Long-term safety of crisaborole ointment 2% in children and adults with mild to moderate atopic dermatitis - 14/09/17
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.
Le texte complet de cet article est disponible en PDF.Key words : atopic dermatitis, crisaborole, eczema, long-term safety, ointment, PDE4, phosphodiesterase-4, topical treatment
Abbreviations used : AD, AE, ISGA, PDE4, SAE, TCI, TCS, TEAE
Plan
Funding sources: Sponsored by Anacor Pharmaceuticals Inc, a wholly owned subsidiary of Pfizer Inc. |
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Conflicts of interest: The institutes of Drs Eichenfield, Call, Forsha, Hebert, Stein Gold, and Tschen received research funding from Anacor Pharmaceuticals Inc. All research funding for Dr Hebert was paid to UTHealth McGovern Medical School–Houston, Houston, Texas. Dr Spellman received consulting fees from Anacor Pharmaceuticals Inc. Dr Hebert received advisory board honoraria from Anacor Pharmaceuticals Inc and Pfizer Inc. Drs Eichenfield and Stein Gold received advisory board honoraria from Anacor Pharmaceuticals Inc and Pfizer Inc. Dr Stein Gold received advisory board honoraria from Medimetriks, and her institution received funding from GlaxoSmithKline to conduct clinical trials. Dr Tschen's institute received research funding from Regeneron Pharmaceuticals, Perrigo Company plc, Therapeutics Inc, Taro Pharmaceuticals, Watson Pharmaceuticals Inc, and Otsuka America Pharmaceutical Inc. At the time of the study, Ms Van Syoc and Dr Zane were employees and shareholders of Anacor Pharmaceuticals Inc. Dr Fowler had no conflicts of interest to report. |
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Please visit www.jaad.org for a complete list of investigators for Study AD-303. |
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Reprints not available from the authors. |
Vol 77 - N° 4
P. 641 - octobre 2017 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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