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Upadacitinib Safe and Effective for Atopic Dermatitis in Adolescents at 76 Weeks: RCT Analysis
Upadacitinib (15 and 30 mg) was evaluated in adolescents with moderate to severe AD aged 12 to 17 years, with and without topical corticosteroids.
In a study that assessed 3 randomized clinical trials of adolescents with moderate-to-severe atopic dermatitis (AD) who were treated with upadacitinib (Rinvoq; abbvie) results demonstrated sustained efficacy responses through 76 weeks to go along with a favorable safety profile. These results were published in JAMA Dermatology.
AD is a common, chronic inflammatory skin disease that can appear at any point in life although the highest incidence of onset is observed in childhood, according to the study authors, led by Amy S Paller, MS, MD, of the Departments of Dermatology and Pediatrics in the Feinberg School of Medicine at Northwestern University, Chicago, IL.
"Upadacitinib is an oral, once-daily selective small-molecule JAK inhibitor with greater inhibitory potency for JAK1 than JAK2, JAK3, or tyrosine kinase 2," Paller and colleagues wrote. "It is approved in many jurisdictions, including the European Union, Japan, Canada, and the US, for the treatment of moderate to severe AD in patients 12 years and older."
In the Measure Up 1 (NCT03569293), Measure Up 2 (NCT03607422), and AD Up (NCT03568318) trials—ongoing, double-blind, placebo-controlled phase 3 randomized clinical trials featuring adolescents aged 12 to 17 years with moderate to severe AD—once-daily upadacitinib, 15 mg or 30 mg, was superior to placebo alone (Measure Up 1 and Measure Up 2 trials) or with topical corticosteroids (AD Up trial) through 16 weeks, and was sustained through 52 weeks during blinded extension phases of the studies.
To further evaluate the once-daily JAK inhibitor, the study investigators sought to assess the efficacy of upadacitinib, 15 mg and 30 mg, with or without topical corticosteroids, in the same patient population through 76 weeks.
FINDINGS
"The Measure Up 1, Measure Up 2, and AD Up studies demonstrated the efficacy and adverse events of upadacitinib through 52 weeks in adults and adolescents with atopic dermatitis (AD); however, longer-term outcomes (longer than 1 year) in adolescents have not previously been available," authors stated.
Data from the trio of randomized clinical trials were collected from August 2018 to April 2022, and were analyzed from June 2022 to September 2023. In the trials, adolescents were randomly assigned to receive once-daily upadacitinib 15 mg, 30 mg, or placebo alone (Measure Up 1 and Measure Up 2) or with topical corticosteroids (AD Up).
The study featured co-primary endpoints including:
- Achievement of 75% reduction or more in the Eczema Area and Severity Index Score (EASI-75) from baseline
- Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of clear (0) or almost clear (1) with 2 grades or more of improvement
- Worst Pruritus Numerical Rating Scale (WP-NRS) improvement of 4 points or greater through week 76 for participants with a WP-NRS score of 4 points or higher at baseline.
A total of 542 adolescents across all 3 studies were included, of which 52.4% were female.
According to study results at week 76, EASI-75 among those who received a 15 mg dose of upadacitinib was achieved by 89.1%, 84.4%, and 87.8% in the Measure Up 1, Measure Up 2, and AD Up trials, respectively. Among the 30 mg cohort in each trial, EASI-75 was achieved by 96.1%, 93.6%, and 82.7% of adolescents, with results having indicated maintenance or improvement in EASI-75 across 76 weeks, respectively.
Similarly, achievement of efficacy measured by vIGA-AD score of 0 or 1 and WP-NRS improvement of 4 points or more from baseline were either maintained or improved through 76 weeks of upadacitinib 15 mg or 30 mg treatment, according to the study. Additionally, no new safety signals were observed with either dose through the extended evaluation period.
Conclusion
"In summary, these results through 76 weeks demonstrated that upadacitinib, with a favorable benefit-risk profile, was an effective long-term treatment option for adolescents with moderate to severe AD," stated the study authors.
