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New phase 3 data on patients with eczema in China and Japan showed that crisaborole, 2%, was efficacious and safe in patients aged 2 and older, lining up with data from studies done in Western countries.
Crisaborole ointment is safe and well-tolerated in Chinese and Japanese patients with mild-to-moderate atopic dermatitis in the age range of ≥2 years, according to recent findings.1
These findings were the result of research done to examine the limited number of atopic dermatitis treatment options available for pediatric patients, as well as the frequent unfavorable side effect profiles for these few options.2
This new research was conducted to examine emerging options for treatment such as Janus kinase (JAK)-inhibitors, like ruxolitinib, and phosphodiesterase 4 (PDE4) inhibitors such as crisaborole. The research was authored by Jianzhong Zhang, MD, PhD, from Peking University People's Hospital in Beijing.
Zhang and colleagues noted that crisaborole ointment, 2%—a nonsteroidal PDE4 inhibitor—has been approved for mild-to-moderate eczema in several countries following the strong results of the CORE 1 and CORE 2 studies done in the US for patients ≥2 years of age.3
“However, only a low proportion (approximately 5%) of the overall patient population included in these studies were Asian, therefore the efficacy and safety of crisaborole in the Asian AD population is unclear,” Zhang and colleagues wrote. “The objective of the CrisADe CLEAR study was to analyze the efficacy and safety of crisaborole in Chinese and Japanese patients aged ≥2 years with mild-to-moderate AD.”
The investigators conducted a study that was randomized, multicenter, vehicle-controlled phase 3 trial with Japanese and Chinese participants in the age bracket of ≥2 years, with those assessed having cases of mild-to-moderate atopic dermatitis affecting ≥5% treatable body surface area (BSA).
Study participants with reported medical conditions or who had previously participated in crisaborole clinical studies were excluded by the team. During the course of the study, they were assigned 2 to 1 at baseline to be given, for 28 days, either crisaborole or vehicle 2 times-per-day, respectively.
The investigators instructed the participants to apply the study treatment (crisaborole ointment or vehicle) twice daily for 28 total days to cover each lesion and to newly identified atopic dermatitis lesions. Emollients, moisturizers, and sunscreen were permitted by the research team for areas surrounding but not on or overlapping the treatable atopic dermatitis-involved areas.
On day 36 and day 60 following the end of treatment, the investigators conducted their follow-up meetings with patients.
The primary endpoint was determined to be the percentage change from baseline on the Eczema Area and Severity Index (EASI) on day 29, with key secondary endpoints being the achievement of ISGA improvement and success, change from baseline on the Peak Pruritus Numerical Rating Scale (PP-NRS), and improvement and success in ISGA over time.
Safety was assessed through the use of rates of treatment-emergent adverse events (TEAEs) and clinically significant changes in vital signs and clinical laboratory parameters. Efficacy analyses were performed on the full analysis set, and statistical significance was defined as P ≤ 0.05.
The investigators performed efficacy analyses on the set of analyses, which included data on all those who had been randomly assigned to crisaborole or vehicle, regardless of their discontinuation decisions.
Overall, the research team reported that those treated with the study drug demonstrated a substantial reduction in EASI total score at day 29 compared to those in the control arm (P=0.0002). Additionally, those in the crisaborole-treatment group showed higher rates of improvement in ISGA at day 29 compared with those in the control arm (P=0.0124 and P=0.0078, respectively).
The investigators also noted that those in the study drug arm had a substantial decrease in PP-NRS at week 4 compared to those in the control arm (P=0.0009). Additionally, the team noted that there were no identified new safety concerns.
“Because patients from Western countries were not included in this study, these results cannot be directly compared with those from Western populations,” they wrote. “The study duration was not long enough to observe the long-term safety and efficacy of treatment in the Asian population studied.”