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Phase 3 trial demonstrated the pharmacokinetic, efficacy and
safety equivalence of biosimilar CT-P10 and RTX in patients with RA.
As per recent multinational, randomized, double-blind
trial published in Mabs Journal, the rituximab (RTX) and its biosimilar CT-P10
appeared to have identical immunogenicity, pharmacodynamics, safety and efficacy measures in managing
rheumatoid arthritis (RA). Park W and colleagues conducted the trial within 372
RA patients, out of which 161 patients allocated to CT-P10 group and 211 to RTX
group. The change in primary efficacy endpoint from baseline to week 24 was
measured through Disease Activity Score 28 (by using joints-C-reactive
protein). The AUC from time zero to last
measurable concentration, from time zero to infinity and maximum level after
two infusions were used to measure co-primary pharmacokinetic endpoints. The
safety, immunogenicity and pharmacodynamics were also determined.
The change in DAS28-CRP noticed from baseline to 24 weeks was -2.09 for RTX and
-2.13 for CT-P10. The co-primary
pharmacokinetic endpoints exhibit the equivalence margin of 80-125%. The
estimated treatment difference between CT-P10 and RTX presented efficacy
equivalence margin of ±0.5. The safety, immunogenicity and pharmacodynamics and
pharmacokinetics profiles of both drugs were identical up to 24 weeks. The
efficacy to control RA through CT-P10 and RTX was same as well. As per results
RA management was equally controlled by
CT-P10 and RTX.
MAbs.
Comparison of biosimilar CT-P10 and innovator rituximab in patients with rheumatoid arthritis: a randomized controlled Phase 3 trial.
Park W et al.
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