In three randomized clinical trials, upadacitinib demonstrated significant efficacy in the treatment of moderate to severe atopic dermatitis (AD) in adolescents 12 to 17 years of age. Patients receiving Upadacitinib 15 mg or 30 mg once daily achieved a 75% reduction in Eczema Area and Severity Index and Investigator Global Index score of 0 or 1 at Week 16. Adverse events reported were similar to those observed in adults and included acne, upper respiratory tract infection, and elevated creatine phosphokinase levels. Overall, upadacitinib appears to be a safe and effective treatment option for adolescents with moderate to severe AD.
Importance
Atopic dermatitis usually appears in childhood. Continuity of disease into adolescence and adulthood. It is important to evaluate new treatment options in adolescents because of the large unmet need in this population.
Objective
To assess the efficacy and safety of upadacitinib for the treatment of moderate-severe atopic dermatitis in adolescents.
Design, setting and participants
Adolescents enrolled in 3 randomized, double-blind, placebo-controlled Phase 3 clinical trials Phase 3 randomized controlled clinical trials in over 20 countries in Europe, North and South America, Oceania, the Middle East and Asia Forecast Analysis – Pacific Region July 2018 to December 2020. Participants were adolescents aged 12 to 17 with moderate to severe atopic dermatitis. The data analysis was done from April to August 2021.
Interference
Patients were randomized (1:1:1) to once-daily oral upadacitinib 15 mg, upadacitinib 30 mg, or placebo alone (Example 1 and Measure 2 Up) or with topical corticosteroids (AD Up).
Results and Key Measures
Safety and efficacy, including an improvement of at least 75% from baseline in eczema area and severity index and an Investigator’s Global Score for atopic dermatitis score of 0 (clear) or 1 (almost clear) at Week 16 (co-primary endpoint) Assessment is included.
Result
A total of 552 adolescents (290 females; 262 males) were randomized. The mean (SD) ages were 15.4 (1.8), 15.5 (1.7) and 15.3 (1.8) years for adolescents at measurement 1, measurement 2 and AD above, respectively. Measure Up 1, Measure Up 2 and AD Up have a higher proportion of adolescents (in %) respectively. [IC del 95%]) achieved at least a 75% improvement in eczema area and severity index at week 16 with upadacitinib 15 mg (73%) [63%-84%]69% [57%-81%]63% [51%-76%]), and upadacitinib 30 mg (78% [68%-88%]73% [62%-85%]84% [75%-94%]), compared to placebo (12% [4%-20%]13% [5%-22%]30% [19%-42%], p < 0.001 nominal for all comparisons versus placebo). Similarly, a greater proportion of adolescents treated with upadacitinib achieved a validated investigator’s global assessment for atopic dermatitis score 0 or 1 at week 16 and had an improved quality of life with upadacitinib compared to placebo .
In general, upadacitinib was well tolerated by the adolescents. Acne was the most frequent adverse event, and they were all mild or moderate.
Conclusion and Relevance
In this analysis of 3 randomized clinical trials, upadacitinib was an effective treatment with an acceptable safety profile for adolescents with moderate to severe atopic dermatitis.
