@article{7168e7114de7423299baf233a0b3898f,
title = "Observational data from the adalimumab post-marketing PYRAMID registry of patients with Crohn's disease who became pregnant: A post hoc analysis",
abstract = "Background: PYRAMID was an international post-marketing registry that aimed to collect data on the long-term safety and effectiveness of adalimumab treatment per local standard of care in patients with moderately to severely active Crohn's disease (CD). Here, we present post hoc analyses of observational data from patients who became pregnant while participating in this registry and receiving adalimumab. Methods: From the subpopulation of patients receiving adalimumab who became pregnant while taking part in PYRAMID, data on patient characteristics, pregnancy outcomes, and complications of pregnancy were analysed retrospectively. Results: Across the PYRAMID registry, 293 pregnancies occurred in patients who had gestational adalimumab exposure (average disease duration at last menstrual period: 8.6 years), resulting in 300 pregnancy outcomes. A total of 197 pregnancies (67.2%) were exposed to adalimumab in all trimesters per physician's decision. Of the known reported outcomes (96.3%), 81.7% (236/289) were live births, 10.4% (30/289) were spontaneous abortions, 4.8% (14/289) elective terminations, 2.8% (8/289) ectopic pregnancies, and 0.3% (1/289) was a stillbirth. Congenital malformations (pulmonary valve stenosis and tricuspid valve incompetence) were reported in one infant. In addition to the pregnancy outcomes described above, 23 complications of pregnancy were reported in 20 patients. Conclusions: This analysis showed that adalimumab treatment in patients with CD, who became pregnant whilst participating in the PYRAMID registry, contributed no additional adverse effects during the pregnancy course or on pregnancy outcomes.",
keywords = "Crohn's disease, PYRAMID registry, adalimumab, anti-tumour necrosis factor, pregnancy",
author = "Ailsa Hart and Geert D{\textquoteright}Haens and Mareike Bereswill and Tricia Finney-Hayward and Jasmina Kalabic and Gweneth Levy and Huifang Liang and Seow, {Cynthia H.} and Loftus, {Edward V.} and Remo Panaccione and Walter Reinisch and Jack Satsangi",
note = "Funding Information: AH has served as consultant, advisory board member, or speaker for AbbVie, Arena, Atlantic, Bristol‐Myers Squibb, Celgene, Celltrion, Falk, Ferring, Janssen, MSD, Napp Pharmaceuticals, Pfizer, Pharmacosmos, Shire, and Takeda; and also serves on the Global Steering Committee for Genentech. GD has received consulting and/or lecture fees from AbbVie, ActoGeniX, AIM, Boehringer Ingelheim, Centocor, Chemo Centryx, Cosmo Technologies, Elan Pharmaceuticals, enGene, Falk Pharma, Ferring, Galapagos, Giuliani SpA, Given Imaging, GlaxoSmithKline, Janssen Biologics, MSD, Neovacs, Novo Nordisk, Otsuka, PDL BioPharma, Pfizer, Receptos, Salix, Schering‐Plough, SetPoint, Shire Pharmaceuticals, Takeda, Tillotts Pharma, UCB Pharma, Versant, and Vifor Pharma; research grants from AbbVie, Dr Falk Pharma, Given Imaging, Janssen, MSD, and PhotoPill; and speaking honoraria from AbbVie, Ferring, MSD, Norgine, Shire, Tillotts, Tramedico, and UCB Pharma. CHS has received speaker fees from AbbVie, Ferring, Janssen, Pfizer, Shire, and Takeda; and has served as a consultant and/or advisory board member for AbbVie, Actavis, Ferring, Janssen, Pfizer, Shire, and Takeda. EVL has received consulting fees from AbbVie, Allergan, Amgen, Arena, Boehringer Ingelheim, Bristol‐Myers Squibb, Calibr, Celgene, Celltrion Healthcare, Eli Lilly, Genentech, Gilead, Iterative Scopes, Janssen, Ono Pharma, Pfizer, Scipher Medicine, Sun Pharma, Takeda, and UCB; and research support from AbbVie, Amgen, Bristol‐Myers Squibb, Celgene, Genentech, Gilead, Janssen, Pfizer, Receptos, Robarts Clinical