Equivalence of GP2015, etanercept demonstrated
medwireNews: Findings from the EQUIRA trial suggest that the etanercept biosimilar GP2015 has similar efficacy and safety profiles to its reference product.
Marco Matucci-Cerinic (University of Florence, Italy) and co-investigators demonstrated that improvements in DAS28-CRP scores over 24 weeks were comparable among 168 patients with rheumatoid arthritis and an inadequate response to prior DMARD treatment who were randomly assigned to receive GP2015 50 mg once weekly and their 155 counterparts given etanercept at the same dose, with least squares mean decreases of 2.80 versus 2.73 points.
The difference of 0.07 points had 95% confidence intervals that were “well contained” within the prespecified equivalence margin, report the researchers in RMD Open.
They add that ACR20, 50, and 70 response rates, as well as improvements in functioning and fatigue scores, were also comparable between the two groups.
A similar 43.5% of patients in the GP2015 group and 49.5% of those in the etanercept group experienced treatment-emergent adverse events, and “[n]o new safety findings or concerns were reported” in the study, say Matucci-Cerinic and team.
“The results from this study providing evidence of biosimilarity between GP2015 and [etanercept] may aid clinical decision-making around the use of biologics/biosimilars in the treatment of rheumatoid arthritis,” they conclude.
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