Effect of treatment with original or biosimilar adalimumab on SARS-CoV2 vaccination antibody titers

IF 5.2 2区 医学 Q1 PHARMACOLOGY & PHARMACY
Eva Dokoupilová , David Vetchý , Sylvie Pavloková , Markéta Hanuštiaková
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Abstract

The technological process of production of biosimilars determines the degree of biosimilarity to the original biological drug. In particular, the focus is on the similarity of immunogenic responses. The primary endpoint of our retrospective study was to find the differences in SARS-CoV-2 antibody amount between patients treated with original adalimumab and biosimilar adalimumab MSB11022 (Idacio) and the differences in the SARS-CoV-2 antibody amount between patients treated with and without biological treatment. We collected the gender, autoimmune disease type, age, and treatment data of the patients in the outpatient clinic MEDICAL PLUS, s.r.o., Uherske Hradiste. These patients suffer from autoimmune rheumatic diseases. All patients received the mRNA vaccine (Pfizer/BioNTech – BNT162b2), with a 21-day (interquartile range, 21–24) gap between the two vaccinations. Patients receiving adalimumab were able to develop cellular immune responses after the second vaccination dose, as well as the individuals without adalimumab. In the period of 6–23 weeks after the second vaccination dose (D63 – D182), the SARS-CoV-2 antibody levels did not change significantly in the patients receiving the original adalimumab, while in the patients receiving biosimilar adalimumab a significant decrease was revealed. A statistically significant difference in the SARS-CoV-2 antibody amount between the patients without biological treatment (median: 504.3 U/mL) and with biological treatment (Original and Biosimilar – median: 47.2 and 28.2 U/mL, respectively) was confirmed on day 182. According to our observation, the effect of the treatment type on the increase/decrease of antibodies over time is dominant, while the impact of other variables (gender, methotrexate treatment, autoimmune disease type, and age) was confirmed as insignificant or minor.

Abstract Image

使用阿达木单抗原药或生物类似药治疗对 SARS-CoV2 疫苗抗体滴度的影响
生物仿制药的生产技术过程决定了与原始生物药物的生物相似程度。其中,重点是免疫原反应的相似性。我们的回顾性研究的主要终点是发现使用阿达木单抗原药和生物仿制药阿达木单抗 MSB11022(Idacio)治疗的患者之间 SARS-CoV-2 抗体数量的差异,以及使用和未使用生物治疗的患者之间 SARS-CoV-2 抗体数量的差异。我们收集了乌赫尔斯克赫拉迪斯特 MEDICAL PLUS, s.r.o. 门诊患者的性别、自身免疫性疾病类型、年龄和治疗数据。这些患者都患有自身免疫性风湿病。所有患者都接种了mRNA疫苗(辉瑞/BioNTech - BNT162b2),两次接种间隔21天(四分位数间距,21-24)。接受阿达木单抗治疗的患者与未接受阿达木单抗治疗的患者一样,都能在第二次接种后产生细胞免疫反应。在第二剂疫苗接种后的 6-23 周内(D63 - D182),接种原阿达木单抗的患者的 SARS-CoV-2 抗体水平没有显著变化,而接种生物类似物阿达木单抗的患者的抗体水平则显著下降。第 182 天,未接受生物治疗的患者(中位数:504.3 U/mL)与接受生物治疗的患者(原始阿达木单抗和生物类似物--中位数分别为 47.2 U/mL和 28.2 U/mL)之间的 SARS-CoV-2 抗体水平差异有统计学意义。根据我们的观察,治疗类型对抗体随时间增减的影响是主要的,而其他变量(性别、甲氨蝶呤治疗、自身免疫性疾病类型和年龄)的影响被证实是不显著或次要的。
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来源期刊
International Journal of Pharmaceutics: X
International Journal of Pharmaceutics: X Pharmacology, Toxicology and Pharmaceutics-Pharmaceutical Science
CiteScore
6.60
自引率
0.00%
发文量
32
审稿时长
24 days
期刊介绍: International Journal of Pharmaceutics: X offers authors with high-quality research who want to publish in a gold open access journal the opportunity to make their work immediately, permanently, and freely accessible. International Journal of Pharmaceutics: X authors will pay an article publishing charge (APC), have a choice of license options, and retain copyright. Please check the APC here. The journal is indexed in SCOPUS, PUBMED, PMC and DOAJ. The International Journal of Pharmaceutics is the second most cited journal in the "Pharmacy & Pharmacology" category out of 358 journals, being the true home for pharmaceutical scientists concerned with the physical, chemical and biological properties of devices and delivery systems for drugs, vaccines and biologicals, including their design, manufacture and evaluation. This includes evaluation of the properties of drugs, excipients such as surfactants and polymers and novel materials. The journal has special sections on pharmaceutical nanotechnology and personalized medicines, and publishes research papers, reviews, commentaries and letters to the editor as well as special issues.
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