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Randomized Controlled Trial
. 2020 Nov;37(6):1030-1037.
doi: 10.1111/pde.14328. Epub 2020 Sep 27.

Improvement in disease severity and pruritus outcomes with crisaborole ointment, 2%, by baseline atopic dermatitis severity in children and adolescents with mild-to-moderate atopic dermatitis

Lawrence F Eichenfield  1 , Gil Yosipovitch  2 , Linda F Stein Gold  3 , Mizuho Kalabis  4 , Chuanbo Zang  4 , Bonnie Vlahos  4 , Paul Sanders  5 , Daniela E Myers  4 , Andrew G Bushmakin  6 , Joseph C Cappelleri  6 , Melissa Olivadoti  4 , Amy S Paller  7
Affiliations
Randomized Controlled Trial

Improvement in disease severity and pruritus outcomes with crisaborole ointment, 2%, by baseline atopic dermatitis severity in children and adolescents with mild-to-moderate atopic dermatitis

Lawrence F Eichenfield et al. Pediatr Dermatol. 2020 Nov.

Abstract

Background/objectives: Crisaborole ointment, 2%, is a nonsteroidal phosphodiesterase 4 inhibitor for the treatment of mild-to-moderate atopic dermatitis (AD). This pooled post hoc analysis of two phase 3 trials (NCT02118766, NCT02118792) assessed improvement and time to improvement in Investigator's Static Global Assessment (ISGA) and Severity of Pruritus Scale (SPS) outcomes in pediatric patients with mild-to-moderate AD.

Methods: Patients aged ≥2 years were randomly assigned 2:1 to receive twice-daily crisaborole or vehicle for 28 days. Patients aged 2-17 years were pooled for this analysis. Proportions of patients and time to achieving ISGA success (clear [0] or almost clear [1] with ≥2-grade improvement from baseline), ISGA clear/almost clear, ≥1-grade improvement in ISGA, SPS success (SPS score ≤1 with ≥1-grade improvement), or ≥1-grade improvement in SPS score were analyzed and stratified by baseline ISGA.

Results: At first postbaseline assessment (day 8), significantly higher proportions of crisaborole- than vehicle-treated patients achieved ISGA success, ISGA clear/almost clear, ≥1-grade ISGA improvement, SPS success, or ≥1-grade improvement in SPS regardless of baseline ISGA. Differences were significantly greater over time for all outcomes for patients with moderate baseline ISGA and numerically greater for those with mild baseline ISGA. Median times to ISGA and SPS outcomes were shorter for crisaborole versus vehicle.

Conclusion: Improvement in ISGA and SPS outcomes were observed with crisaborole in pediatric patients with mild-to-moderate baseline AD.

Keywords: atopic dermatitis; pruritus; therapy-topical.

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Conflict of interest statement

Lawrence F. Eichenfield has been an investigator for Pfizer Inc, AbbVie, Eli Lilly, Galderma, LEO Pharma, Medimetriks, Sanofi‐Regeneron, and Valeant/Ortho Dermatologics and a consultant or participant in a data safety monitoring board for Almirall, Amgen, Asana, Dermavant, Dermira, Eli Lilly, Forte Biosciences, Galderma, LEO Pharma, Matrisys, Novartis, Sanofi‐Regeneron and Valeant/Ortho Dermatologics. Gil Yosipovitch has been a member of scientific advisory boards for Pfizer Inc, Bayer, CeraVe, Eli Lilly, Galderma, Kiniksa, Menlo Therapeutics, Novartis, Sanofi‐Regeneron, Trevi Therapeutics, and Sienna Biopharmaceuticals and a principal investigator for Pfizer Inc, Kiniksa, LEO Pharma, Menlo Therapeutics, Sun Pharmaceutical Industries, and Vanda Pharmaceuticals. Linda F. Stein Gold has received grants from Pfizer Inc, Incyte, and LEO Pharma and has received payment for lectures from Pfizer Inc and LEO Pharma. Mizuho Kalabis and Melissa Olivadoti were employees and stockholders of Pfizer Inc at the time of this analysis. Chuanbo Zang, Bonnie Vlahos, Paul Sanders, Daniela E. Myers, Andrew G. Bushmakin, and Joseph C. Cappelleri are employees and stockholders of Pfizer Inc. Amy S. Paller has been an investigator for AbbVie, AnaptysBio, Eli Lilly, Galderma, Incyte, LEO Pharma, Janssen, Novartis, and Sanofi‐Regeneron and has been a consultant with honoraria for Pfizer Inc, Amgen, Asana BioSciences, Dermavant, Dermira, Galderma, Eli Lilly, Forte Biosciences, LEO Pharma, Menlo Pharmaceuticals, MorphoSys/Galapagos, Novartis, and Sanofi‐Regeneron.

Figures

FIGURE 1
FIGURE 1
Patients achieving ISGA outcomes by baseline disease severity. A, ISGA success.a B, ISGA clear or almost clear. C, ≥1‐grade improvement in ISGA. CI, confidence interval; ISGA, Investigator's Static Global Assessment. aISGA success defined as clear (0) or almost clear (1) with ≥2‐grade improvement from baseline. *P < .05, **P < .0001 compared with vehicle
FIGURE 2
FIGURE 2
Time to achieving ISGA outcomes by baseline disease severity. A, ISGA success.a B, ISGA clear or almost clear. C, ≥1‐grade improvement in ISGA. ISGA, Investigator's Static Global Assessment; NE, not evaluable; NR, not reached. aISGA success defined as clear (0) or almost clear (1) with ≥2‐grade improvement from baseline. b P value from log‐rank test
FIGURE 3
FIGURE 3
Patients achieving SPS outcomes by baseline disease severity. (A) SPS success.a (B) ≥1‐grade improvement in SPS score. CI, confidence interval; ISGA, Investigator's Static Global Assessment; SPS, Severity of Pruritus Scale. aSPS success defined as SPS score ≤ 1 with ≥1‐grade improvement from baseline. *P < .05, **P < .0001 crisaborole compared with vehicle
FIGURE 4
FIGURE 4
Time to achieving SPS outcomes by baseline disease severity. A, SPS success.a B, ≥1‐grade improvement in SPS score. ISGA, Investigator's Static Global Assessment; SPS, Severity of Pruritus Scale. aSPS success defined as SPS score ≤ 1 with ≥ 1‐grade improvement from baseline. b P value from log‐rank test
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