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OPA-15406 effective in treating atopic dermatitis

Patients with atopic dermatitis who used the phosphodiesterase-4 inhibitor OPA-15406 showed clinical improvement in Investigator Global Assessment of Disease Severity, Eczema Area and Severity Index and visual analog scale pruritus scores, according to recent data.

“The [phosphodiesterase-4] inhibitor OPA-15406, applied topically as a 0.3% (wt/wt) or 1% (wt/wt) ointment, provided therapeutic benefit to patients with mild-to-moderate [atopic dermatitis],” Jon M. Hanifin, MD, from the Oregon Health and Science University in Portland, Oregon, and colleagues wrote. “OPA-15406 treatment was also associated with improvements in patient-reported outcomes, notably improvements in [visual analog scale] pruritus scores, with significant treatment effects observed for the 1% formulation relative to vehicle at most time points in the study.”

In a randomized, double-blinded, vehicle-controlled, phase 2 study, Hanafin and colleagues evaluated patients who received OPA-15406 0.3% (n=41), OPA-15406 1% (n=43) or vehicle (n=37) twice per day over a period of 8 weeks. The primary endpoint was a change in Investigator Global Assessment of Disease Severity to 0 or 1 points with a minimum 2-point grade reduction.

The researchers found the OPA-15406 1% group reached the primary endpoint at week 4 compared with the vehicle group (P = .0165) and showed a mean percentage improvement of Eczema Area and Severity Index score from baseline (31.4% vs. 6%; P = .0005) at week 1, with a higher improvement seen at week 2 (39% vs. 3%; P = .0001) that continued for 8 weeks. The visual analog scale for pruritus scores improved in the OPA-15406 1% group with a 36.4% mean change within the first week of treatment (P = .0011).

Among all patients, there was a 51% rate of adverse events, with 9% of patients showing adverse events potentially related to treatment. Twenty-six patients experienced worsening of their atopic dermatitis. Of the five patients with worsening atopic dermatitis potentially related to treatment, none were in the OPA-15406 1% group. – by Jeff Craven

Disclosure: Hanifin reports serving as a consultant for Anacor Pharmaceutical, Dermira, Leo Pharma, and Otsuka Pharmaceuticals and participating in studies for Anacor Pharmaceutical, Chugai Pharmaceutical, Merck and Pfizer. Please see the full study for a list of all other authors’ relevant disclosures.