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Oct. 19, 2004 (San Antonio) — Severe flares among women with
systemic lupus erythematosus (SLE) who are prescribed oral contraceptives
are rare, according to results from the Safety of Estrogen in Lupus
Erythematosus-National Assessment (SELENA) trial.
Michelle Petrie, MD, MPH, from Johns Hopkins University in Baltimore,
Maryland, said that for 20 years she followed standard practice
and refused to prescribe oral contraceptives to young women with
SLE. But in the 12-month, randomized, double-blind study of 183
premenopausal women conducted by Dr. Petrie and colleagues, only
seven severe flares occurred of the 91 patients receiving oral contraceptives.
The same number was recorded for the 92 women receiving placebo.
Mild-to-moderate flares were also comparable among the young women
at 15 U.S. centers participating in the study — 1.41 flares
per patient in the oral contraceptive group compared with 1.40 flares
per patient in the placebo group.
In her presentation here at the 68th annual scientific meeting
of the American College of Rheumatology (ACR), Dr. Petrie applauded
her coinvestigator, Jill P. Buyon, MD, from the Hospital for Joint
Diseases of New York University School of Medicine in New York City,
for initiating the SELENA trial.
"This is a clinical trial you can take home with you. It will
change the way you practice," Dr. Petrie told session attendees.
Oral contraceptives are safe for about two thirds of SLE patients,
according to the trial's conclusions. The exception would be young
women judged to be at increased risk for thrombosis.
Ellen Ginzler, MD, PhD, moderator of a press conference on the
trial later in the day, agreed that the study should change practice.
Dr. Ginzler, chief of rheumatology at the State University of New
York Downstate Medical Center in Brooklyn, said the results are
"very believable" for several reasons. One is that the
prevalence of severe flares was comparable to results in other lupus
studies that did not address the issue of oral contraceptives.
Another is the participation of African-American and Hispanic patients,
who made up half the population in the study. SLE is prevalent among
minorities, but they are often underrepresented in trials, she said,
calling attention to similar results for patients in a Mexican study
being presented as a poster at the ACR meeting.
In the latter study, F. Jorge Sanchez-Guerrero, MD, from the Instituto
Nacional de Ciencias Medicas y Nutricion in Mexico City, compared
the safety of combined oral contraceptives (COCs), progestin-only
oral contraceptives (POCs), and intrauterine devices (IUDs) in 162
women who met ACR criteria for SLE. The investigators concluded,
"Global disease activity and lupus flares were similar among
the three groups. COCs and POCs increased the risk of thrombotic
events, and IUD increased the risk of severe infections."
At the press conference, Dr. Sanchez-Guerrero said his group believes
the choice of a contraceptive method in women with lupus must take
into account the patient's condition, the methods, and "the
expressed desire of the woman."
Dr. Buyon told Medscape that making oral contraception an option
for SLE patients is important because it can also afford them protection
against osteoporosis and other disorders.
The SELENA trial required patients to use a back-up method of contraception
because they were blinded to whether they were receiving placebo
or an active contraceptive (triphasic 35 µg ethinylestradiol/0.5
- 1.0 mg norethindrone). Two unplanned pregnancies did occur,
according to Dr. Petrie.
Patients were excluded if they had a history of thrombosis or moderate-
to high-titer anticardiolipin antibodies or lupus anticoagulant.
The average age of participants was 30 years. At randomization,
about three quarters of patients had inactive disease, while the
rest had stable or active disease.
ACR 68th Annual Scientific Meeting: Abstract 523, presented Oct.
18, 2004; abstract 1845, presented Oct. 21, 2004.
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