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Flu vaccine efficacy not impacted by timing to Remicade infusion in IBD
While serologic protection was achieved in only a relatively low proportion of IBD patients on Remicade maintenance therapy who received an influenza vaccination, timing of vaccination relative to infusion did not appear to affect the development of serologic protection in a randomized trial.
“A major concern regarding vaccination of IBD patients on maintenance infliximab [Remicade, Janssen] is the ability of a medically suppressed immune system to mount an appropriate immune response,” the researchers wrote. “As maintenance infliximab is administered every 6 to 8 weeks, the effect of timing of influenza vaccination relative to infliximab on immune response also requires consideration.”
Thus, researchers from the University of Calgary in Canada performed a parallel group, prospective, open-label study during the 2012 to 2013 influenza season. Patients with IBD on maintenance infliximab therapy were randomly assigned to receive the seasonal inactivated influenza vaccine (Fluviral, GlaxoSmithKline) around the time of infliximab infusion (0-4 days after; n = 69) or midway between infusions (21-28 days after; n = 68). Serum samples were analyzed for hemagglutination inhibition antibody (HAI) titers before and 3 to 5 weeks after vaccination, and serologic protection was defined by a postvaccine titer of at least 1:40, while immunogenic response was defined as at least a fourfold increase between pre- and postvaccine HAI titers.
Comparable rates of serologic protection were achieved by patients vaccinated around the time of infusion and those vaccinated midway between infusions (H1N1, 67.2% vs. 64.7%; H3N2, 43.3% vs. 48.5%; influenza B, 68.7% vs. 79.4%). Immunogenic response rates were also comparable between groups for all antigens (27.7% vs. 36.7%; 27.7% vs. 23.3%; and 34.9% vs. 40%, respectively).
Odds of achieving serologic protection to H1N1 only were decreased by concomitant immunomodulators (adjusted OR = 0.4; 95% CI, 0.2-0.9), and odds of achieving immunogenic response to H1N1 only were decreased by longer use of infliximab (aOR = 0.5; 95% CI, 0.3-0.9). Odds of achieving immunogenic response (but not serologic protection) to all antigens was decreased by history of previous influenza vaccinations.
Adverse events occurred in 59.4% and 61.2% of the respective patient groups, but none experienced a serious adverse event, and disease activity increased significantly in only 6% of patients regardless of vaccine timing.
“Serologic protection to influenza vaccine is achieved in only approximately 45% to 80% of IBD patients on maintenance infliximab varying by antigen. Yet, importantly, vaccine timing relative to infliximab infusion does not affect the achievement of serologic protection, and the influenza vaccine is safe in this population,” the researchers concluded. “Therefore, influenza vaccination at any point during the infliximab infusion schedule is recommended for patients with IBD.” – by Adam Leitenberger
Disclosures: This study was financially supported by Janssen. deBruyn reports she has participated in advisory boards with Janssen, AbbVie and Nestle, and has received research support from and served as a speaker for Janssen. Please see the full study for a list of all other researchers’ relevant financial disclosures.