皮下注射阿巴西普治疗 2-5 岁多关节型幼年特发性关节炎患者对白喉/破伤风疫苗抗体应答的维持。
Maintenance of antibody response to diphtheria/tetanus vaccine in patients aged 2-5 years with polyarticular-course juvenile idiopathic arthritis receiving subcutaneous abatacept.
机构信息
Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Pediatric Rheumatology Research Institute, Bad Bramstedt, Germany.
出版信息
Pediatr Rheumatol Online J. 2020 Feb 22;18(1):19. doi: 10.1186/s12969-020-0410-x.
BACKGROUND
Patients with polyarticular-course juvenile idiopathic arthritis (pJIA), receiving disease-modifying anti-rheumatic drugs with immunosuppressive effects, may be at increased risk of vaccine-preventable infections. This substudy assessed protective antibody responses to diphtheria and tetanus vaccination given prior to study enrolment in patients with pJIA.
FINDINGS
This was a substudy of a 24-month, single-arm, open-label, multicenter, Phase III trial (NCT01844518) of subcutaneous abatacept in children with active pJIA (N = 219). Patients aged 2-5 years, with ≥2 continuous months of weekly weight-tiered (10-< 25 kg [50 mg], 25-< 50 kg [87.5 mg]) subcutaneous abatacept treatment (with/without methotrexate and/or low-dose corticosteroids), who received diphtheria/tetanus vaccine prior to enrolment, were eligible. Protective antibody levels to diphtheria/tetanus (> 0.1 IU/mL), and safety, were assessed. Overall, 29 patients were analyzed: 19 (65.5%), 1 (3.4%) and 9 (31.0%) patients had > 12, 6-12 and 2-< 6 months of abatacept exposure, respectively. All patients had protective antibody levels to tetanus and 26 (89.7%) patients had protective antibody levels to diphtheria. Of the 3 patients without protective antibody levels to diphtheria, each had an antibody level of 0.1 IU/mL, bordering the lower threshold of protection. Concomitant use of methotrexate and/or low-dose corticosteroids had no evident effect on antibody levels. No unexpected adverse events, including cases of diphtheria or tetanus, were reported during the 24-month period.
CONCLUSIONS
Patients aged 2-5 years with pJIA who received 2-24 months of weekly subcutaneous abatacept, with or without concomitant methotrexate and/or low-dose corticosteroids, maintained effective diphtheria and tetanus vaccination protection without new safety signals.
TRIAL REGISTRATION
ClinicalTrials.gov (NCT01844518); registered May 1, 2013; https://clinicaltrials.gov/ct2/show/NCT01844518?term=NCT01844518&rank=1.
背景
接受具有免疫抑制作用的疾病修饰抗风湿药物治疗的多关节病程幼年特发性关节炎（pJIA）患者，发生疫苗可预防感染的风险可能会增加。这项子研究评估了 pJIA 患者在入组前接受的白喉和破伤风疫苗接种的保护性抗体反应。
结果
这是一项为期 24 个月、单臂、开放标签、多中心、III 期皮下阿巴西普治疗儿童活动性 pJIA 的研究（NCT01844518）的子研究（N=219）。年龄为 2-5 岁、接受过≥2 个月每周体重分层（10-<25kg[50mg]、25-<50kg[87.5mg]）皮下阿巴西普治疗（联合/不联合甲氨蝶呤和/或低剂量皮质类固醇），并且在入组前接受过白喉/破伤风疫苗接种的患者符合条件。评估了对白喉/破伤风的保护性抗体水平（>0.1IU/mL）和安全性。总体上，分析了 29 名患者：19 名（65.5%）、1 名（3.4%）和 9 名（31.0%）患者的阿巴西普暴露时间分别>12、6-12 和 2-<6 个月。所有患者对白喉均有保护性抗体水平，26 名（89.7%）患者对白喉有保护性抗体水平。在 3 名没有保护性抗体水平的白喉患者中，每位患者的抗体水平为 0.1IU/mL，接近保护的下限。同时使用甲氨蝶呤和/或低剂量皮质类固醇对抗体水平没有明显影响。在 24 个月期间，未报告任何意外的不良事件，包括白喉或破伤风病例。
结论
接受 2-24 个月每周皮下阿巴西普治疗的 2-5 岁 pJIA 患者，联合或不联合甲氨蝶呤和/或低剂量皮质类固醇，在没有新的安全信号的情况下，保持对白喉和破伤风疫苗接种的有效保护。
试验注册
ClinicalTrials.gov（NCT01844518）；注册日期：2013 年 5 月 1 日；https://clinicaltrials.gov/ct2/show/NCT01844518？term=NCT01844518&rank=1.
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