Infliximab is a biological medication based on tumor necrosis factor alpha (TNFα) inhibition used for the treatment of rheumatoid arthritis. TNFα is an inflammatory cytokine produced by macrophages/monocytes during acute inflammation. Based on treatment experience, a significant portion of patients fail to respond adequately to infliximab therapy.
Egis Pharmaceuticals PLC has started the development of the infliximab complementary diagnostic (CLDx) test, complying with the effective European regulations, for the prediction of infliximab treatment responsiveness before treatment initiation of RA patients.
217 bio-naïve RA patients were enrolled in an international multicentric clinical study complying with Good Clinical Practice. The milestones of the development were the followings:
- Biomarker search with Artificial Intelligence (AI)
• Gene expression profiling based on Next-Generation Sequencing (NGS)
• Biomarker screening
- Test development
• Selection of biomarker and technological platform (RT-qPCR)
• Algorithm development
• Model validation
- Manufacturing of the test for clinical performance evaluation study
- Clinical performance evaluation
The successful clinical performance evaluation, which proves the efficacy and safety of the IVD test, was the final milestone in the development of the PREDYSTIC® Infliximab RA Kit.
For the latest information, visit the Linkedin page of the PREDYSTIC® Infliximab RA Kit.