Positive Phase III STYLE study results for Otezla to treat scalp psoriasis.- Celgene

Celgene Corporation has announced results from the phase III STYLE study, which showed that Otezla (apremilast) 30 mg twice daily achieved a highly statistically significant improvement in the primary endpoint of the Scalp Physician�s Global Assessment (ScPGA) response [defined as ScPGA score of clear (0) or almost clear with at least a 2-point reduction from baseline] at week 16 compared with placebo.

In addition to achieving the primary endpoint, statistical significance was also met for the secondary endpoint of the whole body itch numeric rating scale (NRS) [defined as at least a 4-point reduction from baseline] at week 16 with Otezla versus placebo. The safety profile was generally consistent with the known safety profile of Otezla ,and no new safety signals were identified in the trial. Treatment-emergent adverse events that occurred in at least 5 percent of patients in either treatment group were diarrhea (30.5 percent for OTEZLA and 10.8 percent for placebo), nausea (21.5 percent and 5.9 percent, respectively), headache (11.5 percent and 4.9 percent) and vomiting (5.5 percent and 2.0 percent).

�The scalp is the most commonly affected area in moderate to severe plaque psoriasis, impacting up to 80 percent of patients,� said Terrie Curran, President, Celgene Inflammation and Immunology. �The area is difficult to treat with topical therapies, and clinical data from systemic therapies are limited. We are encouraged by the significant improvements in this trial and look forward to sharing these data to further enhance the Otezla label.