Comparative safety and efficacy of Rituximab biosimilar (Truxima) and the reference rituximab product (MabThera) in the treatment of different types of adult glomerulonephritis

Mahmoud Mansour, Tariq Aldebasi, Abeer Alzubaidi, Abdulsalam Alanazi, Abdulaziz Alarifi, Fahad Almutairi, Mohammed Alfaifi, Norah Aldeghaither, Yousef Al-Rajhi, Saad Alnofaie

Abstract


Background: The most important advancement in the treatment of glomerulonephritis is the application of rituximab (MabThera®), for several decades. Rituximab biosimilar (Truxima®) was approved for the same indications offering significant cost savings. This study aimed to compare the safety and efficacy of rituximab biosimilar (Truxima) with the reference rituximab product (MabThera) in the treatment of glomerulonephritis, using both laboratory and clinical parameters to assess their similarity.

Methods: We examined the clinical results retrospectively and collected the data of the laboratory parameters from 65 patients suffering from glomerulonephritis treated with either Truxima or MabThera, for disease induction and maintenance of remission, at the King Abdulaziz Medical Centre, Al-Riyadh between 2019 and 2023.

Result: The present study shows no significant difference in rates of remission and relapse between patients receiving Truxima or MabThera treatment.  There were no significant differences in the patients’ complete renal recovery at 6 months between the two groups, P = .692. Additionally, no remarkable differences between both medications in the patients' time to relapse. A comparison of mean clinical data for serum creatinine, cholesterol and blood indices at baseline, 6 months and 12 months of the patients in Truxima® and MabThera® groups revealed that patients who received MabThera® had a significantly higher WBC count at 6th month, P = .030 only.

Conclusion: The current study shows that (Truxima) is just as safe and effective as its original product, (MabThera). Therefore, Truxima is a more affordable and safer alternative that potentially increases rituximab accessibility to patients.

Keywords: Truxima; Mabthera; Glomerulonephritis; Efficacy; Safety


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DOI: http://dx.doi.org/10.62940/als.v12i2.3711

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