One-year data from the second double blind, placebo-controlled Phase III study PHOENIX 1 has shown that therapy with ustekinumab given every 12 weeks provided sustained, clinically meaningful improvement in the treatment of moderate to severe plaque psoriasis through one year.
According to findings presented at the Annual Meeting of the American Academy of Dermatology, 87 percent of patients responding to ustekinumab 45 mg maintenance therapy and 91 percent of patients responding to ustekinumab 90 mg maintenance therapy sustained at least a 75 percent improvement in psoriasis through one year, as measured by the Psoriasis Area and Severity Index (PASI 75).
Ustekinumab is a new, 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 are also believed to play a role in immune-mediated inflammatory disorders, including psoriasis.
In December 2007, Centocor Inc announced that a Biologics License Application (BLA) for ustekinumab had been submitted to the US Food and Drug Administration (FDA) and Janssen-Cilag International NV announced its submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMEA).
“These findings show that ustekinumab may control plaque psoriasis with as few as four injections a year,” says lead study investigator Kenneth Gordon, MD, associate professor, Feinberg School of Medicine, Northwestern University, and Head of Dermatology, Evanston Northwestern Healthcare, Skokie, USA.
“We are encouraged by the results seen in clinical trials to date and the hope that ustekinumab may hold for patients and the dermatology community.”
“The Phase III efficacy and safety data for ustekinumab are promising and offer hope to a patient population in need of additional therapeutic options,” says Kim Papp, MD, PhD, Probity Medical Research, Waterloo, Ontario, Canada and lead study investigator.