AB0618 Tolerability and safety of 23-valent polysaccharide pneumococcal vaccine in patients with systemic vasculitis, preliminary results

Abstract

BackgroundSystemic vasculitis (VS) is a severe autoimmune disease requiring active immunosuppressive therapy. The probability of infectious complications in these patients is very high. Immunization with the 23-valent polysaccharide pneumococcal vaccine (PPV-23) is required to reduce the risk of severe respiratory infections in this group of patients.ObjectivesThe aim of the study was to study the tolerability and safety of PPV-23 in patients with SV.MethodsAt this stage, the study included 13 patients with WS: 10 with vasculitis associated with antineutrophil cytoplasmic antibodies (ANCA) (AAV), (5 with granulomatosis with polyangitis (GPA), 4 with eosinophilic granulomatosis with polyangiitis (EGPA), 2 - with microscopic polyangiitis (MPA)), 1 - with polyarteritis nodosa, 1 - with Takayasu’s arteritis (AT); of which 10 women, 3 men, aged 22 to 76 years. 9 (69%) patients were older than 50 years. Remission of the disease was observed in 1 patient (EGPA), in 3 - low disease activity, in 9 - active vasculitis (all 9 with AAV, BVAS from 4 to 13). All patients received glucocorticoids (GC): 2 - 55-60 mg/day, 9 - 10-20 mg/day, 2-2.5-5 mg/day; 5 -bDMARD: 4 - rituximab (RTM), 1 - TNF inhibitors; 11 - cytostatics (CS): 4 - mycophenolate mofetil (MM), 3 - azathioprine (AZ), 2 - cyclophosphamide (CPh), 2 - methotrexate (MTX). Two patients were on induction therapy (GC 55-60 mg + CPh) with a plan to switch to RTM. Only 1 patient with EGPA received HA as monotherapy. The 23-valent polysaccharide pneumococcal vaccine was administered subcutaneously in 0.5 ml (1 dose). The follow-up period was 1-6 months. During the visits, standard clinical and laboratory tests and the determination of antibodies to S.pneumoniae were carried out.ResultsVaccination tolerance was good in all patients. One (7,7%) patient with EGPA (in remission) had a mild local reaction (pain at the injection site) within 1 day. Another 1 (7,7%) patient with severe concomitant pathology (EGPA + multiple sclerosis) had a general reaction in the form of a transient increase in weakness in the lower extremities for up to 5 days (this symptom was a manifestation of polyneuropathy, persisted earlier, and to a greater extent was associated with multiple sclerosis than with EGPA). Vaccinal reactions were completely reversible and did not require additional prescriptions. During the follow-up period, no deterioration in the course of SV was recorded in any case, and no new autoimmune phenomena, both laboratory and clinical, were noted in any of them. 7 (53,8%) patients (all 5 with GPA, 2 with EGPA) had ENT lesions (destructive rhinosinusitis (5), sinusitis (2)) with frequent exacerbations. 1 patient with GPA reported a significant improvement in the condition of the ENT organs (no exacerbations of rhinosinusitis, disappearance of nasal discharge for 5 months). In the remaining 6 patients, the condition also remained stable, no progression of sinusitis was noted during the observation period (1-4 months). No infections of the lower respiratory tract were registered during the observation period.Conclusion1. All patients had a high risk of infectious complications: combined immunosuppressive therapy (92% of patients), age over 50 years (69% of patients), severe lesion of ENT organs (53,8% of patients). 2. The tolerance of PPV-23 vaccination was good. 3. There was no deterioration in the course of SV.Disclosure of InterestsNone declared