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This new data was presented at EADV in Berlin, with the findings of 3 studies expanding the range of effectiveness of this treatment to 140-weeks for patients with eczema.
The drug upadacitinib may be safe and effective long-term in treating patients with moderate-to-severe atopic dermatitis (AD) across 140 weeks, according to new data presented at the 32nd European Academy of Dermatology and Venereology (EADV) Congress in Berlin.1
These findings, announced by AbbVie from EADV, were derived from the phase 3 studies titled Measure Up 1, Measure Up 2, and AD Up, and the investigators found that a substantially higher number of subjects treated with 15 mg or 30 mg of the drug achieved the primary objectives.
"We are encouraged by these results as they solidify upadacitinib's potential to improve care for people living with atopic dermatitis," Jonathan Silverberg, MD, PhD, MPH, professor of dermatology and director of clinical research at the George Washington University School of Medicine and Health Sciences, said in a statement.
In the Measure Up 1 and Measure Up 2 trials, the investigators conducted their research at multiple centers, employing a randomized, double-blind, parallel-group, and placebo-controlled design for the studies. The team examined upadacitinib in subjects aged 12 years and older with AD who also needed systemic treatment.
Patients were randomly-assigned to be given either 15 mg of upadacitinib, 30 mg, or a placebo, with the primary objectives being to find the percentage of subjects who reported a 75% reduction in their Eczema Area and Severity Index (EASI 75) and a validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0/1 following 16 total weeks of treatment. Those who first had the placebo were switched to either be given 15 mg or 30 mg at 16-weeks.
The AD Up study was a phase 3 trial conducted at multiple centers with a double-blind, randomized, parallel-group, and placebo-controlled study design. The purpose, patient population, and age range were the same as in Measure Up 1 and 2.
Study subjects were assigned randomly to be given either 15 or 30 mg of upadacitinib, or a placebo, but all were in combination with topical corticosteroids (TCS). The main objectives of this research were to find the percentage of subjects who were shown to have gotten an EASI 75 score and a validated vIGA-AD score of 0/1 following 16 weeks of upadacitnib treatment.
Those who first were given the placebo in addition to TCS were then switched to being given either 15 mg of upadacitinib or 30 mg in combination with TCS by the point of 16-weeks.
In the all 3 of the investigations, the research team reported a substantially greater proportion of those given upadacitinib treatment (15 mg or 30 mg) were able to reach the primary objectives, demonstrating enhanced clearance of their skin as measured by EASI 75 and vIGA-AD 0/1 at 16-weeks, in contrast to the placebo arm.
Moreover, the team noted that more subjects given the drug were able to accomplish the secondary goal of EASI 90 as well as another endpoint focusing on alleviating itch (WP-NRS 0/1) at the point of 16-weeks, in comparison to placebo. The efficacy of both doses of the drug managed to hold steady with these measurements over all 3 trials until the 140-week milestone.
"While upadacitinib has been shown to be an effective treatment option for patients with atopic dermatitis in the short term, these data demonstrate a consistent safety profile and efficacy with long-term treatment,” Silverberg concurred in his statement.