Dawn B Beaulieu1, Ashwin N Ananthakrishnan2, Christopher Martin3, Russell D Cohen4, Sunanda V Kane5, Uma Mahadevan6. 1. Division of Gastroenterology, Hepatology, and Nutrition, Vanderbilt University Medical Center, Nashville, Tennessee. 2. Division of Gastroenterology, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts. Electronic address: aananthakrishnan@mgh.harvard.edu. 3. Division of Gastroenterology and Hepatology, Department of Medicine, University of North Carolina, Chapel Hill, North Carolina. 4. Section of Gastroenterology, Hepatology and Nutrition, University of Chicago Medicine, Chicago, Illinois. 5. Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota. 6. Division of Gastroenterology, University of California-San Francisco, San Francisco, California.
Abstract
BACKGROUND & AIMS: In women with inflammatory bowel diseases (IBDs), exposure to immunomodulator or biologic therapy has not been associated with adverse events during pregnancy or outcomes of newborns. We investigated whether exposure of patients to these agents during pregnancy affects serologic responses to vaccines in newborns. METHODS: We collected data from the Pregnancy in IBD and Neonatal Outcomes registry, which records outcomes of pregnant women with diagnosis of IBD receiving care at multiple centers in the United States, from 2007 through 2016. Serum samples collected from infants at least 7 months old were analyzed for titers of antibodies to Haemophilus influenzae B (HiB) or tetanus toxin; mothers completed a survey of vaccine practices and outcomes from July 2013 through October 2016. Umbilical cord blood samples from 33 infants were assayed for concentration of biologic agents. Vaccination response was compared between infants born to mothers exposed to biologic therapy (infliximab, adalimumab, certolizumab pegol, golimumab, natalizumab, vedolizumab, or ustekinumab-either as a single agent or in combination with an immunomodulator, at any time between conception and delivery) and infants born to unexposed mothers. RESULTS: A total of 179 women completed the vaccine survey (26 biologic unexposed, 153 exposed to a biologic agent). We found no significant difference in proportions of infants with protective antibody titers against HiB born to exposed mothers (n = 42, 71%) vs unexposed mothers (n = 8, 50%) (P = .41). We also found no difference in the proportion of infants with protective antibody titers to tetanus toxoid born to exposed mothers (80%) vs unexposed mothers (75%) (P = .66). The median concentration of infliximab in cord blood did not differ significantly between infants with vs without protective antibody titers to HiB (P = .30) or tetanus toxoid (P = .93). Mild reactions were observed in 7/40 infants who received rotavirus vaccine and whose mothers had been exposed to biologic therapies. CONCLUSIONS: Vaccination of infants against HiB and tetanus toxin, based on antibody titers measured when infants were at least 7 months old, does not appear to be affected by in utero exposure to biologic therapy.
BACKGROUND & AIMS: In women with inflammatory bowel diseases (IBDs), exposure to immunomodulator or biologic therapy has not been associated with adverse events during pregnancy or outcomes of newborns. We investigated whether exposure of patients to these agents during pregnancy affects serologic responses to vaccines in newborns. METHODS: We collected data from the Pregnancy in IBD and Neonatal Outcomes registry, which records outcomes of pregnant women with diagnosis of IBD receiving care at multiple centers in the United States, from 2007 through 2016. Serum samples collected from infants at least 7 months old were analyzed for titers of antibodies to Haemophilus influenzae B (HiB) or tetanus toxin; mothers completed a survey of vaccine practices and outcomes from July 2013 through October 2016. Umbilical cord blood samples from 33 infants were assayed for concentration of biologic agents. Vaccination response was compared between infants born to mothers exposed to biologic therapy (infliximab, adalimumab, certolizumab pegol, golimumab, natalizumab, vedolizumab, or ustekinumab-either as a single agent or in combination with an immunomodulator, at any time between conception and delivery) and infants born to unexposed mothers. RESULTS: A total of 179 women completed the vaccine survey (26 biologic unexposed, 153 exposed to a biologic agent). We found no significant difference in proportions of infants with protective antibody titers against HiB born to exposed mothers (n = 42, 71%) vs unexposed mothers (n = 8, 50%) (P = .41). We also found no difference in the proportion of infants with protective antibody titers to tetanus toxoid born to exposed mothers (80%) vs unexposed mothers (75%) (P = .66). The median concentration of infliximab in cord blood did not differ significantly between infants with vs without protective antibody titers to HiB (P = .30) or tetanus toxoid (P = .93). Mild reactions were observed in 7/40 infants who received rotavirus vaccine and whose mothers had been exposed to biologic therapies. CONCLUSIONS: Vaccination of infants against HiB and tetanus toxin, based on antibody titers measured when infants were at least 7 months old, does not appear to be affected by in utero exposure to biologic therapy.
