Remicade shows improvement in both the arthritis and psoriasis associated with psoriatic arthritis

Data released from a phase III trial with REMICADE(R) (infliximab) showed improvement in both the arthritis and psoriasis associated with psoriatic arthritis (PsA). In this trial, REMICADE provided a 70 percent improvement (as measured by ACR 70) in symptoms of arthritis in nearly one-third of patients, compared with only 2 percent of patients on placebo at 24 weeks.

In patients with psoriasis that involved 3 percent or more of their body surface area (BSA), treatment with REMICADE resulted in an impressive improvement with over 40 percent of patients achieving a 90 percent or more improvement in PASI score and 21 percent of patients achieving 100 percent improvement in PASI score as early as week 14 with response maintained throughout the study. In addition, REMICADE was efficacious in the treatment of dactylitis and enthesopathies, two common manifestations of PsA causing pain and swelling. These findings from the IMPACT 2 Psoriatic Arthritis phase III trial are being presented at two major medical meetings: the European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology and the International Psoriasis Symposium (IPS).

"Patients with psoriatic arthritis require treatments that address the dual challenges of this disorder," said Christian Antoni, MD, Friedrich- Alexander-University, Erlangen, Germany. "The results of IMPACT are compelling as they support the potential of REMICADE in alleviating both the skin and joint symptoms of this condition."

"The results of IMPACT 2 are exciting and promising for both physicians and patients," remarked Kim Papp, M.D., Ph.D., Associate Clinical Professor, University of Western Ontario and one of the study's lead investigators. "In this study, a significant number of patients achieved total or almost total clearance of their psoriatic skin disease."

"These data are important to rheumatologists because they suggest that it is possible to rapidly achieve relief from the signs and symptoms of arthritis for a substantial number of patients with this potentially debilitating disease," said Arthur Kavanaugh, M.D., Professor of Medicine, Center for Innovative Therapy, UCSD, Division of Rheumatology, Allergy and Immunology, and one of the lead investigators in the trial.

IMPACT 2 is a phase III, multi-center, randomized, double-blind, placebo- controlled trial initiated to evaluate the safety and efficacy of REMICADE in patients with active PsA who had an inadequate response to disease modifying antirheumatic drugs (DMARD) or nonsteroidal anti-inflammatory drugs (NSAID) therapy. IMPACT 2 reinforces the findings of an earlier study, IMPACT, which showed that REMICADE significantly improved the signs and symptoms of PsA, including psoriasis in 104 patients who failed treatment with at least one DMARD. The primary endpoint for IMPACT 2 was a 20 percent improvement in American College of Rheumatology criteria (ACR 20) at week 14. The proportion of patients achieving ACR 20 response in the REMICADE group was significantly greater than placebo (p<0.001) both at week 14 (58.0 percent and 11.0 percent, respectively) and week 24 (54.0 percent and 16.0 percent, respectively). Centocor plans to submit a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) later this year to request approval for this new use.

REMICADE is a monoclonal antibody that specifically targets and irreversibly binds to tumor necrosis factor-alpha (TNF-alpha) on the cell membrane and in the blood. Overproduction of TNF-alpha is believed to play a role in RA and CD and in a wide range of Immune-Mediated Inflammatory Disorders (I.M.I.D.) in which REMICADE is currently being studied.