Baricitinib in adult patients with moderate-to-severe atopic dermatitis: A phase 2 parallel, double-blinded, randomized placebo-controlled multiple-dose study.
Administration, Cutaneous
Adrenal Cortex Hormones
/ administration & dosage
Adult
Azetidines
/ administration & dosage
Dermatitis, Atopic
/ drug therapy
Dermatologic Agents
/ administration & dosage
Double-Blind Method
Drug Administration Schedule
Drug Therapy, Combination
Female
Humans
Janus Kinase 1
/ antagonists & inhibitors
Janus Kinase 2
/ antagonists & inhibitors
Male
Middle Aged
Purines
Pyrazoles
Severity of Illness Index
Sulfonamides
/ administration & dosage
Treatment Outcome
EASI
JAK-STAT signaling
SCORAD
atopic dermatitis
baricitinib
phase 2
pruritus
topical corticosteroids
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 2019
Apr 2019
Historique:
received:
12
10
2017
revised:
20
12
2017
accepted:
13
01
2018
pubmed:
8
2
2018
medline:
23
4
2019
entrez:
8
2
2018
Statut:
ppublish
Résumé
Baricitinib, an oral selective inhibitor of Janus kinase 1 and Janus kinase 2, modulates proinflammatory cytokine signaling. The efficacy and safety of baricitinib were evaluated in patients with moderate-to-severe atopic dermatitis (AD). In this phase 2, randomized, double-blind, placebo-controlled study, 124 patients with moderate-to-severe AD applied topical corticosteroids (TCSs) for 4 weeks before randomization to once-daily placebo, 2 mg of baricitinib, or 4 mg of baricitinib for 16 weeks. Use of TCSs was permitted during the study. The primary outcome was the proportion of patients achieving at least a 50% reduction in the Eczema Area and Severity Index (EASI-50) compared with placebo. Significantly more patients who received baricitinib, 4 mg, achieved EASI-50 than did patients receiving placebo (61% vs 37% [P = .027]) at 16 weeks. The difference between the proportion of patients receiving baricitinib, 2 or 4 mg, who achieved EASI-50 and the proportion of patients receiving placebo and achieving EASI-50 was significant as early as week 4. Baricitinib also improved pruritus and sleep loss. Treatment-emergent adverse events were reported in 24 of the patients receiving placebo (49%), 17 of those receiving 2 mg of baricitinib (46%), and 27 of those receiving 4 mg of baricitinib (71%). A TCS standardization period before randomization reduced disease severity, limiting the ability to compare results with those of baricitinib monotherapy. Longer studies are required to confirm baricitinib's efficacy and safety in patients with AD. Baricitinib used with TCSs reduced inflammation and pruritus in patients with moderate-to-severe AD.
Sections du résumé
BACKGROUND
BACKGROUND
Baricitinib, an oral selective inhibitor of Janus kinase 1 and Janus kinase 2, modulates proinflammatory cytokine signaling.
OBJECTIVES
OBJECTIVE
The efficacy and safety of baricitinib were evaluated in patients with moderate-to-severe atopic dermatitis (AD).
METHODS
METHODS
In this phase 2, randomized, double-blind, placebo-controlled study, 124 patients with moderate-to-severe AD applied topical corticosteroids (TCSs) for 4 weeks before randomization to once-daily placebo, 2 mg of baricitinib, or 4 mg of baricitinib for 16 weeks. Use of TCSs was permitted during the study. The primary outcome was the proportion of patients achieving at least a 50% reduction in the Eczema Area and Severity Index (EASI-50) compared with placebo.
RESULTS
RESULTS
Significantly more patients who received baricitinib, 4 mg, achieved EASI-50 than did patients receiving placebo (61% vs 37% [P = .027]) at 16 weeks. The difference between the proportion of patients receiving baricitinib, 2 or 4 mg, who achieved EASI-50 and the proportion of patients receiving placebo and achieving EASI-50 was significant as early as week 4. Baricitinib also improved pruritus and sleep loss. Treatment-emergent adverse events were reported in 24 of the patients receiving placebo (49%), 17 of those receiving 2 mg of baricitinib (46%), and 27 of those receiving 4 mg of baricitinib (71%).
LIMITATIONS
CONCLUSIONS
A TCS standardization period before randomization reduced disease severity, limiting the ability to compare results with those of baricitinib monotherapy. Longer studies are required to confirm baricitinib's efficacy and safety in patients with AD.
CONCLUSIONS
CONCLUSIONS
Baricitinib used with TCSs reduced inflammation and pruritus in patients with moderate-to-severe AD.
Identifiants
pubmed: 29410014
pii: S0190-9622(18)30129-4
doi: 10.1016/j.jaad.2018.01.018
pii:
doi:
Substances chimiques
Adrenal Cortex Hormones
0
Azetidines
0
Dermatologic Agents
0
Purines
0
Pyrazoles
0
Sulfonamides
0
JAK1 protein, human
EC 2.7.10.2
JAK2 protein, human
EC 2.7.10.2
Janus Kinase 1
EC 2.7.10.2
Janus Kinase 2
EC 2.7.10.2
baricitinib
ISP4442I3Y
Types de publication
Clinical Trial, Phase II
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
913-921.e9Informations de copyright
Copyright © 2018. Published by Elsevier Inc.