BAT2506 vs. Golimumab: Phase 3 Psoriatic Arthritis Trial Results at 24 Weeks

A phase 3, multicenter, double-blind, randomized, parallel-group study comparing biosimilar BAT2506 with reference golimumab in patients with active psoriatic arthritis. The dataset includes 704 randomized patients and results for efficacy, safety, pharmacokinetics, and immunogenicity up to Week 24. Honghu Tang authored the dataset, which was last updated on 2026-04-23.

Use Cases

• Assess therapeutic equivalence based on the primary endpoint of ACR20 response at Week 14.
• Compare safety and immunogenicity profiles between biosimilar and reference drug groups.
• Analyze pharmacokinetic data from the 24-week initial treatment period.
• Evaluate the impact of switching from reference to biosimilar treatment at Week 24.

Strengths

• Dataset includes results from 704 randomized patients, providing a substantial sample size for analysis.
• Primary efficacy analysis includes 90% and 95% confidence intervals for risk difference, supporting statistical equivalence.
• Data covers multiple endpoints: efficacy, pharmacodynamics, pharmacokinetics, safety, and immunogenicity.

Limitations

• Column-level documentation is absent; field semantics must be inferred after download.
• Row count is unknown, which may limit suitability assessment for specific analytical tasks.
• The 794.2 KB file size suggests a limited scope, likely containing summary results rather than individual patient-level data.

Provenance

Source

figshare, with linked ClinicalTrials.gov identifier NCT05046431.

Collection Method

Data originates from a phase 3, multicenter, double-blind, randomized, parallel-group clinical study.

Time Range

Covers a 24-week initial treatment period.

Freshness

Last updated 2026-04-23 05:14:55; freshness should be verified.

Geography

Multicenter study; specific geographic locations are not detailed in the provided metadata.