Approval Status: Approved December 2016
Specific Treatments: atopic dermatitis
Therapeutic Areas Dermatology
Eucrisa (crisaborole) is a phosphodiesterase 4 inhibitor.
Eucrisa is specifically indicated for the topical treatment of mild to moderate atopic dermatitis in patients 2 years of age and older.
Eucrisa is supplied as an ointment for topical administration. A thin layer of Eucrisa should be applied twice daily to affected areas.
The FDA approval of Eucrisa was based on two multicenter, randomized, double-blind, parallel-group, vehicle-controlled trials (Trials 1 and 2) in a total of 1,522 subjects 2 to 79 years of age (86.3% of subjects were 2 to 17 years of age) with a 5% to 95% treatable body surface area. At baseline, 38.5% of the subjects had an Investigator’s Static Global Assessment [ISGA] score of 2 (mild), and 61.5% had an ISGA score of 3 (moderate), in the overall assessment of atopic dermatitis (erythema, induration/papulation, and oozing/crusting) on a severity scale of 0 to 4. In both trials, subjects were randomized 2:1 to receive Eucrisa or vehicle applied twice daily for 28 days. The primary efficacy endpoint was the proportion of subjects at Day 29 who achieved success, defined as an ISGA grade of Clear (score of 0) or Almost Clear (score of 1) with a 2-grade or greater improvement from baseline, comparing Eucrisa-treated subjects to vehicle-treated subjects. In Trial 1, 32.8% of subjects achieved the primary endpoint compared to 25.4% in the vehicle group. Trial 2, 31.4% of subjects achieved the primary endpoint compared to 18% in the vehicle group.
Adverse effects associated with the use of Eucrisa may include, but are not limited to, the following:
- application site pain
Mechanism of Action
Eucrisa (crisaborole) is a phosphodiesterase 4 inhibitor. PDE-4 inhibition results in increased intracellular cyclic adenosine monophosphate (cAMP) levels. The specific mechanism(s) by which crisaborole exerts its therapeutic action for the treatment of atopic dermatitis is not well defined.
For additional information regarding Eucrisa or atopic dermatitis, please visit http://labeling.pfizer.com/ShowLabeling.aspx?id=5331