Switching from originator rituximab to the biosimilar CT-P10 has been shown to be a safe and effective strategy for managing systemic lupus erythematosus (SLE), according to research published in the European Review for Medical and Pharmacological Sciences. The study offers valuable insights into the use of biosimilars in treating this complex autoimmune disease.
Study Design and Patient Population
The study retrospectively evaluated the efficacy and safety of switching from originator rituximab to CT-P10 in SLE patients. The majority of the patients were female (86.4%), with a mean age of 40.3 years. The average treatment duration was 35.6 months for the originator rituximab and 17 months for CT-P10. A significant portion of the patient population had at least one comorbidity (68.2%), with hypertension being the most prevalent (63.6%). The kidney was the most frequently involved organ (63.6%).
Efficacy Assessment
Disease activity was monitored using the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K). Notably, SLEDAI-2K scores significantly decreased after the switch to CT-P10. Specifically, SLEDAI-2K scores were 2 and 0, respectively, approximately 3 months before and after the administration of the first dose of biosimilar CT-P10 (P = .027). A statistically significant difference was also observed between the SLEDAI-2K score 3 months after the last dose of the originator (median, 2.5) and the score approximately 3 months after the first dose of the biosimilar (median, 0.0) (P = .011).
Safety Profile
The study also examined the adverse effects associated with both treatments. The originator rituximab had an adverse effect frequency of 15.3 per 100 patient-years, with urinary tract infections being the most common infection (7.7 per 100 patient-years). In contrast, the biosimilar CT-P10 had a higher adverse effect frequency of 39 per 100 patient-years, with pneumonia being the most common infection (19.5 per 100 patient-years).
Limitations and Considerations
The study authors acknowledged several limitations, including the small number of participants, the retrospective study design, and the shorter follow-up duration after switching to the biosimilar. Additionally, the absence of a control group and the fact that most patients were not in flare during the efficacy evaluation should be considered when interpreting the results. The COVID-19 pandemic also coincided with the switching period, potentially influencing the outcomes.
Implications for Clinical Practice
Despite these limitations, the study suggests that CT-P10 can be a viable alternative to originator rituximab in SLE patients. The observed reduction in SLEDAI-2K scores indicates that the biosimilar is effective in controlling disease activity. However, the higher frequency of adverse effects warrants careful monitoring of patients after switching to CT-P10. Further research with larger sample sizes and longer follow-up periods is needed to confirm these findings and to fully characterize the long-term safety and efficacy of rituximab biosimilars in SLE.
