PURPOSE OF THE STUDY:
To assess improvement of mild-to-moderate atopic dermatitis (AD) disease severity and pruritus with the use of crisaborole ointment 2%.
In the study, the researchers included pediatric patients aged ≥2 years with mild-to-moderate AD from 2 phase 3 studies. The severity of AD was determined by Investigator’s Static Global Assessment (ISGA) score.
Patients were randomly assigned 2:1 to receive either crisaborole or vehicle twice daily applied to affected areas (excluding the scalp) for 28 days in 2 identically designed, multicenter, double-blinded, vehicle-controlled phase 3 study. The ISGA outcomes included the number of patients and time to reaching an ISGA score of clear (0) or almost clear (1) with ≥2-grade improvement from the baseline. Moreover, on study days 8, 15, 22, and 29, investigators evaluated the share of patients achieving ISGA clear or almost clear and/or ≥1-grade improvement in ISGA. The Severity of Pruritus Scale (SPS) outcomes included the number of patients who reach SPS success. SPS success was defined as SPS score ≤ 1with ≥ 1-grade improvement from baseline and the time to reach that success. Furthermore, at weeks 1, 2, 3, and 4, the proportion of patients attaining a ≥1-grade improvement in SPS score from the baseline were stratified. An electronic diary was used by patients or caregivers to evaluate SPS twice daily through day 29. If there were <2 SPS assessment entries on day 1 for a patient, they were excluded from the data set.
Of the 1016 patients enrolled, 874 (86%) were pediatric ages 2 to 17 years and included in this post hoc subanalysis. Demographics and baseline disease characteristics were similar between both study arms. Irrespective of the baseline disease severity, a significantly greater proportion of crisaborole-treated patients reached ISGA success on day 8, when compared with vehicle-treated patients. This significant difference continued to be true for those patients with moderate baseline ISGA until day 29. However, after day 8, those with a mild baseline ISGA did not have a significant ISGA difference until day 22. Throughout the study, a significantly larger number of the crisaborole-treated arm reached ISGA clear or almost clear compared with the vehicle-treated arm in both baseline disease severity subgroups. Similarly, in both disease severity groups, crisaborole-treated patients achieved a ≥1-grade improvement in ISGA, compared with that of vehicle-treated patients. SPS outcomes also revealed significant improvement in the crisaborole-treated arm, compared with that of the vehicle-treated arm, on day 8. These SPS outcomes persisted again for the moderate baseline ISGA subgroups through the end of the study. Furthermore, crisaborole-treated patients of both subgroups achieved a ≥1-point SPS score improvement in a significantly shorter median time than vehicle-treated patients did.
Pediatric patients with mild-to-moderate baseline AD saw an improvement in ISGA and SPS outcomes with the use of crisaborole.
With this study, the authors continue to prove crisaborole as a suitable choice as a nonsteroid management option for mild-to-moderate AD. Naturally, independent studies in which researchers comparing crisaborole to corticosteroid standard of care options as well as time to reoccurrence of flares would be of value.