Dataset Information

Prediction of fetal loss in Chinese pregnant patients with systemic lupus erythematosus: a retrospective cohort study.

ABSTRACT:

Objective

To develop a predictive model for fetal loss in women with systemic lupus erythematosus (SLE).

Design

A retrospective cohort study.

Setting

Data were collected in a tertiary medical centre, located in Shanghai, China, from September 2011 to May 2017.

Participants

338 pregnancies with SLE were analysed retrospectively. Cases of multiple pregnancy and those in which artificial abortion was performed for personal reasons were excluded.

Primary outcome measures

Fetal loss was the primary outcome. A stepwise regression to identify the predictors related to the fetal loss and coefficient B of each variable was used to develop a predictive model and make a corresponding risk classification. The Hosmer-Lemeshow test, Omnibus test and area under the receiver-operating characteristic curve (AUC) were used to assess the goodness-of-fit and discrimination of the predictive model. A 10-fold cross validation was used to assess the model for overfitting.

Results

Unplanned pregnancies (OR 2.84, 95% CI 1.12 to 7.22), C₃ hypocomplementemia (OR 5.46, 95%?CI 2.30 to 12.97) and 24 hour-urinary protein level (0.3?protein<1.0?g/24?hours: OR 2.10, 95% CI 0.63 to 6.95; protein?1.0?g/24?hours: OR 5.89, 95% CI 2.30 to 15.06) were selected by the stepwise regression. The Hosmer-Lemeshow test resulted in p=0.325; the Omnibus test resulted in p<0.001?and the AUC was 0.829 (95% CI 0.744 to 0.91) in the regression model. The corresponding risk score classification was divided into low risk (0-3) and high risk groups (>3), with a sensitivity of 60.5%, a specificity of 93.3%, positive likelihood ratio of 9.03 and negative likelihood ratio of 0.42.

Conclusions

A predictive model for fetal loss in women with SLE was developed using the timing of conception, C₃ complement and 24 hour-urinary protein level. This model may help clinicians in identifying women with high risk pregnancies, thereby carrying out monitoring or/and interventions for improving fetal outcomes.

SUBMITTER: Wu J

PROVIDER: S-EPMC6377554 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Prediction of fetal loss in Chinese pregnant patients with systemic lupus erythematosus: a retrospective cohort study.

Wu Jiayue J Zhang Wei-Hong WH Ma Jinghang J Bao Chunde C Liu Jinlin J Di Wen W

BMJ open 20190211 2

<h4>Objective</h4>To develop a predictive model for fetal loss in women with systemic lupus erythematosus (SLE).<h4>Design</h4>A retrospective cohort study.<h4>Setting</h4>Data were collected in a tertiary medical centre, located in Shanghai, China, from September 2011 to May 2017.<h4>Participants</h4>338 pregnancies with SLE were analysed retrospectively. Cases of multiple pregnancy and those in which artificial abortion was performed for personal reasons were excluded.<h4>Primary outcome measu ...[more]

