scholarly journals Outcomes following biosimilar TNF inhibitors use for inflammatory-mediated immune disorders in pregnancy

2021 ◽  
pp. 1753495X2110287
Author(s):  
R Scott ◽  
H Parker ◽  
S Mccartney ◽  
P Harrow ◽  
D Williams ◽  
...  

Background Biosimilar tumour necrosis factor inhibitors (TNFi) are increasingly used to treat inflammatory immune-mediated disorders as they cost less than the originator biologic drug. More women are therefore becoming pregnant on biosimilar TNFi. This is the first paper to explore the safety and efficacy of biosimilar therapies in pregnancy. Methods A retrospective review of clinical data reviewed pregnancy outcomes and inflammatory disease activity in 18 pregnancies where the mother was using a biosimilar TNFi at conception. Results Biosimilar therapy was not associated with congenital abnormalities, preterm birth or other adverse pregnancy outcomes. Stopping biosimilar TNFi in pregnancy was associated with childbirth at an earlier gestation, as well as a flare of inflammatory disease in pregnancy or post-partum. Conclusions Women and clinicians should feel confident in using biosimilar TNFi in early pregnancy, and continuing them through pregnancy to prevent flares in late pregnancy or the early post-partum.

2014 ◽  
Vol 34 (5) ◽  
pp. 445-459 ◽  
Author(s):  
S Mozaffari ◽  
AH Abdolghaffari ◽  
S Nikfar ◽  
M Abdollahi

Several studies have indicated the harmful effect of flare-up periods in pregnant women with inflammatory bowel disease (IBD) on their newborns. Therefore, an effective and safe medical treatment during pregnancy is of great concern in IBD patients. The aim of this study was to perform a meta-analysis on the outcomes of thiopurines use and a systematic review of antitumor necrosis factor (anti-TNF) drugs used during pregnancy in women with IBD. The results of cohorts evaluating the safety of anti-TNF drugs during pregnancy up to July 2013 were collected and analyzed. In the meta-analysis, a total of 312 pregnant women with IBD who used thiopurines were compared with 1149 controls (women with IBD who were not treated with any medication and women who were exposed to drugs other than thiopurines) to evaluate the drug effect on different pregnancy outcomes, including prematurity, low birth weight, congenital abnormalities, spontaneous abortion, and neonatal adverse outcomes. Results of statistical analysis demonstrated that congenital abnormalities were increased significantly in thiopurine-exposed group in comparison with control group who did not receive any medicine for IBD treatment. The summary odds ratio was 2.95 with 95% confidence interval = 1.03–8.43 ( p = 0.04). We observed no significant differences in occurrence of other adverse pregnancy outcomes between compared groups. The results of cohorts evaluated the safety of anti-TNF drugs during pregnancy demonstrated no increase in occurrence of adverse pregnancy outcomes in comparison with controls except for the significant decrease in gestational age of newborns of drug-exposed mothers in one trial. In conclusion, a benefit–risk ratio should be considered in prescribing or continuing medicinal therapy during pregnancy of IBD patients.


2019 ◽  
Author(s):  
Ying Dong ◽  
Yanhong Zhai ◽  
Jing Wang ◽  
Xin Xie ◽  
Chunhong Zhang ◽  
...  

Abstract Background As one of the most common pregnant complications, the gestational diabetes mellitus (GDM) is associated with significant adverse pregnant outcomes and it is crucial to accurately monitor the glycemic states of GDM patients. The HbA1c which is a traditional long-term glycemic marker used in diabetic patients, is not recommended in GDM patients during pregnancy. Recently, many efforts have been focused on the alternative marker glycated albumin (GA) and its application in pregnancy during which profound physiological changes take place. Our objective was to determine the reference intervals (RIs) of GA in healthy Chinese pregnant women and to assess the predictive value of serum GA in adverse pregnant outcomes. Methods Totally 479 healthy subjects including 153 in the first trimester, 174 in the second trimester, and 152 in the third trimester were enrolled from March to July 2019, for the purpose of establishing the trimester-specific RIs of GA. The diagnostic value of GA for GDM patients was evaluated and compared with that of fasting plasma glucose (FPG) at 24-28 weeks of gestation. The association between GA in the late pregnancy and the adverse pregnant outcomes was analyzed retrospectively with the data collected from January to June 2018 at our hospital. Results The estimated RIs of GA in present study were 10.87-15.09 %, 10.04-13.50 %, and 9.78-13.03 % in the first, second, and third trimesters respectively. The areas under receiver operating characteristic (ROC) curves were 0.503 for GA and 0.705 for FPG. More importantly, the GA levels of the third trimester did not show significant changes in women with large-for-date birth weight, preterm delivery, postpartum hemorrhage or hypertension when compared in women with normal pregnancy outcomes. The exception was that the GDM patients who developed preeclampsia did have a lower GA level in their late pregnancy. Conclusions Our results show that the GA was continuously decreased as the gestational age went up. It has limited value in diagnosing GDM and predicting adverse pregnancy outcomes.


