title: Slowing of disease progression in rheumatoid arthritis patients during long-term treatment with leflunomide or sulfasalazine.
abstract: 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.
authors.affiliation: Kongsvinger Sjukehus, Norway. arvilar@online.no
authors.forename: A
authors.initials: A
authors.lastname: Larsen
authors.forename: T K
authors.initials: TK
authors.lastname: Kvien
authors.forename: M
authors.initials: M
authors.lastname: Schattenkirchner
authors.forename: R
authors.initials: R
authors.lastname: Rau
authors.forename: D L
authors.initials: DL
authors.lastname: Scott
authors.forename: J S
authors.initials: JS
authors.lastname: Smolen
authors.forename: B
authors.initials: B
authors.lastname: Rozman
authors.forename: R
authors.initials: R
authors.lastname: Westhovens
authors.forename: M
authors.initials: M
authors.lastname: Tikly
authors.forename: C
authors.initials: C
authors.lastname: Oed
authors.forename: R
authors.initials: R
authors.lastname: Rosenburg
mesh_terms: D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000473:pathology; D018450:Disease Progression; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007555:Isoxazoles / Q000009:adverse effects / Q000627:therapeutic use*; D000077339:Leflunomide; D008297:Male; D008875:Middle Aged; D011859:Radiography; D012460:Sulfasalazine / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D007555:Isoxazoles; D012460:Sulfasalazine; D000077339:Leflunomide