Combined oral contraceptives in women with systemic lupus erythematosus

Michelle Petri, Mimi Y. Kim, Kenneth C. Kalunian, Jennifer Grossman, Bevra H. Hahn, Lisa R. Sammaritano, Michael Lockshin, Joan T. Merrill, H. Michael Belmont, Anca D. Askanase, W. Joseph McCune, Michelene P Hearth-Holmes, Mary Anne Dooley, Joan Von Feldt, Alan Friedman, Mark Tan, John Davis, Mary Cronin, Betty Diamond, Meggan Mackay & 5 others Lisa Sigler, Michael Fillius, Ann Rupel, Frederick Licciardi, Jill P. Buyon

Research output: Contribution to journalArticle

592 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)2550-2558
Number of pages9
JournalNew England Journal of Medicine
Volume353
Issue number24
DOIs
StatePublished - Dec 15 2005

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Contraceptives, Oral, Combined
Oral Contraceptives
Systemic Lupus Erythematosus
Placebos
Venous Thrombosis
Thrombosis
Norethindrone
Lupus Coagulation Inhibitor
Anticardiolipin Antibodies
Thrombophlebitis
Ethinyl Estradiol
Confidence Intervals
Transplants

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Petri, M., Kim, M. Y., Kalunian, K. C., Grossman, J., Hahn, B. H., Sammaritano, L. R., ... Buyon, J. P. (2005). Combined oral contraceptives in women with systemic lupus erythematosus. New England Journal of Medicine, 353(24), 2550-2558. https://doi.org/10.1056/NEJMoa051135

Combined oral contraceptives in women with systemic lupus erythematosus. / Petri, Michelle; Kim, Mimi Y.; Kalunian, Kenneth C.; Grossman, Jennifer; Hahn, Bevra H.; Sammaritano, Lisa R.; Lockshin, Michael; Merrill, Joan T.; Belmont, H. Michael; Askanase, Anca D.; McCune, W. Joseph; Hearth-Holmes, Michelene P; Dooley, Mary Anne; Von Feldt, Joan; Friedman, Alan; Tan, Mark; Davis, John; Cronin, Mary; Diamond, Betty; Mackay, Meggan; Sigler, Lisa; Fillius, Michael; Rupel, Ann; Licciardi, Frederick; Buyon, Jill P.

In: New England Journal of Medicine, Vol. 353, No. 24, 15.12.2005, p. 2550-2558.

Research output: Contribution to journalArticle

Petri, M, Kim, MY, Kalunian, KC, Grossman, J, Hahn, BH, Sammaritano, LR, Lockshin, M, Merrill, JT, Belmont, HM, Askanase, AD, McCune, WJ, Hearth-Holmes, MP, Dooley, MA, Von Feldt, J, Friedman, A, Tan, M, Davis, J, Cronin, M, Diamond, B, Mackay, M, Sigler, L, Fillius, M, Rupel, A, Licciardi, F & Buyon, JP 2005, 'Combined oral contraceptives in women with systemic lupus erythematosus', New England Journal of Medicine, vol. 353, no. 24, pp. 2550-2558. https://doi.org/10.1056/NEJMoa051135
Petri M, Kim MY, Kalunian KC, Grossman J, Hahn BH, Sammaritano LR et al. Combined oral contraceptives in women with systemic lupus erythematosus. New England Journal of Medicine. 2005 Dec 15;353(24):2550-2558. https://doi.org/10.1056/NEJMoa051135
Petri, Michelle ; Kim, Mimi Y. ; Kalunian, Kenneth C. ; Grossman, Jennifer ; Hahn, Bevra H. ; Sammaritano, Lisa R. ; Lockshin, Michael ; Merrill, Joan T. ; Belmont, H. Michael ; Askanase, Anca D. ; McCune, W. Joseph ; Hearth-Holmes, Michelene P ; Dooley, Mary Anne ; Von Feldt, Joan ; Friedman, Alan ; Tan, Mark ; Davis, John ; Cronin, Mary ; Diamond, Betty ; Mackay, Meggan ; Sigler, Lisa ; Fillius, Michael ; Rupel, Ann ; Licciardi, Frederick ; Buyon, Jill P. / Combined oral contraceptives in women with systemic lupus erythematosus. In: New England Journal of Medicine. 2005 ; Vol. 353, No. 24. pp. 2550-2558.
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abstract = "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.",
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AU - Petri, Michelle

AU - Kim, Mimi Y.

AU - Kalunian, Kenneth C.

AU - Grossman, Jennifer

AU - Hahn, Bevra H.

AU - Sammaritano, Lisa R.

AU - Lockshin, Michael

AU - Merrill, Joan T.

AU - Belmont, H. Michael

AU - Askanase, Anca D.

AU - McCune, W. Joseph

AU - Hearth-Holmes, Michelene P

AU - Dooley, Mary Anne

AU - Von Feldt, Joan

AU - Friedman, Alan

AU - Tan, Mark

AU - Davis, John

AU - Cronin, Mary

AU - Diamond, Betty

AU - Mackay, Meggan

AU - Sigler, Lisa

AU - Fillius, Michael

AU - Rupel, Ann

AU - Licciardi, Frederick

AU - Buyon, Jill P.

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N2 - 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.

AB - 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.

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