Long-term safety and effectiveness of roflumilast cream 0.3% in adults with chronic plaque psoriasis: A 52-week, phase 2, open-label trial.
J Am Acad Dermatol
; 91(2): 273-280, 2024 Aug.
Article
em En
| MEDLINE
| ID: mdl-38556093
ABSTRACT
BACKGROUND:
Efficacy and/or safety profiles limit topical psoriasis treatments.OBJECTIVE:
Evaluate long-term effects of once-daily roflumilast cream 0.3% in patients with psoriasis.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:
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:
Intertriginous-IGA and Psoriasis Area and Severity Index (PASI) were not evaluated in all patients.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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Psoríase
/
Benzamidas
/
Índice de Gravidade de Doença
/
Ciclopropanos
/
Inibidores da Fosfodiesterase 4
/
Creme para a Pele
/
Aminopiridinas
Limite:
Adult
/
Aged
/
Female
/
Humans
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Male
/
Middle aged
Idioma:
En
Ano de publicação:
2024
Tipo de documento:
Article