The retrospective evaluation of efficacy and safety data after switching from originator rituximab to biosimilar rituximab (CT-P10) in patients diagnosed with systemic lupus erythematosus: a single-center experience
A. Ekin, S. Mısırcı, B.N. Coşkun, B. Yağız, E. Dalkılıç, Y. Pehlivan Division of Rheumatology, Faculty of Medicine, Bursa Uludag University, Bursa, Turkey. aliekin49@hotmail.com
OBJECTIVE: In our study, we analyzed the efficacy and safety data of patients with systemic lupus erythematosus (SLE) after switching to biosimilar rituximab (RTX).
PATIENTS AND METHODS: Twenty-two patients who switched to RTX were included in the study. Efficacy data were analyzed using the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score, and safety data were analyzed using the frequency of side effects.
RESULTS: The mean treatment duration of originator RTX was 35.6 ± 23.0 months, and the median treatment duration of biosimilar RTX was 17 months. The SLEDAI-2K score, approximately three months after the first dose of biosimilar RTX, was significantly lower (p = 0.027). A statistically significant difference was found between the SLEDAI-2K score assessed at the follow-up visit three months after the last dose of originator RTX and the SLEDAI-2K score obtained approximately three months after the first dose of biosimilar RTX (p = 0.011) and the calculated median SLEDAI-2K score was significantly lower than the SLEDAI-2K score assessed after administration of originator RTX. The side effect frequency that developed during the treatment of originator RTX was 15.3 per 100 patient-years. The most common side effect was infection, which was 15.3 per 100 patient-years. The most frequent infection was urinary tract infection. The side effect frequency during treatment of biosimilar RTX was 39 per 100 patient-years, and the most frequent infection was pneumonia.
CONCLUSIONS: In our study, SLEDAI-2K scores demonstrated that no efficacy loss was experienced after switching to CT-P10 molecule, which is a biosimilar RTX. It was observed that switching to biosimilar RTX did not decrease treatment efficacy in the patient group diagnosed with SLE and biosimilar RTX was found to be safe.
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A. Ekin, S. Mısırcı, B.N. Coşkun, B. Yağız, E. Dalkılıç, Y. Pehlivan
The retrospective evaluation of efficacy and safety data after switching from originator rituximab to biosimilar rituximab (CT-P10) in patients diagnosed with systemic lupus erythematosus: a single-center experience
Eur Rev Med Pharmacol Sci
Year: 2024
Vol. 28 - N. 10
Pages: 3513-3522
DOI: 10.26355/eurrev_202405_36286