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Medication use among pregnant women with systemic lupus erythematosus and general population comparators.

ABSTRACT: The aim was to characterize SLE medication trends before, during and after pregnancy and to compare other commonly used medications during SLE pregnancies with non-SLE pregnancies.Women with pregnancies ending in live birth or stillbirth were identified from the Swedish Medical Birth Register (2006-12). National registers were used to identify women with prevalent SLE during pregnancy and a sample without SLE and to identify prescription medications dispensed from 3 months pre-pregnancy until 6 months postpartum. We reported the prevalence of DMARDs, systemic CSs and NSAIDs (aspirin reported separately) in SLE pregnancies. We calculated prevalence estimates of other medications that were dispensed during pregnancy to ? 5% of SLE pregnancies and for the same medications among non-SLE pregnancies.There were 483 pregnancies among women with SLE and 5723 pregnancies among women without SLE. In SLE pregnancies, 49.3% had one or more dispensing for DMARDs during pregnancy; the prevalence was 48.0% for CSs, 40.8% for aspirin and 6.0% for other NSAIDs and varied by pregnancy period. The prevalence of common medications among SLE pregnancies was 1.2- to 20-fold higher than among non-SLE pregnancies; for example, dalteparin (20.9 vs 1.0%), paracetamol (18.2 vs 2.9%) and levothyroxine (15.9 vs 4.9%).In nearly half of SLE pregnancies, women were dispensed DMARDs and CSs. Commonly used medications in SLE pregnancies had far higher prevalence estimates compared with non-SLE pregnancies. Research regarding benefits and risks of commonly used medications on SLE pregnancies, breast milk and long-term outcomes for offspring is needed.

SUBMITTER: Palmsten K

PROVIDER: S-EPMC5850850 | biostudies-other | 2017 Apr

REPOSITORIES: biostudies-other

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Medication use among pregnant women with systemic lupus erythematosus and general population comparators.

Palmsten Kristin K Simard Julia F JF Chambers Christina D CD Arkema Elizabeth V EV

Rheumatology (Oxford, England) 20170401 4

<h4>Objective</h4>The aim was to characterize SLE medication trends before, during and after pregnancy and to compare other commonly used medications during SLE pregnancies with non-SLE pregnancies.<h4>Methods</h4>Women with pregnancies ending in live birth or stillbirth were identified from the Swedish Medical Birth Register (2006-12). National registers were used to identify women with prevalent SLE during pregnancy and a sample without SLE and to identify prescription medications dispensed fr ...[more]

PMID: 28013193

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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:Practicing physicians have requested efficacy and safety data for belimumab, when used with specific systemic lupus erythematosus (SLE) medications. This was a post hoc analysis of pooled efficacy and safety data from patients who received belimumab 10 mg/kg plus standard of care (SoC) or placebo (SoC) in two Phase III, randomized trials, BLISS-52 and BLISS-76. Patients were categorized into four groups based on baseline concomitant medication usage: steroids only; antimalarials (AM) only; steroids + AM; or steroids + AM + immunosuppressants (IS). The primary endpoint was the SLE Responder Index (SRI) at Week 52. SRI over time and individual SRI components were secondary endpoints. Time to first flare and changes in concomitant medications were exploratory endpoints. Safety was assessed using adverse event (AE) reporting. Across 834 patients, steroids + AM was the largest group (n = 346, 41.5%) and AM only was the smallest (n = 77, 9.2%). Disease duration was shortest in the steroids + AM group (5.7 years vs 6.4-7.1 years); SELENA-SLEDAI scores were similar across groups. At Week 52, the percentage of SRI responders was greatest in the steroids + AM group for belimumab 10 mg/kg (59%) compared with placebo (44%); treatment response and SRI component improvements were also observed across other groups. The probability of experiencing an SLE flare was reduced in the steroids-only group for patients who received belimumab 10 mg/kg compared with placebo (64.3% vs 78.1%; hazard ratio 0.64; 95% confidence interval: 0.42-0.96). There was little or no change in daily AM or IS dose in any group. For all groups, there was a general decrease in steroid dose over time; a quarter to a third of patients experienced decreased steroid doses at Week 52. The overall safety profile was similar across treatment arms and concomitant medication groups, with the exception of serious AEs in the steroids + AM group (belimumab 10 mg/kg 16%, placebo 8%). The efficacy and safety of belimumab in combination with SoC was demonstrated for various groupings of steroids, AM and IS. These findings may improve the understanding of the safety and efficacy of adding belimumab to different treatments.

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Medication use among pregnant women with systemic lupus erythematosus and general population comparators.

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Medication use among pregnant women with systemic lupus erythematosus and general population comparators.

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