1. Upadacitinib, a new once-daily oral systemic medication, reduces eczema severity and improves clinician- and patient-reported measures in adolescents with atopic dermatitis.
2. Upadacitinib is generally well tolerated, with the most frequently reported side effect being mild to moderate acne. Serious adverse events such as herpes zoster occur very infrequently.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Atopic dermatitis (AD) is a common chronic inflammatory skin disease that affects around 15% of adolescents aged 12 to 17 years. It is characterized by intense itching, which can lead to poorer mental health and significantly impact quality of life. While topical corticosteroids and calcineurin inhibitors have been the main treatment options for AD, there are new treatments emerging that target inflammatory mediators, such as the Jak inhibitor. This study aimed to analyze the safety and efficacy of one of these systemic treatments, upadacitinib, through three randomized clinical trials. The results demonstrated that a higher proportion of adolescents achieved significant relief from their eczema when treated with upadacitinib at doses of 15 mg and 30 mg compared to those given a placebo. The assessment was based on several scoring tools for AD, including EASI 75, EASI 90, vIGA-AD, WP-NRS-4, DLQI, and POEM. Regarding the safety profile, serious adverse events such as infections and herpes zoster were very rare in both dosage groups. The most commonly reported side effects were mild to moderate acne, headaches, upper respiratory tract infections, elevated creatine phosphokinase (CPK) levels, and nasopharyngitis. There are some limitations to consider. The study period of 16 weeks may not have been sufficient to fully characterize the long-term safety profile of upadacitinib. Additionally, the study design did not allow for a statistical comparison between the two dosage groups, which would provide valuable insights for clinical practice. Nevertheless, this study demonstrated that upadacitinib is both effective and well-tolerated in adolescents with moderate-to-severe AD, yielding similar results to those observed in adults.
Click to read the study in JAMA Dermatology
In-Depth [meta-analysis]: This study analyzed data from three randomized, double-blind, placebo-controlled phase 3 clinical trials known as Measure Up 1, Measure Up 2, and AD Up. The study involved 552 adolescents aged 12 to 17 with moderate-to-severe atopic dermatitis from over 20 countries from July 2018 to December 2020. The study demonstrated good participant retention, with 93-98% of adolescents completing the 16-week double-blind period. At the 16th week of treatment, a significantly greater number of adolescents achieved at least a 75% improvement in the Eczema Area and Severity Index when treated with upadacitinib at doses of 15 mg (63-73%) and 30 mg (73-84%) compared to those receiving the placebo (12-30%; p<0.001). The most commonly reported adverse effect of upadacitinib was acne, which affected 10-13% of those on the 15 mg dose and 15-16% of those on the 30 mg dose, as opposed to 2-3% on the placebo. The occurrence of serious adverse effects was infrequent, with only one patient developing impetigo and four developing herpes zoster. Overall, these findings highlight the promising safety and efficacy profile of upadacitinib, offering new hope for adolescents living with this chronic skin condition.
Image: PD
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