P599 Trimester exposure and pregnancy outcomes in women exposed to golimumab: Results from the company pharmacovigilance database

Abstract Background Rheumatologic disorders and inflammatory bowel disease can affect women of childbearing potential. Golimumab (GLM) is approved for several rheumatological indications and ulcerative colitis (UC). To characterise pregnancy outcomes in patients treated with GLM, data obtained from maternal exposure to GLM are presented. Methods These dataset includes individual patient cases reported to the manufacturer through 06 April 2019. Cases included in the analysis were medically confirmed cases of maternal exposures to GLM during pregnancy or within 3 months prior to conception, and a reported pregnancy outcome. Both prospectively reported (ie, pregnancy outcome not known when first reported) and retrospectively reported cases (ie, pregnancy outcome known when first reported) were included. Cases originated from various sources, including spontaneous reporting, clinical studies, and registries. Results Two hundred eight pregnancy cases (131 rheumatological; 43 UC; and 34 other) with 211 reported birth outcomes were identified. Three cases reported twin pregnancies. Of the 208 pregnancy cases, 119 were prospective and 89 were retrospective (Table 1). Average maternal age was 31.9 years. Of the 119 prospectively reported pregnancy cases, 89 (74.8%) resulted in live births, 19 (16.0%) resulted in spontaneous abortion (of these, 42.1% (8/19) received GLM in combination with methotrexate [MTX]), 10 (8.4%) resulted in induced/elective abortion, and 1 (0.8%) resulted in ectopic pregnancy. Overall, 9 congenital anomalies were reported (2 prospective/7 retrospective cases). For 183 of the 208 pregnancy cases with-reported outcomes, the trimester of exposure to GLM was known (Table 2). Among the 110 prospectively reported cases, 82 (74.5%) were exposed during trimester 0 or 1. Of these, 19 had concomitant exposure to MTX, with the following birth outcomes: 8 live births, 8 spontaneous abortions, 3 elective/induced abortions. Eighteen of the prospectively reported cases (16.4%) were exposed to GLM throughout pregnancy (first, second and third trimester) and all resulted in live births. Conclusion The rates of congenital malformations and spontaneous abortions were consistent with published background rates for the general population. Persistent exposure throughout pregnancy was rare, but not associated with apparent clinical sequelae. Limitations of this analysis include the lack of a direct comparison group, the variable amount of data available in the reports, and the possible bias towards reporting more negative outcomes in retrospective cases.

Download Full-text

SAT0117 TRIMESTER EXPOSURE AND PREGNANCY OUTCOMES IN WOMEN EXPOSED TO GOLIMUMAB – RESULTS FROM THE COMPANY PHARMACOVIGILANCE DATABASE

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.2796 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 992.2-992

Author(s):

M. Otero-Lobato ◽

S. Esslinger ◽

S. Gabriel ◽

M. Clark ◽

P. Sheridan ◽

...

Keyword(s):

