Upadacitinib demonstrates fast, efficacious atopic dermatitis treatment
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Upadacitinib, an oral JAK inhibitor, was effective in treating moderate to severe atopic dermatitis in two phase 3 clinical trials.
“Up to recently, we really didn’t have any safe oral medications to give our atopic dermatitis patients,” lead author Emma Guttman-Yassky, MD, PhD, Waldman Professor and system chair of the Kimberly and Eric J. Waldman Department of Dermatology, Icahn School of Medicine at Mount Sinai, and first author of the study, told Healio. “Though dupilumab is a great biologic drug, some of our patients do not want an injection. We definitely need an oral medication that can control the disease and do so rapidly.”
The replicate, double-blind, multicenter, randomized, placebo-controlled Measure Up 1 and Measure Up 2 trials randomly assigned patients aged 12 to 75 years 1:1:1 to receive upadacitinib 15 mg, upadacitinib 30 mg or placebo once daily for 16 weeks.
In the Measure Up 1 trial, 70% of the 15 mg treatment group achieved Eczema Area and Severity Index 75 at 16 weeks, while 80% of those in the 30 mg group and 16% of the placebo group met the same endpoint.
The proportion of those achieving validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) response was 48% in the 15 mg group, 62% in the 30 mg group and 8% in the placebo group.
Results were similar in the Measure Up 2 study, with EASI-75 response reached by 60% of the 15 mg group, 73% of the 30 mg group and 13% of the placebo group.
The upadacitinib 15 mg group had vIGA-AD response in 39% of patients, while the 30 mg group had 52% and the placebo group had 5%.
Secondary endpoints, which included EASI-90, EASI-100 and change in EASI score from baseline at week 16, as well as EASI-75 at week 2 and a four-point or greater improvement in Worst Pruritis Numerical Rating Scale score, were also met by both doses of upadacitinib.
At week 2 in the Measure Up 1 trial, 38.1% of patients in the 15 mg group and 47.4% of those in the 30 mg group had achieved EASI-75 compared with 3.6% of those in the placebo group.
In the Measure Up 2 trial, 33% of the 15 mg group and 44% of the 30 mg group achieved EASI-75 after week 2 compared with 3.6% of those in the placebo group.
“The efficacy it shows is unparalleled to any other treatment so far,” Guttman-Yassky said. “It has great efficacy for both the 15 mg and 30 mg doses, and it has quick efficacy. It works within days, and by week 4, you basically reach the maximum efficacy.”
Treatment-emergent adverse events were higher in the two treatment groups compared with placebo.
Serious adverse events were reported in 2% of the 15 mg cohorts, with 1% and 4% of patients discontinuing treatment. The 30 mg groups had serious adverse events in 3% of patients in both the studies, with 4% and 3% discontinuing treatment. The placebo groups had similar rates, with 3% in each study having a serious adverse event and 4% in each study discontinuing treatment.
The possibility of an oral medication becoming available for patients with atopic dermatitis is an exciting one for Guttman-Yassky.
“As a treating physician, I really hope to have this drug approved some time this summer,” she said. “For those who do not want an injection or for those who want to see results very quickly, we want to have the ability to treat with JAK inhibitors such as this one that is so efficacious and fast.”