Safety, immunogenicity and efficacy after switching from reference infliximab to biosimilar SB2 compared with continuing reference infliximab and SB2 in patients with rheumatoid arthritis: Results of a randomised, double-blind, phase III transition study
Annals of Rheumatic Diseases Oct 20, 2017
Smolen JS, et al. - The aims of the present transition-extension period (depicted as transition period hereafter) of the phase III study were to research whether individuals on INF could be readily switched to SB2 without major concerns and whether comparable effectiveness, safety and immunogenicity were maintained after the switch when compared with both ongoing reference INF and also SB2. The effectiveness, safety and immunogenicity profiles remained comparable among the INF/SB2, INF/INF and SB2/SB2 groups up to week 78, with no treatment-emergent issues or clinically relevant immunogenicity after switching from INF to SB2.
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