S'abonner

Long-term safety of crisaborole ointment 2% in children and adults with mild to moderate atopic dermatitis - 14/09/17

Doi : 10.1016/j.jaad.2017.06.010 
Lawrence F. Eichenfield, MD a, b, , Robert S. Call, MD c, Douglass W. Forsha, MD d, Joseph Fowler, MD e, Adelaide A. Hebert, MD f, Mary Spellman, MD g, Linda F. Stein Gold, MD h, Merrie Van Syoc, BS i, Lee T. Zane, MD j, Eduardo Tschen, MD, MBA k
a Division of Pediatric Dermatology, Rady Children's Hospital, San Diego, California 
b Departments of Dermatology and Pediatrics, University of California, San Diego, California 
c Clinical Research Partners, Richmond, Virginia 
d Jordan Valley Dermatology and Research Center, West Jordan, Utah 
e Dermatology Specialists Research, Louisville, Kentucky 
f Department of Dermatology, UTHealth McGovern Medical School–Houston, Houston, Texas 
g Paid consultant to Anacor Pharmaceuticals Inc, Palo Alto, California 
h Henry Ford Health System, Detroit, Michigan 
i Pfizer Inc, New York, New York 
j Anacor Pharmaceuticals Inc, acquired by Pfizer Inc, New York, New York 
k Academic Dermatology Associates, Albuquerque, New Mexico 

Correspondence to: Lawrence F. Eichenfield, MD, Pediatric Dermatology, Rady Children's Hospital–San Diego, 8010 Frost St, San Diego, CA 92123.Pediatric Dermatology, Rady Children's Hospital–San Diego8010 Frost StSan DiegoCA92123

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.
 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.
 Please visit www.jaad.org for a complete list of investigators for Study AD-303.
 Reprints not available from the authors.


© 2017  American Academy of Dermatology, Inc.. Publié par Elsevier Masson SAS. Tous droits réservés.
Ajouter à ma bibliothèque Retirer de ma bibliothèque Imprimer
Export

    Export citations

  • Fichier

  • Contenu

Vol 77 - N° 4

P. 641 - octobre 2017 Retour au numéro
Article précédent Article précédent
  • Variations in risk of asthma and seasonal allergies between early- and late-onset pediatric atopic dermatitis: A cohort study
  • Joy Wan, Nandita Mitra, Ole J. Hoffstad, Joel M. Gelfand, Albert C. Yan, David J. Margolis
| Article suivant Article suivant
  • The relationship between duration of psoriasis, vascular inflammation, and cardiovascular events
  • Alexander Egeberg, Lone Skov, Aditya A. Joshi, Lotus Mallbris, Gunnar H. Gislason, Jashin J. Wu, Justin Rodante, Joseph B. Lerman, Mark A. Ahlman, Joel M. Gelfand, Nehal N. Mehta

Bienvenue sur EM-consulte, la référence des professionnels de santé.
L’accès au texte intégral de cet article nécessite un abonnement.

Déjà abonné à cette revue ?

Mon compte


Plateformes Elsevier Masson

Déclaration CNIL

EM-CONSULTE.COM est déclaré à la CNIL, déclaration n° 1286925.

En application de la loi nº78-17 du 6 janvier 1978 relative à l'informatique, aux fichiers et aux libertés, vous disposez des droits d'opposition (art.26 de la loi), d'accès (art.34 à 38 de la loi), et de rectification (art.36 de la loi) des données vous concernant. Ainsi, vous pouvez exiger que soient rectifiées, complétées, clarifiées, mises à jour ou effacées les informations vous concernant qui sont inexactes, incomplètes, équivoques, périmées ou dont la collecte ou l'utilisation ou la conservation est interdite.
Les informations personnelles concernant les visiteurs de notre site, y compris leur identité, sont confidentielles.
Le responsable du site s'engage sur l'honneur à respecter les conditions légales de confidentialité applicables en France et à ne pas divulguer ces informations à des tiers.


Tout le contenu de ce site: Copyright © 2024 Elsevier, ses concédants de licence et ses contributeurs. Tout les droits sont réservés, y compris ceux relatifs à l'exploration de textes et de données, a la formation en IA et aux technologies similaires. Pour tout contenu en libre accès, les conditions de licence Creative Commons s'appliquent.