The Efficacy and Safety of Hepatitis A Vaccine in Children and Young Adults With an Autoinflammatory Diseases on Canakinumab and Tocilizumab Treatments: A Prospective Observational Controlled Study

IF 2.4 4区 医学 Q2 RHEUMATOLOGY
Kenan Barut, Mehmet Yildiz, Ömer Faruk Beşer, Fatih Haslak, Aybuke Gunalp, Elif Kılıç Konte, Esma Aslan, Ümit Gül, Nergis Akay, Amra Adrovic, Sezgin Sahin, Pelin Yüksel Mayda, Bekir Kocazeybek, Özgür Kasapçopur
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Abstract

Intro

In this prospective interventional study, we aimed to assess the efficacy and safety of the hepatitis A vaccine in patients with autoinflammatory diseases undergoing canakinumab and tocilizumab treatments.

Methods

A total of 24 patients with autoinflammatory diseases on canakinumab and tocilizumab treatments and 39 healthy children who were seronegative for hepatitis A were included in the study. All participants were vaccinated with 2 doses of inactivated hepatitis A vaccine at 6-month intervals. One month after the last vaccination, venous blood samples were collected from each participant, and the anti-HAV IgM and IgG titers were measured.

Results

The patient group consisted of 19 patients with systemic juvenile idiopathic arthritis (sJIA) and 5 patients with cryopyrin-associated periodic fever. The mean age of the patient group and the healthy controls were 14.1 ± 3.7 and 12.4 ± 3.2 years, respectively. All patients with cryopyrin-associated periodic fever and 52.6% (10/19) of the patients with sJIA were on canakinumab. The remaining 9 patients (47.3%) with sJIA were using tocilizumab. Among sJIA patients, 15 were also on methotrexate, and 14 were on prednisolone. All of the participants were negative for hepatitis A serology. After two doses of hepatitis A vaccine, all the patients with autoinflammatory diseases (24/24) and 84.6% (33/39) of the healthy controls were detected as positive for anti-HAV IgG (p = 0.04). The mean anti-HAV Ig G titers of the patient group and the control group one month after the last dose of vaccination were 5.25 ± 1.49 IU/L and 10.5 ± 7.02 IU/L, respectively (p < 0.001). Neither disease flares nor adverse effects related to vaccination were observed within the study period.

Conclusion

Hepatitis A vaccine is effective and safe in children with autoinflammatory diseases on biologic therapy. Long-term follow-up data, including larger patient cohorts, are needed to draw a solid conclusion about the safety of hepatitis A vaccine in patients receiving canakinumab and tocilizumab therapy.

A型肝炎疫苗在患有自身炎症性疾病的儿童和年轻人中使用Canakinumab和Tocilizumab治疗的有效性和安全性:一项前瞻性观察性对照研究
在这项前瞻性介入研究中,我们旨在评估甲型肝炎疫苗在接受canakinumab和tocilizumab治疗的自身炎症性疾病患者中的有效性和安全性。方法选取经canakinumab和tocilizumab治疗的自身炎症性疾病患者24例和健康甲型肝炎血清阴性儿童39例作为研究对象。所有参与者每隔6个月接种2剂甲型肝炎灭活疫苗。最后一次接种后1个月,采集受试者静脉血,测定抗甲型肝炎IgM和IgG滴度。结果本组19例全身性幼年特发性关节炎(sJIA), 5例低温素相关周期性发热。患者组和健康对照组的平均年龄分别为14.1±3.7岁和12.4±3.2岁。所有低温霉素相关周期性发热患者和52.6%(10/19)的sJIA患者使用canakinumab。其余9例sJIA患者(47.3%)使用托珠单抗。在sJIA患者中,15例同时使用甲氨蝶呤,14例使用强的松龙。所有参与者的甲型肝炎血清学结果均为阴性。两剂甲型肝炎疫苗接种后,所有自身炎症性疾病患者(24/24)和84.6%(33/39)的健康对照组抗- hav IgG阳性(p = 0.04)。最后一次接种后1个月,患者组和对照组的平均抗hav igg滴度分别为5.25±1.49 IU/L和10.5±7.02 IU/L (p < 0.001)。在研究期间未观察到与疫苗接种相关的疾病发作或不良反应。结论甲型肝炎疫苗对自身炎症性疾病儿童进行生物治疗是安全有效的。需要长期随访数据,包括更大的患者队列,才能得出关于接受canakinumab和tocilizumab治疗的患者使用甲型肝炎疫苗安全性的可靠结论。
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来源期刊
CiteScore
3.70
自引率
4.00%
发文量
362
审稿时长
1 months
期刊介绍: The International Journal of Rheumatic Diseases (formerly APLAR Journal of Rheumatology) is the official journal of the Asia Pacific League of Associations for Rheumatology. The Journal accepts original articles on clinical or experimental research pertinent to the rheumatic diseases, work on connective tissue diseases and other immune and allergic disorders. The acceptance criteria for all papers are the quality and originality of the research and its significance to our readership. Except where otherwise stated, manuscripts are peer reviewed by two anonymous reviewers and the Editor.
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