What the trial was testing
The ANTELOPE enrolled 265 patients with multiple sclerosis. The study was sponsored by Polpharma Biologics S.A. and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was a large trial designed to confirm whether the treatment works well enough for wider use. Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
The biosimilar matched the original drug in reducing new brain lesions and was just as safe.
JAMA neurology · 2023 · NCT04115488
These findings — that the biosimilar and original drug caused nearly the same number of new brain lesions — were published in the JAMA neurology and represent the headline result of the study.
Researchers tracked outcomes across 265 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with multiple sclerosis, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
This biosimilar is not yet FDA-approved in the United States, though the original natalizumab (Tysabri) is approved for relapsing forms of MS. If you're on Tysabri or considering natalizumab, talk to your doctor about whether a biosimilar option might become available and what it could mean for your treatment costs.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open multiple sclerosis trials
The DANCEREX Proof-of-Concept Study for Chronic Neurological Disorders
The goal of this clinical trial is to test a new digital therapeutic solution which combines a holistic, multidimensional rehabilitation program based on dance and music with an innovative motivational system (DANCEREX-DTx) in Chronic Neurological Disorders (Multiple Sclerosis and pre-Mild Cognitive Impairment - MCI/ MCI at risk of Alzheimer's Disease). The main questions it aims to answer are 1\] efficacy of the digital therapeutic solution in terms of adherence, clinical/functional measures, quality of life and surrogate measures; 2\] usability and acceptability of the system. Participants will be randomized (with an allocation ratio of 2:2:1) into the experimental group (DANCEREX - 24 sessions of multidimensional dance-based program integrated with an innovative motivational system), active comparator group (24 sessions of multidimensional dance-based program) and placebo group (24 sessions of educational program). Researchers will compare the experimental group to the other two groups to see if a digital therapeutic solution integrating a multidimensional dance-based program and motivational system is effective in increasing adherence to rehabilitation treatment.
Effects of Sleep Quality on Functional and Cognitive Outcomes in Multiple Sclerosis
The goal of this observational study is to investigate the effects of sleep quality on cognitive flexibility, physical activity level, body awareness, and reaction time in individuals with Multiple Sclerosis. The main question it aims to answer is: Does sleep quality influence cognitive flexibility, physical activity level, body awareness, and reaction time in individuals with Multiple Sclerosis? Researchers will compare individuals with good and poor sleep quality to determine whether differences in sleep quality result in variations in cognitive and physical performance outcomes. Participants will complete standardized assessments of sleep quality, cognitive flexibility, physical activity, and body awareness, and will perform a computer-based reaction time test. In addition, participants will wear a wearable activity tracker for 7 days to objectively measure physical activity levels.