Abstract
Backgorund Rituximab is an anti-CD20 monoclonal antibody used in the
treatment of rheumatoid arthritis. The molecule CT -P10 is a biosimilar of
rituximab used in rheumatoid arthritis and has the same safety and efficacy.
Material and methods The aim of our study was to investigate whether drug
efficacy decreases after the mandatory switch from originator rituximab to
biosimilar rituximab, whether there is an increase in disease activity indices
in patients with rheumatoid arthritis receiving rituximab, that could indicate
decreased efficacy, and whether the frequency of adverse events related to drug
safety remains comparable. We analysed 131 patients with rheumatoid arthritis
who received rituximab therapy between January 2010 and December 2022.These
patients were switched from the originator rituximab to biosimilar rituximab and
followed up.
Results After the switch, a statistically significant decrease in HAQ,
DAS-28-CRP, and CDAI scores was observed, while there was no increase in disease
activity in other scales. We found that the frequency of adverse events
associated with originator rituximab treatment was correlated with anti-CCP
positivity (OR=5.436; p=0.006), the presence of an infection requiring
hospitalisation (OR=3.917; p=0.012), and the duration of first rituximab
treatment (OR=1.032; p<0.001). Similarly, adverse events associated with the
use of biosimilar rituximab were associated with a history of infection
requiring hospitalisation (OR=50.762; p<0.001).There was not a statistically
significant difference between the originator and biosimilar rituximab for total
adverse events.
Conclusion Our results suggest that the use of biosimilar rituximab does
not lead to an increase in disease activity indices, indicating comparable
efficacy, and that the risk of adverse drug reactions is largely similar between
the use of original rituximab and biosimilar rituximab.
Keywords biosimilar - effectiveness - rheumatoid arthritis - rituximab - safety
Schlüsselwörter Biosimilar - Wirksamkeit - Rheumatoide Arthritis - Rituximab - Sicherheit
