American Academy of Dermatology Meeting
American Academy of Dermatology Meeting
Source/Disclosures
Source:

Silverberg JI, et al. Efficacy and safety of abrocitinib in patients with moderate-to-severe atopic dermatitis (AD): results from the phase 3 JADE MONO-2 study. Presented at: AAD VMX; June 12-14, 2020 (virtual meeting).

Disclosures: Gooderham reports she receives grants, personal fees or nonfinancial support from Pfizer, AbbVie, Amgen, Akros Pharma, Arcutis, Bausch Health (Valeant), Bristol Myers Squib, Boehringer Ingelheim, Celgene, Dermira, Eli Lily, Galderma, Janssen, Kyowa Kirin, Leo Pharma, Medimmune, Merck, Novartis, Regeneron, Roche, Sanofi, Genzyme, Sun Pharma and UCB.
June 26, 2020
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Abrocitinib beneficial in treating moderate, severe atopic dermatitis

Source/Disclosures
Source:

Silverberg JI, et al. Efficacy and safety of abrocitinib in patients with moderate-to-severe atopic dermatitis (AD): results from the phase 3 JADE MONO-2 study. Presented at: AAD VMX; June 12-14, 2020 (virtual meeting).

Disclosures: Gooderham reports she receives grants, personal fees or nonfinancial support from Pfizer, AbbVie, Amgen, Akros Pharma, Arcutis, Bausch Health (Valeant), Bristol Myers Squib, Boehringer Ingelheim, Celgene, Dermira, Eli Lily, Galderma, Janssen, Kyowa Kirin, Leo Pharma, Medimmune, Merck, Novartis, Regeneron, Roche, Sanofi, Genzyme, Sun Pharma and UCB.
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The use of abrocitinib in the treatment of moderate to severe atopic dermatitis was beneficial while lowering the risk for adverse events, according to findings presented at the American Academy of Dermatology virtual meeting.

The phase 3 randomized, placebo-controlled, double-masked JADE MONO-2 trial included patients with moderate to severe AD older than 12 years of age who were randomly assigned into groups receiving 200 mg of abrocitinib (Pfizer), 100 mg of abrocitinib or placebo once daily during a span of 12 weeks.

“Abrocitinib significantly improved the signs and symptoms of subjects with moderate to severe atopic dermatitis in both adolescents and adults,” Melinda Gooderham, MD, of Queens University and SKiN Centre for Dermatology in Peterborough, Canada, said in the presentation. “There was a significant and rapid improvement in itch in both doses compared to placebo as early as day 2 of treatment, and abrocitinib was well tolerated and had an acceptable short-term safety profile here with low incidence of serious [adverse events] and various infections.”

Primary endpoints included Investigator’s Global Assessment response of 0/1 with at least a two-grade improvement and Eczema Area and Severity Index improvement of 75% or greater at week 12. Secondary endpoints included improvement of 4 points or more on the Peak Pruritus Numerical Rating Scale at week 12 and EASI improvement of 90% or greater.

When comparing data from the 200 mg and 100 mg abrocitinib groups with placebo, the study identified IGA achievement of 38.1% for 200 mg and 28.4% for 100 mg vs 9.1% for placebo (P < .001) and EASI-75 of 61% for 200 mg and 44.5% for 100 mg vs 10.4% for placebo (P < .0001) after 12 weeks. PP-NRS was achieved in 55.3% for 200 mg and 45.2% for 100 mg vs 11.5% for placebo (P < .0001), and EASI-90 was achieved in 37.7% for 200 mg and 23.9% for 100 mg vs. 3.9% for placebo.

The rate of serious infection was less than 2% in all groups. Treatment was stopped due to adverse events in 3.2% of patients in the 200 mg group, 3.8% in the 100 mg group and 12.8% in the placebo group.

“The discontinuation rates were highest in the placebo group, and this was mainly driven by insufficient clinical response and no longer willing to participate,” Gooderham said during the presentation.