Comparison of rituximab originator (MabThera^®) to biosimilar (Truxima^®) in patients with multiple sclerosis

Abstract

Background: Rituximab’s originator MabThera® or Rituxan® has demonstrated high efficacy in multiple sclerosis (MS). Because of the patent expiration, rituximab biosimilars have been developed. However, because a biosimilar is not the exact copy of the originator, the efficacy and safety of a biosimilar may significantly differ. Objectives: To compare the efficacy and safety of the biosimilar Truxima® and the originator MabThera® in MS. Methods: Consecutive MS patients receiving MabThera® or Truxima® were prospectively followed during 1 year after treatment introduction. Allocation to each treatment depended on the period of introduction and not the physician’s choice. Lymphocyte count, clinical and magnetic resonance imaging (MRI) activity, Expanded Disability Status Scale (EDSS), and adverse events were compared. Results: In total, 105 and 40 patients received MabThera® and Truxima®, respectively. The two groups did not differ in baseline characteristics. Effect on CD19+ lymphocytes and disease activity were similar during follow-up. EDSS remained stable, with no difference between groups. Adverse events were similar between groups. Conclusion: The efficacy and safety of the rituximab biosimilar Truxima® seem equivalent to the originator MabThera® in MS patients. Truxima® could represent a relatively cheap and safe therapeutic alternative to MabThera® and could improve access to highly efficient therapy for MS in low- or middle-income countries.

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

“…Phase III clinical trials in rheumatoid arthritis and lymphoma revealed similar pharmacodynamics, immunogenicity, and safety profiles between MabThera and Truxima (12). Similarly, in patients with immune thrombocytopenic purpura (13) and multiple sclerosis (14), there were no differences between the biosimilar and the originator in clinical outcomes, infective complications, infusion reactions, and B-cell depletion. In addition, several second generation anti-CD20 drugs are in development.…”

Rituximab for the treatment of multiple sclerosis: a review

“…Since a biosimilar is not the exact copy of the originator, its efficacy and safety may significantly differ. For these reasons, a recent study tested the equivalence of the RTX biosimilar CT-P10 and its originator RTX used for MS treatment in terms of efficacy, safety, and tolerability [178]. Concerning efficacy, similar CD19 + lymphocyte depletion, relapse rate and evolution of MRI activity were observed between the two groups of treatment.…”

“…Results suggest that CT-P10 could represent a relatively cheaper and safe therapeutic alternative and could improve access to a highly efficient therapy for MS in low-or middleincome countries. Recently, a prospective study demonstrated the equivalence of the RTX biosimilar Truxima® compared to its originator MabThera® in terms of efficacy, safety, and tolerability in a MS population [178]. Clinical use in other neurological disorders RTX has been approved for the treatment of B-cell lymphomas (i.e., non-Hodgkin's lymphoma, chronic lymphatic leukemia) in 1997.…”

Rituximab in Multiple Sclerosis: Are We Ready for Regulatory Approval?

“…Perez et al. confirmed the similarity of rituximab originator and biosimilar in 145 MS patients (RR and progressive) ( 98 ). Patients in the two groups did not differ in CD19+ lymphocyte counts at each follow-up examination and showed a comparable reduction in relapse rate at 12 months (from 0.50 to 0.02 for originator and from 0.40 to 0.025 for biosimilar), whereas EDSS remained stable in both groups at 6 and 12 months.…”