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STUDY DEMONSTRATES SAFETY OF ORAL CONTRACEPTIVES IN WOMEN WITH LUPUS
(01/04/2006) by NIH Press Release
In a major study funded by the National Institute of Arthritis and
Musculoskeletal and Skin Diseases (NIAMS), a part of the National
Institutes of Health (NIH), women with either inactive or stable
systemic lupus erythematosus (lupus) -- a disease in which the
body's immune system mistakenly attacks and damages healthy tissues
of the skin, joints and internal organs -- were able to take oral
contraceptives without increased risk of flares, or periods of
increased disease activity, that characterize the disease.
Safe and effective contraception is an issue that many women of
childbearing age face. But for women with lupus, doctors have often
been hesitant to prescribe one of the most effective forms of
contraception -- oral contraceptives, or the "pill" -- for fear that
it might increase disease activity.
In the 15-center study of 183 women with inactive or stable lupus,
those taking oral contraceptives (triphasic 35
µg.ethinylestradiol/0.5-1 mg norethindrone for twelve 28-day cycles)
had no statistically significant difference in the occurrence of
flares than those taking a placebo. Severe flares occurred in about
7 percent of the women, regardless of whether they received oral
contraceptives or placebo. A severe flare was defined by several
criteria, including the presence of new or worsening central nervous
system involvement; inflammation of the blood vessels (vasculitis),
kidneys (nephritis) and/or muscles (myositis); and/or blood
problems, including low platelet count (thrombocytopenia) and
destruction of the red blood cells (hemolytic anemia).
Mild-to-moderate flares and disease complications were similar
between the two groups over the 12-month follow-up as well.
Mild-to-moderate flares included fevers and inflammation of the
skin, joints, the sac of fibrous tissue that surrounds the heart
(pericarditis), and mucous membranes lining the nose and mouth.
Reluctance to prescribe oral contraceptives and other hormones for
women with lupus arose in part from the fact that lupus is far more
common in women (women with the disease outnumber men 10 to 1), and
that it typically begins during the childbearing years (after the
onset and before the cessation of menstruation) when female hormone
levels are at their peak. In mouse models of lupus, giving estrogen
makes lupus worse and, depending on the genetic background,
influences the activity of white blood cells called B cells that are
believed to play a key role in the disease process.
But for most women with moderate lupus that is inactive or stable,
taking estrogen -- whether as part of an oral contraceptive or
hormone replacement therapy -- appears to have no detrimental effect
on disease activity, say co-authors Jill Buyon, M.D., of New York's
Hospital for Joint Diseases, and Michelle Petri, M.D., M.P.H., of
the Johns Hopkins University, who jointly led the study. However,
they note that oral contraceptives still are not advised for women
who have a history of, or are at high risk for, blood clots, because
estrogens have been associated with dangerous blood clots.
The recently published study on oral contraceptives is one of two
separate randomized, placebo-controlled studies that comprise the
Safety of Estrogens in Lupus Erythematosus, National Assessment
(SELENA) Trial. The other study, which showed no increased risk of
severe flares in postmenopausal women on hormone replacement
therapy, was published earlier this year (Buyon JP, et. al. The
effect of combined estrogen and progesterone hormone replacement
therapy on disease activity in systemic lupus erythematosus: a
randomized trial," "Ann Intern Med" 2005; 142: 953-962).
"There are settings in which estrogens might provide benefit," say
the authors. Among women with lupus, they say, there is a high
elective abortion rate -- approaching 23 percent of pregnancies --
which may reflect a failure of the birth control method used or the
absence of an adequate birth control program.
"Estrogen, as used in this study, appears to be safe in the majority
of women with stable disease," says NIAMS Director Stephen I. Katz,
M.D., Ph.D. "This research brings us another step forward in
improving quality of life for people with rheumatic disease."
In addition to NIAMS, other funders of the study included NIH's
Office of Research on Women's Health, Office of Research on Minority
Health, National Center for Research Resources and National
Institute of Allergy and Infectious Diseases.
The mission of the National Institute of Arthritis and
Musculoskeletal and Skin Diseases (NIAMS), a part of the Department
of Health and Human Services' National Institutes of Health, is to
support research into the causes, treatment, and prevention of
arthritis and musculoskeletal and skin diseases; the training of
basic and clinical scientists to carry out this research; and the
dissemination of information on research progress in these diseases.
For additional information, call NIAMS's Clearinghouse toll free at
1-877-22-NIAMS, or visit the NIAMS Web site at www.niams.nih.gov.
The National Institutes of Health (NIH) -- "The Nation's Medical
Research Agency" -- includes 27 Institutes and Centers and is a
component of the U. S. Department of Health and Human Services. It
is the primary Federal agency for conducting and supporting basic,
clinical, and translational medical research, and it investigates
the causes, treatments, and cures for both common and rare diseases.
For more information about NIH and its programs, visit
http://www.nih.gov.
Petri M, et al. Combined oral contraceptives in women with systemic
lupus erythematosus. "N Engl J Med" 2005;353:2550-2558.
This NIH News Release is available online at:
http://www.nih.gov/news/pr/dec2005/niams-22.htm.
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