Biosimilar Rituximab in Active RA Trial

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Questions and Answers

What was the main objective of Part 1 of the Phase 3 RCT?

To demonstrate pharmacodynamics of CT-P10

To assess the safety of CT-P10

To demonstrate PK equivalence of CT-P10, US-RTX, and EU-RTX (correct)

To evaluate the immunogenicity of RTX

How many patients completed the course of treatment out of the total assigned?

345 patients (correct)

300 patients

372 patients

161 patients

Which factors were primarily assessed in both parts of the study?

Immunogenicity and safety

Pharmacokinetics and efficacy (correct)

Adverse events and patient demographics

Efficacy and pharmacodynamics

What were the most commonly reported reasons for discontinuation during the study?

Patient withdrawal of consent and adverse events Signup and view all the answers

How many patients were assigned to the CT-P10 treatment?

145 patients Signup and view all the answers

What is a significant requirement for establishing the equivalence between biosimilar and reference product?

Demonstration of acceptable safety and immunogenicity Signup and view all the answers

Which of the following is true about CT-P10?

It shares an identical primary structure with RTX. Signup and view all the answers

What was the purpose of the Phase 1 study of CT-P10?

To demonstrate equivalent pharmacokinetics to EU-sourced RTX Signup and view all the answers

What was the sample size of patients screened for the study involving CT-P10?

495 patients Signup and view all the answers

What criteria are essential for proving equivalency in biosimilar products?

Pharmacokinetics, efficacy, safety, and immunogenicity Signup and view all the answers

What does the abbreviation RCT stand for in the context of clinical trials?

Randomized Controlled Trial Signup and view all the answers

What aspect of CT-P10's structure is described as highly similar to RTX?

Higher-order structures and post-translational modifications Signup and view all the answers

Which statement about the timeline of the study initiation and conclusion is correct?

The first patient was recruited in August 2014 and the last visit was in January 2016. Signup and view all the answers

What does the term 'PK' refer to in the context of this study?

Pharmacokinetics Signup and view all the answers

Which drug is referred to as 'CT-P10' in this study?

A biosimilar of rituximab Signup and view all the answers

What was the sample size for the CT-P10 group in the study?

62 Signup and view all the answers

What does the acronym 'CI' refer to in the context of this trial?

Confidence Interval Signup and view all the answers

What was the primary conclusion regarding the pharmacokinetics (PK) of CT-P10 in relation to the reference products?

CT-P10 demonstrated PK equivalence when compared to both licensed reference products. Signup and view all the answers

What aspects of the trial were highlighted as strengths?

Randomized design and high patient retention rates. Signup and view all the answers

Which analysis is reported up to week 24 in this study?

Immunogenicity and safety profiles Signup and view all the answers

What does AUC0–∞ represent in pharmacokinetic studies?

Area Under Curve to infinity Signup and view all the answers

What was the percentage of patients reporting adverse events (AE) in the CT-P10 group?

59.6% Signup and view all the answers

Which treatment group had the highest percentage of treatment-related adverse events?

CT-P10 Signup and view all the answers

Which adverse event was most frequently reported in the CT-P10 group?

Infection Signup and view all the answers

What criterion defined 'active disease' in the study?

Presence of ≥6 swollen joints and ≥6 tender joints Signup and view all the answers

How many serious adverse events (SAE) were reported in the EU-RTX group?

0 Signup and view all the answers

Which patient group had the lowest incidence of upper respiratory tract infections?

EU-RTX Signup and view all the answers

What percentage of patients in the US-RTX group experienced pruritus?

3.3% Signup and view all the answers

What was a noted safety concern during the study?

Unexpected safety issues Signup and view all the answers

What was the mean age of participants in the CT-P10 group?

52.4 years Signup and view all the answers

Which racial demographic constituted the highest percentage in the US-RTX group?

White Signup and view all the answers

What was the mean weight of participants in the EU-RTX group?

76.3 kg Signup and view all the answers

What percentage of the CT-P10 group reported being RF positive?

82.8% Signup and view all the answers

Among participants with prior anti-TNF blocker status, what was the percentage indicating an inadequate response in the RTXb group?

88.6% Signup and view all the answers

What was the mean duration of TNF-antagonist use for participants in the US-RTX group?

13.7 months Signup and view all the answers

What was the mean SJC at baseline for the RTXb group?

15.3 Signup and view all the answers

Which prior anti-TNF antagonist was used by the highest percentage of participants in the CT-P10 group?

Adalimumab Signup and view all the answers

What is the mean ESR at baseline across all groups listed?

54.9 mm/h Signup and view all the answers

What was the mean baseline CRP for participants in the EU-RTX group?

2.1 mg/dL Signup and view all the answers

What was the mean DAS28-CRP score among participants in the CT-P10 group?

5.8 Signup and view all the answers

What percentage of the Non-EU group participants were female?

85.3% Signup and view all the answers

What percentage of the participants in the RTXb group had previously used two anti-TNF blockers?

13.3% Signup and view all the answers

What was the mean height of participants in the US-RTX group?

165.4 cm Signup and view all the answers

Study Notes

Biosimilar Rituximab (CT-P10) vs. Reference Rituximab (RTX) in Active Rheumatoid Arthritis (RA)

A Phase 3 randomized controlled trial (RCT) compared the pharmacokinetics (PK), efficacy, immunogenicity, and safety of CT-P10 (a biosimilar rituximab) to RTX (reference rituximab) in patients with active RA.
The study enrolled 372 patients with active RA who had previously received inadequate response to or were intolerant of TNF-antagonist treatment.
The study's primary endpoint was PK equivalence of CT-P10, US RTX, and EU RTX over 24 weeks, with a secondary endpoint of efficacy equivalence of CT-P10 and RTX.
The trial demonstrated PK equivalence between CT-P10 and RTX up to week 24, showing similar serum concentration profiles for both drugs over time.
CT-P10 and RTX groups also exhibited similar efficacy, with the primary efficacy analyses at week 24 showing comparable levels of disease activity.
Similar immunogenicity profiles were observed between groups, with low rates of antibody development in both groups.
CT-P10 demonstrated acceptable safety, comparable to RTX, with no unexpected safety concerns reported.
Importantly, the study found no significant differences in adverse events (AEs), serious adverse events (SAEs), and immunogenicity profiles between CT-P10 and RTX.

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Description

This quiz examines a Phase 3 clinical trial comparing the biosimilar rituximab (CT-P10) and reference rituximab (RTX) in patients with active rheumatoid arthritis (RA). The study assessed pharmacokinetics, efficacy, immunogenicity, and safety over 24 weeks, providing insights into the equivalence of the two treatments.