RESEARCH - Steroid-sparing effects of MTX in SLE

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Arthritis Rheum. 2008 Nov 26;59(12):1796-1804.

Steroid-sparing effects of methotrexate in systemic lupus

erythematosus: A double-blind, randomized, placebo-controlled trial.

Fortin PR, Abrahamowicz M, Ferland D, Lacaille D, CD, Zummer M;

Canadian Network For Improved Outcomes in Systemic Lupus

ErythematosusThe Canadian Network for Improved Outcomes in Systemic

Lupus Erythematosus is a voluntary group of Canadian Lupus

Investigators with no other funding than that of the sponsor of the

study (The Arthritis Society of Canada) with participation from

Faulding Canada, Inc. (now Mayne Pharma [Canada] Inc.) under an

Arthritis Society industry peer¡¾review grant..

University Health Network, Toronto Western Hospital, Toronto Western

Research Institute, Toronto, Ontario, Canada.

OBJECTIVE: To assess the potential benefits of methotrexate in

patients with systemic lupus erythematosus (SLE).

METHODS: 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 alpha = 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.

RESULTS: 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).

CONCLUSION: 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.

PMID: 19035431

http://www.ncbi.nlm.nih.gov/pubmed/19035431

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