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
- adjuvanted vaccine
- IBD clinical
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J-FR and PP contributed equally to the article.
In addition to the authors, the following investigators participated in the study: Rita Monterubbianesi (S Camillo-Forlanini Hospital, Rome, Italy), Benedikt Blaha (Wilhelminenspital, Vienna, Austria), Monica Cesarini (University of Rome Sapienza, Policlinico Umberto, Rome, Italy), Thomas Haas (Paracelsus Medical University, Salzburg, Austria) and Reingard Platzer (Landesklinikum, Wiener Neustadt, Austria).
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.