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Long-term safety of crisaborole ointment 2% in children and adults with mild to moderate atopic dermatitis.
J Am Acad Dermatol. 2017 Oct; 77(4):641-649.e5.JA

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.

Authors+Show Affiliations

Division of Pediatric Dermatology, Rady Children's Hospital, San Diego, California; Departments of Dermatology and Pediatrics, University of California, San Diego, California. Electronic address: leichenfield@rchsd.org.Clinical Research Partners, Richmond, Virginia.Jordan Valley Dermatology and Research Center, West Jordan, Utah.Dermatology Specialists Research, Louisville, Kentucky.Department of Dermatology, UTHealth McGovern Medical School-Houston, Houston, Texas.Paid consultant to Anacor Pharmaceuticals Inc, Palo Alto, California.Henry Ford Health System, Detroit, Michigan.Pfizer Inc, New York, New York.Anacor Pharmaceuticals Inc, acquired by Pfizer Inc, New York, New York.Academic Dermatology Associates, Albuquerque, New Mexico.

Pub Type(s)

Journal Article
Multicenter Study

Language

eng

PubMed ID

28823881

Citation

Eichenfield, Lawrence F., et al. "Long-term Safety of Crisaborole Ointment 2% in Children and Adults With Mild to Moderate Atopic Dermatitis." Journal of the American Academy of Dermatology, vol. 77, no. 4, 2017, pp. 641-649.e5.
Eichenfield LF, Call RS, Forsha DW, et al. Long-term safety of crisaborole ointment 2% in children and adults with mild to moderate atopic dermatitis. J Am Acad Dermatol. 2017;77(4):641-649.e5.
Eichenfield, L. F., Call, R. S., Forsha, D. W., Fowler, J., Hebert, A. A., Spellman, M., Stein Gold, L. F., Van Syoc, M., Zane, L. T., & Tschen, E. (2017). Long-term safety of crisaborole ointment 2% in children and adults with mild to moderate atopic dermatitis. Journal of the American Academy of Dermatology, 77(4), 641-e5. https://doi.org/10.1016/j.jaad.2017.06.010
Eichenfield LF, et al. Long-term Safety of Crisaborole Ointment 2% in Children and Adults With Mild to Moderate Atopic Dermatitis. J Am Acad Dermatol. 2017;77(4):641-649.e5. PubMed PMID: 28823881.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Long-term safety of crisaborole ointment 2% in children and adults with mild to moderate atopic dermatitis. AU - Eichenfield,Lawrence F, AU - Call,Robert S, AU - Forsha,Douglass W, AU - Fowler,Joseph,Jr AU - Hebert,Adelaide A, AU - Spellman,Mary, AU - Stein Gold,Linda F, AU - Van Syoc,Merrie, AU - Zane,Lee T, AU - Tschen,Eduardo, Y1 - 2017/08/18/ PY - 2017/02/23/received PY - 2017/05/31/revised PY - 2017/06/04/accepted PY - 2017/8/22/pubmed PY - 2017/9/28/medline PY - 2017/8/22/entrez KW - PDE4 KW - atopic dermatitis KW - crisaborole KW - eczema KW - long-term safety KW - ointment KW - phosphodiesterase-4 KW - topical treatment SP - 641 EP - 649.e5 JF - Journal of the American Academy of Dermatology JO - J. Am. Acad. Dermatol. VL - 77 IS - 4 N2 - 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. SN - 1097-6787 UR - https://www.unboundmedicine.com/medline/citation/28823881/Long_term_safety_of_crisaborole_ointment_2_in_children_and_adults_with_mild_to_moderate_atopic_dermatitis_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0190-9622(17)31814-5 DB - PRIME DP - Unbound Medicine ER -