Efficacy and Safety of Vaccination Against Pandemic 2009 Influenza A (H1N1) Virus Among Patients With Rheumatic Diseases
Efficacy and Safety of Vaccination Against Pandemic 2009 Influenza A (H1N1) Virus Among Patients With Rheumatic Diseases
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DOI：
10.1002/acr.20465
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发表时间：
2011-07-01
影响因子：
4.7
通讯作者：
Mandelboim, Michal
中科院分区：
文献类型：
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作者：
Elkayam, Ori;Amir, Sharon;Mandelboim, Michal
Objective.评估类风湿关节炎（RA）、系统性红斑狼疮（SLE）、银屑病关节炎（PsA）和强直性脊柱炎（AS）患者接种H1N1流感疫苗的有效性和安全性，并与健康对照组进行比较。研究人群包括41例RA患者，21例SLE患者，17例PsA患者，15例AS患者和25例健康对照。所有人都接种了诺华MF59佐剂H1N1v单价流感疫苗。在第1天和4周后再次通过血凝抑制试验评估疫苗的免疫原性。计算每组的几何平均滴度和血清转化率。使用RA和PsA的28关节疾病活动性评分（DAS 28）、系统性红斑狼疮疾病活动性指数（SLEDAI）和Bath强直性脊柱炎疾病活动性指数（BASDAI）评估疫苗的安全性。除AS组较低外，所有患者的H1N1抗体基线保护水平比例相似。所有5组的几何平均滴度均显著增加。相当大比例的患者和对照组对疫苗有反应。健康对照组的反应优于其他各组：RA为84%，SLE为56%，PsA为67%，AS为53%。多变量logistic回归分析确定RA和PsA为反应显著降低的参数。DAS28、BASDAI和SLEDAI在疫苗接种后保持不变。接种H1N1流感疫苗。使用佐剂化的H1N1v单价流感病毒是安全的，并在患有RA、SLE、PsA和AS的患者中诱导适当的应答。
Objective. To assess the efficacy and safety of vaccination against pandemic H1N1 virus in patients with rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), psoriatic arthritis (PsA), and ankylosing spondylitis (AS) compared with healthy controls.Methods. The study population comprised 41 RA patients, 21 SLE patients, 17 PsA patients, 15 AS patients, and 25 healthy controls. All were vaccinated using the Novartis MF59-adjuvanted H1N1v monovalent influenza vaccine. The immunogenicity of the vaccine was assessed on day 1 and again 4 weeks later by hemagglutination inhibition assay. Geometric mean titers and seroconversion rates were calculated for each group. The safety of the vaccine was evaluated using the 28-joint Disease Activity Score (DAS28) for RA and PsA, the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI).Results. The proportion of baseline protective levels of antibodies against H1N1 was similar in all but the AS group, in which it was lower. The geometric mean titers increased significantly in all 5 groups. A substantial proportion of patients and controls responded to the vaccine. The healthy controls demonstrated a better response than each of the other groups: 84% versus 56% for RA, 67% for SLE, 59% for PsA, and 53% for AS. Multivariate logistic regression analysis identified RA and PsA as parameters of significantly lower response. The DAS28, BASDAI, and SLEDAI remained unchanged after vaccination.Conclusion. Vaccination against pandemic H1N1. using an adjuvanted H1N1v monovalent influenza is safe and induced an appropriate response in patients with RA, SLE, PsA, and AS.