In the Journals

Eucrisa demonstrated safety in atopic dermatitis

Lawrence Eichenfield
Lawrence F. Eichenfield

Encouraging safety outcomes were reported in a cohort of patients with atopic dermatitis who were treated with long-term Eucrisa.

“Crisaborole is a ‘first-in-class’ medication, offering a new approach to treating inflammatory eczema,” study author Lawrence F. Eichenfield, MD, chief of pediatric and adolescent dermatology, professor of dermatology and pediatrics, and vice chair in the department of dermatology at the University of California San Diego School of Medicine, told Healio. “Not a topical corticosteroid or calcineurin inhibitor, it was important to see how crisaborole worked in longer-term regimens of care beyond the 4-week course of the phase 3 trial.”

The multicenter, open-label, 48-week included 517 patients with mild-to-moderate disease who underwent analysis for treatment-emergent and serious adverse events. Eligible participants had completed two pivotal phase 3 studies in which they were treated with the topical phosphodiesterase-4 inhibitor, Eucrisa (crisaborole, Anacor Pharmaceuticals), for 28 weeks.

The investigators evaluated patients every 4 weeks during treatment, which was applied twice daily.

Results indicated that 65% of the cohort experienced at least one treatment-emergent event in the pivotal phase 3 studies and the current study. Mild treatment-emergent events comprised 51.2% of this incidence, whereas 44.6% of patients experienced moderate events. The majority of these events (93.1%) were deemed to be unrelated to the study drug.

Clinicians observed consistency in the treatment-emergent event profile, with 10.2% of patients experiencing events that were related to treatment. Of these treatment-related events, dermatitis atopic occurred in 3.1% of patients, while 2.3% experienced application-site pain, and 1.2% experienced application site infections. The majority of the dermatitis atopic and infections were resolved quickly. Similarly, most patients who required rescue therapy eventually returned to treatment with crisaborole.

“While efficacy was not formally assessed, the safety data were quite reassuring for patients, families and health care practitioners,” Eichenfield said. “The drug appeared to be generally well-tolerated, other than some local stinging and burning at low rates, without signs of immunosuppression, systemic effects, effects of laboratory work, and, as expected, no atrophy.”

The discontinuation rate due to treatment-emergent events was 1.7%.

Patients did not experience an increase in treatment-related adverse effects over time, according to the results. The researchers did not observe cutaneous reactions at the application site.

Crisaborole was used primarily as monotherapy, according to the investigators.

“Crisaborole is approved for mild to moderate atopic dermatitis, without a limitation of time of usage, and without a specific ‘second-line’ classification label,” Eichenfield said. “Having a large number of children, adolescents and adults who were treated with crisaborole for 6 months to 1 year, either continuously or for multiple months, and doing so with signs of drug safety, allows us to consider utilizing the drug for both flared eczema and in longer-term disease control regimens.” – by Rob Volansky

Disclosures: The authors report that the institutes of Eichenfield, Call, Forsha, Hebert, Stein Gold, and Tschen received research funding from Anacor Pharmaceuticals Inc. Please see the full study for a list of all relevant financial disclosures.

Lawrence Eichenfield
Lawrence F. Eichenfield

Encouraging safety outcomes were reported in a cohort of patients with atopic dermatitis who were treated with long-term Eucrisa.

“Crisaborole is a ‘first-in-class’ medication, offering a new approach to treating inflammatory eczema,” study author Lawrence F. Eichenfield, MD, chief of pediatric and adolescent dermatology, professor of dermatology and pediatrics, and vice chair in the department of dermatology at the University of California San Diego School of Medicine, told Healio. “Not a topical corticosteroid or calcineurin inhibitor, it was important to see how crisaborole worked in longer-term regimens of care beyond the 4-week course of the phase 3 trial.”

The multicenter, open-label, 48-week included 517 patients with mild-to-moderate disease who underwent analysis for treatment-emergent and serious adverse events. Eligible participants had completed two pivotal phase 3 studies in which they were treated with the topical phosphodiesterase-4 inhibitor, Eucrisa (crisaborole, Anacor Pharmaceuticals), for 28 weeks.

The investigators evaluated patients every 4 weeks during treatment, which was applied twice daily.

Results indicated that 65% of the cohort experienced at least one treatment-emergent event in the pivotal phase 3 studies and the current study. Mild treatment-emergent events comprised 51.2% of this incidence, whereas 44.6% of patients experienced moderate events. The majority of these events (93.1%) were deemed to be unrelated to the study drug.

Clinicians observed consistency in the treatment-emergent event profile, with 10.2% of patients experiencing events that were related to treatment. Of these treatment-related events, dermatitis atopic occurred in 3.1% of patients, while 2.3% experienced application-site pain, and 1.2% experienced application site infections. The majority of the dermatitis atopic and infections were resolved quickly. Similarly, most patients who required rescue therapy eventually returned to treatment with crisaborole.

“While efficacy was not formally assessed, the safety data were quite reassuring for patients, families and health care practitioners,” Eichenfield said. “The drug appeared to be generally well-tolerated, other than some local stinging and burning at low rates, without signs of immunosuppression, systemic effects, effects of laboratory work, and, as expected, no atrophy.”

The discontinuation rate due to treatment-emergent events was 1.7%.

Patients did not experience an increase in treatment-related adverse effects over time, according to the results. The researchers did not observe cutaneous reactions at the application site.

Crisaborole was used primarily as monotherapy, according to the investigators.

“Crisaborole is approved for mild to moderate atopic dermatitis, without a limitation of time of usage, and without a specific ‘second-line’ classification label,” Eichenfield said. “Having a large number of children, adolescents and adults who were treated with crisaborole for 6 months to 1 year, either continuously or for multiple months, and doing so with signs of drug safety, allows us to consider utilizing the drug for both flared eczema and in longer-term disease control regimens.” – by Rob Volansky

Disclosures: The authors report that the institutes of Eichenfield, Call, Forsha, Hebert, Stein Gold, and Tschen received research funding from Anacor Pharmaceuticals Inc. Please see the full study for a list of all relevant financial disclosures.