TY - JOUR
T1 - Characterization of acne associated with upadacitinib treatment in patients with moderate-to-severe atopic dermatitis
T2 - A post hoc integrated analysis of 3 phase 3 randomized, double-blind, placebo-controlled trials
AU - Mendes-Bastos, Pedro
AU - Ladizinski, Barry
AU - Guttman-Yassky, Emma
AU - Jiang, Ping
AU - Liu, John
AU - Prajapati, Vimal H.
AU - Simpson, Eric L.
AU - Vigna, Namita
AU - Teixeira, Henrique D.
AU - Barbarot, Sebastien
N1 - Publisher Copyright:
© 2022 American Academy of Dermatology, Inc.
PY - 2022/10
Y1 - 2022/10
N2 - Background: Acne is the most frequent adverse event associated with upadacitinib treatment in patients with moderate-to-severe atopic dermatitis. Objective: To characterize the adverse event of acne associated with upadacitinib. Methods: This was a post hoc integrated analysis of 3 phase 3 randomized, double-blind, placebo-controlled trials of upadacitinib, alone (NCT03569293 and NCT03607422) or in combination with topical corticosteroids (NCT03568318). Data included were from the 16-week placebo-controlled period. Results: Over 16 weeks, 84 of 857 (9.8%), 131 of 864 (15.2%), and 19 of 862 (2.2%) patients randomized to receive upadacitinib 15 mg, upadacitinib 30 mg, and placebo, respectively, experienced acne. All cases of acne, except 1, were mild/moderate in severity; 2 patients discontinued treatment due to moderate acne. Acne occurred at higher rates among younger, female, and non-White patients. Acne required no intervention in 40.5% and 46.6% of patients receiving upadacitinib 15 and 30 mg, respectively; most remaining cases were managed with topical antibiotics, benzoyl peroxide, and/or retinoids. Acne also had no impact on patient-reported outcomes. Limitations: This study was relatively short in duration and had a small patient population. Conclusions: Acne associated with upadacitinib for atopic dermatitis treatment is usually mild/moderate in severity and managed with topical therapies or no intervention.
AB - Background: Acne is the most frequent adverse event associated with upadacitinib treatment in patients with moderate-to-severe atopic dermatitis. Objective: To characterize the adverse event of acne associated with upadacitinib. Methods: This was a post hoc integrated analysis of 3 phase 3 randomized, double-blind, placebo-controlled trials of upadacitinib, alone (NCT03569293 and NCT03607422) or in combination with topical corticosteroids (NCT03568318). Data included were from the 16-week placebo-controlled period. Results: Over 16 weeks, 84 of 857 (9.8%), 131 of 864 (15.2%), and 19 of 862 (2.2%) patients randomized to receive upadacitinib 15 mg, upadacitinib 30 mg, and placebo, respectively, experienced acne. All cases of acne, except 1, were mild/moderate in severity; 2 patients discontinued treatment due to moderate acne. Acne occurred at higher rates among younger, female, and non-White patients. Acne required no intervention in 40.5% and 46.6% of patients receiving upadacitinib 15 and 30 mg, respectively; most remaining cases were managed with topical antibiotics, benzoyl peroxide, and/or retinoids. Acne also had no impact on patient-reported outcomes. Limitations: This study was relatively short in duration and had a small patient population. Conclusions: Acne associated with upadacitinib for atopic dermatitis treatment is usually mild/moderate in severity and managed with topical therapies or no intervention.
KW - acne
KW - adverse event
KW - atopic dermatitis
KW - topical corticosteroids
KW - upadacitinib
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U2 - 10.1016/j.jaad.2022.06.012
DO - 10.1016/j.jaad.2022.06.012
M3 - Article
C2 - 35714786
AN - SCOPUS:85133785603
SN - 0190-9622
JO - Journal of the American Academy of Dermatology
JF - Journal of the American Academy of Dermatology
ER -