Crisaborole once-daily (QD) ointment is effective and well tolerated for long-term maintenance treatment and flare reduction in adult and pediatric patients with mild-to-moderate atopic dermatitis (AD), according to study findings published in American Journal of Clinical Dermatology.
Researchers conducted a randomized, double-blind, 52-week, phase 3 CrisADe CONTROL study which enrolled patients aged 3 months and older with mild-to-moderate AD involving a percentage of treatable body surface area of at least 5.
The participants received crisaborole twice daily (BID) in the open-label run-in period for a maximum of 8 weeks. Those who responded during the run-in period were randomly assigned to the double-blind maintenance period in a 1:1 ratio to receive crisaborole QD or vehicle QD for 52 weeks. Postrandomization follow-up was performed every 4 weeks during the 52-week double-blind maintenance period.
The participants who met the criteria for having a flare (Investigator’s Static Global Assessment [ISGA] ≥2) were switched to begin a flare treatment period, when they received open-label crisaborole BID for up to 12 weeks per flare. If a flare resolved, (ISGA ≤1), the patient was switched back to the original maintenance treatment.
Researchers conducted a randomized, double-blind, 52-week, phase 3 CrisADe CONTROL study which enrolled patients aged 3 months and older with mild-to-moderate AD involving a percentage of treatable body surface area of at least 5.
The participants received crisaborole twice daily (BID) in the open-label run-in period for a maximum of 8 weeks. Those who responded during the run-in period were randomly assigned to the double-blind maintenance period in a 1:1 ratio to receive crisaborole QD or vehicle QD for 52 weeks. Postrandomization follow-up was performed every 4 weeks during the 52-week double-blind maintenance period.
The participants who met the criteria for having a flare (Investigator’s Static Global Assessment [ISGA] ≥2) were switched to begin a flare treatment period, when they received open-label crisaborole BID for up to 12 weeks per flare. If a flare resolved, (ISGA ≤1), the patient was switched back to the original maintenance treatment.
A total of 497 participants (mean [SD] age, 19.9 [18.4] years; 57% women) were included in the open-label run-in period, of whom 270 were enrolled in the 52-week double-blind maintenance period. There were 135 participants assigned to the crisaborole group and 135 assigned to the vehicle group.
The median Kaplan-Meier estimate of flare-free maintenance was significantly longer for use of crisaborole compared with vehicle (111 days; 95% CI, 56-224 vs 30 days; 95% CI, 28-56, respectively; P =.0034). The participants who received crisaborole had a longer duration of flare-free maintenance vs those treated with vehicle when the analysis was stratified according to age group, race (except the group categorized as “other”), ethnicity, ISGA score at randomization, and duration of open-label run-in treatment.
The participants who were treated with crisaborole had a significantly greater mean number of flare-free days vs those who received vehicle (234.0 days vs 199.4 days, respectively; P =.0346), with a difference of 34.6 days (95% CI, 2.53-66.64).
The mean number of flares was significantly lower for patients who received crisaborole compared with vehicle (0.95 vs 1.36, respectively; P =.0042). An increased proportion of patients having no flares was observed in the crisaborole-treated group (44 [35.2%]) compared with the vehicle-treated group (33 [25.6%]).
No clear trend was observed regarding the maintenance of pruritus response until onset of the first flare between crisaborole- and vehicle-treated patients.
In the 52-week double-blind maintenance period, 36 participants (26.7%) who received crisaborole QD and 49 participants (36.3%) who received vehicle QD had all-causality treatment-emergent adverse events (TEAEs). A total of 2 (1.5%) and 4 participants (3.0%) reported treatment-related adverse events in the crisaborole and vehicle groups, respectively. In the flare period, 37 participants (22.2%) had TEAEs. The most common TEAEs (occurring in ≥2% of participants) were AD (4 patients [2.4%]) and application site infection (4 participants [2.4%]).
Among several study limitations, the population aged 3 to 24 months was small, and only a crisaborole QD maintenance regimen was used. Also, there was no comparison of crisaborole with other first-line treatment options for AD.
“Crisaborole ointment, 2%, QD represents a potential long-term maintenance treatment option in pediatric (aged ≥3 months) and adult patients with mild-to-moderate AD who previously responded to crisaborole BID,” concluded the researchers.
References:
Eichenfield LF, Gower RG, Xu J, et al. Once‑daily crisaborole ointment, 2%, as a long‑term maintenance treatment in patients aged ≥ 3 months with mild‑to‑moderate atopic dermatitis: a 52‑week clinical study. Am J Clin Dermatol. Published online May 15, 2023. doi:10.1007/s40257-023-00780-w
