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Dermatologic, Rheumatologic Psoriatic Arthritis Symptoms Respond to Infliximab: Presented at EULAR

By Paula Moyer

BERLIN, GERMANY -- June 15, 2004 -- Infliximab (Remicade) is an effective treatment for addressing both psoriatic plaques and joint disease in psoriatic arthritis, say researchers.

Principal investigator Arthur Kavanaugh, MD, professor of medicine and director of the center for innovative therapy in the division of rheumatology, allergy, and immunology at the University of California-San Diego in San Diego, California, presented study findings here June 12th at the European Congress of Rheumatology. He said, "Patients who had had a suboptimal response to other therapies responded to infliximab." Dr. Kavanaugh added, "Both components of the disease responded to treatment."

Following up on the Infliximab Multinational Psoriatic Arthritis Controlled Trial (IMPACT), Dr. Kavanaugh and coinvestigators undertook IMPACT2 and sought to confirm the efficacy and safety of infliximab treatment in a large cohort of patients.

They recruited 200 patients, median age 47 years, who had had psoriatic arthritis for at least 6 months and who had had a suboptimal response to treatment. Patients who used nonsteroidal anti-inflammatory drugs (NSAIDs) or disease-modifying antirheumatic drugs (DMARDs) were eligible for enrollment in the study.

Eligible patients had 5 or more swollen joints and 5 or more tender joints, a psoriatic target skin lesion of at least 2 cm in diameter, and either serum C-reactive protein (CRP) levels of at least 1.5 mg/dL or morning stiffness lasting 45 or more minutes. Patients who were taking methotrexate, NSAIDs, or low-dose corticosteroids were permitted to continue these therapies at stable doses.

The subjects had had psoriatic arthritis for a median of 5.4 years and a median of 22 tender joints and 12 swollen joints. The median PASI score was 5.5 and 86% of patients had psoriasis involving at least 3% of body surface area. At baseline, 46% of patients were receiving methotrexate.

The investigators assigned patients to receive infusions of placebo or infliximab, with treatment infusions consisting of 5 mg/kg, and received at weeks 0, 2, 6, 14, and 22. The primary efficacy endpoint for signs and symptoms was a 20% improvement in the American College of Rheumatology criteria (ACR20) at week 14. Secondary endpoints included the proportion of patients achieving at least 75% improvement in PASI (Psoriasis Area and Severity Index) score at week 14, Psoriatic Arthritis Response Criteria at week 14, and ACR20 response at week 24.

At week 14, 2.5% of patients in the placebo group had reductions of at least 75% in the Psoriasis Area and Severity Index (PASI 75), compared to 63.9% of those in the treatment arm (P <.001). At week 24 the PASI 75 scores were 1.1% for the placebo arm and 60.2% for the treatment arm (P <.001). The investigators also assessed reductions of enthesitis and dactylitis, which were significantly reduced both at week 14 (P =.016 and P =.075, respectively) and at week 24 (P =.002 and P <.001), respectively. At the time of Dr. Kavanaugh's presentation, the investigators were still analyzing the study's ACR20 data.


[Presentation title: Infliximab Improves Arthritis and Psoriasis in Patients With Active Polyarticular Psoriatic Arthritis: Results of the IMPACT2 Trial. Abstract SAT0050]

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