Delgocitinib ointment, a topical Janus kinase inhibitor, in adult patients with moderate to severe atopic dermatitis: A phase 3, randomized, double-blind, vehicle-controlled study and an open-label, long-term extension study.
Atopic dermatitis
JAK inhibitor
JTE-052
Janus kinase
QOL
delgocitinib
eczema
inflammation
ointment
pruritus
skin barrier
topical therapy
Journal
Journal of the American Academy of Dermatology
ISSN: 1097-6787
Titre abrégé: J Am Acad Dermatol
Pays: United States
ID NLM: 7907132
Informations de publication
Date de publication:
Apr 2020
Apr 2020
Historique:
received:
29
08
2019
revised:
02
12
2019
accepted:
06
12
2019
pubmed:
8
2
2020
medline:
18
11
2020
entrez:
8
2
2020
Statut:
ppublish
Résumé
Previous studies showed the potential effectiveness of delgocitinib ointment, a novel topical Janus kinase inhibitor, in atopic dermatitis (AD). This study aimed to evaluate the efficacy and safety of delgocitinib 0.5% ointment. In part 1, a 4-week double-blind period, Japanese patients aged 16 years or older with moderate or severe AD were randomly assigned in a 2:1 ratio to delgocitinib 0.5% ointment or vehicle ointment. Eligible patients entered part 2, a 24-week extension period, to receive delgocitinib 0.5% ointment. At the end of treatment in part 1, the least-squares mean percent changes from baseline in the modified Eczema Area and Severity Index score, the primary efficacy endpoint, were significantly greater in the delgocitinib group than in the vehicle group (-44.3% vs 1.7%, P < .001). The improvement in modified Eczema Area and Severity Index score was maintained in part 2. Most adverse events were mild and unrelated to delgocitinib across the study periods. Only Japanese patients were included. The vehicle-controlled period lasted only 4 weeks. In part 2, topical corticosteroids were allowed for the treatment of worsening of AD. Delgocitinib ointment was effective and well tolerated in Japanese adult patients with moderate to severe AD for up to 28 weeks.
Sections du résumé
BACKGROUND
BACKGROUND
Previous studies showed the potential effectiveness of delgocitinib ointment, a novel topical Janus kinase inhibitor, in atopic dermatitis (AD).
OBJECTIVE
OBJECTIVE
This study aimed to evaluate the efficacy and safety of delgocitinib 0.5% ointment.
METHODS
METHODS
In part 1, a 4-week double-blind period, Japanese patients aged 16 years or older with moderate or severe AD were randomly assigned in a 2:1 ratio to delgocitinib 0.5% ointment or vehicle ointment. Eligible patients entered part 2, a 24-week extension period, to receive delgocitinib 0.5% ointment.
RESULTS
RESULTS
At the end of treatment in part 1, the least-squares mean percent changes from baseline in the modified Eczema Area and Severity Index score, the primary efficacy endpoint, were significantly greater in the delgocitinib group than in the vehicle group (-44.3% vs 1.7%, P < .001). The improvement in modified Eczema Area and Severity Index score was maintained in part 2. Most adverse events were mild and unrelated to delgocitinib across the study periods.
LIMITATIONS
CONCLUSIONS
Only Japanese patients were included. The vehicle-controlled period lasted only 4 weeks. In part 2, topical corticosteroids were allowed for the treatment of worsening of AD.
CONCLUSION
CONCLUSIONS
Delgocitinib ointment was effective and well tolerated in Japanese adult patients with moderate to severe AD for up to 28 weeks.
Identifiants
pubmed: 32029304
pii: S0190-9622(19)33289-X
doi: 10.1016/j.jaad.2019.12.015
pii:
doi:
Substances chimiques
Dermatologic Agents
0
Janus Kinase Inhibitors
0
Ointments
0
Pyrroles
0
delgocitinib
9L0Q8KK220
Types de publication
Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
823-831Commentaires et corrections
Type : ErratumIn
Informations de copyright
Copyright © 2019 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.