Upadacitinib improves atopic dermatitis in two phase 3 trials
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Two phase 3 clinical trials of upadacitinib showed positive results in adolescent and adult patients with atopic dermatitis, according to a presentation at the European Academy of Dermatology and Venereology virtual congress.
The Measure Up 1 and Measure Up 2 studies evaluated the safety and efficacy of monotherapy upadacitinib (Rinvoq, AbbVie), an oral JAK-1 inhibitor, in patients ages 12 to 75.
“What’s nice here, which attests to the efficacy of the drug, is that the phase 3 data is even better than phase 2,” Emma Guttman-Yassky, MD, told Healio/Dermatology.
Both trials included study arms receiving 15 mg and 30 mg of upadacitinib, as well as a placebo arm.
At week 16, an Eczema Area and Severity Index score of 75 (EASI 75) was achieved by 69.6% of patients in the 15 mg arm and 79.7% of the 30 mg arm of the Measure Up 1 study, compared to 16.3% of the placebo arm. In the Measure Up 2 study 60.1% of the 15 mg arm and 72.9% of the 30 mg arm reached EASI 75 at week 16, compared to 13.3% of the placebo arm.
A Validated Investigator’s Global Assessment score of 0/1 was achieved by 48.1% and 62% of the Measure Up 1 15 mg and 30 mg arms, respectively, compared to 8.4% of the placebo arm. The Measure Up 2 study had a vIGA score of 0.1 in 38.8% of the 15 mg dose and 52% of the 30 mg dose at week 16, while the placebo group had 4.7%.
EASI 90 was achieved in 53.1% and 65.8% of patients in Measure Up 1 and 42.4% and 58.5% in Measure Up 2, while EASI 100 was reached by 16.7% and 27% in the first trial and 14.1% and 18.8% in the second.
“The efficacy showed early in the game,” Guttman-Yassky said. “It was achieved by week 4 and maintained through week 16. When you look at days, you can see even after 2 days there was a major improvement.”
Secondary endpoints, including itch, symptom frequency and quality of life also improved in the treatment groups.
Serious adverse effects were recorded in six and five patients in the 15 mg treatment arms and eight and seven of those in the 30 mg arms. The most frequent adverse events included acne, upper RTI, nasopharyngitis and headache.
“Atopic dermatitis is a disease that really affects all aspects of a patients’ life,” Guttman-Yassky said. “From the perspective of a patient who wants to achieve a high resolution of response and a quick effect, we can achieve it with this treatment.”
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Guttman E. Safety and efficacy of upadacitinib monotherapy in adolescents and adults with moderate-to-severe atopic dermatitis: Results from 2 pivotal, phase 3, randomized, double-blinded, placebo-controlled studies (Measure Up 1 and Measure Up 2). Presented at: European Academy of Dermatology and Venereology Congress; Oct 29-31, 2020 (virtual meeting).
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