Efficacy and safety of leflunomide compared with placebo and sulphasalazine in active rheumatoid arthritis: a double-blind, randomised, multicentre trial. European Leflunomide Study Group

Phase II trials of leflunomide, an inhibitor of de-novo pyrimidine synthesis, have shown efficacy in rheumatoid arthritis. This double-blind randomised trial compared leflunomide with placebo and sulphasalazine in active rheumatoid arthritis. 358 patients were randomly assigned leflunomide (100 mg d...

Full description

Saved in:
Bibliographic Details
Published in:The Lancet (British edition) 1999-01, Vol.353 (9149), p.259
Main Authors: Smolen, J S, Kalden, J R, Scott, D L, Rozman, B, Kvien, T K, Larsen, A, Loew-Friedrich, I, Oed, C, Rosenburg, R
Format: Article
Language:English
Subjects:
Algorithms
Analysis of Variance
Antirheumatic Agents - therapeutic use
Arthritis, Rheumatoid - diagnostic imaging
Arthritis, Rheumatoid - drug therapy
Disease Progression
Double-Blind Method
Female
Humans
Immunosuppressive Agents - adverse effects
Immunosuppressive Agents - therapeutic use
Isoxazoles - adverse effects
Isoxazoles - therapeutic use
Leflunomide
Male
Middle Aged
Placebos
Radiography
Statistics, Nonparametric
Sulfasalazine - therapeutic use
Treatment Outcome
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Phase II trials of leflunomide, an inhibitor of de-novo pyrimidine synthesis, have shown efficacy in rheumatoid arthritis. This double-blind randomised trial compared leflunomide with placebo and sulphasalazine in active rheumatoid arthritis. 358 patients were randomly assigned leflunomide (100 mg daily on days 1-3, then 20 mg daily), placebo, or sulphasalazine (0.5 g daily, titrated progressively to 2.0 g daily at week 4). The primary endpoints were tender and swollen joint counts and investigator's and patient's overall assessments. Analyses were by intention to treat. The mean changes in the leflunomide, placebo, and sulphasalazine groups were -9.7, -4.3, and -8.1 for tender joint count; -7.2, -3.4, and -6.2 for swollen joint count; -1.1, -0.3, and -1.0 for physician's overall assessment; and -1.1, -0.4, and -1.1 for patient's overall assessment. Leflunomide and sulphasalazine were significantly superior to placebo (p=0.0001 for joint counts; p
ISSN:0140-6736