SAT0395 Assessment of efficacy and safety of a trivalent split-virus influenza vaccine in patients with rheumatic diseases
Authors: D. Bukhanova, B. Belov, G. Trasova, S. Erdes, T. Dubinina, G. Lukina, N. Demidova, A. Volkov, N. Yudkina
Journal: Annals of the Rheumatic Diseases (2018)

<h3>Background</h3> In current rheumatology practice concurrent infections produce significant negative impact on patients' morbidity, mortality and quality of life, especially in cases of systemic connective tissue diseases. Based on WHO estimations the annual incidence of influenza in adult population amounts to 5%–10% worldwide. Influenza can lead to hospitalisation (3 to 5 million cases per year) and even death (250–500 thousand cases per year). Flu and its complications rates are higher in patients with rheumatic diseases (RD) as compared to general population. Therefore, prevention of influenza should be viewed as integral part of RD population management. <h3>Objectives</h3> To study the safety and efficacy of inactivated split-virus influenza vaccine in patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS), and systemic scleroderma (SS) treated with diseases modifying anti rheumatic drugs (DMARDs) and biologic diseases modifying anti rheumatic drugs (bDMARDs). <h3>Methods</h3> 133 subjects (97 females and 36 males, aged 22–82 y) with recent acute respiratory viral infections (ARVI) and flu episodes in medical records were enrolled, including 52 RA patients, 34 AS patients, 7 SS patients and 40 healthy volunteers as the control group. 39 RA pts received methotrexate (MTX), 12 – TNFα inhibitors+MTX, 8 – leflunomide, 2 – abatacept, 2 – sulfasalazine, 1 – tofacitinib +MTX. 19 AS patients were treated with nonsteroidal anti-inflammatory drugs (NSAIDs), 15 –with TNFα inhibitors. The RD duration ranged from 2 months to 46 years. All participants were injected subcutaneously with one dose (0.5 ml) of the "Vaxigrip" vaccine containing the actual influenza virus strains with ongoing therapy. The control visits were scheduled at baseline, and in 1, 3 and 6 months after vaccination (Visits 0, 1, 2 and 3, respectively). Standard clinical and laboratory tests were performed during each visit. <h3>Results</h3> Vaccine tolerability was good in 103 participants (77,4%). Post-vaccination pain, swelling and redness of the skin up to 2 cm in diameter were registered in 20 cases (15%), low-grade fever, myalgia and malaise were documented in 10 cases (7,5%). There was no causal relationship between these reactions and principal therapy, therefore, no modifications of therapeutic regimens were required, and complete resolution occurred within 24 hours without additional interventions. No RD exacerbations or emergence of <i>de novo</i> autoimmune disorders were observed during the FUP. At baseline mean pts' DAS28 and BASDAI scores were 3.56 and 3.85, improving up to 1.99 and 3,09, respectively, 6 mo post-vaccination. For the entire FUP there were no cases of influenza or influenza-like illness registered. <h3>Conclusions</h3> Therefore, the preliminary results show good tolerability and efficacy of inactivated split-virus influenza vaccine in RA, AS, and SS patients. Future studies on larger patients' populations are warranted for more complete evaluation of vaccine safety and efficacy. <h3>Disclosure of Interest</h3> None declared