EN | RU
EN | RU

Help Support

Back

Biosimilar CT-P10 found equivalent to rituximab in terms of efficacy and safety profiles in RA treatment

Biosimilar CT-P10 found equivalent to rituximab in terms of efficacy and safety profiles in RA treatment Biosimilar CT-P10 found equivalent to rituximab in terms of efficacy and safety profiles in RA treatment
Biosimilar CT-P10 found equivalent to rituximab in terms of efficacy and safety profiles in RA treatment Biosimilar CT-P10 found equivalent to rituximab in terms of efficacy and safety profiles in RA treatment

What's new?

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.

Source:

MAbs.

Article:

Comparison of biosimilar CT-P10 and innovator rituximab in patients with rheumatoid arthritis: a randomized controlled Phase 3 trial.

Authors:

Park W et al.

Comments (0)

You want to delete this comment? Please mention comment Invalid Text Content Text Content cannot me more than 1000 Something Went Wrong Cancel Confirm Confirm Delete Hide Replies View Replies View Replies ru en
Try: