FDA approval of the novel topical ointment Eucrisa (cisaborole) provides patients with an additional option for the treatment of mild to moderate atopic dermatitis, or eczema.
Atopic dermatitis, commonly known as eczema, is a chronic inflammatory skin disease that is characterized by a rash that makes the skin red, scaly, and very itchy. The cause of eczema is unknown, but researchers believe it is a complex disease affected by both genetic and environmental factors. Eczema typically begins in childhood and can last until adulthood. The scratching of affected skin can lead to infections, as well as the thickening and hardening of the skin.
As eczema is a condition that is often long lasting, good skin care, lifestyle changes, and medicine are critical to reduce discomfort and manage the disease. The U.S. FDA has recently approved Pfizer’s novel topical ointment Eucrisa for the treatment of mild to moderate eczema. Eucrisa is a phosphodiesterase 4 inhibitor that reduces inflammatory conditions via a currently unknown mechanism of action.
FDA approval of Eucrisa was based on the successful results of two large, multicenter, Phase 3 clinical trials. Approximately 1500 people with eczema ranging in age from 2 to 79 were treated with Eucrisa or a non-medicated ointment control treatment twice daily for 28 days. Prior to the start of the trials, 38% and 62% of participants had an Investigator’s Static Global Assessment Score (ISGA) of 2 (mild) or 3 (moderate), respectively. The ISGA score enables health care providers to grade the severity of skin conditions and includes the assessment of redness, hardening, and oozing/crusting of the skin.
The results showed that Eucrisa was an effective treatment for eczema compared to control treatment, where 31% of participants saw an improvement in their condition, some within 8 days. The primary measure of success was based on improvement of participant’s skin and ISGA score of 0 (clear) or 1 (almost clear) with at least a two-grade increase. In comparison to the control treatment, 13% patients that received Eucrisa achieved this success in ISGA scores.
The success of the Eucrisa clinical trial and resulting FDA approval represents an alternative treatment option for patients suffering from eczema, a population that has not had a new prescription treatment in 10 years.
Written By: Fiona Wong, PhD