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Equivalence of rituximab biosimilar in rheumatoid arthritis Posted 29/09/2017

A network meta-analysis was used by researchers from Italy to ‘reinforce the clinical data available’ for the equivalence of the rituximab biosimilar CT‑P10 [1].

South Korean biotechnology company Celltrion’s rituximab biosimilar Truxima (CT‑P10) was approved for use in Europe in February 2017 [2]. However, despite assurances from the European Medicines Agency (EMA) some physicians may still be reluctant to prescribe biosimilars due to the fact that ‘the number of patients evaluated in pre-approval trials is more limited for biosimilars than for originators’.

To ‘enhance the clinical evidence’ supporting the equivalence of CT‑P10, authors from the Health Technology Assessment Unit of Italy’s Ente di Supporto Tecnico Amministrativo Regionale (ESTAR) and from the Italian Society of Clinical Pharmacy and Therapeutics carried out a network meta-analysis on the biosimilar.

They retrospectively applied this approach to the approval of the rituximab biosimilar (CT‑P10) in the treatment of active rheumatoid arthritis in combination with methotrexate in patients not responsive to methotrexate monotherapy.

The ACR50 response was chosen as the clinical endpoint, as this endpoint is suitable for the naïve patients with active disease that were enrolled in the various trials included in the analysis. The clinical data on CT‑P10 were extracted from the randomized trial carried out by Yoo and colleagues [3], while the meta-analysis published by Hazlewood and colleagues provided the data on both the originator MabThera/Rituxan (rituximab) and the previous standard of care (SOC), i.e. methotrexate monotherapy.

The meta-analysis estimated an odds ratio (OR) of 1.30 [95% credible interval (CrI): 0.636–2.719] for the comparison originator versus biosimilar, 0.21 (95% CrI: 0.089–0.485) for SOC versus biosimilar and 0.274 (95% CrI: 0.177–0.414) for SOC versus originator. In terms of effectiveness, CT‑P10 ranked first in 76% of Bayesian simulations and second in 24%, while the originator ranked first in 24% and second in 76%. The SOC always ranked third.

The authors concluded that ‘the clinical consequences generated by our network meta-analysis should be seen as a reinforcement of the clinical evidence available on the biosimilar and as a confirmation of the homogeneity of the overall clinical material included in this effectiveness assessment’.

Conflict of interest
The authors of the research paper [1] declared that there were no conflicts of interest.

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1. Chiumente M, Messori A. Rituximab biosimilar in rheumatoid arthritis: an enhanced-evidence assessment to evaluate equivalence with the originator based on network meta-analysis. Ther Adv Musculo Dis. 2017; Published online 23 August 2017.
2. GaBI Online - Generics and Biosimilars Initiative. EC approval for first cancer biosimilar Truxima [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 29]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-first-cancer-biosimilar-Truxima
3. GaBI Online - Generics and Biosimilars Initiative. Comparable efficacy and safety observed in patients switched to biosimilar CT-P10 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 29]. Available from: www.gabionline.net/Biosimilars/Research/Comparable-efficacy-and-safety-observed-in-patients-switched-to-biosimilar-CT-P10

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