Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disorder that primarily affects reproductive-aged women and often presents after puberty. 1 With the exception of barrier methods, prescribing safe and appropriate contraception in women with SLE often presents a challenge to the practitioner involved in female health care as exogenous estrogen is believed to cause flare-ups in SLE activity as well as exacerbate hypercoagulability. 2 This is especially a concern and relative contraindication in those patients who also suffer from antiphospholipid antibody syndrome (APS).
SAFETY OF ESTROGEN IN LUPUS ERYTHEMATOSUS NATIONAL ASSESSMENT TRIAL
The Safety of Estrogen in Lupus Erythematosus National Assessment (SELENA) trial, funded by the National Institutes of Health, was announced in 1996 as the first randomized, double-blind placebo-controlled multi-center clinical trial to study the safety of exogenous use of estrogen in women with SLE. The purpose of this study was to determine the effects of both oral contraceptive (OC) use and estrogen use in hormone replacement therapy (HRT) on SLE disease activity and severity. 3
This study, however, was recently halted due to lack of patient enrollment in the OC arm of the study as well as the July findings of the Women’s Health Initiative concerning use of HRT. In a personal communication with Lisa Sigler, research manager to Michelle M. Petri, MD, director of the Johns Hopkins Lupus Center, the patients enrolled in both the HRT and OC arms of the trial are still following up with this research facility, and this center anticipates publication of findings by the end of 2003.
While there is no definite proof that combination OCs exacerbate SLE, it does appear that some women with SLE may be more likely to suffer adverse events from use. In addition, there is concern that OC use can increase the risk of, and induce thromboses in women with SLE who also suffer from APS. 4 It does appear best to avoid combination OCs in SLE patients with high levels of antiphospholipid antibodies, and it is contraindicated for use in patients with active lupus nephritis. 5 However, recent data suggest that OC use may be safe for some groups of women with SLE.
Lakasing and Khamashta conducted a questionnaire-based study to determine contraceptive practices of women with SLE and/or APS to establish incidence of complications related to use of different types of contraceptives. This study comprised of 86 women with SLE and/or APS. 6
One of the 19 (5%) women with SLE who used OCs at the time of diagnosis reported a severe lupus flare; seven of 32 (22%) of the women with APS using OCs suffered from thromboses during OC use; and there were no reported problems specific to patients with SLE and/or APS who reported using other forms of contraception. 6 Based on these results, the authors concluded that there was no clinically significant association between OC use and lupus flare. However, there was a higher incidence of thromboses in women with APS who used OCs containing second or third generation progestogens, which suggests that women with this condition should be advised against OC use. 6
In 1999, Rampone et al conducted a study to assess the relationship between OC use in women with SLE. 7 In this study, 20 reproductive-aged women with SLE who specifically suffered from cutaneous manifestations were studied for 1 year of use. 7 All participants in this group were prescribed gestodene at a dose of 0.075 mg and etinilestrdiol at a dose of 0.02 mg per day. These patients were compared with a similar control group of women with SLE not using OCs. 7
In the results, 5 out of the 20 patients were required to stop OC use 4 or 5 months into the study; this discontinuation was due to SLE relapse. The remaining 15 patients did not suffer from relapse of SLE. Based on these findings, the authors concluded that use of newer estrogen-protestogen OCs does not constantly cause exacerbation of SLE in women. 7 However, the authors do recommend strict follow-up and management of all patients with SLE using hormonal contraceptives. 7