Johnson & Johnson has been boosted by late-stage data which shows that the firm’s investigational drug ustekinumab demonstrated superior efficacy to Enbrel in treating patients with moderate-to-severe psoriasis.

J&J says that a 903-patient Phase III head-to-head study comparing ustekinumab and Enbrel (etanercept), which is marketed by Wyeth and Amgen, had a primary endpoint of the percentage of participants achieving at least a 75% reduction in psoriasis at week 12. The data was presented at the European Academy of Dermatology and Venereology meeting in Paris.

At week 12, after two subcutaneous injections at weeks 0 and 4, 68% and 74% of patients receiving ustekinumab 45mg or 90mg, respectively, achieved a PASI (Psoriasis Area and Severity Index) 75 compared with 57% for those on Enbrel 50mg subcutaneous injections given twice weekly for 12 weeks. Investigators also reported that patients receiving ustekinumab achieved higher marked improvements in psoriasis as assessed by PASI 90, or nearly complete clearance of the condition

Bruce Strober of the New York University School of Medicine and a trial investigator, said the findings “reinforce the promise of ustekinumab as an infrequently administered and highly effective biologic therapy for the treatment of adults with moderate to severe psoriasis”. He added that currently available biologics have provided great advances in this field “yet unmet needs in treatment remain for patients living with this chronic inflammatory disease.”

The drug, a human monoclonal antibody that targets the cytokines interleukin-12 and -23, was unanimously recommended for approval by the Dermatologic and Ophthalmic Drugs Advisory Committee of the US Food and Drug Administration in June. Last month, the agency extended its review of ustekinumab to December to give it time to study amendments J&J had made to its application, though the firm made it clear that no additional clinical trials have been requested.

If approved, ustekinumab would compete with Enbrel, which dominates the psoriasis market, as well as Abbott Laboratories’ Humira (adalimumab) and J&J’s own Remicade (infliximab). Analysts believe ustekinumab can become a blockbuster, especially given its less-frequent dosing regimen.