In the phase III clinical trial, eight out of 10 patients receiving Remicade induction therapy achieved 75% improvement in psoriasis by week 10. Similar results were seen in the second phase III study.
“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 Gottlieb, professor of dermatology, Tufts-New England Medical Center.
Psoriasis is an inflammatory disorder characterized by raised, inflamed, red lesions, or plaques, which can cause physical pain and emotional distress. It is estimated that as many as 7.5 million people in the US have psoriasis.
Centocor commented that as a result of the approval it would 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.
Remicade is the first and only anti-TNF-alpha treatment to receive 13 FDA approvals across inflammatory diseases in gastroenterology, rheumatology and dermatology.
Remicade is currently used to treat arthritis and is one of Johnson & Johnsons best selling products.