Which Influenza Vaccine Is More Immunogenic in Rheumatoid Arthritis?

A high-dose trivalent inactivated influenza vaccine (HD-TIV) is not only safe for patients with seropositive rheumatoid arthritis (RA), but also more immunogenic than a standard-dose quadrivalent influenza vaccine (SD-QIV) among this patient population, according to results of a first-of-its-kind randomized, double-blind clinical trial.

To compare the immunogenicity and safety of SD-QIV (15 μg hemagglutinin per strain) with HD-TIV (60 µg hemagglutinin per strain) among adults with RA who are positive for rheumatoid factor and/or anticyclic citrullinated peptide antibodies, the study authors enrolled 279 patients with RA who had visited any of three McGill University–affiliated hospitals between October 24, 2016, and December 6, 2017.

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Based on the RA treatment they had been receiving for 3 months prior to and at enrollment, the participants were stratified into one of three groups:

1. Those who were taking conventional or targeted synthetic disease-modifying antirheumatic drugs (DMARDs) as monotherapy or in combination.
2. Those who were taking a biological DMARD, with or without methotrexate, hydroxychloroquine, or sulfasalazine (or a combination thereof).
3. Those who were taking abatacept, tofacitinib, or rituximab, with or without methotrexate, hydroxychloroquine, or sulfasalazine (or a combination thereof).

The researchers randomly assigned participants to receive either SD-QIV (n=140) or HD-TIV (n=139). The seroconversion rate per strain at day 28 was analyzed for 136 participants from the SD-QIV group and for 138 participants from the HD-TIV group.

Participants who received HD-TIV were more likely to seroconvert than those who received SD-QIV. The following seroconversion odds ratios were calculated:

• 2.99 (95% CI, 1.46-6.11) for seroconversion to strain A/H3N2
• 1.95 (95% CI, 1.19-3.22) for seroconversion to strain B/Brisbane
• 3.21 (95% CI, 1.57-6.56) for seroconversion to strain A/H1N1 (during the 2016-2017 influenza season)
• 2.44 (95% CI, 1.18-5.06) for seroconversion to strain A/H1N1 (during the 2017-2018 influenza season)

The participants in RA treatment groups 1 and 2 experienced similar results; RA treatment group 3 did not have a sufficient number of participants for the researchers to draw conclusions.

Local and systemic adverse events (AEs) were similar in both vaccine groups, with no serious AEs reported between days 0 and 28 in any group. Additionally, neither vaccine increased RA disease activity.

“This is the first [randomized controlled trial] comparing standard dose influenza vaccine with HD-TIV in patients with [RA],” the researchers concluded. “It provides evidence of the immunogenicity and safety of the HD-TIV in this population, enhancing our ability to provide informed vaccine recommendations for patients with [RA] and possibly for people living with other chronic inflammatory rheumatic diseases on similar background therapies.”

—Colleen Murphy

Reference:

Colmegna I, Useche ML, Rodriguez K, et al. Immunogenicity and safety of high-dose versus standard-dose inactivated influenza vaccine in rheumatoid arthritis patients: a randomised, double-blind, active-comparator trial. Lancet. 2020;2(1):14-23. doi:10.1016/S2665-9913(19)30094-3.