1 Adverse Reaction Overview The most common adverse drug reactions reported in clinical trials among patients with mild to moderate atopic dermatitis 2 years of age and older have been application site reactions. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
EUCRISATM (Crisaborole Ointment) Page 7 of 21 In two randomized, double-blind, parallel-group, vehicle-controlled Phase 3 clinical trials (Studies AN2728-AD-301 and AN2728-AD-302), 1012 patients 2 to 79 years of age with mild to moderate atopic dermatitis were treated with EUCRISA twice daily for 4 weeks.
The adverse reaction reported by ≥1% of EUCRISA-treated patients is listed in Table 2. 20%) a Refers to skin sensations such as burning or stinging. In one double-blind, vehicle-controlled, maintenance trial (C3291035), 497 subjects 5 months to 79 years of age with mild to moderate atopic dermatitis entered into an open-label period and were first treated with EUCRISA twice daily for up to 8 weeks.
The adverse reactions observed in the open-label period were consistent with the known safety profile of twice daily EUCRISA. During the double-blind maintenance period, 135 subjects out of 270 randomized subjects were treated with EUCRISA and 135 subjects received vehicle once daily for 52 weeks or until they developed a flare.
The adverse reactions observed with once daily EUCRISA treatment were similar to vehicle. 1 Clinical Trial Adverse Reactions – Pediatrics In a multicenter, open-label, uncontrolled trial, 137 pediatric subjects aged 3 months to less than 2 years were treated with EUCRISA twice daily for 4 weeks.
Overall, the safety profile of EUCRISA in this age group was consistent with that of Studies AN2728-AD-301 and AN2728-AD-302 in subjects 2 years of age and older. Use of EUCRISA twice daily in pediatric patients aged 3 months to 17 years is further supported by data from the open-label period of up to 8 weeks in C3291035, a vehicle-controlled maintenance trial in 327 pediatric subjects.
Once daily use of EUCRISA in 82 pediatric subjects 3 months to 17 years is supported by data from the 52-week double-blind maintenance period of C3291035. No new safety concerns were identified in C3291035 in pediatric subjects. 3 Less Common Clinical Trial Adverse Reactions The following adverse reactions were observed in <1% of patients treated with EUCRISA.
General disorders and administration site conditions: application site reactions (including contact dermatitis and pruritus) Skin and subcutaneous tissue disorders: flare of atopic dermatitis. EUCRISATM (Crisaborole Ointment) Page 8 of 21 In an open-label, single arm, long-term safety study, 517 patients 2 to 72 years of age (including 454 patients 2 to 17 years of age), who had completed one of the Phase 3 studies without safety issues that precluded further treatment, were treated with EUCRISA twice daily intermittently for up to 48 weeks in 28 day on-treatment or off-treatment cycles.
A total of 9 (2%) patients discontinued the therapy due to adverse events. The most frequently reported adverse events included atopic dermatitis, application site pain, and application site infection. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Results for clinical laboratory testing have not identified clinically important changes from baseline to the end of study in mean or median values for any hematology or biochemistry parameters in any of the clinical studies in patients with atopic dermatitis.
5 Post-Market Adverse Reactions The following adverse reactions have been identified during post-approval use of EUCRISA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Application site reactions