Pregnancy Outcome ◽

Birth Outcomes ◽

Pregnancy Outcomes ◽

Congenital Anomalies ◽

Spontaneous Abortions ◽

Live Births ◽

Elective Abortion ◽

Induced Abortions ◽

Pharmacovigilance Database ◽

Inflammatory Bowel

Background:Rheumatologic disorders and inflammatory bowel disease can affect women of childbearing potential. Golimumab (GLM) is approved for several rheumatologic indications and ulcerative colitis (UC).Objectives:To characterize pregnancy outcomes in patients treated with GLM, data obtained from maternal exposure to GLM are presented.Methods:This dataset includes individual patient cases reported to the manufacturer through 06 April 2019. Cases included in the analysis were medically confirmed cases of maternal exposures to GLM during pregnancy or within 3 months prior to conception, and a reported pregnancy outcome. Both prospectively reported (ie, pregnancy outcome not known when first reported) and retrospectively reported cases (ie, pregnancy outcome known when first reported) were included. Cases originated from various sources, including spontaneous reporting, clinical studies, and registries.Results:Two hundred eight pregnancy cases (131 rheumatologic indications; 43 UC; and 34 other) with 211 reported birth outcomes were identified. Of these 208 pregnancy cases, 119 were prospective and 89 were retrospective. Average maternal age was 31.9 years. Of the 119 prospectively reported pregnancy cases, 89 (74.8%) resulted in live births, 19 (16.0%) resulted in spontaneous abortion (of these, 42.1% (8/19) received GLM in combination with methotrexate [MTX]), 10 (8.4%) resulted in induced/elective abortion, and 1 (0.8%) resulted in ectopic pregnancy. Overall, 9 congenital anomalies were reported (2 prospective and 7 retrospective cases).For 183 of the 208 pregnancy cases with reported outcomes, the trimester of exposure to GLM was known. Among the 110 prospectively reported cases, 82 (74.5%) were exposed during trimester 0 or 1. Of these, 19 had concomitant exposure to MTX, with the following birth outcomes: 8 live births, 8 spontaneous abortions, 3 elective/induced abortions. Eighteen of the prospectively reported cases (16.4%) were exposed to GLM through trimesters 1-3 and all resulted in live births (none with congenital anomalies; 1 infant with exposure to GLM and MTX was born preterm).Conclusion:The rates of congenital malformations and spontaneous abortions were consistent with published background rates for the general population. Persistent exposure throughout pregnancy was rare. Limitations of this analysis include the lack of a direct comparison group, the variable amount of data available in the reports, and the possible bias towards reporting more negative outcomes in retrospective cases.Disclosure of Interests:Marijo Otero-Lobato Shareholder of: Johnson & Johnson, Employee of: Johnson & Johnson, Suzan Esslinger Shareholder of: Johnson & Johnson, Consultant of: Johnson & Johnson, Novartis, Eli Lilly and Sandoz, Employee of: Johnson & Johnson, Susan Gabriel Shareholder of: Johnson & Johnson, Employee of: Johnson & Johnson, Merck, GSK, Michael Clark Shareholder of: Johnson & Johnson, Employee of: Johnson & Johnson, Pamela Sheridan Shareholder of: Johnson & Johnson, Roche Pharmaceuticals, Employee of: Johnson & Johnson, Roche, Novartis, Bayer, Anja Geldhof Shareholder of: Johnson & Johnson, Employee of: Johnson & Johnson

Download Full-text

O-234 Using serum metabolomics to identify biomarkers of viable early, intrauterine pregnancy: an untargeted 1H NMR-based approach

Human Reproduction ◽

10.1093/humrep/deab128.058 ◽

2021 ◽

Vol 36 (Supplement_1) ◽

Author(s):

C Hill ◽

M Phelan ◽

A Horne ◽

K Gemzell-Danielsson ◽

N Tempest ◽

...

Keyword(s):

