Session Type: ACR Plenary Session
Session Time: 11:00AM-12:30PM
Background/Purpose: Rheumatoid arthritis (RA) patients have 2.75 fold increased risk of influenza and influenza-related illness than age-matched healthy controls. For this reason, RA patients are a priority group for annual vaccination. Although vaccination is currently the most effective intervention against influenza and its associated complications, vaccine induced antibody responses and protection in RA are low. It is unknown if the use of a high dose vaccine (high dose trivalent inactivated influenza vaccine: HD-TIV) can improve protection over that conferred by the standard vaccine (standard dose quadrivalent inactivated influenza vaccine: SD-QIV) in RA.
Methods: We conducted a treatment-stratified, randomized, modified double-blind, active-controlled trial in adult seropositive RA patients (rheumatoid factor and/or anti-cyclic citrullinated peptide antibodies) to assess antibody responses to either SD-QIV (15 μg of hemagglutinin (HA) per strain) or HD-TIV (60 μg of HA per strain) (NCT02936180). Subjects were recruited at a tertiary care center during the 2016–2017 (year 1) and the 2017–2018 (year 2) Northern-Hemisphere influenza seasons. They were stratified by the treatment received for 3 months prior to enrolment and during the study: DMARDs (Group 1-G1), anti-cytokine therapy (G2), anti-B-cell therapy and small molecules (G3). Seroconversion (SC) and seroprotection (SP) rates were assessed using pre- (Day 0 – D0) and post-vaccine (D28) serum hemagglutination inhibition (HI) titers. SC was defined as at least a four-fold HI antibody increase from D0. SP rate was defined as percent with HI titres ≥1:40 at D28. Vaccine strains were A/HongKong/4801/2014(H3N2), B/Brisbane/60/2008 in Y1/2 with A/California/7/2009(H1N1) in Y1 and A/Michigan/45/2015(H1N1) in Y2.
Results: A total of 279 seropositive RA patients were enrolled. 140 (50.2%) received SD-QIV and 139 (49.8%) received HD-TIV. The mean age (±SD) was 61.0±12.9 and 80% were female. According to treatment, 138 (49.5%) patients were in G1; 92 (33%) in G2 and 49 (17.6%) in G3. SP rates pre-vaccine were comparable between HD-TIV and SD-QIV groups. Overall responses to vaccination were consistently higher with the HD-TIV. SC (H3N2 22.3% vs 8.6%; B/Bris 44.6% vs 28.6%; H1N1 51.1% vs 30.0%) and SP rates (H3N2 48.5% vs 30.9%; B/Bris 60.9% vs 50.7%; H1N1 80.4% vs 73.5%) were seen in patients that received the HD-TIV compared to the SD-QIV. In logistic regression models including age, vaccine type, treatment (G1, G2 and G3); Charlson comorbidity index, and RA duration; vaccine dose and age were the only predictors of the influenza vaccine seroresponse. Patients that received HD-TIV were 2.8 times more likely to H3N2 seroconvert (odds ratio 2.84; 95% confidence interval 1.38 – 5.87), 2 times more likely to B/Bris seroconvert (1.91; 1.15-3.17), and 2.3 times more likely to H1N1 seroconvert (2.33; 1.42-3.85).
Conclusion: In seropositive RA patients, the use of HD-TIV substantially improves the immune response to vaccination compared to SD-QIV. This is the first study documenting a successful intervention to enhance vaccine responses in immunocompromised hosts.
To cite this abstract in AMA style:Colmegna I, Useche M, Rodriguez K, Hudson M, Bernatsky S, Nedjar H, Rahme E, Ward B. Efficacy of High-Dose Versus Standard-Dose Influenza Vaccine in Seropositive Rheumatoid Arthritis Patients [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 10). https://acrabstracts.org/abstract/efficacy-of-high-dose-versus-standard-dose-influenza-vaccine-in-seropositive-rheumatoid-arthritis-patients/. Accessed July 9, 2020.
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