Long-term safety of crisaborole ointment 2% in children and adults with mild to moderate atopic dermatitis
| Autor: | Eduardo Tschen, Mary Spellman, Adelaide A. Hebert, Robert S. Call, Lawrence F. Eichenfield, Douglass W. Forsha, Linda Stein Gold, Joseph F. Fowler, Merrie Van Syoc, Lee T. Zane |
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| Rok vydání: | 2017 |
| Předmět: |
Adult
Boron Compounds Male medicine.medical_specialty Adolescent Pain Dermatology Infections Severity of Illness Index Dermatitis Atopic Ointments 030207 dermatology & venereal diseases 03 medical and health sciences Young Adult 0302 clinical medicine Disease severity medicine Humans In patient Adverse effect Child Aged business.industry Inflammatory skin disease Crisaborole Atopic dermatitis Middle Aged medicine.disease Bridged Bicyclo Compounds Heterocyclic Symptom Flare Up Treatment period 030220 oncology & carcinogenesis Child Preschool Disease Progression Female Long term safety Dermatologic Agents Phosphodiesterase 4 Inhibitors business |
| Zdroj: | Journal of the American Academy of Dermatology. 77(4) |
| ISSN: | 1097-6787 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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