Abrocitinib (2) – Cibinqo®

• Clinical trials
  • The JADE DARE study is a double-blind RCT comparing abrocitinib with dupilumab in adults.
  • The JADE TEEN trial is a double-blind RCT comparing abrocitinib and placebo over a treatment period of 12 weeks.

Young people aged 12 to ≤ 17 years with moderate to severe atopic dermatitis who are eligible for systemic therapy

• For adolescents aged 12 to ≤ 17 years with moderate to severe atopic dermatitis who are eligible for systemic therapy, additional benefit is not proven.
• No RCT could be identified that directly compared abrocitinib with the appropriate comparator therapy, dupilumab, in adolescents aged 12 years and over with moderate to severe atopic dermatitis who are eligible for systemic therapy.
• In principle, the data from adults can be extrapolated to adolescents in the therapeutic indication for atopic dermatitis, as the pathogenesis and clinical presentation are sufficiently similar in adolescents and adults.
• However, the available data are not suitable for extrapolating the results from adults in the JADE DARE study to adolescents, as there are significant uncertainties, which are explained below:
• The endpoints (EASI 100, SCORAD 100, SCORAD 90 and POEM 0), which formed the basis for deriving the additional benefit for adults in the resolution of 7 July 2022, no statistically significant effects were observed at week 12 in the JADE TEEN study.
• Statistically significant advantages were observed at week 12 for the operationalisations POEM 0 to 2, SCORAD 75 and EASI 90.
• No statistically significant differences were observed for these response thresholds at the final data cut-off for the JADE DARE study.
• Consequently, no statistically significant differences were observed in adolescents for the operationalisations of the endpoints that formed the basis for deriving additional benefit in adults.
• Given that the JADE TEEN study is also a placebo-controlled trial, the effects in the operationalisations POEM 0 to 2, SCORAD 75 and EASI 90 at week 12 are, taken together, not considered sufficiently large to assume that the results can be extrapolated from adults to adolescents.
• Furthermore, no data were presented for the 100 mg dose of abrocitinib, although this would have been relevant for assessing the additional benefit in adolescent patients.
• Taken together, the current data set does not allow the results from adults in the JADE DARE study to be extrapolated to adolescents.
• Overall, no additional benefit of abrocitinib compared with the appropriate comparator therapy has been established for adolescents aged 12 to ≤ 17 years with moderate to severe atopic dermatitis who are eligible for systemic therapy.
• Overall assessment
  • Overall, no additional benefit of abrocitinib compared with the appropriate comparator therapy is identified for adolescents aged 12 to ≤ 17 years with moderate to severe atopic dermatitis who are eligible for systemic therapy.

Courtesy translation only, please refer to the German original.