Rituximab biosimilar in rheumatoid arthritis: an enhanced-evidence assessment to evaluate equivalence with the originator based on network meta-analysis
Chiumente M, Messori A
Analisi statistiche e metanalisi
Ther Adv Musculoskelet Dis
The number of patients evaluated in pre-approval trials is more limited for biosimilars than for originators. For this reason, some physicians are reluctant to employ biosimilars in clinical practice and continue to prefer originators. We performed a network meta-analysis comparing rituximab biosimilar CT-P10 with MabThera/Rituxan (originator). The clinical endpoint chosen for our network meta-analysis was the rate of ACR50 response. It is well known that three different endpoints defined by the ACR can be employed for assessing the effectiveness of treatments for RA: ACR20, ACR50, and ACR70. In our network meta-analysis, we adopted the endpoint based on ACR50. In conclusion, apart from its simplicity, the methodological approach described herein is advantageous because it relies on a clinical material that, in most cases, is already available. On the other hand, 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.
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