Dr. Fortin holds a Distinguished Senior Research Investigator award from The Arthritis Society.
Systemic Lupus Erythematosus
Steroid-sparing effects of methotrexate in systemic lupus erythematosus: A double-blind, randomized, placebo-controlled trial
Version of Record online: 26 NOV 2008
Copyright © 2008 by the American College of Rheumatology
Arthritis Care & Research
Volume 59, Issue 12, pages 1796–1804, 15 December 2008
How to Cite
Fortin, P. R., Abrahamowicz, M., Ferland, D., Lacaille, D., Smith, C. D., Zummer, M. and Canadian Network For Improved Outcomes in Systemic Lupus Erythematosus (2008), Steroid-sparing effects of methotrexate in systemic lupus erythematosus: A double-blind, randomized, placebo-controlled trial. Arthritis & Rheumatism, 59: 1796–1804. doi: 10.1002/art.24068
- Issue online: 26 NOV 2008
- Version of Record online: 26 NOV 2008
- Manuscript Accepted: 31 JUL 2008
- Manuscript Received: 5 JUN 2007
To assess the potential benefits of methotrexate in patients with systemic lupus erythematosus (SLE).
A 12-month, double-blind, placebo-controlled trial of methotrexate with folic acid was conducted. Intent-to-treat analyses were performed with mixed linear models and α = 0.04 (96% confidence interval [96% CI]) to account for interim analysis of longitudinal data to assess the treatment effects on lupus disease activity and daily steroid dose across monthly measurements, and to test if the treatment effects depended on selected participant characteristics.
Of 215 participants screened, 94 were excluded, 35 declined, and 86 were randomized (methotrexate = 41, placebo = 45). The groups were balanced for demographic and disease characteristics. Antimalarial use was more frequent in the placebo group, which was adjusted for in multivariable analyses. Sixty participants (27 methotrexate, 33 placebo) completed the study and 26 terminated early. Among participants who had the same baseline prednisone dose, those taking methotrexate received, on average, 1.33 mg/day less prednisone during the trial period (96% CI 0.06, 2.72 mg/day; a 22% reduction of their average-during-trial daily dose) compared with those in the placebo group. For the primary measure of disease activity (revised Systemic Lupus Activity Measure), methotrexate use was also associated with a marginally significant reduction in the mean during-trial score of 0.86 units (96% CI 0.01, 1.71; P = 0.039). A significant interaction between treatment and baseline damage was found (P = 0.001).
Methotrexate conferred a significant advantage in participants with moderately active lupus by lowering daily prednisone dose and slightly decreasing lupus disease activity. As a therapeutic option in moderate SLE, methotrexate can be considered to be steroid sparing.