2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Tanapak Wisetmongkolchai ◽  
Fuanglada Tongprasert ◽  
Kasemsri Srisupundit ◽  
Suchaya Luewan ◽  
Kuntharee Traisrisilp ◽  
...  

AbstractObjectivesTo compare the rate of fetal loss in pregnancy after second trimester amniocentesis between procedures performed by experts and non-experts and to assess other pregnancy complications as secondary outcomes.MethodsA retrospective cohort study was performed on singleton pregnancies that underwent mid-trimester amniocenteses in a single institution. The fetal loss rates of procedures performed by experts and non-experts were collected and analyzed. Other adverse pregnancy outcomes were also examined.ResultsIn total, 14,450 amniocenteses were performed during the study period. These included 11,357 (78.6%) procedures in the group expert operators and 3,093 (21.4%) procedures in the group non-expert operators. In the non-expert group, the fetal loss rate was slightly increased but not significantly (p=0.24).In addition, the higher number of spontaneous abortions was associated with blood-stained amniotic fluid sample (p<0.001; RR=9.28). Multiple needle insertions also increased in the non-expert group significantly. However, no difference in pregnancy outcomes was found between in single and multiple needle insertions.ConclusionsThe amniocentesis procedures performed by the non-experts was not increase the fetal loss rate. However, the other adverse pregnancy outcomes, including preterm birth, low birth weight and fetal growth restriction were significantly increased in the non-expert group.


2019 ◽  
Vol 34 (1) ◽  
pp. 36-42
Author(s):  
Sameena Chowdhury ◽  
Sharmin Abbasi

Dengue fever during pregnancy is increasing day by day in Bangladesh. The knowledge of adverse effects on mother and neonate remains limited and there are also lack of management guideline in this regard. Mortality rate for severe dengue fever is 0.8–2.5%, and pregnancy should be considered as a coexisting risk factor for serious infection. However, the maternal and fetal outcomes not fully understood. Some review articles on outcomes of neonates born to mother with dengue fever was reported, and demonstrated that preterm birth and low birth weight were the most common adverse pregnancy outcomes; however, dengue fever was not significantly associated with these adverse outcomes, suggesting that symptomatic dengue fever may indicate risk. Other adverse effects such as stillbirth or postpartum hemorrhage (PPH) remain unclear. Therefore, we aimed to brief review of recent management guideline of OGSB about dengue fever in pregnancy. Bangladesh J Obstet Gynaecol, 2019; Vol. 34(1): 36-42


Circulation ◽  
2020 ◽  
Vol 141 (Suppl_1) ◽  
Author(s):  
Amanda M Perak ◽  
Alan Kuang ◽  
Nicola Lancki ◽  
Darwin R Labarthe ◽  
Svati H Shah ◽  
...  

