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Efficacy and safety of crisaborole ointment, a novel, nonsteroidal phosphodiesterase 4 (PDE4) inhibitor for the topical treatment of atopic dermatitis (AD) in children and adults.
J Am Acad Dermatol. 2016 Sep; 75(3):494-503.e6.JA

Abstract

BACKGROUND

Additional topical treatments for atopic dermatitis (AD) are needed that provide relief while minimizing risks.

OBJECTIVE

We sought to assess the efficacy and safety of crisaborole ointment, a phosphodiesterase 4 inhibitor, in two phase III AD studies (AD-301: NCT02118766; AD-302: NCT02118792).

METHODS

Two identically designed, vehicle-controlled, double-blind studies enrolled and randomly assigned (2:1, crisaborole:vehicle) patients aged 2 years or older with an Investigator's Static Global Assessment (ISGA) score of mild or moderate for twice-daily application for 28 days. The primary end point was ISGA score at day 29 of clear (0)/almost clear (1) with 2-grade or greater improvement from baseline. Additional analyses included time to success in ISGA score, percentage of patients achieving clear/almost clear, reduction in severity of AD signs, and time to improvement in pruritus.

RESULTS

More crisaborole- than vehicle-treated patients achieved ISGA score success (clear/almost clear with ≥2-grade improvement; AD-301: 32.8% vs 25.4%, P = .038; AD-302: 31.4% vs 18.0%, P < .001), with a greater percentage with clear/almost clear (51.7% vs 40.6%, P = .005; 48.5% vs 29.7%, P < .001). Crisaborole-treated patients achieved success in ISGA score and improvement in pruritus earlier than those treated with vehicle (both P ≤ .001). Treatment-related adverse events were infrequent and mild to moderate in severity.

LIMITATIONS

Short study duration was a limitation.

CONCLUSIONS

Crisaborole demonstrated a favorable safety profile and improvement in all measures of efficacy, including overall disease severity, pruritus, and other signs of AD.

Authors+Show Affiliations

Northwestern University, Feinberg School of Medicine, Chicago, Illinois. Electronic address: APaller@nm.org.Rady Children's Hospital-San Diego, San Diego, California; University of California, San Diego, La Jolla, California.Icahn School of Medicine at Mount Sinai, New York, New York.Anacor Pharmaceuticals, Inc, Palo Alto, California.National Jewish Health, Denver, Colorado; University of Colorado School of Medicine, Denver, Colorado.Clinical Research Partners, Richmond, Virginia.Rady Children's Hospital-San Diego, San Diego, California; University of California, San Diego, La Jolla, California.Jordan Valley Dermatology and Research Center, West Jordan, Utah.Pi-Coor Clinical Research, Burke, Virginia.Oregon Health and Science University, Portland, Oregon.Anacor Pharmaceuticals, Inc, Palo Alto, California.Henry Ford Health System, Detroit, Michigan.Pennsylvania State University, Hershey, Pennsylvania.Anacor Pharmaceuticals, Inc, Palo Alto, California.Anacor Pharmaceuticals, Inc, Palo Alto, California.University of Texas Health Science Center Houston, Houston, Texas.

