Safety of Thiopurines and Anti-TNF-α Drugs During Pregnancy in Patients With Inflammatory Bowel Disease

Casanova, M J; Chaparro, María; Domènech, Eugeni; Acosta, Manuel Barreiro‐de; Bermejo, Fernando; Iglesias, Eva; Gomollón, Fernando; Rodrigo, Luı́s; Calvet, Xavier; Esteve, María; García‐Planella, Esther; García-López, Santiago; Taxonera, Carlos; Calvo, Marta; López, María José Otero; Ginard, Daniel; Gómez-García, M; Garrido, Elena; Pérez-Calle, J L; Beltrán, Belén; Piqueras, Marta; Saro, Cristina; Botella, Belén; Dueñas, Carmen; Ponferrada, Ángel; Mañosa, Míriam; García–Sánchez, Valle; Maté, José; Gisbert, Javier P.

doi:10.1038/ajg.2012.430

Cited by 204 publications

(193 citation statements)

References 46 publications

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“…However, utilization of AZA during pregnancy has been studied systematically in infl ammatory bowel disease with 3,000 AZA-exposed pregnancies showing an association with preterm births but no increase in congenital abnormalities or LBWs ( 137 ). Studies of AZA in other autoimmune diseases and infl ammatory bowel disease have found scattered reports of preterm births but no increased risk of congenital abnormalities, spontaneous abortions, or infections supporting the growing evidence regarding the acceptability of AZA during pregnancy (138)(139)(140)(141)(142). Th e mounting evidence of AZA's safety during pregnancy coupled with the importance of achieving and maintaining AIH disease control during pregnancy supports the mandate that treatment continuation for AIH is critical in optimizing maternal and fetal outcomes.…”

Section: Autoimmune Hepatitismentioning

confidence: 99%

ACG Clinical Guideline: Liver Disease and Pregnancy

Tran

Ahn

Reau

2016

American Journal of Gastroenterology

242

257

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Consultation for liver disease in pregnant women is a common and oftentimes vexing clinical consultation for the gastroenterologist. The challenge lies in the need to consider the safety of both the expectant mother and the unborn fetus in the clinical management decisions. This practice guideline provides an evidence-based approach to common diagnostic and treatment challenges of liver disease in pregnant women. Am J Gastroenterol 2016; 111:176-194; doi: 10.1038/ajg.2015 Initial evaluation of pregnant patientA pregnant patient presenting with abnormal liver tests should undergo standard workup as with any non-pregnant individual (strong recommendation, very low level of evidence). Imaging in pregnancyUltrasound is safe and the preferred imaging modality used in assessment of abnormal liver tests suggestive of biliary tract disease (strong recommendation, low level of evidence).Magnetic resonance imaging without gadolinium can be used in the second and third trimester (conditional recommendation, low level of evidence).Computed tomography scans carry a risk of teratogenesis and childhood hematologic malignancies but may be used judiciously with minimized radiation protocols (2-5 rads; conditional recommendation, very low level of evidence). Endoscopy in pregnancyEndoscopy is safe in pregnancy but should be deferred until the second trimester if possible (strong recommendation, low level of evidence).Meperidine and propofol can be used for endoscopic sedation (strong recommendation, moderate level of evidence). Management of biliary disease in pregnancyERCP can be performed when indicated for pregnant women presenting with biliary disease that strongly necessitates intervention such as biliary pancreatitis, symptomatic choledocholithiasis, and/or cholangitis. Minimizing fetal exposure to fl uoroscopy is imperative (strong recommendation, low level of evidence).Symptomatic cholecystitis should be managed with early surgical intervention with laparoscopic cholecystectomy (strong recommendation, low level of evidence). Liver masses in pregnancyAsymptomatic hemangioma and focal nodular hyperplasia do not need routine imaging or surveillance during pregnancy (strong recommendation, very low level evidence).Hepatic adenomas should be monitored with ultrasound during pregnancy for growth. Patients with large adenomas (>5 cm) should be referred for resection prior to pregnancy (strong recommendation, low level of evidence). Hepatitis B in pregnancyActive-passive immunoprophylaxis with hepatitis B immunoglobulin and the HBV vaccination series should be administered to all infants born to HBV-infected mothers to prevent perinatal transmission (strong recommendation, low level of evidence).Women chronically infected with HBV and high viral load (>10 6 log copies/ml (200,000 IU/ml) and higher) should be offered antiviral medication with tenofovir or telbivudine in the third trimester to reduce perinatal transmission of HBV (strong recommendation, low level of evidence).C-section should not be performed electively in HBV-pos...