Pregnant Women ◽

Pregnancy Outcome ◽

1H Nmr ◽

Early Pregnancy ◽

Pregnancy Outcomes ◽

Hydatidiform Mole ◽

First Trimester ◽

Intrauterine Pregnancy ◽

Ectopic Pregnancies ◽

Twin Pregnancies

Abstract Study question Which metabolites are associated with a viable intrauterine pregnancy (VIUP) when compared to other early pregnancy outcomes (failed intrauterine and ectopic pregnancies)? Summary answer Serum levels of four metabolites (phenylalanine, alanine, glutamate and glutamine) were significantly altered in VIUPs compared to other early pregnancy outcomes. What is known already Around 10% of all intrauterine pregnancies are lost in the first trimester. A further 1-2% of pregnancies are located outside the endometrial cavity; these ectopic pregnancies are the leading cause of maternal mortality in the first trimester of gestation. Early miscarriages may also cause significant morbidity when bleeding or infection occurs. The symptoms of miscarriages and ectopic pregnancy are often similar (pain and bleeding), however, such symptoms are also common in VIUPs. To date, no biomarkers have been identified to differentiate VIUPs from non-viable and ectopic pregnancies. Study design, size, duration This is a prospective cohort study that included 332 pregnant women at less than ten weeks of gestation, who attended the early pregnancy assessment unit (EPAU) at Liverpool Women’s Hospital with pain and/or bleeding. Participants/materials, setting, methods Blood samples were collected from the 332 pregnant women prior to final clinical diagnosis of pregnancy outcome. Serum samples were subjected to NMR metabolomics profiling (14 spectra that did not meet the recommended minimum reporting standards were removed from subsequent analysis). 1D 1H-NMR spectra were acquired at 37 °C on a 700 MHz spectrometer. Relative metabolite abundances underwent statistical analysis using MetaboAnalyst 5.0 (p-value FDR adjusted). Main results and the role of chance Final pregnancy outcomes were as follows: one hydatidiform mole (0.3%), 48 ectopic pregnancies (14.4%), three pregnancies of unknown location (PULs, 0.9%), 78 failed pregnancies of unknown location (FPULs, 23.4%), 47 miscarriages (14.1%), two vanishing twin pregnancies (0.6%) and 153 VIUPs (45.8%). Due to small sample numbers, the hydatidiform mole, PULs and vanishing twin pregnancies were excluded from further analysis. To compare VIUPs to other pregnancy outcomes, ectopic pregnancies, FPULs and miscarriages were grouped together. Univariate analysis of serum metabolite concentrations identified four metabolites (phenylalanine, alanine, glutamate and glutamine) as significantly different in VIUPs compared to other pregnancy outcomes. Multivariate partial least squared discriminant analysis provided only weak correlation between the serum metabolome and pregnancy outcome. In summary, we have identified differences in the metabolome of women with VIUPs compared to other common pregnancy outcomes, which may provide diagnostic utility. Limitations, reasons for caution In this study, women with VIUPs presented with pain and/or bleeding. The presence of symptoms may influence the metabolome of this group versus VIUPs without symptoms, thus limiting the translation of our findings. Furthermore, environmental factors were not controlled (e.g. fasting status), making it likely that cohort heterogeneity was enhanced. Wider implications of the findings This study identifies a metabolite profile associated with VIUPs. These findings may be useful in the development of a diagnostic test to confirm VIUPs and thus exclude potentially life-threatening pregnancy outcomes. Such a test would be invaluable in clinical emergencies. Trial registration number NA

Download Full-text

Pregnancy Outcomes in Subjects Exposed to Certolizumab Pegol

The Journal of Rheumatology ◽

10.3899/jrheum.140189 ◽

2015 ◽

Vol 42 (12) ◽

pp. 2270-2278 ◽

Cited By ~ 46

Author(s):

Megan E.B. Clowse ◽

Douglas C. Wolf ◽

Frauke Förger ◽

John J. Cush ◽

Amanda Golembesky ◽

...

Keyword(s):

Pregnancy Outcomes ◽

Additional Data ◽

Certolizumab Pegol ◽

Harmful Effect ◽

First Trimester ◽

Safety Database ◽

Live Births ◽

Induced Abortions ◽

Concomitant Medications ◽

Almost All

Objective.To provide information on pregnancy outcomes in women receiving certolizumab pegol (CZP).Methods.The UCB Pharma safety database was searched for pregnancies through to September 1, 2014. Reports for maternal and paternal CZP exposure were included and outcomes examined, and data on CZP exposure, pregnancy, comorbidities, and infant events were extracted by 2 independent reviewers. Concomitant medications and disease activity were reviewed for clinical trial patients.Results.Of 625 reported pregnancies, 372 (59.5%) had known outcomes. Paternal exposure pregnancies (n = 33) reported 27 live births, 4 miscarriages, 1 induced abortion, and 1 stillbirth. Maternal exposure pregnancies (n = 339) reported 254 live births, 52 miscarriages, 32 induced abortions, and 1 stillbirth. Almost all reported pregnancies had exposure to CZP in the first trimester, when organogenesis takes place, and a third of them continued the drug into the second and/or third trimesters. The most frequent indications for maternal CZP use were Crohn disease (192/339) and rheumatic diseases (118/339). Twelve cases of congenital malformation and a single neonatal death were reported.Conclusion.Analysis of pregnancy outcomes after exposure to CZP supports previous reports, suggesting a lack of harmful effect of maternal CZP exposure on pregnancy outcomes. However, additional data from a larger number of outcomes after exposure and studies including an unexposed comparison group are required to fully evaluate CZP safety and tolerability in pregnancy.

