Centocor, Inc. (HORSHAM, Pa.), a wholly owned subsidiary of Johnson & Johnson, announced that the US FDA has approved Remicade® (infliximab) for the treatment of adult patients with chronic severe (ie, extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and for whom other systemic therapies are medically less appropriate. The recommended dose is an infusion of 5 mg/kg followed by additional doses at 2 and 6 weeks after the first infusion and then every 8 weeks thereafter. Data from two multi-center, randomized, double-blind, placebo-controlled trials - EXPRESS and EXPRESS II — served as the primary basis for approval. More than 1200 patients participated in the two phase III clinical trials.

"The approval of Remicade is a much-needed addition for patients living with severe psoriasis," said Gail Zimmerman, President and CEO, National Psoriasis Foundation. Alan Menter, MD, Chairman, Division of Dermatology, Baylor University Medical Center, and lead US study investigator stated, "The approval of Remicade offers dermatologists a treatment option that has been clinically proven to rapidly and dramatically clear the skin of patients with a high disease burden."

The European Infliximab for Psoriasis [Remicade] Efficacy and Safety Study (EXPRESS) was a phase III, multi-center, randomized, double-blind, placebo- controlled trial that evaluated the safety and efficacy of Remicade induction and maintenance therapy in 378 adult patients with chronic, stable plaque psoriasis involving at least 10% body surface area (BSA), a minimum Psoriasis Area Severity Index (PASI) score of 12, and who were candidates for phototherapy or systemic therapy. Beginning at week 24, patients randomized to the placebo group were crossed over to receive Remicade therapy through week 46. In this clinical trial, nearly eight out of 10 patients receiving Remicade 5 mg/kg induction therapy achieved 75% improvement in psoriasis as measured by PASI 75 by week 10% vs 3% of patients receiving placebo (P <.001).

The Evaluation of Infliximab for Psoriasis in a [Remicade] Efficacy and Safety Study II (EXPRESS II) was a phase III, multicenter, randomized, double-blind, placebo-controlled trial that evaluated the safety and efficacy of Remicade in 835 adult patients with chronic, stable plaque psoriasis involving at least 10% BSA, a minimum PASI score of 12, and who were candidates for phototherapy or systemic therapy. Patients were randomized to induction doses of Remicade 3 mg/kg or 5 mg/kg or placebo at weeks 0, 2, and 6. Patients in the active induction treatment groups were randomized again at week 14 to receive either scheduled or "as needed" maintenance treatment at the same dose administered during the induction phase. Patients in the placebo group were crossed over at week 16 to receive Remicade 5 mg/kg at weeks 16, 18, and 22, then every 8 weeks through week 46. At week 10, 75% of patients receiving Remicade 5 mg/kg achieved PASI 75 vs 2% of patients receiving placebo (P <.001). These results were maintained at 6 months by administration every 8 weeks of Remicade 5 mg/kg maintenance infusions. The majority of patients who continued on this regimen achieved PASI 75 at week 50, the last visit in both studies.

In the EXPRESS study, there were more serious adverse events (AEs), including one fatal infection, in the Remicade group compared with placebo group. In the EXPRESS II study, serious AE rates were similar in the Remicade 5 mg/kg and placebo groups. The only clinically significant laboratory abnormalities that occurred more frequently in the Remicade groups compared with the placebo groups were elevated liver enzyme tests. Centocor will expand its
educational programs to help dermatologists and their patients achieve the benefits of Remicade and to help manage and minimize the potential risks of biologic therapies, like Remicade.

It is estimated that 2% of the US population has psoriasis, and about 30% of people with psoriasis have cases that are considered moderate to severe.

"The rapidity and consistency with which Remicade can improve clearance of patients' skin is a major step forward for a patient population where persisting unmet needs in treatment exist," said Alice B. Gottlieb, MD, PhD, dermatologist-in-chief, professor of dermatology, Tufts-New England Medical Center, and pivotal US study investigator.

Remicade is the first and only anti-TNF-α treatment to receive 13 FDA approvals across inflammatory diseases in gastroenterology, rheumatology, and dermatology and has now been used to treat more than 800,000 patients worldwide, more than all other anti-TNF agents combined.

—A. Techman

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