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H1N1 vaccines in a large observational cohort of patients with inflammatory bowel disease treated with immunomodulators and biological therapy
  1. Jean-François Rahier1,
  2. Pavol Papay2,
  3. Julia Salleron3,
  4. Shaji Sebastian4,
  5. Manuela Marzo5,
  6. Laurent Peyrin-Biroulet6,
  7. Valle Garcia-Sanchez7,
  8. Walter Fries8,
  9. Dirk P van Asseldonk9,
  10. Klaudia Farkas10,
  11. Nanne K de Boer11,
  12. Taina Sipponen12,
  13. Pierre Ellul13,
  14. Edouard Louis14,
  15. Simon T C Peake15,
  16. Uri Kopylov16,
  17. Jochen Maul17,
  18. Badira Makhoul18,
  19. Gionata Fiorino19,
  20. Yazdan Yazdanpanah20,
  21. Maria Chaparro21,
  22. for the European Crohn's and Colitis Organisation (ECCO)
  1. 1Gastroenterology Unit, Cliniques Universitaires UCL Mont-Godinne, Yvoir, Belgium
  2. 2Gastroenterology Unit, Medical University Vienna, Vienna, Austria
  3. 3Biostatistics Unit, Université Lille Nord de France, CHUR Lille, France
  4. 4Gastroenterology Unit, Hull Royal Infirmary, Hull, UK
  5. 5Gastroenterology Unit, Universita Cattolica del Sacro Cuore, Roma, Italy
  6. 6Gastroenterology Unit, Université Henri Poincaré 1, CHU de Nancy, France
  7. 7Gastroenterology Unit, H Reina Sofia, Cordoba, Spain
  8. 8Gastroenterology Unit, University of Messina, Messina, Italy
  9. 9Gastroenterology Unit, VU University Medical Center, Amsterdam, The Netherlands
  10. 10Gastroenterology Unit, University of Szeged, Szeged, Hungary
  11. 11Gastroenterology Unit, Kennemer Gasthuis, Haarlem, Netherlands
  12. 12Gastroenterology Unit, Helsinki University Central Hospital, Helsinki, Finland
  13. 13Gastroenterology Unit, Mater Dei Hospital, Msida, Malta
  14. 14Gastroenterology Unit, Liège University and CHU Liège, Belgium
  15. 15Gastroenterology Unit, St Marks Hospital, London, UK
  16. 16Gastroenterology Unit, Chaim Sheba Tel Hashomer Medical Center, Ramat Gan, Israel
  17. 17Gastroenterology Unit, Charité - Universtiätsmedizin Berlin, Germany
  18. 18Gastroenterology Unit, Rambam Human Health Care Campus, Haifa, Israel
  19. 19Gastroenterology Unit, IBD Unit, IRCCS Humanitas, Rozzano, Milan, Italy
  20. 20Service Universitaire des Maladies Infectieuses et du Voyageur, CHU Tourcoing and ATIP-Avenir INSERM U995, Tourcoing, France
  21. 21Gastroenterology Unit, La Princesa and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Madrid, Spain
  1. Correspondence to Dr Jean-François Rahier, Service d'Hépatogastroentérologie, Cliniques Universitaires UCL Mont-Godinne, 1 avenue Dr Therasse, 5530 Yvoir, Belgium; jfrahier{at}


Background Safety data are lacking on influenza vaccination in general and on A (H1N1)v vaccination in particular in patients with inflammatory bowel disease (IBD) receiving immmunomodulators and/or biological therapy.

Aims and methods The authors conducted a multicentre observational cohort study to evaluate symptoms associated with influenza H1N1 adjuvanted (Pandemrix, Focetria, FluvalP) and non-adjuvanted (Celvapan) vaccines and to assess the risk of flare of IBD after vaccination. Patients with stable IBD treated with immunomodulators and/or biological therapy were recruited from November 2009 until March 2010 in 12 European countries. Harvey–Bradshaw Index and Partial Mayo Score were used to assess disease activity before and 4 weeks after vaccination in Crohn's disease (CD) and ulcerative colitis (UC). Vaccination-related events up to 7 days after vaccination were recorded.

Results Of 575 patients enrolled (407 CD, 159 UC and nine indeterminate colitis; 53.9% female; mean age 40.3 years, SD 13.9), local and systemic symptoms were reported by 34.6% and 15.5% of patients, respectively. The most common local and systemic reactions were pain in 32.8% and fatigue in 6.1% of subjects. Local symptoms were more common with adjuvanted (39.3%) than non-adjuvanted (3.9%) vaccines (p<0.0001), whereas rates of systemic symptoms were similar with both types (15.0% vs 18.4%, p=0.44). Among the adjuvanted group, Pandemrix more often induced local reactions than FluvalP and Focetria (51.2% vs 27.6% and 15.4%, p<0.0001). Solicited adverse events were not associated with any patient characteristics, specific immunomodulatory treatment, or biological therapy. Four weeks after vaccination, absence of flare was observed in 377 patients with CD (96.7%) and 151 with UC (95.6%).

Conclusion Influenza A (H1N1)v vaccines are well tolerated in patients with IBD. Non-adjuvanted vaccines are associated with fewer local reactions. The risk of IBD flare is probably not increased after H1N1 vaccination.

  • Inflammatory bowel disease
  • influenza
  • safety
  • vaccination
  • adjuvanted vaccine
  • IBD clinical

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  • See Commentary, p 433

  • J-FR and PP contributed equally to the article.

  • Linked articles 236679.

  • Competing interests J-FR received lecture fees from speaking at continuing medical education events from Abbott Laboratories and Schering-Plough and paid advisory board for Glaxo Smithkline. PP received consulting fees and speaker fees from Abbott Laboratories; LP-B has received consulting fees from Abbott Laboratories and UCB Pharma. VG received lecture fees from speaking at continuing medical education events from Abbott Laboratories and MSD. WF received a research grant from Schering-Plough. TS received lecture fees from speaking at continuing education events from Abbott, MSD and Tillotts Pharma. EL received research grants from MSD, AstraZeneca and Abbott, speaker fees from Abbott, AstraZeneca, Ferring, Falk, MSD/Schering Plough, Menarini, Movetis and Nycomed and he served as a consultant or advisor for Abbott, AstraZeneca, MSD/Schering Plough, Millenium, Ferring, Shire. JM has served as a consultant for Schering Plough and has received speaker fees from Abbott. YY has received travel grants, honoraria for presentation at workshops and consultancy honoraria from Bristol-Myers Squibb, Boehringer Ingelheim, Gilead, Glaxo-SmithKline, Merck, Pfizer, Roche and Tibotec. BB received speaker honoraria from Abbott. TH received honoraria from Abbott and MSD. RP received honoraria from Abbott and MSD.

  • Patient consent Obtained.

  • Ethics approval This study was conducted with the approval of the UCL Mont Godinne University Hospital, Yvoir, Belgium.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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