Download Full-text

Pregnancy outcomes from the global pharmacovigilance database on interferon beta-1b exposure

Therapeutic Advances in Neurological Disorders ◽

10.1177/1756286420910310 ◽

2020 ◽

Vol 13 ◽

pp. 175628642091031 ◽

Cited By ~ 4

Author(s):

Kerstin Hellwig ◽

Fernando Duarte Caron ◽

Eva-Maria Wicklein ◽

Aasia Bhatti ◽

Alessandra Adamo

Keyword(s):

Cohort Study ◽

Health Status ◽

Spontaneous Abortion ◽

Birth Defects ◽

Pregnancy Outcomes ◽

Congenital Anomalies ◽

Interferon Beta ◽

Live Births ◽

Congenital Birth Defects ◽

Pharmacovigilance Database

Background: The goal of the present cohort study was to review outcomes of patients exposed to interferon beta-1b during pregnancy. Methods: Pregnancy cases with exposure to interferon beta-1b reported to Bayer’s pharmacovigilance (PV) database from worldwide sources from January 1995 through February 2018 were retrieved for evaluation. Only cases where pregnancy outcomes were unknown at the time of reporting (i.e. prospective cases) were included in the analysis of this retrospective cohort study. Results: As of February 2018, 2581 prospective pregnancies exposed to interferon beta-1b were retrieved from the database; 1348 pregnancies had documented outcomes. The majority of outcomes [1106 cases (82.0%)] were live births. Health status was known for 981 live births (no known health status for 125). Most of the prospective pregnancies with known outcomes corresponded to live births with no congenital anomalies [896 cases (91.3%)]. Spontaneous abortion occurred in 160 cases (11.9%). Congenital birth defects were observed in 14/981 live births with known health status [1.4%, 95% confidence interval (CI) 0.78–2.38]. No consistent pattern in the type of birth defect was identified. Rates of both spontaneous abortion and birth defects were not higher than the general population. Conclusions: These PV data, the largest sample of interferon beta-1b-exposed patients reported to date, suggest no increase in risk of spontaneous abortion or congenital anomalies in women exposed during pregnancy.

Download Full-text

N11 Pregnancy Outcomes in Patients with inflammatory bowel disease: A single-centre experience

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjz203.995 ◽

2020 ◽

Vol 14 (Supplement_1) ◽

pp. S662-S662

Author(s):

Y BAILEY ◽

C Hanna ◽

A O’Connor ◽

N Breslin ◽

B Ryan ◽

...

Keyword(s):

