Phase 2, 3 trials show Centocor's Remicade improves symptoms for psoriatic arthritis patients

By E. Janene Geiss

Philadelphia, Nov. 16 - Centocor announced Wednesday that new phase 2 and phase 3 data, including two-year treatment duration, show a significantly higher proportion of patients with active psoriatic arthritis receiving Remicade achieved and sustained a high degree of clinical improvement in arthritis, according to a company news release.

Patients were assessed using the rheumatoid arthritis definition for "major clinical response," compared with patients receiving placebo. Major clinical response is defined as maintenance of a 70 percent improvement in the American College of Rheumatology score for six continuous months.

Remicade maintenance therapy also resulted in the inhibition of structural damage and significant improvements in functional status and quality of life as maintained over the course of one year, officials said.

Remicade (infliximab) currently is indicated for reducing signs and symptoms of active arthritis in patients with psoriatic arthritis.

"Previous study findings have shown the rapidity and therapeutic intensity of infliximab in treating the joint and skin manifestations associated with active psoriatic arthritis," said Arthur Kavanaugh, director of the Center for Innovative Therapy, Division of Rheumatology, Allergy and Immunology, University of California, San Diego, and lead study investigator, in the statement.

"These data demonstrate the rapid efficacy of infliximab can be sustained over time, especially as it relates to the arthritic component of this complex disease," he added.

In the two double-blind, placebo-controlled trials, patients were followed for two years and one year and confirmed a significant, high degree of clinical responses in the arthritic component of the disease. Placebo patients in both studies crossed over to active treatment by week 16 in one study and week 24 in the other. In the first study, 35% of all randomized patients (including patients originally randomized to Remicade and placebo) entering the second year (27 out of 78) achieved an ACR 70 improvement at week 98. In the second study, 20% of Remicade randomized patients (20 out of 100) achieved this high degree of improvement at week 54, officials said.

The data will be presented this week at the American College of Rheumatology's annual scientific meeting.

Horsham, Pa.-based biotechnology company Centocor, Inc. is a wholly owned subsidiary of Johnson & Johnson, a worldwide manufacturer of health care products.

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