SAFETY AND EFFECTIVENESS OF TRI VALENT INACTIVATED SPLIT VIRION INFLUENZA VACCINE IN PATIENTS WITH RHEUMATOID DISORD ERS

Objective: to evaluate the safety and effectiveness of vaccination with trivalent split virion influenza vaccine in patients with rheumatoid arthritis (RA) and ankylosing spondylitis (AS), estimate the effect of vaccination on rheumatoid disorder (RD) activity and influenza and influenzalike illnesses morbidity.

Materials and methods. The study included 86 patients (58 females and 28 males aged 22–82 years) with RDs (52 patients with RA and 34 patients with AS), as well as 40 subjects without RD (control group). At the time of study inclusion, all patients were receiving drug therapy. Duration of RD varied from 2 months to 46 years. The Vaxigrip vaccine containing the currents trains of the flu virus for 2016–2017 season or 2017–2018 season was administered subcutaneously as 1 dose (0.5 ml) with continuing antirheumatic therapy. The main control stages were visits 1, 3, and 6 months after vaccination. During the visits, standard clinical and labtests, clinical examination with disease activity evaluation were performed.

Results. In 98 patients, vaccination tolerability was high, no post vaccination reactions were observed. In 20 cases, pain, swelling, and hyperemia of the skin 2 cm in diameter at the point of vaccination were observed; in 8 cases, low-grade fever, myalgia, discomfort, headache were observed. No RD flares or development of new autoimmune disorders were diagnosed during the follow-up period. No cases of influenza or influenza-like illnesses were registered during the follow-up period.

Conclusion. The obtained data demonstrate high tolerability, clinical effectiveness of trivalent split virion influenza vaccine in patients with RA and AS.

1. Wolfe F., Mitchell D. M., Sibley J. T. et al. The mortality of rheumatoid arthritis. Arthritis Rheum 1994;37(4):481–94.

2. Baum J. Infection in rheumatoid arthritis. Arthritis Rheum 1971;14(1):135–7.

3. Singh J. A., Cameron C., Noorbaloochi S. et al. Risk of serious infection in biological treatment of patients with rheumatoid arthritis: a systematic review and metaanalysis. Lancet 2015;386(9990):258–65. DOI: 10.1016/S0140–6736(14)61704–9.

4. Widdifield J., Bernatsky S., Paterson J. M. et al. Serious infections in a populationbased cohort of 86,039 seniors with rheumatoid arthritis. Arthritis Care Res (Hoboken) 2013;65(3):353–61. DOI: 10.1002/acr.21812.

5. Listing J., Gerhold K., Zink A. The risk of infections associated with rheumatoid arthritis, with its comorbidity and treatment. Rheumatology (Oxford) 2013;52(1):53–61. DOI: 10.1093/rheumatology/kes305.

6. Blumentals W. A., Arreglado A., Napalkov P., Toovey S. Rheumatoid arthritis and the incidence of influenza and influenza-related complications: a retrospective cohort study. BMC Musculoskelet Disord 2012;13:158. DOI: 10.1186/1471‑2474‑13‑158.

7. Aletaha D., Neogi T., Silman A. J. et al. 2010 rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative Annals of the Rheumatic Diseases. Ann Rheum Dis 2010;69(9):1580–8. DOI: 10.1136/ard.2010.138461.

8. Van der Linden S., Valkenburg H. A., Cats A. Evaluation of diagnostic criteria for ankylosing spondylitis. A proposal for modification of the New York criteria. Arthritis Rheum 1984;27(4):361–8.

9. Van Assen S., Agmon-Levin N., Elkayam O. et al. EULAR recommendations for vaccination in adult patients with autoimmune inflammatory rheumatic diseases. Ann Rheum Dis 2011;70(3):414–22. DOI: 10.1136/ard.2010.137216.

10. Plotkin S. A. Correlates of protection induced by vaccination. Clinical and Vaccine Immunology. Clin Vaccine Immunol 2010;17(7):1055–65. DOI: 10.1128/CVI.00131–10.

11. Plotkin S. A. Complex correlates of protection after vaccination. Clin Infect Dis 2013;56(10):1458–65. DOI: 10.1093/cid/cit048.

12. Rodriguez-Cundin P., Calvo-Río V., Blanco R. et al. SAT0102 Influence of Vaccination Program To Prevent Acute Respiratory Infection in Rheumatoid Arthritis. Ann Rheum Dis 2016;75:702–8. DOI: 10.1136/annrheumdis-2016-eular. 5211.

13. Stojanovich L., Milanovic M., Djokovic A. THU0290 Effectiveness and Safety of Influenza Vaccination in Patients with Autoimmune Rheumatic Diseases. Ann Rheum Dis 2014;73:283. DOI: 10.1136/annrheumdis2014-eular. 2454.