Assessment of inflammatory changes in Rheumatoid Arthritis trials.

Assessment of inflammatory changes in Rheumatoid Arthritis trials.

Novel quantitative digital image analysis methodology for assessment of inflammatory changes in MRI data in a post-hoc analysis of data acquired from a phase IIb study of baricitinib in patients with active rheumatoid arthritis

Novel quantitative digital image analysis methodology for assessment of inflammatory changes in MRI data in a post-hoc analysis of data acquired from a phase IIb study of Baricitinib in patients with active rheumatoid arthritis

Just published: this important paper describes the use of imaging biomarkers in rheumatoid arthritis (RA) trials and emphasises the importance of image quality control to achieve efficacious dose response.

@IAG, Image Analysis Group, the imaging expert company supported central imaging data review from the Phase II trial of Baricitinib, an oral JAK inhibitor (NCT01185353) conducted by @Eli Lilly, an American pharmaceutical company.

The teams collaborated to further assess inflammatory changes in MRI data of RA patients using IAG’s proprietary quantitative methodology that allowed to extract a continuous volume of inflammation and to assess the severity of inflammation.

These quantitative imaging biomarkers are complimentary to radiological score for RA (RAMRIS) and can be extracted from the same MR images. These AI-driven quantitative imaging techniques bring deeper understanding of inflammatory changes at specific joints and assessment of treatment impact at earlier timepoint. In this case, the changes were visible as early as week 12.

Furthermore, this article explores the use of MRI in RA trials and discusses the optimal set-up at the imaging sites and stringent quality control that are paramount to acquiring imaging data of high quality.

Summary:

  • Over 160 patients were treated with Baricitinib (NCT01185353) and imaged with MRI at the baseline, week 12 and week 24 post-treatment.
  • Dynamic Contrast Enhanced (DCE) MRI was deployed in the MRI acquisition protocol to allow for pharmacokinetic modelling or heuristic time-intensity curve analysis.
  • MRI data were analyzed using IAG’s quantitative computer-aided methodology to extract the continuous volume of inflammatory changes.
  • The quantitative imaging results were compared with RA MRI Score (RAMRIS).
  • The quantitative methodology employed was found highly reproducible, both in terms of the primary and secondary biomarkers (ICC ranging from 93% to 95%), as well as the intermediary baseline intensity values (ICC 99%) used for calculation of the outcome measures.
  • Quality of imaging data is paramount to the success of clinical trials.

Title: Novel quantitative digital image analysis methodology for assessment of inflammatory changes in MRI data in a post-hoc analysis of data acquired from a phase IIb study of baricitinib in patients with active rheumatoid arthritis.

Authors: M Boesen 1S D Beattie 2D E Schlichting 2O Kubassova 3

Full-text: https://pubmed.ncbi.nlm.nih.gov/19671817/

Baricitinib; Biomarker; Inflammation; MRI; Quantitative imaging; Rheumatoid arthritis.

About IAG, Image Analysis Group

IAG, Image Analysis Group is unique partner to life sciences companies. Our goal is to accelerate novel drug development by using the right analytical tools and modern trial infrastructure. We bring AI, Machine Learning, smart image analysis methods and our platform DYNAMIKA to ensure the speed and cost-effectiveness, while delivering true insights about your mechanism of action and patients’ response, in real-time. If you are planning a clinical trial involving imaging, reach to our expert team:  imaging.experts@ia-grp.com

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