Eucrisa Label Updated With Long-Term, Once-Daily Dosing Data for Atopic Dermatitis

The prescribing information for Eucrisa^® (crisaborole) ointment has been updated to include data related to long-term, once daily dosing of the product.

Eucrisa, a phosphodiesterase 4 inhibitor, is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 3 months of age and older. The ointment is applied twice daily to affected areas. Once clinical effect is achieved, reducing application of the product to once daily administration may now be considered, according to the updated labeling.

This dosing update was supported by data from the phase 3 CrisADe CONTROL trial (ClinicalTrials.gov Identifier: NCT04040192), which evaluated long-term maintenance treatment with once-daily crisaborole ointment in patients 3 months of age and older who previously responded to twice-daily treatment (defined as an Investigator’s Static Global Assessment [ISGA] grade of clear [0] or almost clear [1] with a ≥2-grade improvement from baseline and ≥50% reduction from baseline on the Eczema Area and Severity Index) in an open-label run-in period.

Study participants were randomly assigned 1:1 into a double-blind period to receive crisaborole ointment once daily (n=135) or vehicle (n=135) for 52 weeks or until they developed a flare. The primary efficacy endpoint was the duration of flare-free maintenance (from randomization to first flare or last ISGA assessment). The primary safety assessment was the number of participants with treatment-emergent adverse events.

Results showed that the median time of flare-free maintenance was 111 days for patients treated with crisaborole and 30 days for patients who received vehicle (P =.0034). Findings also showed crisaborole-treated patients had more flare-free days (234.0 vs. 199.4, respectively; P =.0346) and fewer flares (0.95 vs. 1.36, respectively; P =.0042) than patients in the vehicle arm. Treatment with crisaborole was reported to be well tolerated with no new safety signals observed over the 52-week period.

Eucrisa is supplied as an ointment containing 20mg of crisaborole per gram in a 60g and 100g tube.