RA Treatments - Leflunomide
Abstract 1201 Two-Year Treatment of Active Rheumatoid Arthritis (RA) with Leflunomide (Lef) Compared with Placebo (Pl) or Methotrexate (MTX)
S Cohen, A Weaver, M Shiff, V Strand for the Leflunomide Study Group Dallas TX, Lincoln NE, Denver CO, Stanford CA
Patients who completed the 1-year North American Leflunomide Study were continued in the same treatment groups for an additional 12 months to assess the durability of the treatment effect. Of the 482 patients in the 1-year study 235 patients (Lef 98/182, Pl 36/118, MTX 101/182) continued into year 2 (2-year cohort). This study looks at treatment response at 12 and 24 months for the 2-year cohort. The Lef group had a 77% ACR 20 and a 57% ACR 50 response at 12 months and a 79% ACR 20 and 56% ACR 50 response at 24 months. The MTX group had a 60% ACR 20 and 32% ACR 50 at 12 months and a 67% ACR 20 and a 43% ACR 50 at 24 months. Of the patients entering year 2, 85% of the Lef group and 79% of the MTX group completed trial.
Editorial Comment: It is clinically relevant to know if patients will continue to respond to a medication. This data supports the concept that both methotrexate and leflunomide are well tolerated and effective over 24 months. It is interesting that the of the ~50% of patients in the MTX and Lef group that entered into the second year, only ~75% met ACR 20 response at 12 months. Thus, the "durability" of the response might represent some patients worsening and some improving during the second year of the study.