Cutting Edge Developments: Treatment in development, technology-based clinical measures, and predicting progression in MS

Presenters at the cutting-edge developments in MS session at #ACTRIMS deliver the latest key findings on pivotal studies. At the session, we heard about an emerging therapy for relapsing-remitting MS (RRMS), an iPad based technology for clinical assessments, and a novel area of study that aims to predict disease progression and treatment response.

Read on for highlights from the #ACTRIMS cutting edge developments in MS research session.

1. Evobrutinib as an emerging treatment option for RRMS

Evobrutinib (EVO) inhibits the activation of Bruton’s tyrosine kinase which prevents the activation of B cells and macrophages, which are believed to be involved in the abnormal immune response in MS. Dr. Xavier Montalban, neurologist from St. Michael’s Hospital in Toronto, and a team of investigators examined the safety and efficacy of EVO compared to a mock drug in people diagnosed with RRMS. In this double-blind, 48-week, phase II study, individuals were randomized between EVO at either 25 mg daily, 75 mg daily, 75 mg twice daily, mock drug or Tecifedera. The primary outcome was the number of Gadolinium-positive lesions and secondary outcomes included annualized relapse rate. EVO at 75 mg once a day and twice a day significantly reduced the number of Gadolinium-positive lesions at 24-weeks. Also, while not statistically significant, EVO led to a decrease in annualized-relapse rate. While serious adverse effects were comparable between most groups, they were higher in the EVO group that was administered the drug 75 mg twice daily. Additional results on EVO at 48-weeks will be presented at future meetings.

2. Clinical assessments using technology-based testing

Dr. Laura Baldassari and the research team at Cleveland Clinic developed a test that can be administered on the iPad called the Multiple Sclerosis Performance Test (MSPT). The test examines processing speed, manual dexterity, walking speed and contrast sensitivity and was integrated as part of the clinical care for patients with MS at the Cleveland Clinic. Dr. Baldassari presented research on the associations between the components of the MSPT and patient-reported outcomes (PRO) and MRI measures. The study recruited 976 patients at the clinic. There were moderate correlations between MSPT, PRO, and MRI measures. Similarities in outcomes were witnessed between the MSPT and PRO including the patient determined disease steps, a measure of disability in MS, and certain measures of quality o life. The lesion volume and whole brain volumes were linked with the processing speed of the MSPT. This research shows the feasibility of using an iPad based test to produce relevant outcome measures that can be evaluated in clinical practice. Further validation and longitudinal assessments of the MSPT test with MRI outcomes is needed.

3. Predicting disability and treatment response using radiomics

The extraction of large amounts of quantitative imaging features from medical devices using algorithms is called radiomics. The use of extracting this data is to develop machine learning models that can provide important information on clinical outcomes. As a key component of diagnosis and monitoring disease is the use of MRI, radiomics can be used to extract data from the images to potentially predict disability and treatment response. Mr. Kareem Wahid, an MD/PhD student from the McGovern Medical School at the University of Texas Health Science Center at Houston, compared the radiomic measures with clinical data. A cohort of 92 individuals diagnosed with relapsing-remitting MS was selected for the comparison analysis. In the preliminary analysis, Mr. Wahid showed better predictive performance compared to clinical features and lesion volumes for measuring disability progression and treatment response using radiomics. This early study sets the foundation to further explore radiomics for the prediction of clinical outcomes in MS. Furthermore, as MS varies between person to person, there is a need to shift to a paradigm of a more personalized approach. Radiomics has the potential to contribute to the enhancement of precision medicine in MS.

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