Back to the Future: Novel Digital Biomarkers and Regulatory Updates at EULAR 2023
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Medical imaging and associated scoring techniques have significantly enhanced our understanding of patient diagnosis and their response to #therapies. Many such scoring techniques came from research and their first application was in drug development trials.
Today, clinical trials require designs and endpoints which can give quick definitive answers about novel treatments in smaller patient cohorts and allow determining competitive edge of a novel drug candidate.
Each #rheumatic indication presented at #EULAR has its own specifics and challanges. The common thread for all of them is in finding objective measures to truly reflect the disease manifistations vs the drug's MoA.
For those developing treatments in #Osteoarthritis (#OA), the holy grail lies in finding interventions and, most importantly, optimal endpoints, which can clearly separate placebo response from the response of those receiving a treatment. Many of the OA drug developers do not want to find themselves with a very expensive ibuprofen and target the disease modification, in addition to #pain. We wrote about pain vs disease modification in a separate piece, available here.
Recently, the definition of #disease #modification has been broaden to include changes in synovial #inflammation, #oedema, #cartilage #morphology and #thickness. The question of the right trial design, its cost and timing are critical for the success of biotech and pharma players.
The pathology of primary osteoarthritis (OA) begins with structural cartilage damage, which initiates a self-propagating inflammatory pathway that further exacerbates cartilage deterioration. Many of the current trials focus on managing inflammatory symptoms (pain) or development of a joint-cushioning injections. The most acute focus right now is on the underlying cellular pathology of OA and treatments targeting the biochemical mechanisms of cartilage degradation, as well as novel cell and gene therapies.
Join us at EULAR 2023 or reach out imaging.experts@ia-grp.com
· A Phase 2b double-blind placebo-controlled randomized clinical trial of SB-061, an aggrecan mimetic, in subjects with symptomatic knee osteoarthritis.
· The influence of baseline demographics on variability of OA pain assessed by WOMAC pain change from baseline in interventional trials.
When it comes to #inflammatory #arthritis (#rheumatoid,#psoriatic), the key to a successful trial is striking the perfect balance between speed, cost, and quality of results. IAG’s team and collaborators are presenting several studies at #EULAR23, detailing the use of novel imaging in assessing the structural efficacy of anti-inflammatory treatment for Psoriatic Arthritis (#PsA).
Psoriatic arthritis (PsA) is a complex condition characterized by a myriad of symptoms, including inflammatory arthritis, enthesitis, dactylitis, and spondylitis.
In two separate studies, a team led by Prof. P Mease and Prof. M. Østergaard used dedicated hand #MRI and #wholebody MRI to assess the impact of the oral immunomodulating phosphodiesterase-4 inhibitor, Apremilast ( Amgen ) on PsA.
In the first study, Østergaard and IAG’s team used dedicated MRI of the hand to evaluate the efficacy of Apremilast in reducing inflammation in PsA patients as part of the phase 4 MOSAIC study. Patients treated with apremilast showed significant improvements in both clinical and MRI indices of inflammation by week 24 and week 48. The results highlight the value of using MRI and PsA MRI Scores as measures of inflammatory disease activity and change following treatment.
In a second study, the teams employed whole-body MRI to assess how apremilast affects inflammation in peripheral joints and entheses of PsA patients. Patients treated with Apremilast experienced significant reductions in total peripheral inflammation, as assessed by whole-body MRI, highlighting the drug's efficacy in managing inflammatory manifestations of PsA.
These studies underscore the critical role advanced imaging techniques play in accurately assessing the impact of new treatments on complex conditions like PsA.
· Apremilast Reduces Inflammation as Measured by MRI of the Hand in Patients With Psoriatic Arthritis: Primary Results from the Phase 4 MOSAIC Study (poster)
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· Efficacy of Apremilast on Whole-Body Inflammation Indices in Patients With Psoriatic Arthritis: Assessments by Whole-Body Magnetic Resonance Imaging in the Phase 4 MOSAIC Study (publication)
· How to diagnose axial involvement in psoriasis / psoriatic arthritis? Differential diagnosis with mechanic ally induced changes and relevance for the treatment (oral discussion with Mikkel Østergaard )
Join us at EULAR 2023 or reach out imaging.experts@ia-grp.com
Lastly, IAG’s team and collaborators will present a novel index to assess treatment impact in phase 2 trial of #SystemicSclerosis, which is a rare chronic disease of unknown cause characterized by diffuse fibrosis and vascular abnormalities in the skin, joints, and internal organs:
· MRI Digital Artery Volume Index (DAVIX©) as quantitative, continuous imaging outcome measure of vascular disease in systemic sclerosis (poster)
· A proof of biological concept trial of CM101 to target CCL24 in Systemic Sclerosis: A biomarker informed, precision medicine approach (publication, Chemomab Therapeutics )
· 2023 Update of EULAR recommendations for the treatment of systemic sclerosis (oral presentation, Francesco Del Galdo )
The use of imaging outcome measures to assess vascular disease in systemic sclerosis has been a long-standing challenge. IAG team and Drs Del Galdo and Hughes introduced the MRI-based Digital Artery Volume Index (DAVIX©) as a potential solution. This index provides a quantitative, continuous imaging outcome measure of vascular disease in systemic sclerosis.
The team found that the #DAVIX© score could effectively predict the burden of digital ulcer disease and other vascular endpoints, including clinical manifestations and patient-reported outcomes. This finding demonstrates the potential value of innovative imaging indices in promoting the implementation of new trials in conditions like systemic sclerosis.
We can feel the wind of change at EULAR, a shift towards quantitative objective measures to help drug developers to make fast go/ no-go decisions while truly exploring the mechanism of action of their therapeutics.
Our studies and many other presented at EULAR this year underscore the critical role of innovative imaging techniques and Artificial Intelligence (AI) in advancing our understanding of novel therapeutics. By balancing speed and cost vs comprehensive assessment of a new therapeutic, they contribute significantly to the precision and efficiency of clinical trials, supporting the development of more effective therapies for complex conditions.
Join us at EULAR 2023 or reach out imaging.experts@ia-grp.com
IAG, Image Analysis Group is a unique partner to life sciences companies. IAG leverages expertise in medical imaging and the power of Dynamika™ – our proprietary cloud-based platform, to de-risk clinical development and deliver lifesaving therapies into the hands of patients much sooner. IAG provides early drug efficacy assessments, smart patient recruitment and predictive analysis of advanced treatment manifestations, thus lowering investment risk and accelerating study outcomes. IAG bio-partnering takes a broader view on asset development bringing R&D solutions, operational breadth, radiological expertise via risk-sharing financing and partnering models.
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