Journal Article

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

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

2011

Overview

BackgroundSafety 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 methodsThe 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.ResultsOf 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%).ConclusionInfluenza 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.

• Publisher: BMJ Publishing Group Ltd and British Society of Gastroenterology,BMJ Publishing Group,BMJ Publishing Group LTD,BMJ Group
• Subject: adjuvanted vaccine / Adjuvants, Immunologic / Adult / Age / Biological and medical sciences / Crohn's disease / Data processing / Digestive tract / Fatigue / Female / Gastroenterology & hepatology / Gastroenterology. Liver. Pancreas. Abdomen / Gastroentérologie & hépatologie / Human health sciences / Humans / IBD clinical / Immunization / Immunocompromised Host / Immunologic Factors - therapeutic use / Immunomodulation / Immunomodulators / Inflammatory bowel disease / Inflammatory bowel diseases / Inflammatory Bowel Diseases - drug therapy / Inflammatory Bowel Diseases - immunology / Inflammatory Bowel Diseases/drug therapy/immunology / Influenza / Influenza A / Influenza A Virus, H1N1 Subtype - immunology / Influenza Vaccines - adverse effects / Influenza, Human - prevention & control / Intestine / Male / Medical sciences / Middle Aged / Other diseases. Semiology / Pain / Pandemics / Pharmacology. Drug treatments / Prospective Studies / safety / Sciences de la santé humaine / Severity of Illness Index / Stomach. Duodenum. Small intestine. Colon. Rectum. Anus / Ulcerative colitis / vaccination / Vaccines