Publications by authors named "M Scaramozza"

Introduction: Dimethyl fumarate (DMF) has demonstrated a favorable benefit-risk profile in patients with relapsing-remitting multiple sclerosis (RRMS) in clinical and real-world studies. The ESTEEM study (NCT02047097) was conducted to assess the long-term safety and effectiveness of delayed-release DMF in patients with relapsing forms of MS in routine clinical practice. We report final outcomes from ESTEEM with up to 6.

View Article and Find Full Text PDF

Background: Smartphones and wearables are revolutionizing the assessment of cognitive and motor function in neurological disorders, allowing for objective, frequent, and remote data collection. However, these assessments typically provide a plethora of sensor-derived measures (SDMs), and selecting the most suitable measure for a given context of use is a challenging, often overlooked problem.

Objective: This analysis aims to develop and apply an SDM selection framework, including automated data quality checks and the evaluation of statistical properties, to identify robust SDMs that describe the cognitive and motor function of people with multiple sclerosis (MS).

View Article and Find Full Text PDF
Article Synopsis
  • Multiple sclerosis (MS) research often overlooks racial and ethnic minorities, particularly Black or African Americans, who are underrepresented in clinical trials despite significant differences in disease outcomes.
  • The EVOLVE-MS-1 study assessed the long-term safety and efficacy of diroximel fumarate in adults with relapsing-remitting MS, focusing on outcomes in Black versus non-Black patients.
  • Of the 1057 participants, only 6.8% were Black, with similar levels of adverse effects reported across both groups, though a higher percentage of Black patients discontinued treatment for reasons such as personal choice or adverse events.
View Article and Find Full Text PDF

Introduction: In EVOLVE-MS-1 (NCT02634307), mean absolute lymphocyte count (ALC) on diroximel fumarate (DRF) declined from baseline by approximately 28% in year 1, then stabilized, similar to ALC decline observed with dimethyl fumarate (DMF). Prior studies reported that clinical efficacy of DMF was not substantially different in patients with and without lymphopenia.

Methods: EVOLVE-MS-1-an open-label, 96-week, phase 3 study-assessed DRF safety and exploratory efficacy in patients with relapsing-remitting multiple sclerosis.

View Article and Find Full Text PDF

Background: The Konectom™ smartphone-based cognitive processing speed (CPS) test is designed to assess processing speed and account for impact of visuomotor function on performance.

Objective: Evaluate reliability and validity of Konectom CPS Test, performed in clinic and remotely.

Methods: Data were collected from people with multiple sclerosis (PwMS) aged 18-64 years and healthy control participants (HC) matched for age, sex, and education.

View Article and Find Full Text PDF