PMID: 30755448

Similar Datasets

Project description:ObjectiveTo completely and quantifiably determine the effect of systemic lupus erythematosus (SLE) on pregnancy outcomes in a Chinese cohort.DesignA retrospective cohort study.SettingData were collected at a tertiary medical centre located in Shanghai, China, from September 2011 to May 2017.ParticipantsWe assigned 338 pregnant women with SLE to the study cohort and 1014 randomly selected pregnant women without SLE (three for every woman with SLE) to a comparison cohort. The relevant medical records of all pregnant women were retrospectively reviewed. Cases of multiple pregnancy and cases in which an artificial abortion was performed for personal reasons were excluded.Primary and secondary outcome measuresMaternal and fetal outcomes were primary outcomes, and management of antenatal care was the secondary outcome.ResultsThe risks of pregnancy-induced hypertension (OR 2.68, 95% CI 1.75 to 4.09), pre-eclampsia (OR 3.13, 95% CI 1.95 to 5.03) and premature rupture of membranes (OR 2.53, 95% CI 1.46 to 4.40) were significantly different between women with and without SLE. Gestational diabetes was negatively associated with SLE in pregnant women (OR 0.49, 95% CI 0.28 to 0.85). Pregnant women with SLE displayed significantly higher rates of fetal loss (OR 10.23, 95% CI 5.08 to 20.59), including spontaneous abortion (OR 4.42, 95% CI 1.52 to 12.80), therapeutic abortion (OR 16.57, 95% CI 5.80 to 47.35) and stillbirth (OR 13.25, 95% CI 1.49 to 118.11), and a higher risk of preterm birth (OR 3.15, 95% CI 2.21 to 4.50), intrauterine growth restriction (OR 2.20, 95% CI 1.35 to 3.58), a child who was small for the gestational age (OR 1.86, 95% CI 1.11 to 3.13), a caesarean section (OR 4.73, 95% CI 3.30 to 6.80) or a neonatal intensive care unit admission (OR 3.48, 95% CI 2.21 to 5.48) than women in the non-SLE population after adjusting for confounding factors.ConclusionsIn this study, SLE significantly increased the risk of adverse pregnancy outcomes. Therefore, a preconception assessment and close antenatal monitoring by both rheumatologists and obstetricians should be performed in pregnant women with SLE.

Project description:This study aims to analyze the relationship between pregnancy and lupus, and explore the risk factors that adversely affect maternal and infant outcomes.The pregnancy outcomes in 112 pregnant females (mean age 24.3±2.8 years; range 20 to 35 years) with systemic lupus erythematosus (SLE) were retrospectively analyzed. Pregnancy outcomes before and after pregnancy were compared, and the associations with lupus nephritis, positive anti-Ro/SSA antibody, positive La/SSB antibody, complement 3 and complement 4, high blood pressure, positive anti- cardiolipin (aCL) antibody, Raynaud's phenomenon, and lupus recurrence were evaluated. Factors contributing to adverse outcomes were analyzed using multinomial logistic regression.The live birth rate in females diagnosed with SLE before a pregnancy was higher than that in females diagnosed with SLE after a pregnancy. The fetal mortality rate in females diagnosed with SLE after a pregnancy was higher than that in females diagnosed with SLE before a pregnancy. However, the abortion rate in females diagnosed with SLE before a pregnancy was also significantly higher than that in females diagnosed with SLE after a pregnancy. The incidence of preterm birth in females diagnosed with SLE after a pregnancy was higher than that in females diagnosed with SLE after a pregnancy. Preterm birth was more likely to occur in females positive for Ro/SSA antibody. Patients with hypertension and Raynaud's phenomenon had a higher risk of intrauterine growth retardation. In addition, the presence of aCL antibody was associated with pregnancy loss. Multinomial logistic regression analysis showed that many factors might be associated with adverse pregnancy outcomes, including lupus nephritis, positive Ro/SSA antibody, positive La/SSB antibody, complement 3 and complement 4, positive aCL antibody, lupus recurrence, hypertension, and Raynaud's phenomenon.Lupus nephritis, Ro/SSA antibody, aCL antibody, hypertension, Raynaud's phenomenon, and lupus recurrence are important factors associated with adverse pregnancy outcomes.

