AB0309 SAFETY OF 23-VALENT POLYSACCHARIDE PNEUMOCOCCAL VACCINE IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS
Authors: G. Tarasova, B. Belov, M. Cherkasova, E. Aseeva, T. Reshetnyak, N. Kosheleva, T. Popkova
Journal: Annals of the Rheumatic Diseases (2021)

Background: Vaccination of patients with autoimmune diseases with pneumococcal vaccines is necessary to prevent severe respiratory infections in this group of patients. The main issue of immunization of patients with systemic lupus erythematosus (SLE) remains the issue of safety. Objectives: The aim of the study was to study the safety of the 23-valent polysaccharide pneumococcal vaccine (PPV-23) in patients with SLE. Methods: The study included 73 patients with a reliable diagnosis of SLE, of which women - 64, men - 9, aged 19 - 68 years. 69 patients received glucocorticoids (GC) 5-30 mg/day, 55- hydroxychloroquine (GCH), 37-cytostatics (CS), 27 – biologics (14 – rituximab (RTM), 11 – belimumab (BLM), 2-BLM and RTM). 1 dose (0.5 ml) of PPV23 was administered subcutaneously. 60 patients were examined within 1 year, 13 - within 2-3 months. Results: Vaccination tolerance was assessed in 73 patients: in 33 (45.2%) - vaccine reactions were absent, in 36 (49.3%) - local reactions of mild and moderate severity were noted (pain, swelling, skin hyperemia at the injection site of the vaccine), lasting from 2 to 7 days, in 1 (1.4%) - general weakness within 1 month, in 2 (2.7%) - mild diarrhea within 1 day. Vaccinal reactions were typical and completely reversible, did not require additional appointments. One patient (1.4%) developed a hyperergic reaction of the Artyus phenomenon type, which was arrested within 7 days by the use of antihistamines and topical GCs. None of the 60 patients, whose follow-up period was 1 year, had no exacerbations of the disease directly related to vaccination (i.e., in the next 2-3 months). Vaccination was carried out both at a low degree of activity (n = 33 (55%)) and remission (n = 6 (10%)), and at an average (n = 12 (20%)) and high (n = 9 (15%))) the degree of SLE activity. The dynamics of the SLE activity index SLEDAI-2k (Me) during the year was as follows: initially - 4 (2; 6), after 2-3 months - 2 (2; 4), after 12 months - 2 (2; 4). During the year, 7 out of 60 patients had a moderate exacerbation of the disease, which was not related to the vaccination in terms of timing: after 3.5-5 months (3), 12 months (4). An exacerbation occurred in 4 - with a decrease in the HA dose, in 1 - after psychological stress, in 1 - against the background of persistently high immunological activity and insufficient therapy, in 1 - without an increase in immunological activity. In 4 out of 7, exacerbation was manifested by skin rashes and articular syndrome, in 1 - by the development of panniculitis, in 2 - by leukopenia. All these symptoms were noted earlier in the period of exacerbation. In all, the exacerbation was quickly stopped by a moderate increase in the HA dose. In 60 patients, the dynamics of immunological markers of SLE was analyzed during the year after vaccination. There was no evidence of a significant increase in the immunological activity of SLE after vaccination with PPV-23. After vaccination, no new autoimmune phenomena have been identified. In the first 3 months. after vaccination, in isolated cases, there was a transient increase / decrease in SLE markers (a-DNA, ANF, C3, C4) with a subsequent return to the initial values, without symptoms of exacerbation of the disease. Conclusion: 1. During the year of observation, no exacerbations were observed that were reliably associated with vaccination. 2. Vaccination with PPV-23 is safe for SLE patients during periods of low and moderate activity. If necessary, vaccination is possible at high activity without the development of adverse events. 3. The multidirectional dynamics of the main markers of SLE observed during the year reflects the instability of immunological parameters characteristic of SLE. Disclosure of Interests: None declared