Upadacitinib’s Benefit-Risk Profile Favorable in Adolescent Atopic Dermatitis

Upadacitinib has similar safety and efficacy profiles for the treatment of moderate to severe atopic dermatitis (AD) among adolescents as observed among adults, according to study findings published in JAMA Dermatology.

Researchers pooled data from Measure Up 1 (ClinicalTrials.gov Identifier: NCT03569293), Measure Up 2 (ClinicalTrials.gov Identifier: NCT03607422), and AD Up (ClinicalTrials.gov Identifier: NCT03568318), which were multicenter, randomized, parallel, double-blind, placebo-controlled, phase 3 trials.

Adolescents (N=552) aged 12 to 17 years with moderate to severe AD were recruited in 35 countries between 2018 and 2020 and randomly assigned in a 1:1:1 ratio to receive either upadacitinib 15 mg, upadacitinib 30 mg, or placebo daily. The efficacy endpoint was defined as a 75% improvement in the Eczema Area and Severity Index (EASI) from baseline plus a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 or 1 at week 16.

The trial cohorts had a mean age range of 15.1 to 15.8 years, 42% to 66% were girls, 30% to 55% had previously received systemic therapy, and mean EASI score at baseline was 27.8 to 31.2 points.

At week 16, the least squares mean change in EASI score from baseline was -22.7 to -24.2 points for upadacitinib 15 mg recipients and -24.2 to -25.6 points for upadacitinib 30 mg recipients compared with -11.0 to -15.2 points for placebo recipients. Overall, both upadacitinib groups were more likely to achieve the EASI efficacy endpoint than placebo at week 16 (all P <.001). Achieving a vIGA-AD score of 0 or 1 was also more likely among upadacitinib recipients compared with placebo at week 16 (all P <.001).

Similar trends were observed for other efficacy endpoints, including Dermatology Life Quality Index (DLQI), Children’s Dermatology Life Quality Index (CDLQI), Patient-Oriented Eczema Measure (POEM), and Hospital Anxiety and Depression Scale-Anxiety, and -Depression scores. Rescue mediations were required by 2% to 5% of upadacitinib 30 mg recipients, 7% to 9% of upadacitinib 15 mg recipients, and 18% to 45% of placebo recipients.

These trends indicated that upadacitinib had similar efficacy among adolescents as observed among adults.

The rates of treatment-emergent adverse events were 61% to 72% for the upadacitinib 30 mg and 57% to 62% for the upadacitinib 15 mg groups compared with 43% to 50% for the placebo cohort. The most common adverse events associated with upadacitinib were acne, headache, upper respiratory tract infection, creatine phosphokinase elevations, and nasopharyngitis.

The major limitation of this analysis is the short follow-up duration. Additional study is needed to evaluate longer-term outcomes.

The study authors conclude, “In this analysis of 3 randomized clinical trials, treatment of moderate-to-severe AD in adolescents with upadacitinib was effective and generally well tolerated, with an overall efficacy and safety profile similar to that observed in adults, and patient-reported outcomes indicated an overall better health-related quality of life compared with placebo. These results support a favorable benefit-risk profile for upadacitinib treatment in adolescents with moderate-to-severe AD.”

Disclosures: This research was supported by AbbVie Inc. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.