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Dupilumab improved disease activity, pruritus in atopic dermatitis patients

SAN DIEGO — Patients with moderate-to-severe atopic dermatitis treated with dupilumab monotherapy displayed rapid improvement in disease activity and pruritus compared with those treated with placebo, according to late-breaking data presented at the 2014 American Academy of Allergy, Asthma & Immunology annual meeting.

“It was shown that this treatment had an acceptable safety profile and was effective in treating moderate-to-severe AD [atopic dermatitis] poorly controlled by topical agents,” researcher Thomas R.M. Bieber, MD, PhD, FAAAAI, said.

Bieber led a European study of 109 adults with moderate-to-severe AD, controlled by topical agents, randomly assigned to 12 weeks of subcutaneous placebo (n=54) or 300 mg dupilumab (n=55) with no topical agents. Eczema Area and Severity Index (EASI) score from baseline to week 12 was used as primary efficacy endpoint. Changes in EASI, body surface area, SCORAD, pruritus numerical rating scale, 5-D Pruritus Scale, proportions of patients achieving EASI reductions of 50% or greater (EASI-50), and Investigator’s Global Assessment (IGA) 0 or 1, were secondary endpoints.

Both groups displayed similar baseline characteristics (EASI mean ± SD: 23.12±12.35, dupilumab; 24.1±12.7, placebo). Change in EASI related to improvements that significantly favored dupilumab (–74%) compared with placebo (–23.3%; P<.0001). Dupilumab had an EASI-50 responder rate of 85.5%, compared with 35.2% for placebo (P<.0001). Dupilumab had better scores in SCORAD and IGA, with pruritus scores also supporting dupilumab (P<.0001).

The dupilumab cohort reported one serious adverse event (SAE) and two skin infections compared with 11 SAEs and 14 skin infections in the placebo cohort.

“Treatment-emergent adverse events (TEAEs) were 74.5% with dupilumab and 77.8% with placebo,” according to the abstract.

“The number of side effects and adverse events were more frequent in patients in the placebo group,” Bieber concluded. “In the placebo group we also had more AD exacerbations as expected. The most common TEAEs were nasopharyngitis, headache and conjunctivitis.”

For more information:

Bieber TRM. Abstract L20.Presented at the American Academy of Allergy, Asthma & Immunology annual meeting; Feb. 28-March 4, 2014; San Diego.

Disclosure: Bieber reports financial ties with L’Oreal, Oxagen, Bioalliance, Regeneron, Sterna Biologicals, Astellas and Basilea.