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

Amy S. Paller, Wynnis L. Tom, Mark G. Lebwohl, Robin L. Blumenthal, Mark Boguniewicz, Robert S. Call, Lawrence F. Eichenfield, Douglass W. Forsha, William C. Rees, Eric Simpson, Mary C. Spellman, Linda F. Stein Gold, Andrea L. Zaenglein, Matilda H. Hughes, Lee T. Zane, Adelaide A. Hebert

Research output: Contribution to journalArticle

175 Citations (Scopus)

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.

Original languageEnglish (US)
JournalJournal of the American Academy of Dermatology
DOIs
StateAccepted/In press - 2016

Fingerprint

Phosphodiesterase 4 Inhibitors
Atopic Dermatitis
Ointments
Safety
Research Personnel
Pruritus
Therapeutics
AN2728
Double-Blind Method

Keywords

  • Atopic dermatitis
  • Crisaborole ointment
  • Eczema
  • Phosphodiesterase 4
  • Pruritus
  • Topical therapy

ASJC Scopus subject areas

  • Dermatology

Cite this

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. / Paller, Amy S.; Tom, Wynnis L.; Lebwohl, Mark G.; Blumenthal, Robin L.; Boguniewicz, Mark; Call, Robert S.; Eichenfield, Lawrence F.; Forsha, Douglass W.; Rees, William C.; Simpson, Eric; Spellman, Mary C.; Stein Gold, Linda F.; Zaenglein, Andrea L.; Hughes, Matilda H.; Zane, Lee T.; Hebert, Adelaide A.

In: Journal of the American Academy of Dermatology, 2016.

Research output: Contribution to journalArticle

Paller, AS, Tom, WL, Lebwohl, MG, Blumenthal, RL, Boguniewicz, M, Call, RS, Eichenfield, LF, Forsha, DW, Rees, WC, Simpson, E, Spellman, MC, Stein Gold, LF, Zaenglein, AL, Hughes, MH, Zane, LT & Hebert, AA 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. https://doi.org/10.1016/j.jaad.2016.05.046
Paller, Amy S. ; Tom, Wynnis L. ; Lebwohl, Mark G. ; Blumenthal, Robin L. ; Boguniewicz, Mark ; Call, Robert S. ; Eichenfield, Lawrence F. ; Forsha, Douglass W. ; Rees, William C. ; Simpson, Eric ; Spellman, Mary C. ; Stein Gold, Linda F. ; Zaenglein, Andrea L. ; Hughes, Matilda H. ; Zane, Lee T. ; Hebert, Adelaide A. / 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. In: Journal of the American Academy of Dermatology. 2016.
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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.",
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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

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.

PY - 2016

Y1 - 2016

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.

AB - 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.

KW - Atopic dermatitis

KW - Crisaborole ointment

KW - Eczema

KW - Phosphodiesterase 4

KW - Pruritus

KW - Topical therapy

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