Slowing of disease progression in rheumatoid arthritis patients during long-term treatment with leflunomide or sulfasalazine

• Published in: Scandinavian journal of rheumatology 2001, Vol.30 (3), p.135-142
• Main Author: Arvi Larsen, Tore K. Kvien, Manfred Schattenkirchner, Rolf Rau, David L. Scott, Josef S. Smolen, Blaz Rozman, R. Westhovens, Mohammed Tikly, Christine Oed, Ronald Rosenburg
• Format: Article
• Language: English
• Subjects: Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal - adverse effects; Anti-Inflammatory Agents, Non-Steroidal - therapeutic use; Arthritis, Rheumatoid - diagnostic imaging; Arthritis, Rheumatoid - drug therapy; Arthritis, Rheumatoid - pathology; Biological and medical sciences; Bones, joints and connective tissue. Antiinflammatory agents; Disease Progression; Double-Blind Method; Female; Humans; Isoxazoles - adverse effects; Isoxazoles - therapeutic use; Leflunomide; Male; Medical sciences; Middle Aged; Pharmacology. Drug treatments; Radiography; Rheumatoid Arthritis Dmards Leflunomide Sulfasalazine Randomized Controlled Trials Radiographic Disease Progression Larsen Scores; Sulfasalazine - adverse effects; Sulfasalazine - therapeutic use; Treatment Outcome
• ISSN: 0300-9742; 1502-7732
• DOI: 10.1080/030097401300162897

Radiographic disease progression with leflunomide and sulfasalazine treatment was assessed in rheumatoid arthritis patients in a double-blind trial that was placebo controlled for the first 6 months. Completers at 6 months opted to continue on 12- and 24-month double-blind extensions; patients in the placebo group were switched to sulfasalazine. Changes in Larsen scores were assessed in evaluable patient cohorts at 6 (n = 228), 12 (n = 136), and 24 (n = 65) months. Changes in Larsen scores and erosive joint counts with leflunomide and sulfasalazine at 6 months showed significantly less radiographic progression than placebo. Sustained retardation of radiographic progression was seen in the 24-month intent-to-treat cohorts (Δ Larsen scores: leflunomide - 0.07, sulfasalazine - 0.03). Changes in erosive joint counts within the 24-month leflunomide cohort suggest halting of disease progression for patients who continued in the study for 2 years (leflunomide-0.92, sulfasalazine 0.80). Leflunomide was well tolerated with no unexpected adverse events during the 2-year period. This study demonstrates that slowing of disease progression with leflunomide, observed as early as 6 months, is maintained long term in patients who complete 2 years of treatment.