“i have ibd and want to get pregnant”but once pregnant, women with ibd have equal chances of...
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Sunhee Park, MDAssistant Clinical Professor GastroenterologyFebruary 29, 2020
“I have IBD and want to get pregnant”
Disclosures
Outline• Background• Pre-conception and family planning• Pregnancy
• Drug safety and risk of adverse outcomes
• Post-partum care
• Surgical considerations in IBD Pregnancy• Dorna Jafari, MD – Colorectal Surgery
Cases
Background
Kappelman et al 2013; Loftus et al 2014; CCFA; AGA
Risks of IBD to Pregnancy
Mahadevan et al 2019
The role of the GI
Mahadevan et al 2019
Pregnancy & Preconception
Planning
Disease & Medication
Management
Fertility Concerns Interdisciplinary Consultations
Healthcare Maintenance
Mahadevan et al 2019
Preconception & Family Planning
Preconception
Mahadevan et al 2019
Family Planning
3-month steroid-free remission prior to conception
Mahadevan et al 2019
Genetic Risk
Kappelman et al 2013; Loftus et al 2014; CCFA; AGA
Fertility Concerns• Women with IBD in remission who have never had surgery have fertility
rates equal to those in the general population • Women who have had IPAA, proctectomies, permanent ostomies have
decreased fertility due to inflammation and scarring of fallopian tubes• IBD patients who have not been able to conceive successfully x 6 months
should be referred for infertility evaluation• IBD meds have no effect on egg freezing or assisted reproductive
technology (ART) efficacy, and hormones used in ART have no adverse effect on IBD disease activity
• ART in IBD women not as effective as in infertile women in the general population, but once pregnant, women with IBD have equal chances of achieving a live birth compared to women in general population who underwent ART
Preconception: Medication• Avoid corticosteroids if possible
• Risk of gestational diabetes, preterm birth, low birth weight • Not good as maintenance therapy
• Methotrexate (teratogen) should be stopped at least 3 months prior to conception
• Stability of new medication for at least 3 months recommended• Biologics and thiopurines are low risk during pregnancy
• Serum drug levels of biologics should be measured and escalated/de-escalated as necessary before conception
• Subtherapeutic levels may lead to flares and supratherapeutic levels may lead to increased placental transfer (?altered levels of biologics during pregnancy)
• Limited data on Tofacitinib, but should be avoided during first trimester• Risk of malformation at supratherapeutic doses in animal studies• t1/2 = 3.2 hours; washout period of 1 week recommended before conception
Plan during Pregnancy
Higher risk of flare during pregnancy in patients with IBD who became pregnant with active disease
Caprilli et al, 2006; Bortoli et al, 2011; Abhyankar et al 2013
Recommendations on Medication Use during Pregnancy
Medical Therapy RecommendationsMedication Recommendations
Loperamide (Imodium) Limited human data; ?CV defects
Diphenoxylate (Lomotil) Limited human data; avoid use
Antibiotics• Metronidazole• Ciprofloxacin• Amoxicillin-Clavulanic Acid• Rifaximin
• Controversial; avoid first trimester (risk of cleft lip)• Low risk• Favorable profile; preferred choice• Avoid; teratogenic in animals
Corticosteroids• Budesonide• Prednisone
• Low risk• Moderate risk; orofacial cleft first-trimester exposure; adrenal
insufficiency, gestational diabetes, preterm birth, infant infectionsUse as adjunctive therapy for flares, but avoid as maintenance regimen
Mahadevan et al 2017
Medication Recommendations
Aminosalicylates• Balsalazide• Mesalamine• Sulfasalazine
• Low risk; maintain prepregnancy dose• Low risk; Asacol HD DBP (dibutyl phthalate) coating teratogenic in animals• Low risk; increase folic acid to 2mg daily
Immunomodulators• Cyclosporine• Methotrexate• Thiopurines
