AbbVie's JAK inhibitor Rinvoq (upadacitinib) has reaffirmed efficacy and safety in treating adolescents with moderate-to-severe atopic dermatitis requiring systemic treatment.
AbbVie Korea said Friday that a study that analyzed three clinical trials conducted on moderate-to-severe adolescent atopic dermatitis patients was published in the JAMA Dermatology, American Medical Association’s journal of dermatology, on April 12,
The study was based on the analysis data of three random, double-blind, placebo-controlled phase 3 clinical trials on 552 adolescent patients – 290 girls and 262 boys at 216 institutions in 35 countries, including two Rinvoq monotherapies (Measure Up 1 and Measure Up 2), and combined therapy with topic corticosteroid (TCS) (AD Up).
The analysis subjects were adolescents aged 12-17 with moderate-to-severe atopic dermatitis, conducted from April to August 2021.
As a result, the Rinvoq group’s rates of attaining EASI 75 (the improvement of eczema area severity index by 75 percent or more) were 73 percent, 69 percent, and 63 percent in the Measure Up 1, Measure Up 2, and AD Up trials, far higher than the corresponding rates of 12 percent, 13 percent, and 30 percent in the placebo group. Also, the rate of attaining 0/1 in vIGA-AD (verified investigators’ general assessment) conducted in the 16th week was higher in the Rinvoq group than in the placebo group.
Similar tendencies showing the superiority of Rinvoq over the placebo group were observed in the EASI attainment rate at the 16th week and clinically significant itching reduction (WP-NRS≥4). In addition, the quality of life has also improved in the Rinvoq group compared to the placebo group.
Rinvoq’s efficacy was largely similar to the effectiveness confirmed in adults aged 18-75 in primary and secondary evaluation indexes. Rinvoq also showed good drug resistance in adolescents.
“In the analysis of the three random clinical trials, Rinvoq showed a permissible safety profile,” researchers said in the paper. “It has been confirmed as an effective treatment for adolescents with moderate-to-severe atopic dermatitis.”
Rinvoq is a drug administered 15 mg or 30 mg orally once a day. It can be used regardless of TCS. The drug has also received insurance benefits for use in adolescents with moderate-to-severe atopic dermatitis and aged 12 or more since April 1.