One-year data from the second Phase III study of ustekinumab showed sustained, clinically meaningful improvement in the treatment of moderate to severe plaque psoriasis through one year, according to data presented at the annual meeting of the American Academy of Dermatology in San Antonio.

Data from the double blind, placebo-controlled study showed ustekinumab given every 12 weeks resulted in 87 percent of patients responding to 45-mg maintenance therapy, and 91 percent of patients responding to ustekinumab 90-mg maintenance therapy.

Patients in each group sustained at least a 75 percent improvement in psoriasis through one year, as measured by the Psoriasis Area and Severity Index (PASI).

Ustekinumab, being developed by Malvern, Pa.-based Centocor Inc., is a human monoclonal antibody with a novel mechanism of action that targets the cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23), naturally occurring proteins that are important in the body's regulation of immune responses and that also are believed to play a role in immune-mediated inflammatory disorders, including psoriasis.

In the study, called PHOENIX 1, investigators reported findings that showed at week 12, after two doses, 67 percent of patients receiving 45-mg ustekinumab and 66 percent of patients receiving 90-mg ustekinumab achieved PASI 75 (compared with 3 percent of patients receiving placebo; P <0.001 for each comparison vs. placebo).

Also, 42 percent of patients in the 45-mg ustekinumab dosing group and 37 percent of patients in the 90-mg ustekinumab dosing group achieved PASI 90, or nearly complete clearance of psoriasis (vs. 2 percent placebo; P < 0.001).

Centocor announced Monday that the biologics license application submitted in December for ustekinumab (CNTO 1275) has been accepted for review by the FDA.