Upadacitinib Found to Be Safe, Effective for Adolescents with Atopic Dermatitis

Article

New data indicates that there is a strong benefit-risk profile for upadacitinib for younger atopic dermatitis patients, with prior data predominantly relating to adult treatment.

Amy S. Paller, MD

Credit: nm.org

Amy S. Paller, MD

Credit: nm.org

Treatment of moderate-to-severe atopic dermatitis (AD) with upadacitinib in adolescents is about as effective and safe as it is for adult AD patients, according to a recent analysis of 3 clinical trials.1

American and European guidelines for AD treatment do not draw many distinctions between the general treatment of AD in adolescent and adult patients.2, 3

To address this fact, this analysis was authored by Amy S. Paller, MD, with the Departments of Dermatology and Pediatrics at Northwestern University Feinberg School of Medicine.

“The objective of this interim analysis was to assess the safety and efficacy of upadacitinib alone or in combination with topical corticosteroids (TCS) in adolescents aged 12 to 17 years with moderate-to-severe AD enrolled in the Measure Up 1, Measure Up 2, and AD Up studies,” Paller and colleagues wrote.

Background and Findings

The investigators performed an analysis of the 3 randomized clinical trials, Measure Up 1, Measure Up 2, and AD Up. Their research involved an analysis of adolescents who were enrolled in all 3 randomized, double-blind, placebo-controlled phase 3 clinical trials that had taken place in over 20 countries across various regions.

The researchers’ data collection was conducted from July of 2018 - December of 2020, and the participants they assessed consisted of adolescents aged 12 to 17 years who had moderate-to-severe AD. They carried out their analysis between April and August of 2021.

The study participants had been randomized to receive once-per-day oral upadacitinib 15 mg, upadacitinib 30 mg, or placebo alone (Measure Up 1 and Measure Up 2) or they were given topical corticosteroids (AD Up).

The investigators included 552 randomized adolescent patients, with 290 females and 262 males. The average age was found to be 15.4 years for the Measure Up 1 study, 15.5 years for Measure Up 2, and 15.3 years for AD Up.

The main outcomes and measures assessed by the investigators were safety and efficacy, using at least a 75% improvement in the Eczema Area and Severity Index (EASI) from baseline and a validated Investigator Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) at 16 weeks.

Overall, the research team found that the proportion of younger patients who achieved a minimum of 75% improvement in the EASI scores was higher with upadacitinib 15 mg for 73%, 69%, and 63%, and with upadacitinib 30 mg with 78%, 73%, and 84% in Measure Up 1, Measure Up 2, and AD Up, respectively, compared to placebo at 12%, 13%, and 30%.

The investigators also found that upadacitinib also resulted in a higher proportion of younger patients got a validated IGA score of 0 or 1 at 16 weeks and improvements in quality of life compared to placebo. They added that the drug was generally well-tolerated in adolescents, with mild-to-moderate acne being the most common adverse event reported.

“These results for skin clearance and itch reduction in adolescents were consistent with those observed in adults,” they wrote. “The studies were not designed to assess statistical differences between the 2 upadacitinib dose groups, although numerically higher efficacy was observed with the higher dose.”

References

  1. Paller AS, Ladizinski B, Mendes-Bastos P, et al. Efficacy and Safety of Upadacitinib Treatment in Adolescents With Moderate-to-Severe Atopic Dermatitis: Analysis of the Measure Up 1, Measure Up 2, and AD Up Randomized Clinical Trials. JAMA Dermatol. Published online April 12, 2023. doi:10.1001/jamadermatol.2023.0391
  2. Ring J, Alomar A, Bieber T, et al; European Dermatology Forum (EDF); European Academy of Dermatology and Venereology (EADV); European Federation of Allergy (EFA); European Task Force on Atopic Dermatitis (ETFAD); European Society of Pediatric Dermatology (ESPD); Global Allergy and Asthma European Network (GA2LEN). Guidelines for treatment of atopic eczema (atopic dermatitis) part I. J Eur Acad Dermatol Venereol. 2012;26(8):1045-1060. doi:10.1111/j.1468-3083.2012.04635.x
  3. Sidbury R, Davis DM, Cohen DE, et al; American Academy of Dermatology. Guidelines of care for the management of atopic dermatitis: section 3: management and treatment with phototherapy and systemic agents. J Am Acad Dermatol. 2014;71(2):327-349. doi:10.1016/j.jaad.2014.03.030
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