Phase 3 infliximab psoriasis data positive at one year

Results from one-year of follow-up in a phase 3 trial investigating infliximab (Remicade, Centocor) for the treatment of moderate to severe psoriasis demonstrate that the dramatic responses achieved rapidly after induction therapy are sustained with maintenance therapy in the majority of patients and without the emergence of new safety concerns, reported Alan Menter, M.D., at Academy '06.

Known as the Evaluation of InfliXimab for Psoriasis (Remicade) Efficacy and Safety Study II (EXPRESS II), the randomized, double-blind phase 3 trial entered 835 patients at 63 centers across the United States, Canada and Europe. Participants were assigned to receive placebo or infliximab 3 mg/kg or 5 mg/kg administered in an induction regimen of three infusions at weeks zero, two and six. At week 14, patients in the infliximab groups were re-randomized to receive maintenance treatment with their original dose of infliximab either on a scheduled basis (every eight weeks) or "as needed." Placebo patients were crossed over at week 16 to receive infliximab 5 mg/kg (induction followed by scheduled maintenance).

At week 10, rates of PASI-75 responders in the placebo and infliximab 3 mg/kg and 5 mg/kg groups were 2 percent, 70 percent and 75 percent, respectively. By week 50, the response endured in about three-fourths of the infliximab patients; the 5 mg/kg scheduled maintenance regimen offered the best results.

Rates of serious adverse events in the infliximab 3 mg/kg, 5 mg/kg and placebo groups were 1 percent, 3 percent and 2 percent, respectively. Laboratory abnormalities were generally uncommon. Significant elevations in alanine aminotransferase were noted in approximately 5 percent of patients through week 50.

"Psoriasis is a lifelong disease and requires control with safe and effective long-term therapy. Results from EXPRESS II together with the previously published outcomes from EXPRESS provide at least one-year data to show infliximab monotherapy achieves that goal in the majority of patients with moderate to severe psoriasis," says Dr. Menter, lead investigator and chairman of dermatology, Baylor University Medical Center, Dallas.

Results of the European InfliXimab for Psoriasis (Remicade) Efficacy and Safety Study (EXPRESS) were published in Lancet in 2005. The results of EXPRESS II will appear in a paper to be published in an upcoming issue of the Journal of the American Academy of Dermatology.

Dr. Menter is a consultant to Centocor as well as all other companies with biologic treatments for psoriasis.

EDITOR'S NOTE: Dermatology Times will include a Psoriasis Supplement with its September print issue.