Abstract:Objectives: For women who suffer from systemic lupus erythematosus (SLE), pregnancy can be a concern, placing the mother and fetus at risk. Our objectives were to assess the risk of adverse pregnancy outcome, disease flares, fertility rate, and co-morbidities in SLE women compared to healthy controls. We also systematically reviewed the literature available on pregnancy outcome in SLE to compare our results to other published data. Our hypothesis was that pregnancy outcome in SLE is improving over time.Methods: A case-control study comparing self-report of the above-mentioned parameters in SLE (N=108) vs healthy controls or patients with non-inflammatory musculoskeletal (MSK) disorders (N=134) was performed. Data were collected using a self-administered questionnaire. Proportions, means and odds ratios were calculated. We searched and quantified the literature on pregnancy outcome, lupus reactivation and fertility rate. Data were summarized and presented in mean % ± SEM and median % with interquartile range (IQR).Results: Gynecological history, fertility rate and age at first pregnancy in SLE patients were comparable to controls. Eighteen percent of SLE patients reported a flare and 18% reported an improvement of symptoms during pregnancy. Twenty-four percent of lupus patients had at least one preterm delivery vs 5% in controls (OR =8.32, p = 0.0008), however other pregnancy outcomes (miscarriage, therapeutic abortion, stillbirth and neonatal death rate) did not differ between the groups. Thyroid problems were reported to be more likely in SLE patients (p = 0.02), but the prevalence of other co-morbidities was similar to controls. A literature review demonstrated that fertility was not affected in SLE patients. Lupus reactivations are common during pregnancy (36.5% ± SEM 3.3%). Most agreed that SLE pregnancies had more fetal loss (19.5% ± SEM 1.6%) and preterm births (25.5% ± SEM 2.2%) when compared to the general population. Over time, the rate of SLE peripartum flares has improved (p = 0.002) and the proportion of pregnancies resulting in live birth has increased (p = 0.024). The frequency of fetal death has not significantly changed. Our findings from the casecontrol study were, in general, consistent with the literature including the frequency of fetal death, neonatal death, live births and pregnancy rate.Conclusion: Prematurity (25.5% ± SEM 2.2%) and fetal death (19.5% ± SEM 1.6%) in SLE pregnancy are still a concern. However, new strategies with respect to pregnancy timing and multidisciplinary care have improved maternal and fetal outcome in SLE.

Objective. To determine the generalizability of randomized controlled trials (RCTs) in the treatment of systemic sclerosis (SSc) using the Canadian Scleroderma Research Group (CSRG) database. Methods. We identified articles related to SSc published from 1958 to 2006. Key points on trial design were recorded. The inclusion/exclusion criteria were used in conjunction with the CSRG database to determine the proportion of patients with SSc who would theoretically be eligible for these trials. Articles were classified into subcategories according to the target system. The CSRG database contains 438 patients with SSc from 14 Canadian centers. Results were in median (%) and mean (%) with 95% confidence intervals (95% CIs). Results. In total, 210 articles were evaluated and 73 were selected for inclusion in this study. The mean percentage of eligible patients with SSc associated with other conditions was 35% (95% CI 17-53) for Raynaud's phenomenon, 24% (95% CI 1-47) for digital ulcers, 48% (95% CI 27-68) for gastrointestinal (GI) involvement, 32% (95% CI 20 -43) for overall disease modification, 6% (95% CI 4 -8) for pulmonary arterial hypertension, 2% (95% CI 0 -4) for interstitial lung disease, and 38% (95% CI 12-64) for other categories. Conclusion. Except for GI trials, <38% of the identified patients with SSc would have been suitable to enter the RCTs. Although some patients would be ineligible because they lack certain organ involvement, RCTs designed to include appropriate patients with SSc are needed; there are few proven treatments and trials typically do not include the majority of those who could potentially benefit from the intervention.

The EIA-SCQ is reliable and valid for use in EIA. It has the potential to become a useful measure of comorbidity in outcome studies of EIA when the resources for a full medical chart review are unavailable.