TY - JOUR
T1 - Slowing of disease progression in rheumatoid arthritis patients during long-term treatment with leflunomide or sulfasalazine
AU - European Leflunomide Study Grp
AU - Kvien, T K
AU - Schattenkirchner, M
AU - Rau, R
AU - Scott, D L
AU - Smolen, J S
AU - Rozman, B
AU - Westhovens, R
AU - Tikly, M
AU - Oed, C
AU - Rosenburg, R
PY - 2001
Y1 - 2001
N2 - 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 (Delta 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.
AB - 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 (Delta 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.
UR - http://www.scopus.com/inward/record.url?scp=17744387698&partnerID=8YFLogxK
U2 - 10.1080/030097401300162897
DO - 10.1080/030097401300162897
M3 - Article
VL - 30
SP - 135
EP - 142
JO - Scandinavian Journal of Rheumatology
JF - Scandinavian Journal of Rheumatology
IS - 3
ER -