Comparison of outcomes using the rituximab originator MabThera with the biosimilar Truxima in patients with ANCA-associated vasculitis

Abstract

Objectives: The use of rituximab (MabThera ® ), an anti-CD20 monoclonal antibody, is the most significant development in the management of anti-neutrophil cytoplasm antibody (ANCA)-associated vasculitis (AAV) since the introduction of cytotoxic therapy in 1950. Truxima ® is the first anti-CD20 biosimilar approved for the same indications, and has been available in the UK since 2017. Significant cost savings have been reported when switching to biosimilars, which could lead to greater patient access to such treatment. Therefore, it is important to know whether patients' clinical and laboratory parameters respond equally well to biosimilars as to reference medicines, tested in clinical trials. Method:We retrospectively reviewed the clinical outcomes and laboratory parameters in 257 consecutive patients treated with anti-CD20 depletion therapy using MabThera or Truxima, for induction and maintenance of remission, in two tertiary renal centres between 2010 and 2019. Results:We demonstrated no difference between patients treated with MabThera or Truxima in rates of remission, relapse, and hospitalization with infection when used for either induction or maintenance of remission of AAV. In one hospital subgroup analysis, we showed comparable levels of hypogammaglobulinaemia, B-cell depletion, and frequency of infusion reactions, with no significant differences. Conclusion:The efficacy and safety of the rituximab biosimilar Truxima are not inferior to the originator MabThera in patients with AAV. Truxima represents a cheaper and safe therapeutic alternative that could increase patient access to rituximab.

Interchangeability and adverse events in originator-rituximab and its biosimilar (CT-P10) among rheumatic patients: a real-life experience

“…Moreover, it is thought that use of high-dose glucocorticoids or a history of immunosuppressive drugs, such as We demonstrated no significant difference between the oRTX and CT-P10 groups with regards to the development of hypogammaglobulinemia, with rates of 10.5% and 27.8% for IgG and 30.3% and 44.0% for IgM, respectively. These results were in accordance with the previously reported range in the literature [15,26,29]. Although the rate of hypogammaglobulinemia was found to be different between the groups, this was not reached a statistical significance due to the assessment of a few numbers of patients whose immunoglobulin levels were measured.…”

“…In phase studies conducted among patients with rheumatoid arthritis and lymphoma, infections occurred in 22-46% of patients in the oRTX group and 24-50% in the CT-P10 group [10, 12-14, 21, 22]. Consistent with our study findings, URTI and UTI were the most frequently reported infections in these studies; however, these rates are lower in studies involving real-life data [15,23,[25][26][27][28]. In a study of diffuse large B-cell lymphoma patients [23], the overall infection rate with rituximab was 14.5%, while in refractory SLE patients [25], this rate was 18.8%, of which 12.5% included severe infections.…”

“…Although the rate of hypogammaglobulinemia was found to be different between the groups, this was not reached a statistical significance due to the assessment of a few numbers of patients whose immunoglobulin levels were measured. Antonelou et al found that in patients with AAV, hypogammaglobulinemia occurred at 22.8% and 36% for IgG and 34.8% and 28% for IgM in oRTX and CT-P10 groups, respectively [15]. In patients with IgG4-related disease, this rate was 10.5% with CT-P10 [26].…”

“…In a study of diffuse large B-cell lymphoma patients [23], the overall infection rate with rituximab was 14.5%, while in refractory SLE patients [25], this rate was 18.8%, of which 12.5% included severe infections. In three different studies with CT-P10 among patients with IgG4-related disease [26], AAV [15], and RA [28], infection was observed in approximately 21% of the patients. In patients with immune-mediated thrombotic thrombocytopenic purpura, infective complications (mainly urinary tract infections) were reported in 15% of patients in the oRTX group and 18% in the CT-P10 group [27].…”

“…All infections, including requiring hospitalization and/or antibiotics or resulting in disability or death within 6 months after the infusion, were recorded. The IgG, IgA, and IgM levels below the lower limit of normal were evaluated as hypogammaglobulinemia [15].…”