If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  ACR: Leflunomide Safe and Effective in Patients with Active Rheumatoid Arthritis 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.
|
