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
Clinical and Instrumental Treatment's Predictors in Subjects With Neurological Diseases Using G-EO Robotic System
The aim of this work is to elaborate a statistical model to predict the effectiveness of robotic treatment in subjects with neurological diseases. The model will be used to understand which subjects are most responsive to this type of treatment
Genes and Environment in Multiple Sclerosis
The purpose of the research study is to identify the genetic, environmental and immune profiles that may increase a person's risk of developing multiple sclerosis (MS). While MS is not a disease caused by a single variation in genetic material (DNA), a single environmental factor, or a single malfunction in immune cells, there are genetic alterations, environmental exposures and immunologic factors that make the development of MS more likely. Obtaining information about who is at risk for MS will be beneficial in the future if the investigators can identify effective ways to prevent or slow down the progression of this disease.