J 2024

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

DOKOUPILOVÁ, Eva, David VETCHÝ, Sylvie PAVLOKOVÁ a M. HANUŠTIAKOVÁ

Základní údaje

Originální název

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

Autoři

DOKOUPILOVÁ, Eva (203 Česká republika, domácí), David VETCHÝ (203 Česká republika, domácí), Sylvie PAVLOKOVÁ (203 Česká republika, domácí) a M. HANUŠTIAKOVÁ (203 Česká republika)

Vydání

INTERNATIONAL JOURNAL OF CLINICAL PHARMACY, NETHERLANDS, SPRINGER, 2024, 2210-7703

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30104 Pharmacology and pharmacy

Stát vydavatele

Nizozemské království

Utajení

není předmětem státního či obchodního tajemství

Odkazy

Impakt faktor

Impact factor: 2.400 v roce 2022

Organizační jednotka

Farmaceutická fakulta

Klíčová slova anglicky

SARS-CoV-2 Adalimumab Original Biosimilar Autoimmune disease Nonparametric statistics

Štítky

Příznaky

Mezinárodní význam, Recenzováno
Změněno: 27. 2. 2024 14:24, Mgr. Daniela Černá

Anotace

V originále

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.