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Comorbidity does not influence crisaborole efficacy in atopic dermatitis

AAD VMX 2021
Phase 3, CrisADe CORE 1 and 2
A post-hoc analysis has demonstrated that topical treatment of atopic dermatitis with crisaborole is successful irrespective of a previous medical history with asthma or allergies.

As patients with atopic dermatitis (AD) are prone to comorbidities such as asthma, food allergies, and allergic rhinitis, the question was raised whether safety and efficacy of crisaborole ointment differs according to the presence of those comorbidities [1,2]. Hence, a post-hoc analysis of 2 randomised, double blind, vehicle-controlled trials with identical design was performed to clarify whether the phosphodiesterase-4-inhibitor ointment treatment led to different results in patients with or without allergic asthma or allergies (A/A) [2].

The phase 3 studies CrisADe CORE 1 (NCT02118766) and CrisADe CORE 2 (NCT02118792) included >1,500 patients aged ≥2 years with mild-to-moderate AD. Mean age within the crisaborole and vehicle groups ranged from 12.1 to 12.4 years. Of patients with a history of A/A, moderate disease according to Investigator’s Static Global Assessment (ISGA) was present in 66.1% (vehicle) versus 63.6% (crisaborole) and in 55.5% versus 58.2%, respectively. In the group with A/A, the rate of patients with a moderate as opposed to severe status according to the Severity of Pruritus Scale (SPS) was 33.2% and 32.3% (moderate) versus 28.3 and 31.3 (severe), respectively.

Results were obtained in the crisaborole and vehicle groups for ISGA clear or almost clear, SPS improvement, and ISGA success, defined as clear or almost clear (0/1) at day 29 with a ≥2-grade improvement from baseline. For the new analysis, these parameters were stratified according to the presence of a history of A/A. All comparisons demonstrated statistical significance in favour of the crisaborole treatment, independent of the atopic comorbidity status. ISGA success was achieved by 29.4% of patients with A/A (P=0.003 vs vehicle) and 35.8% in those without A/A (P=0.006 vs vehicle). ISGA of 0/1 was attained by 52.4% (P=0.01 vs vehicle) in the non-A/A group and by 48.4% (P<0.0001 vs vehicle) in the A/A group. Furthermore, improvement of pruritus was highly significant irrespective of A/A presence (see Figure).

Figure: Significant improvement in AD severity and pruritus with crisaborole independent of atopic comorbidity [2]

CI, confidence interval; ISGA, Investigator’s Static Global Assessment; PMH, past medical history.

The most common treatment-emergent adverse event was pain at the application site, occurring in 5.1% in the A/A cohort and in 3.5% of the non-A/A cohort in patients on crisaborole versus 1.7% and 0.5% in the corresponding vehicle groups. Of note, 6 patients of the A/A group suffered from serious adverse events that were deemed unrelated to treatment and 9 patients in the same group had an exacerbation of their asthma.

The authors concluded that crisaborole is safe and efficacious in AD management, regardless of comorbidity with A/A.

  1. Dharmage SC, et al. 2014;69(1):17-27.
  2. Lio PA, et al. Efficacy and safety of crisaborole in patients with mild-to-moderate atopic dermatitis with and without comorbid allergies or asthma. Poster 26304, AAD VMX 2021, 23-25 April.

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