% or more in the Eczema Area and Severity Index (EASI-75) at Week 16 – one of the co-primary endpoints outside of the US – and 41.5% of patients receiving dupilumab once every two weeks achieving ESI-75, compared to only 8.2% on placebo.

Moreover, 17.9% of those being treated once every four weeks achieved an Investigator’s Global Assessment (IGA) score of 0 or 1 at Week 16, the primary endpoint in the US. A total of 24.4% of those being treated with dupilumab once every two weeks achieved an IGA score of 0 or 1, whereas only 2.4% on placebo achieved the same results.

Secondary endpoints of dupilumab study

A number of secondary endpoints were achieved at 16 weeks in the study. These included a mean 64.8% improvement in EASI score from baseline in the patients treated every four weeks compared to a mean 65.9% improvement in patients treated every two weeks, in contrast to a mean 23.6% improvement in the placebo group. In addition, 8% and 61% of patients treated every two weeks and four weeks, respectively, achieved EASI-50, compared to 12.9% in the placebo group.

There was also a mean 45.5% improvement in the peak pruritus Numerical Rating Scale (NRS) from baseline in the patients treated with dupilumab every four weeks and a mean 47.9% improvement in the patients treated every two week, compared to a mean 19.0% improvement in the placebo group

Patients treated once every two weeks and every four weeks saw a 5.5 point and 8.8 point mean improvement, respectively, in the Children’s Dermatology Life Quality Index (CDLQI), and a 9.5 point and 10.1 point mean improvement, respectively, in the Patient-Oriented Eczema Measure (POEM), where a change of roughly five points is seen as the minimally clinically significant value

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In terms of study design, this Phase III adolescent study had patients randomised into placebo, dupilumab once every two weeks, and dupilumab every four weeks groups, with a 12-week follow-up period after the 16-week treatment period. After this, patients could enter an open-label extension or have a safety follow-up through Week 28.

Qualification criteria and safety profile of dupilumab

To qualify for the trial, patients had to suffer from moderate-severe atopic dermatitis that could not be adequately controlled by topical therapies, have IGA scores of three or greater, have an EASI score of 16 or greater, have a score of four or greater on the pruritus NRS, and have a body surface area (BSA) involvement of 10% or greater.

The safety profile of dupilumab was positive, with the most common adverse event in those who were treated with dupilumab being conjunctivitis and injection-site reactions, which were higher in the dupilumab groups than in the placebo group. However, the placebo group had higher rates of atopic dermatitis exacerbation and non-herpetic skin infection. Both the placebo-corrected efficacy and safety of dupilumab in adolescents were similar to those observed in adult trials.