The Immunogenicity of the Influenza, Pneumococcal, and Hepatitis B Vaccines in Patients With Inflammatory Bowel Disease Treated With Vedolizumab.

Background: Patients with inflammatory bowel disease (IBD) have an elevated risk for infection which is further increased by immunosuppressive medications. The aim of this study was to evaluate the safety and immunogenicity of influenza, PVC13, PPSV23, and hepatitis B vaccines in adults with IBD treated with vedolizumab as compared to those treated with anti-tumor necrosis factor (TNF) agents or nonimmunosuppressive therapy.

Methods: In this prospective controlled trial, patients were vaccinated with the influenza, PVC13, PPSV23, and/or hepatitis B vaccines. Participants were grouped based on IBD medication regimen: (1) vedolizumab monotherapy, (2) vedolizumab plus immunomodulator, (3) anti-TNF plus immunomodulator, and (4) no immunosuppressive therapy (control). Vaccine responses were evaluated by comparing pre- and postvaccination titers. Disease activity and adverse events were monitored by the Harvey-Bradshaw Index or Simple Colitis Clinical Activity Index and by standardized phone interviews.

Results: No serious adverse events or significant changes in disease activity were reported. For the influenza vaccine, baseline titers were high in all groups, and no follow-up titers met criteria for adequate response. For the pneumococcal vaccines, all groups showed response to vaccination; there was no statistically significant difference between the groups. For the hepatitis B vaccine, 62.5% of patients receiving vedolizumab and 33.3% receiving anti-TNF therapy achieved a level of response >10 mIU/mL.

Discussion: The inability to observe a response to the influenza vaccine was influenced by high baseline titers. For the hepatitis B vaccine, patients treated with vedolizumab experienced immunogenic response to vaccination that was noninferior to nonimmunosuppressed controls. All studied vaccines were well-tolerated. Vaccination should be encouraged in all adult patients with IBD.