Project description:Background and objectiveIntravenous (IV) belimumab is the first treatment approved for children ≥5 years of age with active autoantibody-positive systemic lupus erythematosus (SLE) in the USA, Europe, and Japan. Pharmacokinetic data for belimumab were collected from several clinical trials in Chinese and non-Chinese adults and non-Chinese pediatric patients with SLE. This study aimed to predict the belimumab dose-exposure relationship to Chinese pediatric patients with SLE, as part of the belimumab registration process for this population in China, using a population PK modeling approach.MethodsAn initial linear two-compartment population pharmacokinetic model was built using data from adults only, and considering and adjusting for the covariates age, body weight, body mass index, fat-free mass, race, baseline albumin and immunoglobulin G levels. The model was used to study possible ethnic differences between Chinese and non-Chinese adults and to predict pediatric pharmacokinetic data in a study of non-Chinese pediatric patients (PLUTO study; NCT01649765). The predicted data were compared with the observed data from PLUTO. The model was then updated with pediatric data from PLUTO to predict steady-state belimumab exposure in Chinese pediatric patients with SLE receiving belimumab 10 mg/kg IV every 4 weeks.ResultsThe dataset comprised 9650 sampled concentration values from 1783 patients. The pharmacokinetics of belimumab were adequately described by the final model using all adult and pediatric data with the estimated typical clearance of 238 ml/day in adult and pediatric patients and steady-state volume of distribution of 4915 ml in adults. Between-patient variability was modest (coefficients of variation: 26.1% for clearance; 8.9% and 28.5%, respectively, for volumes of distribution of the central and peripheral compartments). Six covariates were identified that influenced pharmacokinetics: age, fat-free mass, an indicator of North East Asian race, baseline albumin, immunoglobulin G, and an early study indicator (two early phase I and phase II belimumab studies: LBSL01 and LBSL02). The analysis showed no apparent difference in steady-state exposure between Chinese and non-Chinese populations and between pediatric and adult populations receiving belimumab 10 mg/kg IV.ConclusionsIn Chinese pediatric patients with SLE, belimumab 10 mg/kg IV every 4 weeks is expected to have exposure similar to that in Chinese adults and non-Chinese pediatric patients with SLE, supporting the use of this regimen in Chinese pediatric patients with SLE.Clinical trial registration numbersNCT01649765, NCT00657007, NCT00071487, NCT01345253, NCT01516450, NCT00410384, NCT00424476, NCT02880852, NCT01583530.

Project description:Background and objectivesOne hypothesis states that IgA nephropathy (IgAN) is a syndrome with an autoimmune component. Recent studies strongly support the notion of shared genetics between immune-related diseases. This study investigated single-nucleotide polymorphisms (SNPs) reported to be associated with systemic lupus erythematosus (SLE) in a Chinese cohort of patients with IgAN and in controls.Design, setting, participants, & measurementsThis study investigated whether SNP markers that had been reported to be associated with SLE were also associated with IgAN in a Chinese population. The study cohort consisted of 1194 patients with IgAN and 902 controls enrolled in Peking University First Hospital from 1997 to 2008.ResultsNinety-six SNPs mapping to 60 SLE loci with reported P values <1 × 10(-5) were investigated. CFH (P=8.41 × 10(-6)), HLA-DRA (P=4.91 × 10(-6)), HLA-DRB1 (P=9.46 × 10(-9)), PXK (P=3.62 × 10(-4)), BLK (P=9.32 × 10(-3)), and UBE2L3 (P=4.07 × 10(-3)) were identified as shared genes between IgAN and SLE. All associations reported herein were corroborated by associations at neighboring SNPs. Many of the alleles that are risk alleles for SLE are protective alleles for IgAN. By analyses of two open independent expression quantitative trait loci (eQTL) databases, correlations between genotypes and corresponding gene expression were observed (P<0.05 in multiple populations), suggesting a cis-eQTL effect. From gene-expression databases, differential expressions of these genes were observed in IgAN. Additive interactions between PXK rs6445961 and HLA-DRA rs9501626 (P=1.51 × 10(-2)), as well as multiplicative interactions between CFH rs6677604 and HLA-DRB1 rs9271366 (P=1.77 × 10(-2)), and between HLA-DRA rs9501626 and HLA-DRB1 rs9271366 (P=3.23 × 10(-2)) were observed. Disease risk decreased with accumulation of protective alleles. Network analyses highlighted four pathways: MHC class II antigen presentation, complement regulation, signaling by the B-cell receptor, and ubiquitin/proteasome-dependent degradation.ConclusionFrom this "systems genetics" perspective, these data provide important clues for future studies on pleiotropy in IgAN and lupus nephritis.

Dataset Information

Prediction of fetal loss in Chinese pregnant patients with systemic lupus erythematosus: a retrospective cohort study.

Objective

Design

Setting

Participants

Primary outcome measures

Results

Conclusions

Publications

Prediction of fetal loss in Chinese pregnant patients with systemic lupus erythematosus: a retrospective cohort study.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets