Celgene Corp.'s Otezla met its main goal in a late-stage study in patients with scalp psoriasis, a type of skin disease.
Under the phase 3 trial, Otezla, when administered twice daily, achieved a highly statistically significant improvement in patients with moderate to severe scalp psoriasis at week 16 compared to placebo. The therapy's effect was measured by the Scalp Physician's Global Assessment response score.
Otezla, or apremilast, also significantly eased itching over the whole body for patients under the trial compared to those receiving placebo, as measured by the whole-body itch numeric scale.
The therapy's safety under the 303-patient study, called Style, was generally consistent with Otezla's known safety profile. Side effects from the treatment include diarrhea, nausea, headache and vomiting.
Psoriasis is a chronic and systemic inflammatory disorder which affects 125 million people worldwide.
Otezla is already approved to treat patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
Summit, N.J.-based Celgene is evaluating the drug as a potential treatment of active ulcerative colitis, a chronic, relapsing inflammatory bowel disease, and Behcet's disease, a rare, chronic multisystem inflammatory syndrome.