Inflammatory Bowel Disease ◽

Bowel Disease ◽

Pregnancy Outcomes ◽

Congenital Abnormalities ◽

Post Partum ◽

National Average ◽

Live Births ◽

National Rate ◽

Vaginal Deliveries ◽

Inflammatory Bowel

Abstract Background This study aimed to examine the current management and outcomes in pregnancy in our cohort of inflammatory bowel disease (IBD) patients. Methods Following ethical approval patients with at least one pregnancy with known Crohn’s Disease (CD) or Ulcerative Colitis (UC) were identified. Using a self-assessment questionnaire basic demographic, clinical data and pregnancy outcomes were recorded. Results Eighty-five patients were recruited between January and October 2019; 38 CD, 26 UC and 1 Indeterminate (ID). The mean age was 28.6 years (range 14–46 years) at diagnosis. In total there were 199 pregnancies: 168 live births, 2 stillbirths (1%); lower than the national rate of 3.0 per 1000 and 29 miscarriages (14.5%) compared with national rates of 1 in 5. The majority attended routine combined GP and maternity services, only 17 (20%) attended a specific high-risk maternity clinic. Biologic usage was similar pre and during pregnancy; 16 (22%), 11 (16%) with a slight increase post pregnancy 19 (30%). Overall 26% continued to smoke and 7% drank alcohol during their pregnancy. The total of reported flares were less frequent during pregnancy 45% (n = 35) vs. pre-partum 61% (n = 47) and post-partum 79% (n = 61), p = 0.021. In all there were 138 vaginal deliveries and 32 (19%) caesarean sections (CS). CS rates did not differ by disease type, UC 9/26 & CD 26/58, p = 0.4 There were 12 (7%) preterm deliveries 3 of which had low birth weights. 2 congenital abnormalities 1 % (cleft palate and spina bifida) lower that the national rate of 2–3% of live births and 14–24% of stillbirths, were recorded. Breast feeding rates were reported at 34% (n = 28), significantly lower than the national average rate of 46.3%. 81% of patients reported having had a recent smear test and 18% reported an abnormal smear. Seventy per cent of patients who reported having an abnormal smear were on immunosuppressant therapy. Conclusion The results from our ongoing study have found less disease activity during pregnancy possibly associated with continued use of biological therapy. However, there were higher rate of flares reported post-partum possibly related loss to immune tolerance developed during pregnancy, or lifestyle and environmental factors. Despite not attending a specific IBD pregnancy service outcomes in our cohort were good with lower than National average rates of miscarriage, stillbirths and congenital abnormalities. Worryingly rates of over a quarter of patients continued to smoke during pregnancy and only a third of patients breastfed; factors which could be targets for future education. High rate of abnormal smear tests, low rate of HPV vaccination warrants further research.

Download Full-text

Pregnancy outcome following first trimester exposure to sumatriptan

Neurology ◽

10.1212/wnl.51.2.581 ◽

1998 ◽

Vol 51 (2) ◽

pp. 581-583 ◽

Cited By ~ 62

Author(s):

S. Shuhaiber ◽

A. Pastuszak ◽

B. Schick ◽

D. Matsui ◽

G. Spivey ◽

...

Keyword(s):

Pregnancy Outcome ◽

Birth Defects ◽

First Trimester ◽

Spontaneous Abortions ◽

Live Births ◽

Increased Risk ◽

Trimester Exposure

We prospectively compared pregnancy outcome after exposure to sumatriptan with that of disease-matched controls and nonteratogen controls. There were no differences in the rates of live births, spontaneous abortions, therapeutic abortions, or major birth defects among the three groups. This first prospective report suggests that the use of sumatriptan during organogenesis is not associated with an apparent increased risk of major birth defects.

Download Full-text

Estimating the Period Prevalence of Publicly Funded Abortion to Space Live Births, 1999 to 2014

Journal of Primary Care & Community Health ◽

10.1177/21501327211012182 ◽

2021 ◽

Vol 12 ◽

pp. 215013272110121

Author(s):

James Studnicki ◽

John W. Fisher ◽

Tessa Longbons ◽

David C. Reardon ◽

Christopher Craver ◽

...

Keyword(s):

