Lupus & methotrexate research
While lupus is not specifically approved for lupus, there have been a large number of studies that intend to measure the effectiveness of the drug for people with lupus. Some studies are quite specific, finding benefit of methotrexate for people with cutaneous lupus, antimalarial-resistant lupus arthritis, and mucocutaneous features.
Methotrexate in systemic lupus erythematosus: a systematic review of its efficacy (2014)
Of 53 potential studies, only nine were eligible for inclusion by the authors (3 randomized controlled trials and six observational studies).
SLEDAI scores: Participants taking methotrexate had significantly less disease activity (p = 0.001)
Corticosteroid use: Participants on methotrexate were able to take significantly lower doses of corticosteroids (p = 0.001)
Double blind, randomized, placebo controlled clinical trial of methotrexate in systemic lupus erythematosus
41 patients began study; 37 completed the 6 month study (2 placebo patients dropped out due to severe flares. 2 methotrexate patients dropped out — one due to pulmonary tuberculosis and the other because of urticaria and severe dyspepsia). Average SLE duration was 82.5 months.
Participants received either a placebo or 15-20 mg/week of methotrexate for six months.
Articular (joint) complaints: 16 placebo participants had joint complaints compared to 1 methotrexate participant (p < 0.001).
Hypocomplementemia (decreased complement levels in the immune system): 11 placebo participants compared to 4 methotrexate participants (p < 0.001)
Average SLEDAI scores: Significantly higher, suggesting higher disease activity, for participants receiving the placebo, at months 3, 4, 5, and 6.
Decreased prednisone dose: 1 placebo participant reduced prednisone dose compared to 13 methotrexate participants (p < 0.001). This finding of decreased steroid use was confirmed in other studies of people with moderately active lupus.
Side effects: 14 methotrexate participants (70%) experienced side effects – most experienced were dyspepsia and increased hepatic enzyme serum levels. 3 placebo participants experienced dyspepsia. These side effects were considered mild.
Additional research examined how well methotrexate was tolerated and the frequency of side effects.
Methotrexate use in systemic lupus erythematosus
101 participants with SLE. 24 participants were treated with methotrexate during 25 treatment episodes (one person was taken off the medication and began it again.)
The median duration of methotrexate treatment episode was 14.4 months (range 5.1 months to 41.6 months).
The median initial methotrexate dose was 7.5 mg/wk (range was 2.5 mg/wk to 10 mg/wk). The median peak dose was 10 mg/wk (range 7.5 mg/wk to 15 mg/wk).
This study found moderate, but not statistically significant decreases in steroid use when taking methotrexate.
2 participants terminated methotrexate as a result of toxicity.
The probability of continuing treatment at 12 months was 68%.