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Background Oral contraceptives are rarely prescribed for women with systemic lupus erythematosus, because of concern about potential negative side effects. In this double-blind, randomized, noninferiority trial, we prospectively evaluated the effect of oral contraceptives on lupus activity in premenopausal women with systemic lupus erythematosus.
Methods A total of 183 women with inactive (76 percent) or stable active (24 percent) systemic lupus erythematosus at 15 U.S. sites were randomly assigned to receive either oral contraceptives (triphasic ethinyl estradiol at a dose of 35 µg plus norethindrone at a dose of 0.5 to 1 mg for 12 cycles of 28 days each; 91 women) or placebo (92 women) and were evaluated at months 1, 2, 3, 6, 9, and 12. Subjects were excluded if they had moderate or high levels of anticardiolipin antibodies, lupus anticoagulant, or a history of thrombosis.
Results The primary end point, a severe lupus flare, occurred in 7 of 91 subjects receiving oral contraceptives (7.7 percent) as compared with 7 of 92 subjects receiving placebo (7.6 percent). The 12-month rates of severe flare were similar: 0.084 for the group receiving oral contraceptives and 0.087 for the placebo group (P=0.95; upper limit of the one-sided 95 percent confidence interval for this difference, 0.069, which is within the prespecified 9 percent margin for noninferiority). Rates of mild or moderate flares were 1.40 flares per person-year for subjects receiving oral contraceptives and 1.44 flares per person-year for subjects receiving placebo (relative risk, 0.98; P=0.86). In the group that was randomized to receive oral contraceptives, there was one deep venous thrombosis and one clotted graft; in the placebo group, there was one deep venous thrombosis, one ocular thrombosis, one superficial thrombophlebitis, and one death (after cessation of the trial).
Conclusions Our study indicates that oral contraceptives do not increase the risk of flare among women with systemic lupus erythematosus whose disease is stable.
Source Information
From Johns Hopkins University School of Medicine, Baltimore (M.P., L.S., M.F.); Albert Einstein College of Medicine–Montefiore Medical Center, Bronx, N.Y. (M.Y.K., B.D., M.M.); University of California, Los Angeles (K.C.K., J.G., B.H.H.); Hospital for Special Surgery, New York (L.R.S., M.L.); Oklahoma Medical Research Foundation, Oklahoma City (J.T.M.); the Hospital for Joint Diseases and Bellevue Hospital at New York University School of Medicine, New York (H.M.B., A.D.A., A.R., F.L., J.P.B.); University of Michigan, Ann Arbor (W.J.M.); Louisiana State University Health Sciences Center, Shreveport (M.H.-H.); University of North Carolina at Chapel Hill, Chapel Hill (M.A.D.); University of Pennsylvania, Philadelphia (J.V.F.); University of Texas, Houston (A.F.); Rheumatology Associates of Long Island, Port Jefferson Station, N.Y. (M.T.); University of California, San Francisco, San Francisco (J.D.); and Medical College of Wisconsin, Milwaukee (M.C.).
Address reprint requests to Dr. Buyon at the Department of Rheumatology, Rm. 1608, Hospital for Joint Diseases, 301 E. 17th St., New York, NY 10003, or at jill.buyon{at}nyumc.org.
Related Letters:
Oral Contraceptives in Women with Systemic Lupus Erythematosus
Schwarz E. B., Lohr P. A., Sánchez-Guerrero J., Jiménez-Santana L., Cravioto M.-d.-C.
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N Engl J Med 2006;
354:1203-1204, Mar 16, 2006.
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