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Dupilumab effectively treated patients with atopic dermatitis

Patients with moderate-to-severe atopic dermatitis treated with dupilumab as monotherapy and in combination with topical glucocorticoids displayed marked improvement in symptoms, according to recent study results.

Researchers conducted four randomized, double blind, placebo-controlled trials of adults with moderate-to-severe atopic dermatitis despite being treated with topical glucocorticoids and calcineurin inhibitors. In a 12-week trial and two 4-week studies, dupilumab was evaluated as monotherapy, and it also was assessed as combination therapy with topical glucocorticoids in a separate 4-week trial.

Eczema Area and Severity Index (EASI) score, investigator’s global assessment score, pruritus, safety assessments, serum biomarker levels and disease transcriptome were used as endpoints.

There were rapid and dose-dependent improvements in the 4-week monotherapy studies, while in the 12-week study, 85% of patients treated with dupilumab and 35% treated with placebo experienced 50% reduction in the EASI score (EASI-50; P<.001). Forty percent of the dupilumab cohort had a score of 0 to 1 (indicating clearing or near-clearing of lesions; P<.001) compared with 7% in the placebo group. Dupilumab-treated patients experienced a 55.7% decrease in pruritus scores vs. 15.1% in the placebo cohort (P<.001).

“In the combination study, 100% of the patients in the dupilumab group, as compared with 50% of those who received topical glucocorticoids with placebo injection, met the criterion for EASI-50 (P=.002), despite the fact that patients who received dupilumab plus glucocorticoids used less than half the amount of topical glucocorticoids used by those who received placebo plus the topical medication (P=.16),” the researchers reported.

Adverse events (AEs) occurred similarly for placebo and dupilumab patients; most events were mild to moderate. Skin infection occurred more frequently with placebo treatment while nasopharyngitis and headache were the most frequent AEs with dupilumab.

“Patients treated with dupilumab had marked and rapid improvement in all the evaluated measures of atopic dermatitis activity,” the researchers concluded. “Side-effect profiles were not dose-limiting.”

Disclosure: See the study for a full list of relevant financial disclosures.