NEW YORK (Reuters Health) – In patients with systemic lupus erythematosus (SLE), the antimalarial drugs chloroquine and hydroxychloroquine have wide-ranging benefits and a good safety profile, published studies indicate.
Based on current evidence, “we recommend the treatment with antimalarials, preferably hydroxychloroquine, of most patients with SLE, starting as soon as the diagnosis has been made,” Dr. Guillermo Ruiz-Irastorza and colleagues conclude in the January 2010 issue of the Annals of the Rheumatic Diseases.
“Our systematic review,” Dr. Ruiz-Irastorza added in an email to Reuters Health, “has shown that antimalarials should be considered the cornerstone of lupus therapy, with strong evidence supporting their role in controlling lupus activity, preventing damage and thrombosis and, subsequently, improving survival — no other drug has demonstrated the latter in lupus.”
Also, he said, “the toxicity of hydroxychloroquine is negligible, being also safe during pregnancy.”
Dr. Ruiz-Irastorza, from Hospital de Cruces, Bizkaia, Spain, and colleagues reviewed 95 published articles on the clinical efficacy and safety of antimalarials in patients with SLE. The analysis included 5 randomized controlled trials, 20 prospective cohort studies, 4 case-control studies, 25 cross-sectional studies, 14 retrospective studies, and 27 case reports or series (toxicity cases).
The researchers found “high levels” of evidence that antimalarials prevent lupus flares and increase long-term survival and “moderate” evidence of protection against irreversible organ damage, thrombosis, and loss of bone mass.
In pregnant women, high-level evidence showed that antimalarials, particularly hydroxychloroquine, decrease lupus activity without harming the fetus.
The analysis also found that toxicity related to antimalarials is “infrequent, mild and usually reversible” and that hydroxychloroquine has a better safety profile than chloroquine.
By contrast, there was only weak evidence of an effect on severe lupus activity, lipid levels, and subclinical atherosclerosis.
Hydroxychloroquine, Dr. Ruiz-Irastorza told Reuters Health, “should be used in all lupus patients unless contraindicated, probably in an indefinite way; it should not be discontinued due to worsening disease, long-term remission or pregnancy.”
Eye exams “should be performed regularly by experienced ophthalmologists — our schedule is once a year — bearing in mind that serious toxicity is extremely rare with hydroxychloroquine,” he added.
“We hope our review helps to increase the rate at which hydroxychloroquine is used in lupus patients, currently below 50% in many cohorts,” Dr. Ruiz-Irastorza said.
The researchers note in their report that future studies and meta-analyses are needed to define the best long-term maintenance dose of hydroxychloroquine — “400 mg/day, 200 mg/day or even less.”
Ann Rheum Dis 2010;69:20-28.