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Section: Autoimmune Hepatitismentioning

confidence: 99%

ACG Clinical Guideline: Liver Disease and Pregnancy

Tran

Ahn

Reau

2016

American Journal of Gastroenterology

242

257

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“…A total of six studies met the final selection criteria for inclusion in the meta-analysis. [46][47][48]50,51,92 …”

Section: Studies Retrievedmentioning

confidence: 99%

Anti-Tumour Necrosis Factor α Therapies and Inflammatory Bowel Disease Pregnancy Outcomes: A Meta-analysis

Shihab

Yeomans

Cruz

2016

ECCOJC

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Background and Aims: Inflammatory bowel disease (IBD) commonly affects women during their reproductive years, leading to concerns regarding pregnancy outcomes and therapeutic safety. The aim of this study was to assess the risks associated with anti-tumour necrosis factor α (anti-TNFα) therapy for pregnancy outcomes, including rates of congenital abnormality, based on published studies. Methods: Published studies were screened from on-line databases and international meeting abstracts. A meta-analysis was performed for adverse pregnancy outcomes (APOs), congenital abnormalities (CAs), preterm birth (PTB) and low birth weight (LBW). The prevalence of CAs was compared with whole-population pooled registry data. Results: In women exposed to anti-TNFα the pooled odds ratio for APOs was 1.14 (95% confidence interval [CI] 0.73-1.78; p = 0.55) compared with disease-matched controls. The pooled odds ratios for CAs, PTB and LBW were 0.89 (0.37-2.13; p = 0.79), 1.21 (0.74-2.00; p = 0.45) and 1.36 (0.77-2.38; p = 0.29) respectively. The rate of CAs in TNFα-exposed women was not statistically different from that in population-wide registries (difference 0.4%, 95% CI −2.0 to +2.7). Conclusions: Anti-TNFα therapy does not increase the risk of APOs, CAs, PTB or LBW compared with disease-matched controls. Furthermore, the risk of CAs is not increased when published prevalence data are compared with data for the general population. These findings may offer some reassurance for women and physicians regarding the safety profile of anti-TNFα during pregnancy in IBD.

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“…41 Despite their overall safety during pregnancy, infliximab and adalimumab cross the placenta in the second and third trimester and are detectable in infants for up to 7 months after birth. 50,51 Although low concentrations of infliximab and adalimumab are generally considered safe for infants, caution should be exercised when considering the rotavirus vaccine in these infants.…”

Section: Pregnancy and Family Planningmentioning

confidence: 99%

Advanced Therapy for Inflammatory Bowel Disease: A Guide for the Primary Care Physician

Thomas

Lodhia

2014

The Journal of the American Board of Family Medicine

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Primary care physicians care for patients with inflammatory bowel disease (IBD) who are receiving advanced therapies that include immunomodulator drugs (eg, azathioprine and methotrexate) and biologic therapy. These agents have significantly improved remission rates and the quality of life for patients suffering from IBD. However, patients taking these drugs need special care and counseling with regard to adverse effects, infection risk, cancer risk, and pregnancy. Newer treatment paradigms incorporate earlier use of biologic therapy, often in combination with immunomodulator drugs, to alter the natural course of the disease. Comprehensive care for these patients, including health maintenance, requires collaboration between primary care physicians and gastroenterologists. Despite their high cost, advanced therapies are likely to be cost-effective. This article discusses general concepts about azathioprine, 6-mercaptopurine, methotrexate, and common biologic drugs used in IBD. ( J Am Board Fam Med 2014;27:411-420.)

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Safety of Thiopurines and Anti-TNF-α Drugs During Pregnancy in Patients With Inflammatory Bowel Disease

Abstract: The treatment with thiopurines and anti-TNF-α drugs does not seem to increase the risk of complications during pregnancy and does seem to be safe for the newborn.

Cited by 204 publications

References 46 publications

ACG Clinical Guideline: Liver Disease and Pregnancy

ACG Clinical Guideline: Liver Disease and Pregnancy

Anti-Tumour Necrosis Factor α Therapies and Inflammatory Bowel Disease Pregnancy Outcomes: A Meta-analysis

Advanced Therapy for Inflammatory Bowel Disease: A Guide for the Primary Care Physician

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