Trials, Takeda, Theravance, and UCB. RP has received consulting and/or lecture fees from AbbVie, Amgen, AstraZeneca, Axcan Pharma [now Aptalis], Biogen Idec, Bristol‐Myers Squibb, Centocor, ChemoCentryx, Eisai Medical Research Inc., Elan Pharmaceuticals, Ferring, Genentech, GlaxoSmithKline, Janssen, MSD, Ocera Therapeutics, Otsuka America Pharmaceutical, Pfizer, Prometheus Laboratories, Schering‐Plough Corporation, Shire Pharmaceuticals, Synta Pharmaceuticals Corp., Takeda, Teva, UCB Pharma, and Warner Chilcott. WR has served as a speaker for Abbott Laboratories, AbbVie, Aesca, Aptalis, Astellas, Celltrion, Centocor, Danone Austria, Elan, Falk Pharma GmbH, Ferring, Immundiagnostik, Mitsubishi Tanabe Pharma Corporation, MSD, Otsuka, PDL, Pharmacosmos, PLS Education, Schering‐Plough, Shire, Takeda, Therakos, Vifor, and Yakult; and has served as a consultant for Abbott Laboratories, AbbVie, Aesca, Amgen, AM Pharma, Astellas, AstraZeneca, Avaxia, Bioclinica, Biogen Idec, Boehringer Ingelheim, Bristol‐Myers Squibb, Celgene, Cellerix, Celltrion, Centocor, Chemocentryx, Covance, Danone Austria, Elan, Ernst and Young, Falk Pharma GmbH, Ferring, Galapagos, Genentech, Gilead, Gr{\"u}nenthal, ICON, Index Pharma, Inova, Janssen, Johnson and Johnson, Kyowa Hakko Kirin Pharma, Lipid Therapeutics, Mallinckrodt, MedImmune, Millennium, Mitsubishi Tanabe Pharma Corporation, MSD, Nestl{\'e}, Novartis, Ocera, Otsuka, PDL, Pfizer, Pharmacosmos, Procter and Gamble, Prometheus, Robarts Clinical Trial, Roland Berger GmbH, Schering‐Plough, Second Genome, SetPoint Medical, Sigmoid, Takeda, Therakos, Tigenix, UCB, Vifor, Zyngenia, and 4SC; has served as an advisory board member for Abbott Laboratories, AbbVie, Aesca, Amgen, AM Pharma, Astellas, AstraZeneca, Avaxia, Biogen Idec, Boehringer Ingelheim, Bristol‐Myers Squibb, Celgene, Cellerix, Celltrion, Centocor, Chemocentryx, Danone Austria, Elan, Ferring, Galapagos, Genentech, Gr{\"u}nenthal, Inova, Janssen, Johnson and Johnson, Kyowa Hakko Kirin Pharma, Lipid Therapeutics, MedImmune, Millennium, Mitsubishi Tanabe Pharma Corporation, MSD, Nestl{\'e}, Novartis, Ocera, Otsuka, PDL, Pfizer, Pharmacosmos, Procter and Gamble, Prometheus, Schering‐Plough, Second Genome, SetPoint Medical, Takeda, Therakos, Tigenix, UCB, Zyngenia, and 4SC; and has received research funding from Abbott Laboratories, AbbVie, Aesca, Centocor, Falk Pharma GmbH, Immundiagnsotik, and MSD. JS has received lecture fees from the Falk Foundation and Takeda. MB, TF‐H, JK, GL, and HL are full‐time employees of AbbVie and may own AbbVie stock and/or stock options. Funding Information: AbbVie Inc. funded the study. AbbVie Inc. and Maccabi Healthcare Services participated in the study design, research, analysis, data collection, interpretation of the data, review, and approval. All authors had access to the relevant data and participated in the drafting, review, and approval of the manuscript. The authors would like to acknowledge Drs. Anne Robinson, Dilek Arikan, and Dianlin Guo, of AbbVie, for careful review of the manuscript. Medical writing assistance under the direction of the authors was provided by Daniela DiBiase, PhD, and Juliet George, PhD, of CMC AFFINITY, McCann Health Medical Communications, and by Russell Craddock, PhD, and Hilary Wong, PhD, of 2 the Nth, Macclesfield, UK, in accordance with Good Publication Practice guidelines. This assistance was funded by AbbVie Inc. Publisher Copyright: {\textcopyright} 2022 AbbVie Inc. United European Gastroenterology Journal published by Wiley Periodicals LLC on behalf of United European Gastroenterology.",
year = "2022",
month = jun,
doi = "10.1002/ueg2.12236",
language = "English (US)",
volume = "10",
pages = "485--495",
journal = "United European Gastroenterology Journal",
issn = "2050-6406",
publisher = "SAGE Publications Inc.",
number = "5",
}