Long-term safety and effectiveness of roflumilast cream 0.3% in adults with chronic plaque psoriasis: a 52-week, phase 2, open-label trial.
durability of response
local tolerability
long-term safety
plaque psoriasis
roflumilast
topical
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:
29 Mar 2024
29 Mar 2024
Historique:
received:
20
09
2023
revised:
15
03
2024
accepted:
19
03
2024
medline:
1
4
2024
pubmed:
1
4
2024
entrez:
31
3
2024
Statut:
aheadofprint
Résumé
Efficacy and/or safety profiles limit topical psoriasis treatments. Evaluate long-term effects of once-daily roflumilast cream 0.3% in patients with psoriasis. In this open-label phase 2 trial, adult patients (N = 332) with psoriasis who completed the phase 2b parent trial or were newly enrolled applied roflumilast once-daily for 52 weeks. Safety and effectiveness were assessed. Overall, 244 patients (73.5%) completed the trial; 13 patients (3.9%) discontinued due to adverse events (AEs) and 3 (0.9%) due to lack of efficacy. Twelve patients (3.6%) reported treatment-related AEs; none were serious. ≥97% of patients had no irritation. No tachyphylaxis was observed with 44.8% of the patients achieving Investigator Global Assessment (IGA) Clear or Almost Clear at Week 52. Intertriginous-IGA and Psoriasis Area and Severity Index (PASI) were not evaluated in all patients. In this long-term trial, once-daily roflumilast cream was well-tolerated and efficacious up to 64 weeks in patients in the earlier trial, suggesting it is suitable for chronic treatment, including the face and intertriginous areas.
Sections du résumé
BACKGROUND
BACKGROUND
Efficacy and/or safety profiles limit topical psoriasis treatments.
OBJECTIVE
OBJECTIVE
Evaluate long-term effects of once-daily roflumilast cream 0.3% in patients with psoriasis.
METHODS
METHODS
In this open-label phase 2 trial, adult patients (N = 332) with psoriasis who completed the phase 2b parent trial or were newly enrolled applied roflumilast once-daily for 52 weeks. Safety and effectiveness were assessed.
RESULTS
RESULTS
Overall, 244 patients (73.5%) completed the trial; 13 patients (3.9%) discontinued due to adverse events (AEs) and 3 (0.9%) due to lack of efficacy. Twelve patients (3.6%) reported treatment-related AEs; none were serious. ≥97% of patients had no irritation. No tachyphylaxis was observed with 44.8% of the patients achieving Investigator Global Assessment (IGA) Clear or Almost Clear at Week 52.
LIMITATIONS
CONCLUSIONS
Intertriginous-IGA and Psoriasis Area and Severity Index (PASI) were not evaluated in all patients.
CONCLUSIONS
CONCLUSIONS
In this long-term trial, once-daily roflumilast cream was well-tolerated and efficacious up to 64 weeks in patients in the earlier trial, suggesting it is suitable for chronic treatment, including the face and intertriginous areas.
Identifiants
pubmed: 38556093
pii: S0190-9622(24)00541-3
doi: 10.1016/j.jaad.2024.03.030
pii:
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
Copyright © 2024. Published by Elsevier Inc.