Authors: Uwe Schauer; Frank Stemberg; Christian H L Rieger; Wolfgang Büttner; Michael Borte; Simone Schubert; Helga Möllers; Frank Riedel; Udo Herz; Harald Renz; Wilhelm Herzog Journal: Clin Diagn Lab Immunol Date: 2003-03
Authors: T V Murphy; P M Gargiullo; M S Massoudi; D B Nelson; A O Jumaan; C A Okoro; L R Zanardi; S Setia; E Fair; C W LeBaron; M Wharton; J R Livengood; J R Livingood Journal: N Engl J Med Date: 2001-02-22 Impact factor: 91.245
Authors: Sarah Sheibani; Russell Cohen; Sunanda Kane; Marla Dubinsky; Joseph A Church; Uma Mahadevan Journal: Dig Dis Sci Date: 2016-01-02 Impact factor: 3.199
Authors: Seper Dezfoli; Henry A Horton; Nattapaun Thepyasuwan; Dror Berel; Stephan R Targan; Eric A Vasiliauskas; Marla Dubinsky; David Q Shih; Manreet Kaur; Dermot P B McGovern; Andrew Ippoliti; Edward J Feldman; Gil Y Melmed Journal: Inflamm Bowel Dis Date: 2015-08 Impact factor: 5.325
Authors: G Andrisani; D Frasca; M Romero; A Armuzzi; C Felice; M Marzo; D Pugliese; A Papa; G Mocci; I De Vitis; G L Rapaccini; B B Blomberg; L Guidi Journal: J Crohns Colitis Date: 2012-06-05 Impact factor: 9.071
Authors: Mette Julsgaard; Lisbet A Christensen; Peter R Gibson; Richard B Gearry; Jan Fallingborg; Christian L Hvas; Bo M Bibby; Niels Uldbjerg; William R Connell; Ourania Rosella; Anne Grosen; Steven J Brown; Jens Kjeldsen; Signe Wildt; Lise Svenningsen; Miles P Sparrow; Alissa Walsh; Susan J Connor; Graham Radford-Smith; Ian C Lawrance; Jane M Andrews; Kathrine Ellard; Sally J Bell Journal: Gastroenterology Date: 2016-04-08 Impact factor: 22.682
Authors: Christopher Andrew Lamb; Nicholas A Kennedy; Tim Raine; Philip Anthony Hendy; Philip J Smith; Jimmy K Limdi; Bu'Hussain Hayee; Miranda C E Lomer; Gareth C Parkes; Christian Selinger; Kevin J Barrett; R Justin Davies; Cathy Bennett; Stuart Gittens; Malcolm G Dunlop; Omar Faiz; Aileen Fraser; Vikki Garrick; Paul D Johnston; Miles Parkes; Jeremy Sanderson; Helen Terry; Daniel R Gaya; Tariq H Iqbal; Stuart A Taylor; Melissa Smith; Matthew Brookes; Richard Hansen; A Barney Hawthorne Journal: Gut Date: 2019-09-27 Impact factor: 23.059
Authors: Michael G Kattah; Jeffrey M Milush; Trevor Burt; Robert P McCabe; Michael I Whang; Averil Ma; Uma Mahadevan Journal: Clin Transl Gastroenterol Date: 2018-04-03 Impact factor: 4.488