Long-term safety and tolerability of apremilast in patients with psoriasis: Pooled safety analysis for ≥156 weeks from 2 phase 3, randomized, controlled trials (ESTEEM 1 and 2).
J Am Acad Dermatol
; 77(2): 310-317.e1, 2017 Aug.
Article
em En
| MEDLINE
| ID: mdl-28416342
ABSTRACT
BACKGROUND:
Randomized, controlled trials demonstrated efficacy and safety of apremilast for moderate-to-severe plaque psoriasis and psoriatic arthritis.OBJECTIVE:
Assess long-term safety of oral apremilast in psoriasis patients.METHODS:
Safety findings are reported for 0 to ≥156 weeks from the Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis (ESTEEM) 1 and 2.RESULTS:
The 0 to ≥156-week apremilast-exposure period included 1184 patients treated twice daily with apremilast 30 mg (1902.2 patient-years). During 0 to ≤52 weeks, the adverse events (AEs) that occurred in ≥5% of patients included diarrhea, nausea, upper respiratory tract infection, nasopharyngitis, tension headache, and headache. From 0 to ≥156 weeks, no new AEs (affecting ≥5% of the population) were reported. AEs, serious AEs, and study drug discontinuations caused by AEs did not increase with long-term exposure. During the 0 to ≥156-week period, the rates of major cardiac events (exposure-adjusted incidence rate [EAIR] 0.5/100 patient-years), malignancies (EAIR 1.2/100 patient-years), depression (EAIR 1.8/100 patient-years), or suicide attempts (EAIR 0.1/100 patient-years) did not increase in comparison with the rates found during the 0 to ≤52-week period. No serious opportunistic infections, reactivation of tuberculosis, or clinically meaningful effects on laboratory measurements were reported.LIMITATIONS:
This study had a high dropout rate (21% of patients ongoing >156 weeks); most were unrelated to safety concerns.CONCLUSIONS:
Apremilast demonstrated an acceptable safety profile and was generally well tolerated for ≥156 weeks.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Psoríase
/
Talidomida
/
Doenças Cardiovasculares
/
Anti-Inflamatórios não Esteroides
/
Depressão
/
Neoplasias
Tipo de estudo:
Clinical_trials
/
Incidence_studies
/
Prognostic_studies
Limite:
Adult
/
Female
/
Humans
/
Male
/
Middle aged
Idioma:
En
Revista:
J Am Acad Dermatol
Ano de publicação:
2017
Tipo de documento:
Article