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The data from the phase 3 AD Up trial add to existing knowledge of the efficacy and safety of upadacitinib for patients with atopic dermatitis.
Upadacitinib (RINVOQ) plus topical corticosteroids may be an effective treatment for atopic dermatitis.
The news comes following the results of AD Up, the third pivotal phase 3 study of the drug, which met the co-primary and all secondary endpoints. Namely, those who used upadacitinib plus topical corticosteroids achieved at least a 75% improvement in the Eczema Area Severity Index (EASI 75) from baseline and a validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0/1 (clear or almost clear) at week 16.
A team of investigators from AbbVie found significantly more patients who received either a 15 mg or 30 mg dose of upadacitinib plus topical corticosteroids demonstrated improvement in skin clearance compared to placebo plus topical corticosteroids at week 16. Of those who received 15 mg or 30 mg of upadacitinib plus the topical corticosteroids 65% and 77%, respectively, achieved EASI 75, while only 26% of patients who received placebo plus topical corticosteroid achieved such a feat (P <.001).
Among patients treated with upadacitinib 15 mg or 30 mg plus topical corticosteroids, 40% and 59%, respectively, achieved vIGA-AD 0/1, compared to 11% of patients receiving placebo plus topical corticosteroids (P <.001).
“Many of the current treatment options rely on patients to self-manage their condition, often with multiple applications of topicals,” Kristian Reich, MD, principal investigator, said in a statement. “Patients could benefit from more therapeutic options that can help control symptoms without the constant need for concomitant topicals, as they strive for relief from this life-long, chronic disease.”
Further findings of AD Up emphasize patients treated with upadacitinib plus topical corticosteroids experienced a clinically meaningful reduction in itch, defined as improvement in Worst Pruritus Numerical Rating Scale of at least 4, compared to patients treated with placebo plus topical corticosteroids. In fact, at week 16, 52% of patients in the 15 mg upadacitinib group, and 64% of those in the 30 mg group plus topical corticosteroids achieved the endpoint compared to 15% of patients who received placebo plus topical corticosteroids (P <.001).
In an additional analysis, treated with either dose of upadacitinib resulted in a higher mean number of topical corticosteroid-free days up to week 16 versus placebo. A topical corticosteroid-free day was defined by a response of EASI 75 or greater without the use of a topical corticosteroid. Those treated with upadacitinib 15 mg or 30 mg had a mean of 34 and 47 topical corticosteroid-free days while maintaining EASI 75 compared with a mean of 8 days for the placebo group (nominal P <.001).
There were no new safety risks observed during the 16-week placebo-controlled period. Only 2.3% of patients in the 15 mg group and 1.3% of the 30 mg groups experienced serious adverse events compared to 3% of those in the placebo group. The most common adverse events for the upadacitinib patients were nasopharyngitis, acne, and upper respiratory tract infection.
“These data build on the positive results from our previous studies in atopic dermatitis, now with additional perspective on the efficacy of (upadacitinib) used with a mainstay treatment for people living with the disease—topical steroids,” Tom Hudson, MD, senior vice president of R&D and chief scientific officer of AbbVie, said.