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

doi:10.1016/j.jaad.2016.05.046

Cited by 463 publications

(387 citation statements)

References 36 publications

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“…Time to success in the ISGA score was significantly shorter in the crisaborole-treated group than in those treated with vehicle. Lastly, the individual score tool (signs of AD scale) revealed a significant reduction in the severity of AD signs, and the twice-daily pruritus severity scoring showed a swift (significant after 8 days) and sustainable improvement in pruritus [60]. However, to summarize the bulk of data on topically administered crisaborole, the difference of approximately 10% in both the ISGA success rate and the improvement score of pruritus between crisaboroleand placebo-treated subjects is modest, and the minimal clinically important difference (MCID) was not defined for the reported outcome measure.…”

Section: Crisaborolementioning

confidence: 93%

“…Therefore, these conclusions on efficacy should be cautiously interpreted. In contrast, the two phase III trials completed in 2015 were published in late 2016 and evaluated in parallel [60]. The 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.…”

Section: Crisaborolementioning

confidence: 99%

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Emerging Treatment Options in Atopic Dermatitis: Topical Therapies

Nygaard

Deleuran

Vestergaard³

2017

Dermatology

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Atopic dermatitis is a chronic inflammatory skin disorder affecting children and adults, with the majority presenting mild to moderate disease severity. The use of topical corticosteroids (TCSs) in combination with emollients has been the mainstay for treating mild to moderate atopic dermatitis since the 1950s, and as a supplement to systemic treatment in severe disease. However, while very effective, TCSs are often accompanied by poor adherence due to corticophobia (fear of using corticosteroids in patients or doctors), unwanted side effects, and in some cases insufficient clinical response. Topical calcineurin inhibitors (TCIs) are able to inhibit the activation of T-lymphocytes and thereby diminish inflammation. In some patients the use of TCIs has been limited due to a localized burning sensation on the first days of treatment, and also due to fear of other adverse effects. Consequently, there has been a need for the development of new topical products for atopic dermatitis. Novel topical therapies are in the pipeline and comprise both new doses and formulations of well-known pharmaceutical molecules and novel approaches targeting unique inflammatory pathways and mechanisms of disease, with a promise of higher efficacy and less harmful side effects. We review topical drugs in the pipeline for atopic dermatitis, and focus on those available in the clinicaltrials.gov database with a first received date from January 1, 2014 to May 31, 2017.

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Section: Crisaborolementioning

confidence: 93%

Section: Crisaborolementioning

confidence: 99%

Emerging Treatment Options in Atopic Dermatitis: Topical Therapies

Nygaard

Deleuran

Vestergaard³

2017

Dermatology

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“…In 2 identically designed studies, more crisaborole- than vehicle-treated patients achieved investigator’s static global assessment (ISGA) success (clear/almost clear with ≥2-grade improvement) [159]. …”

Section: Therapeutic Management Of Admentioning

confidence: 99%

Atopic Dermatitis: Collegium Internationale Allergologicum (CIA) Update 2019

Simon

Wollenberg

Renz

et al. 2019

Int Arch Allergy Immunol

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Atopic dermatitis (AD) is a chronic inflammatory skin disease presenting with recurrent eczematous lesions and intense pruritus. It is common and affects both children and adults, often beginning in infancy. Due to the unpredictable disease course, its visible skin lesions, itching and scratching followed by sleeplessness, other associated atopic diseases, and behavioral and psychiatric disorders, AD is an immense burden for patients and caregivers. AD is determined by a genetic predisposition characterized by an impaired skin barrier and a T-helper-2-predominant inflammation. Restoration of the skin barrier is the main approach for treating and preventing AD. In order to cope with acute flares, usually topical corticosteroids (TCS) are applied, while topical calcineurin inhibitors (TCI) are used mainly for maintenance therapy. There is a small group of patients who are refractory to TCS and TCI and require systemic immunosuppressive drugs such as ciclosporin. Novel, targeted therapies are under clinical investigation, among which an anti-IL-4/IL-13 receptor antibody has recently been approved in several countries. As we learn to understand the pathomechanisms of AD, the characteristics of the different patient subgroups, and the effectiveness of various targeted therapies, a personalized treatment ensuring the best efficacy and safety and, probably, a disease-modifying effect will result.

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“…2 The study populations (n=759 in AD-301 and n=763 in AD-302) included patients 2 years of age and older, with an average age of 12 years across both studies (range, 2-80 years). About one-third of the enrolled patients had mild AD and the rest had moderate disease, based on an Investigator's Static Global Assessment (ISGA) score.…”

Section: Crisaborolementioning

confidence: 99%