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

27417017

Citation

Paller, Amy S., et al. "Efficacy and Safety of Crisaborole Ointment, a Novel, Nonsteroidal Phosphodiesterase 4 (PDE4) Inhibitor for the Topical Treatment of Atopic Dermatitis (AD) in Children and Adults." Journal of the American Academy of Dermatology, vol. 75, no. 3, 2016, pp. 494-503.e6.
Paller AS, Tom WL, Lebwohl MG, et al. Efficacy and safety of crisaborole ointment, a novel, nonsteroidal phosphodiesterase 4 (PDE4) inhibitor for the topical treatment of atopic dermatitis (AD) in children and adults. J Am Acad Dermatol. 2016;75(3):494-503.e6.
Paller, A. S., Tom, W. L., Lebwohl, M. G., Blumenthal, R. L., Boguniewicz, M., Call, R. S., Eichenfield, L. F., Forsha, D. W., Rees, W. C., Simpson, E. L., Spellman, M. C., Stein Gold, L. F., Zaenglein, A. L., Hughes, M. H., Zane, L. T., & Hebert, A. A. (2016). Efficacy and safety of crisaborole ointment, a novel, nonsteroidal phosphodiesterase 4 (PDE4) inhibitor for the topical treatment of atopic dermatitis (AD) in children and adults. Journal of the American Academy of Dermatology, 75(3), 494-e6. https://doi.org/10.1016/j.jaad.2016.05.046
Paller AS, et al. Efficacy and Safety of Crisaborole Ointment, a Novel, Nonsteroidal Phosphodiesterase 4 (PDE4) Inhibitor for the Topical Treatment of Atopic Dermatitis (AD) in Children and Adults. J Am Acad Dermatol. 2016;75(3):494-503.e6. PubMed PMID: 27417017.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of crisaborole ointment, a novel, nonsteroidal phosphodiesterase 4 (PDE4) inhibitor for the topical treatment of atopic dermatitis (AD) in children and adults. AU - Paller,Amy S, AU - Tom,Wynnis L, AU - Lebwohl,Mark G, AU - Blumenthal,Robin L, AU - Boguniewicz,Mark, AU - Call,Robert S, AU - Eichenfield,Lawrence F, AU - Forsha,Douglass W, AU - Rees,William C, AU - Simpson,Eric L, AU - Spellman,Mary C, AU - Stein Gold,Linda F, AU - Zaenglein,Andrea L, AU - Hughes,Matilda H, AU - Zane,Lee T, AU - Hebert,Adelaide A, Y1 - 2016/07/11/ PY - 2016/04/09/received PY - 2016/05/20/revised PY - 2016/05/31/accepted PY - 2016/7/16/entrez PY - 2016/7/16/pubmed PY - 2017/4/28/medline KW - atopic dermatitis KW - crisaborole ointment KW - eczema KW - phosphodiesterase 4 KW - pruritus KW - topical therapy SP - 494 EP - 503.e6 JF - Journal of the American Academy of Dermatology JO - J. Am. Acad. Dermatol. VL - 75 IS - 3 N2 - BACKGROUND: Additional topical treatments for atopic dermatitis (AD) are needed that provide relief while minimizing risks. OBJECTIVE: We sought to assess the efficacy and safety of crisaborole ointment, a phosphodiesterase 4 inhibitor, in two phase III AD studies (AD-301: NCT02118766; AD-302: NCT02118792). METHODS: Two identically designed, vehicle-controlled, double-blind studies enrolled and randomly assigned (2:1, crisaborole:vehicle) patients aged 2 years or older with an Investigator's Static Global Assessment (ISGA) score of mild or moderate for twice-daily application for 28 days. The primary end point was ISGA score at day 29 of clear (0)/almost clear (1) with 2-grade or greater improvement from baseline. Additional analyses included time to success in ISGA score, percentage of patients achieving clear/almost clear, reduction in severity of AD signs, and time to improvement in pruritus. RESULTS: More crisaborole- than vehicle-treated patients achieved ISGA score success (clear/almost clear with ≥2-grade improvement; AD-301: 32.8% vs 25.4%, P = .038; AD-302: 31.4% vs 18.0%, P < .001), with a greater percentage with clear/almost clear (51.7% vs 40.6%, P = .005; 48.5% vs 29.7%, P < .001). Crisaborole-treated patients achieved success in ISGA score and improvement in pruritus earlier than those treated with vehicle (both P ≤ .001). Treatment-related adverse events were infrequent and mild to moderate in severity. LIMITATIONS: Short study duration was a limitation. CONCLUSIONS: Crisaborole demonstrated a favorable safety profile and improvement in all measures of efficacy, including overall disease severity, pruritus, and other signs of AD. SN - 1097-6787 UR - https://www.unboundmedicine.com/medline/citation/27417017/Efficacy_and_safety_of_crisaborole_ointment_a_novel_nonsteroidal_phosphodiesterase_4__PDE4__inhibitor_for_the_topical_treatment_of_atopic_dermatitis__AD__in_children_and_adults_ DB - PRIME DP - Unbound Medicine ER -