Categories
Change Password!
Reset Password!
A phase 3 study (AD Up) was performed to explore the safety and efficacy of upadacitinib (oral Janus kinase inhibitor) and topical corticosteroids versus placebo to manage adolescents (aged 12-17 years) and adults (aged 18-75 years) suffering from atopic dermatitis.
In adults and adolescents with
moderate-to-severe chronic atopic dermatitis, the combination of upadacitinib
and topical corticosteroids had a favorable benefit-risk profile, good
tolerability, and was found to be superior to the combination of placebo and
topical corticosteroids.
A phase 3 study (AD Up) was
performed to explore the safety and efficacy of upadacitinib (oral Janus kinase
inhibitor) and topical corticosteroids versus placebo to manage adolescents
(aged 12-17 years) and adults (aged 18-75 years) suffering from atopic
dermatitis.
Overall, 901 subjects were randomly segregated to receive upadacitinib 15 mg (n=300), upadacitinib 30 mg (n=297), or placebo once daily (n=304), all in combination with topical corticosteroids for about 16 weeks in this randomized, double-blind, placebo-controlled trial.
The percentage of people who had
attained a vIGA-AD response and at least a 75% decline in EASI score from
baseline (EASI-75) were the coprimary outcomes. Safety was determined in all
individuals receiving at least one dose of the study drug, while efficacy was
determined in the intention-to-treat population.
At week 16, the percentage of subjects attaining EASI-75 and the vIGA-AD response was considerably greater in the upadacitinib 15 mg and 30 mg group in comparison with the placebo group. Notably, the adjusted difference in vIGA-AD response vs placebo was 28·5% for the 15 mg upadacitinib arm and 47·6% for the 30 mg upadacitinib arm, while the adjusted difference in EASI-75 response rate vs placebo was 38·1% for the 15 mg upadacitinib arm and 50·6% for the 30 mg upadacitinib arm.
As found during the double-blind period, 30 and 15 mg upadacitinib plus topical corticosteroids displayed good tolerability. Upper respiratory tract infection, acne, oral herpes, nasopharyngitis, elevation of blood creatine phosphokinase levels, atopic dermatitis, and headache were the most commonly reported treatment-emergent adverse events.
The occurrence of acne was greater in the upadacitinib 15 mg and upadacitinib 30 mg recipients compared to the placebo recipients. The occurrence of adverse events that resulted in cessation of study drug and serious side effects were comparable among the therapy groups, as shown in Table 1:
No deaths were witnessed in any
therapeutic group.
Upadacitinib plus topical
corticosteroids are well-tolerated and effectively treat patients suffering
from atopic dermatitis.
The Lancet
Safety and efficacy of upadacitinib in combination with topical corticosteroids in adolescents and adults with moderate-to-severe atopic dermatitis (AD Up): results from a randomised, double-blind, placebo-controlled, phase 3 trial
Kristian Reich et al.
Comments (0)