A trial of contraceptive methods in women with systemic lupus erythematosus.
BACKGROUND
The effects of estrogen-containing contraceptives on disease activity in women with systemic lupus erythematosus have not been determined.


METHODS
We conducted a single-blind clinical trial involving 162 women with systemic lupus erythematosus who were randomly assigned to combined oral contraceptives, a progestin-only pill, or a copper intrauterine device (IUD). Disease activity was assessed at 0, 1, 2, 3, 6, 9, and 12 months according to the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI). The primary outcome was global disease activity, which we estimated by measuring the area under the SLEDAI curve. Secondary outcomes included the maximum SLEDAI score, change in SLEDAI score, incidence of lupus flares, median time to first flare, systemic lupus erythematosus treatment, and adverse events. The results were analyzed by the intention-to-treat method.


RESULTS
At baseline, all demographic features and disease characteristics were similar in the three groups. The mean (+/-SD) SLEDAI score was 6.1+/-5.6 in the group assigned to combined oral contraceptives, 6.4+/-4.6 in the group assigned to the progestin-only pill, and 5.0+/-5.3 in the group assigned to the IUD (54 patients in each group) (P=0.36). Disease activity remained mild and stable in all groups throughout the trial. There were no significant differences among the groups during the trial in global or maximum disease activity, incidence or probability of flares, or medication use. The median time to the first flare was three months in all groups. Thromboses occurred in four patients (two in each of the two groups receiving hormones), and severe infections were more frequent in the IUD group. One patient receiving combined oral contraceptives died from amoxicillin-related severe neutropenia.


CONCLUSIONS
Global disease activity, maximum SLEDAI score, incidence of flares, time to first flare, and incidence of adverse events were similar among women with systemic lupus erythematosus, irrespective of the type of contraceptive they were using.
Sánchez-Guerrero
Jorge
J
Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico. jsanchez@innsz.mx
Uribe
América G
AG
Jiménez-Santana
Luisa
L
Mestanza-Peralta
Marilú
M
Lara-Reyes
Pilar
P
Seuc
Armando H
AH
Cravioto
María-del-Carmen
MD
D000328:Adult; D003276:Contraceptives, Oral / Q000009:adverse effects; D004997:Ethinyl Estradiol / Q000009:adverse effects; D005260:Female; D006801:Humans; D007434:Intrauterine Devices; D016912:Levonorgestrel / Q000009:adverse effects; D008180:Lupus Erythematosus, Systemic / Q000145:classification / Q000503:physiopathology; D011247:Pregnancy; D012720:Severity of Illness Index; D016037:Single-Blind Method
D003276:Contraceptives, Oral; D004997:Ethinyl Estradiol; D016912:Levonorgestrel