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

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.