H1N1 vaccines in a large observational cohort of patients with inflammatory bowel disease treated with immunomodulators and biological therapy

Jean François Rahier, Pavol Papay, Julia Salleron, Shaji Sebastian, Manuela Marzo, Laurent Peyrin-Biroulet, Valle Garcia-Sanchez, Walter Fries, Dirk P. Van Asseldonk, Klaudia Farkas, Nanne K. De Boer, Taina Sipponen, Pierre Ellul, Edouard Louis, Simon T C Peake, Uri Kopylov, Jochen Maul, Badira Makhoul, Gionata Fiorino, Yazdan YazdanpanahMaria Chaparro

Research output: Contribution to journalArticlepeer-review

Abstract

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

Original languageEnglish
Pages (from-to)456-462
Number of pages7
JournalGut
Volume60
Issue number4
DOIs
Publication statusPublished - Apr 2011

ASJC Scopus subject areas

  • Gastroenterology

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