Introduction: Gestational hyperlipidemia has traditionally been considered physiologic and benign, but the significance of inter-individual variation in lipid levels for maternal-fetal health are poorly understood. We examined associations of gestational lipids and apolipoproteins with adverse obstetric and neonatal outcomes. Methods: Data from the Hyperglycemia and Adverse Pregnancy Outcome Study were analyzed, including 1,813 mother-child dyads from 9 field centers in 6 countries: US (25%), Barbados (24%), UK (20%), China (16%), Thailand (8%), and Canada (7%). Fasting lipids and apolipoproteins were directly measured at a mean of 28 (range 23-34) weeks’ gestation. Cord blood was collected at delivery, neonatal anthropometrics were measured within 72 hours, and medical records were abstracted for obstetric outcomes. Logistic regression was utilized to test associations of lipids and apolipoproteins (per +1 SD; log-transformed if skewed) with pregnancy outcomes, adjusted for center, demographics, and maternal covariates such as BMI, blood pressure, and glycemia. Results: See Table for lipid and apolipoprotein levels in pregnant mothers. In fully adjusted models ( Table ), 1 SD higher log-triglycerides (i.e., ~2.7-fold higher triglyceride level) in late pregnancy was significantly associated with higher odds for preeclampsia (OR 1.53 [95% CI, 1.15-2.05]), large for gestational age infant (1.42 [1.21-1.67]), and infant insulin sensitivity <10 th percentile (1.25 [1.03-1.50]), but not with unplanned primary cesarean section or infant sum of skinfolds >90 th percentile. There were no significant associations of maternal HDL-C, LDL-C, or log-ApoB/A1 ratio with any outcome. Conclusion: Triglyceride levels in the latter half of pregnancy were uniquely associated with both maternal risks (preeclampsia) and neonatal risks (large for gestational age and insulin resistance), even after adjustment for maternal BMI, blood pressure, and glycemia.


BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e038187
Author(s):  
Yuelin Wu ◽  
Sheng Wan ◽  
Shengyi Gu ◽  
Zhengqian Mou ◽  
Lingling Dong ◽  
...  

ObjectiveTo assess the associations of gestational weight gain (GWG) in early and late pregnancy with subsequent risks of adverse pregnancy outcomes in Chinese women.DesignProspective cohort study.SettingShanghai, China.ParticipantsWe studied 2630 nulliparous singleton pregnant women with complete data on weight gain in early (≤17 weeks of gestation) and late (>17 weeks) pregnancy in the Shanghai Birth Cohort.MethodsGWG was standardised into z-scores by gestational age and categorised as low (z-score <−1), normal (−1 to +1) and high (>1). The adjusted relative risks (aRRs) and 95%CIs were estimated through log-binomial regression models. Interaction effects between GWG and some other adjustment factors were tested, further stratified analyses were performed separately where interaction terms were significant.Outcome measuresAdverse maternal and neonatal outcomes.ResultsIndependent from GWG in late pregnancy, higher GWG in early pregnancy was associated with higher risks of gestational diabetes mellitus (aRR: 1.66; 95% CI: 1.11 to 2.48), caesarean section (aRR: 1.21; 95% CI: 1.05 to 1.39) and prolonged hospitalisation (aRR: 1.56; 95% CI: 1.03 to 2.38). Higher GWG in late pregnancy was independently associated with higher risks of caesarean section (aRR: 1.24; 95% CI: 1.09 to 1.41), large for gestational age (aRR: 2.01; 95% CI: 1.50 to 2.7) and macrosomia (aRR: 1.90; 95% CI: 1.30 to 2.78). In addition, the risk of gestational hypertension increased significantly with increased total GWG (aRR: 1.78; 95% CI: 1.14 to 2.76). The effects of GWG in late pregnancy on maternal and neonatal outcomes were significantly different between the women bearing a female and the women bearing male fetus.ConclusionThe GWG associations with adverse pregnancy outcomes differ at early and late pregnancy, and there may be effect modification by fetal sex in the association of GWG in late pregnancy with some pregnancy outcomes.


2018 ◽  
Vol 38 (4) ◽  
pp. 461-465 ◽  
Author(s):  
Soon Leong Yong ◽  
Beng Kwang Ng ◽  
Muhammad Abdul Jamil Mohd Yassin ◽  
Syed Zulkifli Syed Zakaria ◽  
Nor Azlin Mohamed Ismail

1974 ◽  
Vol 47 (6) ◽  
pp. 559-565 ◽  
Author(s):  
P. F. Semple ◽  
W. Carswell ◽  
J. A. Boyle

1. A serial study of renal clearance of urate and inulin was made in thirteen normal women in early, mid and late pregnancy and 6–15 weeks after delivery. 2. The mean serum urate concentration was low in early and mid pregnancy but rose in late pregnancy towards the control value. 3. Clearances of urate and inulin were consistently elevated throughout pregnancy to about 150% of the post-partum values. The ratio of clearance of urate to clearance of inulin was the same in pregnancy as it was after the puerperium. 4. The urinary excretion of urate was increased only in late pregnancy.


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