Disclosures: Silverberg reports he serves as an investigator for Celgene, Eli Lilly, F. Hoffmann-LaRoche, Menlo Therapeutics, Realm Therapeutics, Regeneron Pharmaceuticals and Sanofi; consults for AbbVie, Anacor, AnaptysBio, Arena, Dermira, Dermavant Sciences, Eli Lilly, Galderma, GlaxoSmithKline, Glenmark, Incyte, Kiniksa, Leo Pharma, Menlo Therapeutic, Novartis International, Pfizer, Realm Therapeutics, Regeneron and Sanofi; and speaks for Regeneron and Sanofi. Please see the study for all other authors’ relevant financial disclosures.
July 27, 2020
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Study shows further evidence for abrocitinib in moderate to severe atopic dermatitis

Disclosures: Silverberg reports he serves as an investigator for Celgene, Eli Lilly, F. Hoffmann-LaRoche, Menlo Therapeutics, Realm Therapeutics, Regeneron Pharmaceuticals and Sanofi; consults for AbbVie, Anacor, AnaptysBio, Arena, Dermira, Dermavant Sciences, Eli Lilly, Galderma, GlaxoSmithKline, Glenmark, Incyte, Kiniksa, Leo Pharma, Menlo Therapeutic, Novartis International, Pfizer, Realm Therapeutics, Regeneron and Sanofi; and speaks for Regeneron and Sanofi. Please see the study for all other authors’ relevant financial disclosures.
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Two daily dosing regimens of abrocitinib were associated with favorable efficacy and safety outcomes in patients with moderate to severe atopic dermatitis.

“Abrocitinib is under investigation for the treatment of patients with moderate-severe atopic dermatitis,” Jonathan I. Silverberg, MD, PhD, MPH, of the department of dermatology at The George Washington University School of Medicine and Health Sciences, told Healio. He noted that abrocitinib (Pfizer) is a Janus kinase inhibitor.

The double-blinded, parallel-group study included 391 patients aged 12 years or older. Eligible participants had been clinically diagnosed for at least 1 year and demonstrated an insufficient response to topical interventions for at least 4 weeks within the previous 6-month period.

The cohort included patients enrolled at 115 centers from 13 countries between June 29, 2018, and Aug. 13, 2019. The study population was 58.6% male, with a mean age of 35.1 years.

Clinicians treated 155 patients with abrocitinib 200 mg per day, 158 with abrocitinib 100 mg per day and 78 with placebo.

Results at 12 weeks showed that 38.1% of patients in the 200 mg arm and 28.4% of those in the 100 mg arm reached the primary endpoint of Investigator Global Assessment response, defined as 0 for clear, 1 for almost clear and improvement of two or more grades, compared with 9.1% in the placebo arm (P < .001).

For the endpoint of achieving at least 75% improvement in Eczema Area and Severity Index score at week 12, the rates were 61% for abrocitinib 200 mg, 44.5% for abrocitinib 100 mg and 10.4% for placebo (P < .001).

Similarly, Peak Pruritus Numerical Rating Scale response, defined as improvement of four or more points, yielded rates of 55.3% (95% CI, 47.2%-63.5%) for the 200 mg group, 45.2% (95% CI, 37.1%-53.3%) for the 100 mg group and 11.5% (95% CI, 4.1%-19%) for placebo (P<.001).

Both the 200 mg and 100 mg doses of the study drug bested placebo in terms of EASI-90 response, as well, 37.7% and 23.9% vs. 3.9%, respectively.

“Monotherapy with 100 mg and even more so 200 mg daily oral abrocitinib led to rapid and robust improvements of atopic dermatitis signs, symptoms and quality of life impact in adolescents and adults with moderate to severe disease,” Silverberg said.

Safety data showed that 65.8% patients in the abrocitinib 200 mg arm experienced events, while 62.7% of those in the 100 mg arm and 53.8% of those treated with placebo experienced events. The serious adverse event rates were 1.3% in the abrocitinib 200 mg arm, 3.2% in the 100 mg arm and 1.3% in the placebo arm. “Moreover, abrocitinib was found to be well tolerated,” Silverberg said.

The clinicians also observed decreased platelet counts in 1.3% and laboratory values associated with thrombocytopenia in 3.2% of patients in the abrocitinib 200 mg group

“These data provide further support for the efficacy and safety of abrocitinib in adolescents and adults with moderate to severe atopic dermatitis,” Silverberg said.