Long-term safety of crisaborole ointment 2% in children and adults with mild to moderate atopic dermatitis.
J Am Acad Dermatol
; 77(4): 641-649.e5, 2017 Oct.
Article
em En
| MEDLINE
| ID: mdl-28823881
ABSTRACT
BACKGROUND:
Long-term topical treatment is often required for atopic dermatitis (AD), a chronic inflammatory skin disease.OBJECTIVE:
To assess the long-term safety results from a multicenter, open-label, 48-week safety study (AD-303) of patients (N = 517) ≥2 years of age with mild to moderate AD who continued crisaborole treatment, a topical phosphodiesterase-4 inhibitor, after completing a 28-day phase 3 pivotal study (AD-301, AD-302).METHODS:
Global disease severity was assessed in patients every 4 weeks, and if assessed as mild or greater, a 28-day treatment period with crisaborole applied twice daily was initiated. Adverse events (AEs), including treatment-emergent AEs (TEAEs), and serious AEs were analyzed.RESULTS:
During the pivotal studies and AD-303, 65% of patients reported ≥1 TEAE, most of which were mild (51.2%) or moderate (44.6%) and considered unrelated to treatment (93.1%). The frequency and severity of TEAEs were consistent. The most frequently reported treatment-related AEs (overall, 10.2%) were dermatitis atopic (3.1%), application-site pain (2.3%), and application-site infection (1.2%). Nine patients (1.7%) discontinued the long-term study because of TEAEs.LIMITATIONS:
Long-term efficacy was not analyzed.CONCLUSION:
Crisaborole ointment had a low frequency of treatment-related AEs over 48 weeks of treatment of patients with AD.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Compostos de Boro
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Compostos Bicíclicos Heterocíclicos com Pontes
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Dermatite Atópica
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Fármacos Dermatológicos
Tipo de estudo:
Clinical_trials
Limite:
Adolescent
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Adult
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Aged
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Child
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Child, preschool
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Ano de publicação:
2017
Tipo de documento:
Article