Abstract
Objective: to investigate the immunogenicity and safety of 23-valent polysaccharide pneumococcal vaccine in patients with rheumatic diseases (RD). Subjects and methods. The prospective open-label comparative study enrolled 133 people (102 (76.7%) women and 31 (23.3%) men) aged 23 to 76 years, including 79 patients with rheumatoid arthritis (RA), 16 with systemic sclerosis, and 7 with dermatomyositis/polymyositis, as well as 31 subjects without systemic inflammatory RD (a control group), who had a recent history of at least two cases of lower respiratory tract infections (bronchitis, pneumonia). At their inclusion, all the patients with RD were receiving ant-inflammatory therapy, including 52 taking methotrexate (MT), 14 – leflunomide (LEF), and 13 – MT + tumor necrosis factor-α (TNF-α) inhibitors. The 23-valent polysaccharide pneumococcal vaccine Pneumo-23 (Sanofi Pasteur, France) was administered in a single dose of 0.5 ml subcutaneously during continuous MT or LEF therapy for the underlying disease or 3–4 weeks before the use of TNF-α inhibitors. Clinical examinations of the patients and conventional laboratory studies were performed during control visits (1, 3, and 12 months after vaccination). The serum levels of anti-pneumococcal capsular polysaccharide antibodies were measured in 102 patients by enzyme immunoassay using commercial VaccZymeTM Anti-PCP IgG Enzyme Immunoassay kits (The Binding Site Group Ltd, United Kingdom). Results and discussion. No clinical and radiological symptoms of pneumonia were recorded in any case during the follow-up period of 12 months. The patients with RD and the control group showed a significant, more than double increase in anti-pneumococcal antibodies 12 months following vaccination. Vaccination was well tolerated: 90 (68%) patients displayed no adverse events; 37 (28%) had pain, cutaneous swelling and hyperemia up to 2 cm in diameter at the site of injection for vaccination;6 (4%) had low-grade fever. There were no episodes of a RD exacerbation or any new autoimmune disorders during the follow-up period. Conclusion. The findings were suggestive of the sufficient immunogenicity and good tolerability of 23-valent pneumococcal vaccine in patients with RD.
Highlights
Цель исследования – изучение иммуногенности и безопасности 23-валентной полисахаридной пневмококковой вакцины у больных ревматическими заболеваниями (РЗ)
Переносимость вакцинации была хорошей: у 90 (68%) пациентов неблагоприятных реакций не было, у 37 (28%) – отмечены боль, припухлость и гиперемия кожи диаметром до 2 см в месте инъекции вакцины, у 6 (4%) – субфебрилитет
Clinical examinations of the patients and conventional laboratory studies were performed during control visits (1, 3, and 12 months after vaccination)
Summary
Цель исследования – изучение иммуногенности и безопасности 23-валентной полисахаридной пневмококковой вакцины у больных ревматическими заболеваниями (РЗ). В открытое проспективное сравнительное исследование включено 133 человека в возрасте от 23 до 76 лет, из них женщин – 102 (76,7%), мужчин – 31 (23,3%), в том числе 79 больных ревматоидным артритом, 16 – системной склеродермией, 7 – дерматомиозитом/полимиозитом, а также 31 испытуемый без системных воспалительных РЗ (контрольная группа), имеющих в ближайшем анамнезе не менее двух случаев инфекций нижних дыхательных путей (бронхиты, пневмонии). Вакцинацию 23-валентной полисахаридной пневмококковой вакциной «Пневмо-23» (Sanofi Pasteur, Франция) проводили однократно в дозе 0,5 мл подкожно на фоне продолжения терапии основного заболевания МТ или ЛЕФ, либо за 3–4 нед до назначения ингибиторов ФНОα.
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