Pregnancy Outcome ◽

Low Income ◽

Birth Spacing ◽

Cross Sectional ◽

Financial Barriers ◽

Period Prevalence ◽

Live Births ◽

Induced Abortions ◽

Child Spacing ◽

Medicaid Eligibility

Introduction/Objectives: Although a majority of women who have an abortion report having 1 or more children, there is no published research on the number of abortions which occur between live births, after a first child but before the last. The objectives of this research, therefore, were to estimate the period prevalence of an induced abortion separating live births in a population of Medicaid eligible enrollees and to identify the characteristics of enrollees significantly associated with the use of abortion to enable child spacing. Methods: A retrospective, cross-sectional, longitudinal analysis of the pregnancy outcome sequences of eligible enrollees over age 13 from the 17 states where Medicaid included coverage of all abortions, with at least one identifiable pregnancy outcome between 1999 and 2014. Eligibles with a defined sequence of birth-abortion-birth within up to 5 consecutive pregnancies were identified to estimate the number of eligibles who could have practiced birth spacing by abortion. Logistic regression was applied to identify the significant predictor variables of the birth-abortion-birth sequence. Results: There were 50 012 (1.02%) of 4 875 511 Medicaid eligible enrollees exhibited a birth-abortion-birth sequence. Eligibles with the birth-abortion-birth sequence are more likely to be Black than White (OR 2.641, CL 2.581-2.702), less likely to be Hispanic than White (OR 0.667, CL 0.648-0.687), and more likely to have received contraceptive counseling (OR 1.14, CL 1.118-1.163). Increases in months of Medicaid eligibility (OR 1.004, CL 1.003-1.004) and months from first pregnancy to second live birth (OR 1.015, CL 1.015-1.016) are associated with the likelihood of undergoing live births separated by one or more induced abortions. Increases in the age at first pregnancy are associated with a decreased likelihood of the birth-abortion-birth sequence (OR 0.962, CL 0.959-0.964). Conclusion: Birth spacing via abortion is uncommon among a low-income population for whom the financial barriers to abortion are somewhat alleviated.

Download Full-text

Paternal Exposure to Methotrexate and Pregnancy Outcomes

The Journal of Rheumatology ◽

10.3899/jrheum.100600 ◽

2011 ◽

Vol 38 (4) ◽

pp. 628-632 ◽

Cited By ~ 41

Author(s):

DELPHINE BEGHIN ◽

MARIE-PIERRE COURNOT ◽

CATHERINE VAUZELLE ◽

ELISABETH ELEFANT

Keyword(s):

Inflammatory Disease ◽

Pregnancy Outcomes ◽

Malignant Disease ◽

Case Reports ◽

Information Service ◽

Spontaneous Abortions ◽

Major Malformation ◽

Prospective Data ◽

Paternal Exposure ◽

Live Births

Objective.To assess the risk of major malformation in the case of paternal exposure to methotrexate (MTX) at the time of conception.Methods.Using prospective data of our Teratology Information Service, we analyzed outcomes of paternal MTX exposure at the time of conception or up to 3 months before conception.Results.We report on the outcomes of 42 pregnancies involving 40 men treated with MTX at the time of conception. Twenty-three men were treated for an inflammatory disease (54.8%), 9 for psoriasis (21.4%), and 8 for a malignant disease (19.0%). Weekly dosages varied between 7.5 mg and 30 mg. The pregnancies resulted in 36 live births, 3 spontaneous abortions, and 3 voluntary abortions. No congenital malformation was observed at birth.Conclusion.Based on our results and case reports in literature, paternal MTX exposure at the time of conception does not seem to raise any major concern for offspring.

Download Full-text

Estimating the Period Prevalence of Mothers Who Have Abortions: A Population Based Study of Inclusive Pregnancy Outcomes

Health Services Research and Managerial Epidemiology ◽

10.1177/23333928211034993 ◽

2021 ◽

Vol 8 ◽

pp. 233339282110349

Author(s):

James Studnicki ◽

John W. Fisher ◽

Tessa Longbons ◽

David C. Reardon ◽

Donna J. Harrison ◽

...

Keyword(s):

