To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: ACR: Leflunomide Safe and Effective in Patients with Active Rheumatoid Arthritis URL: http://www.pslgroup.com/dg/20DA46.htm Doctor's Guide November 14, 2001
By Claire Sowerbutt Special to DG News
SAN FRANCISCO, CA -- November 14, 2001 - The anti-inflammatory agent, leflunomide, appears to be a safe and effective treatment for patients with active rheumatoid arthritis (RA).
Researchers presented the findings yesterday (Nov. 13) at the American College of Rheumatology meeting, in San Francisco, California.
Results from their five-year follow-up study show that the one-year American College of Rheumatology (ACR) 20 percent, 50 percent and 70 percent response rates were 72.9 percent, 48.3 percent and 14.5 percent, respectively. These ACR values were maintained out to year 4 or end point (69.2 percent, 43.0 percent and 19.6 percent, respectively).
The maximum treatment duration in this study was 5.8 years. Improvement in daily activities and physical function accompanied clinical improvements. It appears that the early efficacy achieved with leflunomide in patients with RA is sustained over the long term.
Additional data show improvements in individual components of the ACR response, including tender and swollen joint count, swollen joint count, investigators' and patients' global assessments, and C-reactive protein (CRP) levels. Improved responses in these areas were also maintained through year 4.
The mean tender joint counts improved from 17.4 at baseline to 6.1 at year 1 and to 5.1 at end point. Similarly, mean swollen joint counts improved from 16.2 at baseline to 6.7 at year 1, which was maintained out to year 4 (5.2) or end point (5.5).
While mean scores for the investigators' and patients' global assessments at baseline were 3.6, and 3.6, respectively, they improved by year 1 to 2.1 and 2.2, respectively. These improvements were also maintained out to year 4, with mean scores for investigators' and patients' global assessments of 2.2 and 2.3, respectively.
C-reactive protein levels decreased from 3.9 mg/dL at baseline to 1.3 mg/dL at year 1. As seen with other measurements, mean CRP levels were maintained out to year 4 (1.2 mg/dL) or end point (1.4 mg/dL).
Safety data show that 85 percent of 214 patients treated with leflunomide experienced adverse events. Most common events were upper respiratory infection, (23.4 percent), diarrhea (8.4 percent), joint disorder (6.5 percent), back pain (6.5 percent) nausea (6.1 percent) bronchitis (6.1 percent) and hypertension (5.1 percent). Fifty-six (26.5 percent) of the reported adverse events were considered to be possibly treatment related.
The safety profile of leflunomide during the follow-up period was found to be similar to that from the first and/or second year of Phase III studies. However, the most common adverse events seen in the Phase III trials occurred at lower frequencies in this study. Investigators reported that there were no unexpected or different adverse events seen during the continued treatment phase of this study. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.