Prospective trial OKs oral contraceptives in lupus: not associated with severe disease flares.(News)

SAN ANTONIO -- Clinicians at last have evidence that oral contraceptives can be prescribed to carefully selected women with systemic lupus erythematosus without triggering disease flares, according to the results of a prospective trial presented at the annual meeting of the American College of Rheumatology.

"This is a clinical trial that you will bring home with you, and it will change the way you practice," said the lead investigator Michele Petri, M.D., who has not prescribed oral contraceptives (OCs) to her lupus patients for the past 20 years. But the new data justify offering women the birth control option, noted the professor of medicine at Johns Hopkins University, Baltimore.

Despite the potential for OCs to prevent steroid-induced osteoporosis and to provide other health benefits, the hormones have rarely been prescribed to lupus patients for fear that they would induce disease flares. Such concerns were founded on evidence primarily from murine models, case-control studies, epidemiologic studies, and retrospective clinical observations.

But a highly anticipated, prospective study funded by the National Institutes of Health now has demonstrated that severe disease flares are no more common among lupus patients taking combined OCs than among those given placebo.

The Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) trial randomized 183 premenopausal women to 1 year of treatment with an OC containing 35 mcg of ethinyl estradiol or a matched placebo.

Two strata of patients were included. The first had inactive disease, rated as a stable Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score of 4 or less. The second group had active stable disease with a SLEDAI between 5 and 12. In both groups the daily prednisone dose was less than 0.5 mg/kg.

Baseline characteristics did not differ between the two groups Patients ranged in age from 18 to 39. A total of 37% were white, 34% were African American, 16% were Hispanic, and 13% were Asian.