In a 76-week study, upadacitinib reached an Eczema Area and Severity Index response rate of up to 96.1% in adolescents with moderate to severe atopic dermatitis, according to recent findings.
A pooled analysis of three Phase 3 randomized clinical trials—Measure Up 1, Measure Up 2, and AD Up—evaluated the long-term efficacy and safety of upadacitinib in adolescents with moderate to severe atopic dermatitis (AD). The trials involved 542 adolescents (aged 12-17 years), randomized 1:1:1 to receive once-daily oral upadacitinib at doses of 15 mg or 30 mg, or placebo, with placebo-treated patients rerandomized to either upadacitinib dose at week 16. The AD Up trial included concurrent topical corticosteroids.
Results showed sustained Eczema Area and Severity Index (EASI)-75 responses, with 89.1%, 84.4%, and 87.8% of participants on the 15 mg dose in each respective trial achieving at least a 75% reduction in EASI scores at week 76. Among those on 30 mg, EASI-75 was achieved by 96.1%, 93.6%, and 82.7%, respectively. More stringent responses, including EASI-90 and EASI-100, were also maintained or improved beyond week 16 through week 76, particularly in the 30 mg group. Pruritus scores, which showed a mean reduction of at least 4 points on the Worst Pruritus Numerical Rating Scale, plateaued after the switch to upadacitinib and remained stable through week 76.
Adverse events (AEs) were reported consistent with the known safety profile of upadacitinib, with no new safety signals. Acne was common but mild, while nausea affected 2.4%-5.5% of participants, occurring more frequently with the 30 mg dose. Herpetic infections (4.0, 1.9, and 1.1 events per 100 patient-years across trials for 15 mg) and creatine kinase elevations (11.6, 11.0, and 7.1 events per 100 patient-years) were within expected ranges. Isolated cases of rhabdomyolysis were noted, associated with physical exertion. Growth measurements over the study period indicated no significant impact from treatment.
These findings, published in JAMA Dermatology, indicate that upadacitinib maintained efficacy and a consistent safety profile through 76 weeks in adolescents with moderate to severe AD.
Full disclosures are available in the published study.
