Efficacy and Safety of Hepatitis B Vaccination in Rheumatoid Arthritis Patients Receiving Disease-Modifying Antirheumatic Drugs and/or Biologics Therapy
Efficacy and Safety of Hepatitis B Vaccination in Rheumatoid Arthritis Patients Receiving Disease-Modifying Antirheumatic Drugs and/or Biologics Therapy
复制标题
DOI：
10.1097/rhu.0000000000000877
复制
发表时间：
2019-12-01
影响因子：
3.4
通讯作者：
Chaiamnuay, Sumapa
中科院分区：
文献类型：
--
作者：
Intongkam, Samanan;Samakarnthai, Parinya;Chaiamnuay, Sumapa
目的评价在类风湿关节炎(RA)患者中应用常规和/或生物抗风湿药物(DMARDS)接种乙肝疫苗的有效性和安全性。方法采用纵向开放标记法。在46例RA患者中，33例仅接受常规合成DMARD，13例同时接受常规合成DMARD和生物DMARDS，9名年龄和性别匹配的健康对照组在0、4和24周接种了20Mg重组乙肝疫苗(EuVax B)。在最后一剂疫苗接种后8周检测乙肝表面抗体水平。血清保护定义为乙肝表面抗体水平达到或超过10mIU/m L。在46名接受乙肝疫苗接种的RA患者和47名未接受治疗的RA患者中，在0、4和32周时记录28个关节的疾病活动性评分。在每次访问中记录不良事件。使用SPSS16.0版进行统计分析。结果RA患者血清保护率低于对照组(%vs.100%，P=0.045)。与对照组相比，接受生物DMARDS和常规DMARDS的患者的血清保护比例较低(分别为50%和100%[p=0.02]和69.7%对100%[p=0.09])。在RA患者中，应答者比无应答者年轻，平均年龄分别为57.5岁(SD，9.0)和64.9岁(SD，10.9)(p=0.04)，更不可能接受利妥昔单抗治疗(6.9%比37.5%，p=0.01)。总体而言，乙肝疫苗接种耐受性良好。接种乙肝疫苗后RA红斑率未见增加。结论接受DMARDS治疗的RA患者对接种乙肝疫苗的体液反应低于对照组。年龄和利妥昔单抗的使用与乙肝疫苗接种反应受损有关。对于RA患者来说，接种乙肝疫苗是安全和耐受性良好的。
Objectives The aims of this study were to assess efficacy and safety of the hepatitis B vaccination in rheumatoid arthritis (RA) patients receiving conventional and/or biological disease-modifying antirheumatic drugs (DMARDs). Methods A longitudinal open-label study was conducted. Of 46 RA patients, 33 received only conventional synthetic DMARDs, and 13 received both conventional synthetic DMARDs and biological DMARDs, and 9 healthy age- and sex-matched control subjects were vaccinated with 20 mu g recombinant hepatitis B vaccine (EuVax B) at weeks 0, 4, and 24. Hepatitis B surface antibody levels were measured 8 weeks after the last dose of vaccination. Seroprotection was defined as hepatitis B surface antibody level of 10 mIU/mL or greater. Disease Activity Score in 28 Joints scores were recorded at weeks 0, 4, and 32 in 46 RA patients who received hepatitis B vaccination and 47 treatment-matched RA patients who did not receive it. Adverse events were recorded at each visit. Statistical analyses were performed using SPSS version 16.0. Results Seroprotection was lower in the RA patients than in the control subjects (64% vs. 100%, p = 0.045). Patients receiving biological DMARDs and conventional DMARDs had a lower proportion of seroprotection compared with the control group (50% vs. 100% [p = 0.02] and 69.7% vs. 100% [p = 0.09], respectively). Among RA patients, responders were younger than nonresponders with a mean age of 57.5 (SD, 9.0) years and 64.9 (SD, 10.9) years (p = 0.04) and less likely to be treated with rituximab (6.9% vs. 37.5%, p = 0.01). Overall, hepatitis B vaccination was well tolerated. The rate of RA flare was not increased after hepatitis B vaccination. Conclusions Patients with RA receiving DMARDs had less humoral response to hepatitis B vaccination as compared with control subjects. Aging and rituximab use were associated with impaired response to hepatitis B vaccination. Hepatitis B vaccination is safe and well tolerated in RA patients.