Efficacy and safety of risankizumab in Japanese patients with moderate to severe plaque psoriasis: Results from the SustaIMM phase 2/3 trial.
Adult
Aged
Antibodies, Monoclonal
/ administration & dosage
Cross-Over Studies
Dose-Response Relationship, Drug
Double-Blind Method
Drug Administration Schedule
Female
Humans
Interleukin-23 Subunit p19
/ antagonists & inhibitors
Japan
Male
Middle Aged
Placebos
/ administration & dosage
Psoriasis
/ diagnosis
Severity of Illness Index
Treatment Outcome
Japanese patient
interleukin-23
plaque psoriasis
psoriasis
risankizumab
Journal
The Journal of dermatology
ISSN: 1346-8138
Titre abrégé: J Dermatol
Pays: England
ID NLM: 7600545
Informations de publication
Date de publication:
Aug 2019
Aug 2019
Historique:
received:
01
03
2019
accepted:
07
05
2019
pubmed:
27
6
2019
medline:
29
10
2019
entrez:
26
6
2019
Statut:
ppublish
Résumé
Risankizumab, a humanized immunoglobulin G1 monoclonal antibody, selectively inhibits interleukin-23, a key cytokine in the pathogenesis of psoriasis, by binding to its p19 subunit. In SustaIMM (ClinicalTrials.gov/NCT03000075), a phase 2/3, double-blinded, placebo-controlled study, Japanese patients with moderate to severe plaque psoriasis (n = 171) were stratified by bodyweight and concomitant psoriatic arthritis and randomized 2:2:1:1 to 75 mg risankizumab, 150 mg risankizumab, placebo with cross-over to 75 mg risankizumab and placebo with cross-over to 150 mg risankizumab. Dosing was at weeks 0, 4, 16, 28 and 40, with placebo cross-over to risankizumab at week 16. The primary end-point was 90% or more improvement from baseline in Psoriasis Area and Severity Index (PASI-90) at week 16 for risankizumab versus placebo. Missing data were imputed as non-response. All primary and psoriasis-related secondary end-points were met for both risankizumab doses (P < 0.001). At week 16, PASI-90 responses were significantly higher in patients receiving 75 mg (76%) or 150 mg (75%) risankizumab versus placebo (2%). Corresponding response rates were 86%, 93% and 10% for static Physician Global Assessment (sPGA) score of clear/almost clear; 90%, 95% and 9% for PASI-75; and 22%, 33% and 0% for PASI-100, with significantly higher responses for both risankizumab doses versus placebo. Through week 52, PASI and sPGA responses increased or were maintained and treatment-emergent adverse events were comparable across treatment groups. Both doses of risankizumab were superior to placebo in treating patients with moderate to severe plaque psoriasis. The safety profile was consistent with previous risankizumab trials, with no new or unexpected safety findings.
Identifiants
pubmed: 31237727
doi: 10.1111/1346-8138.14941
pmc: PMC6771602
doi:
Substances chimiques
Antibodies, Monoclonal
0
IL23A protein, human
0
Interleukin-23 Subunit p19
0
Placebos
0
risankizumab
90ZX3Q3FR7
Banques de données
ClinicalTrials.gov
['NCT03000075']
Types de publication
Clinical Trial, Phase II
Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
686-694Subventions
Organisme : AbbVie
Organisme : Boehringer Ingelheim
Informations de copyright
© 2019 AbbVie. The Journal of Dermatology published by John Wiley & Sons Australia, Ltd on behalf of Japanese Dermatological Association.
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