Dupixent shows continued, increased efficacy during long-term treatment

Long-term treatment with Dupixent was well-tolerated and showed incremental benefit with continued treatment for atopic dermatitis, consistent with results from short-term treatment.

In the study, published in the American Journal of Clinical Dermatology, adolescents with moderate to severe atopic dermatitis who had completed one of the short-term studies continued treatment with Dupixent (dupilumab, Sanofi/Regeneron) for 1 year.

“The patients started treatment with dupilumab once every 4 weeks,” Andrew Blauvelt, MD, MBA, dermatologist and president of Oregon Medical Research Center, and colleagues wrote. “But if their atopic dermatitis did not improve sufficiently, they were given dupilumab every 2 weeks. Through a year of treatment, there were no unexpected side effects.”

The study comprised 294 patients, 102 of whom completed the 52-week visit at the time of the database lock. Also, 43 patients discontinued treatment, the most common reasons being withdrawal, lack of efficacy and the patient reaching 18 years of age.

The mean age of patients was 14.7 years, and most patients were white (69%) and boys (56.8%). Additionally, 41.2% had overweight, 47.3% had moderate to severe disease at baseline, 61.9% had received one or more prior systemic immunosuppressive for atopic dermatitis other than dupilumab and all patients had one or more comorbid allergic condition.

Most patients (73.8%) reported one or more treatment emergent adverse event, which were mostly mild or moderate. Of these, the researchers considered 120 to be related to treatment, with 12 severe and five serious. All of the serious treatment emergent adverse events resolved and none led to discontinuation.

The most frequently reported treatment emergent adverse events based on 100 person-years included nasopharyngitis (20.4%), atopic dermatitis (19%), upper respiratory tract infection (11.9%) and headache (8.8%).

By week 52, 42.7% of patients had an IGA score of 0/1 and 93.1%, 81.2% and 56.4% had EASI-50, EASI-75 and EASI-90 scores, respectively. At this same follow-up period, 29.4% of patients had clear or almost clear skin that was sustained for more than 12 weeks.

Blauvelt and colleagues reported that patients also showed improvement in health-related quality of life and many patients reported this improvement as early as week 4 of treatment.

During the study, 205 patients required uptitration for a mean duration of 12.5 weeks. Among this group, the proportion of patients with IGA 0/1 (35.7%) and EASI-75 (51.9%) increased over time, 48 weeks after the first uptitration visit.

The researchers concluded that treatment with dupilumab demonstrated acceptable safety and sustained efficacy in patients aged 12 years up to 18 years with moderate to severe atopic dermatitis.

“These results support the long-term continuous use of dupilumab in this patient population,” they wrote.