Immunogenicity of High Dose Influenza Vaccine for Patients with Inflammatory Bowel Disease on Anti-TNF Monotherapy: A Randomized Clinical Trial

Abstract

Background Patients with inflammatory bowel disease (IBD) on anti-tumor necrosis factor alpha (TNF) agents may have lower immune response to the influenza vaccine. We aimed to evaluate the immunogenicity of the high dose (HD) vs standard dose (SD) influenza vaccine in patients with IBD on anti-TNF monotherapy. Methods We performed a randomized clinical trial at a single academic center evaluating the immunogenicity of the HD vs SD influenza vaccine in patients with IBD on anti-TNF monotherapy. Influenza antibody concentration was measured at immunization, at 2 to 4 weeks postimmunization, and at 6 months. Results Sixty-nine patients with IBD were recruited into the study, 40 on anti-TNF monotherapy, and 19 on vedolizumab, along with 20 healthy controls (HC). Patients with IBD receiving the HD influenza vaccine had significantly higher H3N2 postimmunization antibodies compared with those who received the SD influenza vaccine (160 [interquartile range 80 to 320] vs 80 [interquartile range 40 to 160]; P = 0.003). The H1N1 postimmunization levels were not significantly higher in the HD influenza vaccine (320 [interquartile range 150 to 320] vs 160 [interquartile range 80 to 320]; P = 0.18). Patients with IBD receiving the HD influenza vaccine and those on vedolizumab who received SD had equivalent antibody concentrations to HC (H1N1 P = 0.85; H3N2 P = 0.23; B/Victoria P = 0.20 and H1N1 P = 0.46; H3N2 P = 0.21; B/Victoria P = 1.00, respectively). Conclusions Patients with IBD on anti-TNF monotherapy receiving the HD influenza vaccine had significantly higher postimmunization antibody levels compared with SD vaccine. Clinicaltrials.gov (#NCT02461758).

High Immunogenicity to Influenza Vaccination in Crohn’s Disease Patients Treated with Ustekinumab

“…Current evidence does not support the use of immunomodulatory agents combined with ustekinumab [ 17 ]. Similar to our results in the ustekinumab group, a recent study showed that immune responses to influenza vaccination in patients treated with vedolizumab, a monoclonal antibody against the α4β7 integrin, were not altered either [ 40 ]. Interestingly, the immune response to an enterally administered vaccine was impaired during treatment with vedolizumab, possibly reflecting the gut-selective action of this therapy [ 42 ].…”

“…A booster vaccination failed to show better protection rates [ 7 , 39 ] and timing relative to infliximab infusion neither showed to affect serological protection [ 13 ]. Recently, a study found that four times higher dose vaccination resulted in higher antibody responses to influenza vaccination compared to the standard dose, without leading to more adverse effects [ 40 ]. Yet, “high dose” vaccination is currently only recommended by American guidelines for patients aged 65 years or older [ 41 ].…”

Brazilian Ibd Study Group Position Statement on Sars-Cov2 Vaccination

“…For instance, it has been shown that immune response to pneumococcal polysaccharide vaccination (PSV-23) is impaired in Crohn's disease (CD) patients on combination of TNF-blockers and immunomodulators (3) and that the serologic conversion rate to influenza vaccine is lower in immunossupressed IBD patients (4,5) . On the other hand, treatment with ustekinumab or vedolizumab does not appear to reduce responses to flu vaccine (6,7) .…”

A comprehensive review of vaccination in patients with inflammatory bowel diseases: An Indian perspective

“…There are studies which have analyzed the high-dose influenza vaccines, which contain four times more hemagglutinin than the standard dose vaccine. A study showed that patients with IBD treated with anti-TNF monotherapy receiving high-dose influenza vaccine had significantly higher seroprotection than standard dose vaccines [24]. The inactive influenza vaccine is safe in patients with IBD on immunosuppressants, with minimal-vaccine associated local reactions without any increase in IBD flares [25].…”