• Limited data; possible risk of preterm birth, low birth weight• Avoid; teratogenic; stop 3-6 months prior to conception• Low risk; delayed infant infections with combination therapy; avoid initiation
during pregnant
Biologics Maintain prepregnancy dosing; low risk
Tofacitinib Limited data; avoid during first trimester
Mahadevan et al 2017
Medical Therapy Recommendations
Biologics in Pregnancy• Infliximab and adalimumab
exposure to anti-TNF (alpha) drugs in utero does not increase short or long-term risk of severe infections in children born to mothers with IBD
• Follow-up mean of 4 years
Chaparro et al 2018; Mahadevan et al 2012
Biologic monotherapy preferred for maintenance therapy in pregnancy if disease well-controlled• Data not consistent; stopping thiopurine therapy is an individualized
decision based on severity of disease• Coelho et al did not find difference in outcome of pregnancy in patients with IBD
between those exposed to thiopurines during pregnancy and those exposure to other drugs or those exposed to no drugs at all
• Prospective study (Julsgaard et al): Anti-TNF drugs detectable until 12 months of age in infants born to mothers who received treatment during pregnancy
• Combination anti-TNF + thiopurine therapy during pregnancy increased the relative risk for infant infections ~3-fold compared with anti-TNF monotherapy
• Live vaccines should therefore be avoided for up to 1 year
Julsgaard et al 2016
Biologic Dosing Recommendations in PregnancyBiologic Recommendations*
Infliximab Low risk; continue until 8-10 weeks before delivery (30-32WG**)
Adalimumab Low risk; continue until 3-4 weeks before delivery (36-37WG)
Certolizumab Low risk; does not cross placenta; continue through pregnancy
Golimumab Low risk; continue until 4-6 weeks before delivery (34-36WG)
Natalizumab Low risk; continue until 4-6 weeks before delivery (34-36WG)
Vedolizumab Low risk; limited data; continue until 8-10 weeks before delivery (30-32WG)
Ustekinumab Low risk; limited data; continue until 8-10 weeks before delivery (30-32WG)
Mahadevan et al 2017
*Based on standard dosing**WG: weeks gestation
Thiopurine Therapy• Initiating thiopurine therapy for the first time during pregnancy not
recommended due to risk of pancreatitis, leukopenia, delayed time to effect
Coelho et al 2011
Anti-integrin Therapy
Delivery Plan
Mahadevan et al 2019
Post-partum Care
Post-Delivery Care
Post-Delivery Care for Baby
IBD Meds during LactationMedication Recommendations
Antibiotics• Metronidazole• Ciprofloxacin• Amoxicillin-Clavulanic Acid• Rifaximin
• Avoid; enters milk• Compatible; enters milk• Compatible; enters milk• Avoid; no human data
Corticosteroids• Budesonide• Prednisone
• Compatible; trace amounts in milk• Compatible; dose-dependent levels in milk
Aminosalicylates• Balsalazide• Mesalamine• Sulfasalazine
• Compatible; low levels in milk
• Diarrhea; sulfapyridine metabolite, excreted in milk at higher concentrations than parent drug
Mahadevan et al 2017 Table 2
IBD Meds during Lactation
Mahadevan et al 2017
Medication Recommendations
Immunomodulators• Cyclosporine
• Methotrexate• Thiopurines• Tacrolimus
• Probably compatible; infant receives <2% mother’s dose; monitor infant levels; limited data
• Lack of data: contraindicated; low doses in milk• Compatible; low levels in milk• Compatible; low levels in milk; limited data; monitor infant levels
Biologics• Infliximab• Adalimumab• Certolizumab• Golimumab• Natalizumab• Vedolizumab• Ustekinumab
• Compatible; low levels in milk• Peak excretion 1-4 days post infusion; ≤0.5% of mother’s plasma concentration• Peak excretion 1-6 days post injection; <1% of mother’s plasma concentration• Peak excretion 0.5-2 days post injection; undetectable• Undetectable• Undetectable• Unknown• Peak excretion in milk 1 day post-injection
Tofacitinib Limited data
Vaccine Recommendations for Newborn
Surgical Considerations in IBD Pregnancy
Dorna Jafari, MDColorectal Surgery
References
Thank Yousandrasp@uci.edu
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