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P159. Response to the 2009 vaccine for influenza A/H1N1 in patients with inflammatory bowel disease on anti TNFα therapy

P159. Response to the 2009 vaccine for influenza A/H1N1 in patients with inflammatory bowel disease on anti TNFα therapy

G. Andrisani1, D. Frasca2, A. Armuzzi1, A. Papa1, M. Marzo1, C. Felice1, G. Mocci1, D. Pugliese1, G. Vitale1, A. Piccioni1, I. De Vitis1, G. Rapaccini1, B. Blomberg2, L. Guidi1

1OU of Internal Medicine and Gastroenterology, Complesso integrato Columbus, Università Cattolica del Sacro Cuore, Roma, Italy; 2Department of Microbiology and Immunology, Miller School of Medicine, Miami, FL, United States

Aim: Patients with inflammatory bowel disease (IBD) are exposed to the same infections affecting the community, in adjunct to the opportunistic infection related to the immune suppression. Some of these infectious diseases may be prevented by the appropriate use of a vaccination program. The immune response to vaccine in these patients is still unclear. Aim of the study was to assess the efficacy and safety of influenza A/H1N1 vaccine in patients with IBD on anti TNFα therapy.

Materials and Methods: We enrolled 5 healthy controls and 62 patients, 26 affected by Ulcerative Colitis (UC) and 36 by Crohn's disease (CD), all undergoing maintenance treatment with anti TNFα. Patients were on anti TNFα monotherapy (47) or on anti TNFα associated with immunosuppressor or corticosteroids (15). Mean age of patients was 45+16. All patients were vaccinated with the adjuvated vaccine A/California/7/2009 (H1N1), Focetria®, Novartis. Sera were obtained during the 2009/10 vaccination campaign before (T0) and 4–6 weeks after the vaccination (T1). Immune response to vaccination was measured by hemoagglutination inhibition assay (HI). The results of HI are expressed as titers ≥1:40 at t1 (seroprotection rate), as well as fold-increase after vaccination (titer at t1/titer at t0, seronversion rate), response rate (seroconversion or titer >1:40 at T1 if lower at T0), geometric mean titer (GMT) and factor increase of GMT between T1 and T0. We recorded the activity indices of disease before and after H1N1 vaccination.

Results: IBD patients on anti TNFα after “pandemic” 2009 influenza vaccine obtained good HI seroprotection rates, while HI seroconversion rates and HI response rates were lower than HC (p = 0.05 and 0.02, respectively). HI GMT and factor increase at 4 weeks were significantly lower in IBD pts. on combined therapy, as compared both to HC and pts on anti TNFα monotherapy (p = 0.017 and 0.005, respectively). Few patients in this study reported systemic adverse events after the vaccination: 3% headache, 3% malaise and 2% shivering. None of them reported a flare of the IBD. Activity indices showed no differences after vaccination.

Conclusion: In our patients the vaccine was safe and did not affect IBD activity. Moreover, patients with IBD undergoing anti TNFα therapy showed a reduced response to the vaccine, as compared to healthy controls, and among these patients those with anti TNF-α therapy and immunosuppressor were more impaired in the response to the vaccine but still able to respond. Vaccination is indicated to protect these patients. A double injection vaccination schedule could be explored to improve the efficacy in the subgroup of patients on combined therapy.