High dose influenza vaccine beneficial for rheumatoid arthritis patients: Lancet
Canada: High dose influenza vaccine is safe and effective for patients with rheumatoid arthritis, a recent study published in The Lancet Rheumatology has suggested.
According to the study, high-dose trivalent inactivated influenza vaccine (HD-TIV) is safe and more immunogenic than standard-dose quadrivalent influenza vaccine (SD-QIV) in patients with seropositive rheumatoid arthritis. "These results are the first evidence to support the use of HD-TIV in these patients," write the authors.
Patients with rheumatoid arthritis have increased risk of seasonal influenza and influenza-related complications but have reduced vaccine immunogenicity. In both rheumatoid arthritis patients and older people, reduced vaccine-induced protective responses have attributed to chronic inflammation, an increased frequency of comorbidities, and polypharmacy. While two influenza vaccines developed for older people have shown greater immunogenicity compared with standard-dose vaccines in other immunocompromised individuals, no studies have compared these formulations to a standard-dose vaccine in patients with chronic rheumatic diseases.
The study by Inés Colmegna, Research Institute of the McGill University Health Centre, McGill University Health Centre, Montreal, QC, Canada, and colleagues investigated the immunogenicity and safety of an HD-TIV (60 μg of HA per strain) in patients with rheumatoid arthritis compared to an SD-QIV.
The study included 274 people with rheumatoid arthritis who were taking disease-modifying antirheumatic drugs (DMARDs) and their treatment had not been modified during the past three months. They were stratified into one of the three groups: - Group 1) Patients taking conventional or targeted synthetic DMARDs (methotrexate, hydroxychloroquine, and sulfasalazine) as monotherapy or in combination; Group 2) patients on a biological DMARD (anti-tumor necrosis factor or anti-interleukin 6), with or without methotrexate, hydroxychloroquine, or sulfasalazine; and patients who were taking abatacept, tofacitinib, or rituximab, with or without methotrexate, hydroxychloroquine, or sulfasalazine. Participants were randomly allocated to receive the SD-QIV or HD-TIV vaccine. The primary outcome was the seroconversion rate per strain at day 28.
Key findings of the study include:
- Between Oct 24, 2016, and Dec 6, 2017, 696 patients with rheumatoid arthritis were invited to participate in the study and 279 were randomly assigned and vaccinated (140 [50%] received SD-QIV and 139 [50%] HD-TIV).
- 136 patients who received SD-QIV and 138 who received HD-TIV were included in the modified intention-to-treat anaysis.
- Patients who received HD-TIV were more likely to seroconvert than those who received SD-QIV: the odds ratio was 2·99 for seroconversion to strain A/H3N2, 1·95 for seroconversion to strain B/Bris, 3·21 for seroconversion to strain A/H1N1, and 2·44 for seroconversion to strain A/H1N1 (in 2017–2018).
- Similar results were observed in patients from groups 1 and 2; the number of individuals in group 3 was insufficient to draw conclusions.
- Local and systemic adverse events were similar in both vaccine groups, no serious adverse events were reported between days 0 and 28 in any group, and neither vaccine increased rheumatoid arthritis disease activity.
"This is the first study to test the immunogenicity of the HD-TIV in patients with autoimmune or inflammatory arthritis with or without biologic therapy," the authors wrote.
Multiple strategies are needed "to enhance protection for patients with rheumatoid arthritis, including the maintenance of high vaccination coverage among the family members and close contacts of patients," they concluded.
The study, "Immunogenicity and safety of high-dose versus standard-dose inactivated influenza vaccine in rheumatoid arthritis patients: a randomised, double-blind, active-comparator trial," is published in The Lancet Rheumatology.
