Oral contraceptive use does not increase the number or severity of flares of inactive or mild, stable systemic lupus erythematosus, according to investigators with the Safety of Estrogens in Lupus Erythematosus—National Assessment (SELENA): Oral Contraceptives trial.
Dr. Michelle Petri, of Johns Hopkins University, Baltimore, and her associates randomized 183 women with inactive (76%) or stable active (24%) disease to receive either placebo or an oral contraceptive (OC).
The OC regimen used involved a 35-mcg triphasic ethinyl estradiol plus norethindrone 0.5–1.0 mg for 12 cycles, each 7 days long.
All women used an alternate form of birth control during the study period. The primary end point of the study was a severe lupus flare.
During the first year of follow-up, 7 of the 91 women on OCs (8%) had at least one severe flare of their SLE as did 7 of 92 women (8%) taking placebo.
Rates of severe flare were similar in the two groups, with a rate of 0.084 severe flares per person-year for the study group and 0.087 severe flares per person-year for the placebo group.
Rates of flares per person-year were 1.40 for OC users and 1.44 for placebo patients.
Serious adverse events requiring hospitalization occurred in 15 patients on OCs and 13 placebo patients.
Thrombosis occurred in two OC users and three women on placebo. Two OC users had abnormal liver function tests, and one developed hypertension.
None of these events occurred among women on placebo.
Seven women on OCs had to discontinue treatment, and 12 women on placebo withdrew from the study (N. Engl. J. Med. 2005; 353:2550–8).
In an accompanying editorial, Dr. Bonnie L. Bermas of Brigham and Women's Hospital in Boston commented that the study “supports the use of combined oral contraceptives by those with inactive or moderately active, stable disease.…”
“[T]he option to use combined oral contraceptives in antiphospholipid antibody-negative patients with mild disease appears worth considering in the appropriate clinical setting” (N. Engl. J. Med. 2005;353:2602–4).