A second Phase III trial of Schering-Plough and Johnson & Johnson’s Remicade has found that it is effective in the treatment of moderate-to-severe psoriasis, improving symptoms dramatically in up to three quarters of patients.
J&J’s Centocor unit filed to expand the indications of Remicade (infliximab) to include psoriasis in the USA last November, shortly after winning approval of the drug as a second-line treatment in psoriasis from the European medicines Agency (EMEA). The drug is already approved in both territories to treat rheumatoid arthritis, active psoriatic arthritis and Crohn’s disease.
In EXPRESS II, 75% of patients who received the standard 5mg/kg dose of Remicade achieved a PASI 75 response - at least 75% improvement in their psoriasis - after 10 weeks. Just 2% of patients taking a placebo achieved that level of improvement in the trial. In addition, 45% of patients on that dose of Remicade achieved nearly complete skin clearance compared with 1 percent of those on placebo, the company said.
"We now have data showing that the majority of patients receiving scheduled Remicade maintenance therapy achieved long-term clinical response in psoriasis, a lifelong, chronic inflammatory disease," said Alan Menter of Baylor University Medical Center, the lead investigator in the trial.
The results of the EXPRESS II study, reported at the American Academy of dermatology meeting on Friday, back up earlier data from the EXPRESS trial which supported the drug’s approval for psoriasis in Europe.