The FDA has approved Remicade for the treatment of adult patients with chronic severe (i.e. extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate. The recommended dose is an infusion of 5 mg/kg followed by additional doses at two and six weeks after the first infusion and then every eight weeks thereafter. In the Phase III clinical trial EXPRESS, eight out of 10 patients receiving Remicade 5 mg/kg induction therapy achieved 75% improvement in psoriasis as measured by Psoriasis Area Severity Index (PASI 75) by week 10. Similar results were seen with EXPRESS II, the second Phase III study. These results were maintained by every eight-week Remicade 5 mg/kg maintenance infusions at six months. The majority of patients who continued on this regimen achieved PASI 75 at week 50, the last visit in both studies. More than 1200 patients participated in the two Phase III clinical trials.

“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 U.S. study investigator. “As a researcher involved in the clinical investigation of REMICADE for the treatment of psoriasis, I’ve seen first-hand its significant results in improving psoriasis in the majority of patients treated.”

Remicade is the first and only anti-TNF-alpha 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, according to its maker, Centocor, Inc., a Johnson & Johnson subsidiary.