medwireNews: The similar efficacy, safety, and immunogenicity profiles of the infliximab biosimilar SB2 and its reference product are maintained for up to 54 weeks among patients with rheumatoid arthritis (RA), suggest follow-up results of a randomized clinical trial.
Previous findings from the trial demonstrated the equivalence of the two drugs at 30 weeks in patients with moderate-to-severe RA despite methotrexate therapy, say the researchers in Rheumatology.
“Since biologics […] can be chronically used, long-term clinical trial data that prove biosimilarity to reference products may further increase the confidence in prescribing biosimilars,” they add.
At the 54-week follow-up, Josef Smolen (University of Vienna, Austria) and colleagues found that the 290 patients receiving SB2 and the 293 receiving infliximab experienced a comparable increase from baseline in modified Sharp/van der Heijde scores, at 0.38 versus 0.37 points, “suggesting a similar rate of radiographic progression.”
Disease activity scores, levels of antidrug antibodies, and the proportion of patients achieving at least a 20% improvement in ACR criteria were also comparable in the two groups at week 54, as was the incidence of treatment-emergent adverse events and serious adverse events.
“All of these findings strongly support the biosimilarity of SB2 to [infliximab] over the long term,” conclude the researchers.
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