Equivalence of PF-06438179/GP1111 and infliximab demonstrated
medwireNews: Results of a phase III trial indicate that the infliximab biosimilar PF-06438179/GP1111 has similar efficacy, safety, and immunogenicity profiles to its reference product.
At week 14, 62.7% of 324 patients with rheumatoid arthritis (RA) who were randomly assigned to receive 3 mg/kg infusions of the biosimilar at weeks 0, 2, and 6, and every 8 weeks thereafter achieved at least a 20% improvement in ACR criteria (ACR20) from baseline, compared with 64.1% of 326 patients given infliximab at the same dosing schedule.
The 95% and 90% confidence intervals for the difference in ACR20 response rates were “entirely contained” within the prespecified equivalence margins, report Stanley Cohen (Metroplex Clinical Research Center, Dallas, Texas, USA) and co-investigators.
Moreover, there were “no clinically meaningful differences” in adverse event profiles between the PF-06438179/GP1111 and infliximab arms, with a corresponding 57.3% and 54.0% of patients experiencing treatment-emergent adverse events, they add. A comparable 48.6% and 51.2% of patients, respectively, developed antidrug antibodies.
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