Vaccination of pneumococcal infection in patients with systemic lupus erythe matosus and antiphospholipid syndrome: experience of 6 years of use

G. Tarasova, B. Belov, T. Reshetnyak, M. Cherkasova
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Abstract

Infections remain one of the main causes of morbidity and mortality in patients with immuno-inflammatory rheumatic diseases. Objective – to study the efficacy, immunogenicity and safety of the 23-valent polysaccharide pneumococcal vaccine (PPV-23) in patients with systemic lupus erythematosus (SLE) and antiphospholipid syndrome (AРS). Materials and methods. 91 patients were included in the study: 78 with SLE, of which 18 (23 %) – with secondary AРS, 13 – with primary AРS. 85 patients received immunosuppressive therapy, including 30 – genetically engineered biological drugs (bDMARD); 23 – anticoagulants. PPV-23 was administered subcutaneously, patients were observed for a year after vaccination. Results. Local reactions were observed in 49% of patients with SLE and secondary AРS, in 23% of patients with primary AРS. General reactions were noted in isolated cases, were short-term and did not require additional prescriptions. During the follow-up period, no exacerbations of SLE, relapses of thrombosis and thromboembolism associated with vaccination were detected; no development of new autoimmune diseases was registered. 10 (13%) patients with SLE were immunized against the background of high activity of the disease, no adverse reactions were recorded. In some patients, a transient increase in a-DNA and ANF was observed during the year without signs of exacerbation of the disease. 56% of patients with SLE and secondary AРS, 15.4% with primary AРS were “responders” to the vaccine. There was no negative effect on the immune response of the dose of GC >10 mg/day, age, duration and activity of the disease. With the treatment of bDMARD, a full-fledged vaccine response was recorded much less frequently than with standard therapy (38% and 67.4%, respectively; p=0.01). After vaccination, there was a significant decrease in the number of lower respiratory tract infections (LRTI) (p=0.0001), including community-acquired pneumonia (PN) (p=0.03) and acute bronchitis (p=0.04), ENT infections (p=0.001). In the treatment of rituximab (RTM), compared with belimumab (BLM), a greater number of LRTI was observed, mainly due to PN. After vaccination on RTM therapy, the number of INDP in general (p=0.008) and PN in particular (p=0.03) decreased, isolated cases of LRTI and ENT organs were recorded on BLM therapy. Within 4–6 years after vaccination, 30 patients with SLE retained the clinical effect of vaccination, while immunogenicity decreased to 18%. Conclusion. Safety, sufficient immunogenicity, and clinical efficacy of PPV-23 in patients with SLE and AРS have been shown. The use of bDMARD reduces the vaccine response. Immunization performed prior to or during treatment with bDMARD lasting <1 year increases the number of vaccine responders.
系统性红斑狼疮和抗磷脂综合征患者肺炎球菌感染的疫苗接种:6年的使用经验
感染仍然是免疫炎性风湿病患者发病和死亡的主要原因之一。目的:研究23价多糖肺炎球菌疫苗(PPV-23)对系统性红斑狼疮(SLE)合并抗磷脂综合征(AРS)患者的疗效、免疫原性和安全性。材料和方法。91例患者纳入研究:78例SLE,其中18例(23%)为继发性AРS, 13例为原发性AРS。85例患者接受免疫抑制治疗,其中30例采用基因工程生物药物(bDMARD);23 -抗凝血剂。PPV-23皮下注射,接种后观察1年。结果。49%的SLE继发性AРS患者有局部反应,23%的原发性AРS患者有局部反应。一般反应在个别病例中被记录,是短期的,不需要额外的处方。在随访期间,未发现与疫苗接种相关的SLE恶化、血栓和血栓栓塞复发;未发现新的自身免疫性疾病。10例(13%)SLE患者在疾病高活跃的背景下进行了免疫接种,无不良反应记录。在一些患者中,在一年中观察到a- dna和ANF的短暂增加,但没有疾病恶化的迹象。56%的SLE继发性AРS患者和15.4%的原发性AРS患者对疫苗有“应答”。GC剂量>10 mg/d、年龄、病程、疾病活动度对免疫应答无负面影响。使用bDMARD治疗时,记录的完全疫苗反应的频率远低于标准治疗(分别为38%和67.4%;p = 0.01)。接种疫苗后,下呼吸道感染(LRTI)数量显著减少(p=0.0001),包括社区获得性肺炎(PN) (p=0.03)、急性支气管炎(p=0.04)、耳鼻喉科感染(p=0.001)。在利妥昔单抗(RTM)治疗中,与贝利单抗(BLM)相比,观察到更多的LRTI,主要是由PN引起的。接种RTM治疗后,总体INDP数(p=0.008),特别是PN数(p=0.03)下降,BLM治疗后有单独的LRTI和耳鼻喉器官病例。接种疫苗后4-6年内,30例SLE患者保留了接种疫苗的临床效果,但免疫原性下降至18%。结论。已经证明PPV-23在SLE和AРS患者中的安全性、足够的免疫原性和临床疗效。使用bDMARD可降低疫苗反应。持续时间<1年的bDMARD治疗之前或期间进行免疫接种可增加疫苗应答者的数量。
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