Evaluation of the immunogenicity of the 13-valent conjugated pneumococcal vaccine in rheumatoid arthritis patients treated with etanercept

详细信息    查看全文

• 作者：É ; va Rá ; kó ; czi^a ; Bianka Perge^b ; Edit Vé ; gh^b ; Pé ; ter Csomor^b ; Anita Pusztai^b ; Szilvia Szamosi^b ; Nó ; ra Bodná ; r^b ; Sá ; ndor Szá ; ntó ; ^b ; Gabriella Szü ; cs^b ; Zoltá ; n Szekanecz^b ; ^{szekanecz.zoltan@med.unideb.hu" class="auth_mail" title="E-mail the corresponding author}
• 关键词：Rheumatoid arthritis ; Conjugated pneumococcal vaccine ; PCV13 ; Etanercept ; Protective antibody level
• 刊名：Joint Bone Spine
• 出版年：2016
• 出版时间：December 2016
• 年：2016
• 卷：83
• 期：6
• 页码：675-679
• 全文大小：529 K

文摘

To prospectively evaluate the immunogenicity of a 13-valent conjugated pneumococcal vaccine (PCV13) in rheumatoid arthritis (RA) patients undergoing etanercept therapy.

Methods

Twenty-two RA patients treated with etanercept (ETA) in combination with methotrexate (MTX) (n = 15) or monotherapy (n = 7) for at least one year were included. Altogether 24 osteoarthritis patients not receiving biological or MTX therapy, treating only NSAIDs or analgesics served as controls. All subjects were vaccinated with a single dose (0.5 ml) of the PCV13. Pneumococcal antibody levels at baseline, 4 and 8 weeks were assessed by a VaccZyme™ Anti-PCP IgG Enzyme Immunoassay Kit. Based on recommendations of the American Academy of Allergy, Asthma & Immunology, an at least two-fold increase in antibody level, as the protective antibody response (pAR) was an indicator of responsiveness (i.e., ratio of postvaccination and prevaccination antibody levels). The antibody levels and their ratios were analysed in a variety of different ways, vaccine safety parameters (fever, infections, changes in regular antirheumatic treatments) were assessed at baseline, 4 and 8 weeks after vaccination.

Results

Four weeks after vaccination, the anti-pneumococcal antibody levels significantly increased in both groups. At week 8, antibody levels somewhat decreased in both groups, however, still remained significantly higher compared to baseline. Compared with postvaccination levels at 4 and 8 weeks between two groups, the mean protective antibody levels were higher in control group (1st month P = 0.016; 2nd month: P = 0.039). Possible predictors of pAR were analysed by logistic regression model. In RA, increases of antibody levels at week 8 compared to baseline exerted a negative correlation with age, (Spearman's R = −0,431; P = 0.045). There were no clinically significant side effects or reaction after administration of vaccine observed in any of these patients after the 2-month follow-up period, all patients medical condition were stable.

Conclusions

In RA patients treated with ETA, vaccination with PCV13 is effective and safe, resulting in pAR one and two months after vaccination. Higher age at vaccination was identified as predictors of impaired pAR. The efficacy of vaccination may be more pronounced in younger RA patients. The vaccine is safe in RA patients on ETA.