Background/Purpose: There is no study regarding short and long-term assessments of 23-valent polysaccharide pneumococcal vaccine (PPV23) in juvenile idiopathic arthritis (JIA) under biologic therapy. The objectives of this study were to assess the humoral response of the PPV23 in JIA patients pre- and post-anti-TNF therapy and controls without this treatment. The possible influence of demographic data, disease activity and treatment on immunogenicity and the potential deleterious effect of vaccine on disease itself were also evaluated.

Methods: 17 JIA patients immediately pre-anti-TNF (etanercept 0.8 mg/kg/week, Group 1) and 10 JIA patients on stable dose of methotrexate (median dose 0.8 mg/kg/week, Group 2) received one dose of pneumococcal vaccine. All patients were evaluated pre-vaccination, 2 months and 12 months post-vaccination for 7 pneumoccocal serotypes (4, 6b, 9v, 14, 18c, 19f, 23f). Serology for each serotype was performed by enzyme immunoassay. The immunogenicity endpoints included the seroprotection rate (SP) (percentage of subjects achieving antibodies titers ≥1.3 micrograms/mL), seroconversion rate (SP) (percentage of subjects with a minimum of 2-fold rise in post-vaccination antibodies titers) and the geometric mean concentration of antibodies (GMC). Adequate vaccine response was considered when SC occurred for at least 50% of vaccine serotypes. Patient and physician visual analogue scales (VAS), Childhood Health Assessment Questionnaire (CHAQ), number of active joints, erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) were evaluated before and after vaccination.

Results: Group 1 and Group 2 were comparable regarding current age (11.6 vs. 9.2 years, p=0.15), female gender (47 vs. 40%, p=1.0), age at diagnosis (7.6 vs. 7.1 years, p=0.9) and disease duration (3.7 vs. 2 years, p=0.1). The frequency of glucocorticoids and non-biologic drugs (methotrexate, leflunomide and cyclosporine) was similar in both groups (p>0.05). Patients in Group 1 had significantly higher number of active joints (4 vs. 0, p=0.02), limited joints (6 vs. 2, p=0.01) and ESR (31 vs. 15 mm/1^sthour, p=0.03) compared to Group 2. Both groups were alike regarding pre-immunization SP and GMC (p>0.05). Two months and 12 months after vaccination, SP, SC and GMC for all pneumoccocal serotypes were similar in JIA patients with and without anti-TNF therapy (p>0.05). Moreover, the frequency of patients achieving adequate vaccine response at 2 months (53 vs. 30%, p=0.424) and 12 months (36 vs. 40%, p=1.0) were similar in both groups. There was a significant decrease in disease parameters, including morning stiffness duration (p=0.001), number of active joints (p<0.001), CRP (p=0.045), patient’s, parent’s and physician’s VAS (p<0.05) and CHAQ (p=0.01) in Group 1. In Group 2, all parameters remained unchanged after immunization (p>0.05). Further comparison of patients with and without adequate response at two months revealed no influence of demographic, clinical and laboratorial JIA parameters  (p>0.05).  Serious adverse events were not observed.

Conclusion: Anti-TNF therapy has no deleterious effect on PPV23 short and long-term immunogenicity in JIA patients and this response does not seem to influence disease parameters.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/23-valent-polysaccharide-pneumococcal-vaccine-in-juvenile-idiopathic-arthritis-patients-anti-tumor-necrosis-factor-therapy-role-in-short-and-long-term-immunogenicity/