Pregnancy Outcome ◽

Low Income ◽

Pregnancy Outcomes ◽

Population Based ◽

Induced Abortion ◽

Cross Sectional ◽

Population Based Study ◽

Period Prevalence ◽

Live Births ◽

Study Population

Introduction: The prevalence of induced abortion among women with children has been estimated indirectly by projections derived from survey research. However, an empirically derived, population-based conclusion on this question is absent from the published literature. Objective: The objective of this study was to describe the period prevalence of abortion among all other possible pregnancy outcomes within the reproductive histories of Medicaid-eligible women in the U.S. Methods: A retrospective, cross-sectional, longitudinal analysis of the pregnancy outcome sequences of eligible women over age 13 from the 17 states where Medicaid included coverage of most abortions, with at least one identifiable pregnancy between 1999 and 2014. A total of 1360 pregnancy outcome sequences were grouped into 8 categories which characterize various combinations of the 4 possible pregnancy outcomes: birth, abortion, natural loss, and undetermined loss. The reproductive histories of 4,884,101 women representing 7,799,784 pregnancy outcomes were distributed into these categories. Results: Women who had live births but no abortions or undetermined pregnancy losses represented 74.2% of the study population and accounted for 87.6% of total births. Women who have only abortions but no births constitute 6.6% of the study population, but they are 53.5% of women with abortions and have 51.5% of all abortions. Women with both births and abortions represent 5.7% of the study population and have 7.2% of total births. Conclusion: Abortion among low-income women with children is exceedingly uncommon, if not rare. The period prevalence of mothers without abortion is 13 times that of mothers with abortion.

Download Full-text

P447 No severe neonatal and maternal complications in inflammatory bowel diseases patients treated with ustekinumab or vedolizumab during pregnancy

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjz203.576 ◽

2020 ◽

Vol 14 (Supplement_1) ◽

pp. S402-S403

Author(s):

P Wils ◽

P Seksik ◽

C Stefanescu ◽

S Nancey ◽

M Allez ◽

...

Keyword(s):

Corpus Callosum ◽

Inflammatory Bowel Diseases ◽

Spontaneous Abortions ◽

Cardiac Malformation ◽

Maternal Complications ◽

Female Population ◽

Neonatal Complications ◽

Live Births ◽

Bowel Diseases ◽

Inflammatory Bowel

Abstract Background Inflammatory bowel diseases (IBD) have a high incidence in the female population of childbearing age. Ustekinumab (UST) and vedolizumab (VDZ) are used in IBD after failure of immunosuppressants and//or anti-TNF therapy. Data on the use and safety of these novel biologics in pregnancy are rare. Methods We conducted a retrospective cohort study in the GETAID and identified female IBD patients who received at least one injection of UST or VDZ during pregnancy or within the 2 months before conception. The aims of the study were to assess the maternal and neonatal complications in these patients and to assess the management of VDZ or UST during pregnancy. Results Seventy-three pregnancies in 68 patients were reported in 21 centres. The median time between UST or VDZ introduction and pregnancy was 11.8 months (IQR: 5.2–17.6) and 10 months (IQR: 5.7–19.5), respectively. Twenty-nine pregnancies occurred in 27 patients on UST resulting in 26 (90%) live births, two (7%) spontaneous abortions, and one (3%) elective termination. Maternal complications were reported in two patients (gestational diabetes and threat of preterm birth). Five (19%) neonatal complications were reported (3 preterm deliveries, one low birth weight and one cardiac malformation). Six (21%) patients received UST in the 2 months before conception and stopped UST with a relapse in one patient (17%). UST was maintained during pregnancy in 22 (79%) patients: 13 patients discontinued UST in the first trimester with a relapse in 4 (31%) patients and 9 patients maintained UST during all pregnancy with a relapse in 3 (33%) patients. Forty-four pregnancies occurred under VDZ resulting in 38 (86%) live births, 5 (11%) spontaneous abortions and one (3%) medical interruption. Maternal complications were reported in 5 women (4 pre-eclampsia and one pregnancy cholestasis). Fourteen (37%) neonatal complications were reported: 7 (18%) premature births, 6 (16%) low birth weights and one (3%) congenital corpus callosum hypoplasia. Fifteen (34%) patients received VDZ in the 2 months before conception and discontinued VDZ with a relapse in 8 (53%) patients. VDZ was maintained during pregnancy in 29 (66%) patients: 16 patients discontinued VDZ in the 1st trimester with a relapse in 8 (50%) patients and 13 patients maintained VDZ during all the pregnancy with a relapse in one (8%) patient. Conclusion We reported 73 pregnancies under VDZ or UST. Except one cardiac malformation on UST and one congenital corpus callosum hypoplasia on VDZ, no serious neonatal or maternal complications were observed. However, additional prospective evaluations regarding pregnancy outcomes with new biologics are needed.

Download Full-text