Multiple Sclerosis (MS) is a complex neurological condition affecting many people worldwide. Among its various forms, relapsing-remitting MS (RRMS) is common and can be challenging to manage. Advancements in medical research have led to the development of biosimilar medications, offering hope for MS treatment. An important clinical trial known as the Antelope trial has shed light on a significant development in this area.
Clinical trial
The trial aimed to compare the effectiveness, safety, and immune response of a proposed biosimilar version of natalizumab (biosim-NTZ), named PB006, with the original natalizumab (ref-NTZ) in individuals diagnosed with RRMS. This was a large-scale trial conducted across 48 centers in 7 countries, involving 264 adults with RRMS.
The primary goal was to evaluate changes in the brain detected by magnetic resonance imaging (MRI) over 24 weeks. These changes, called new active lesions, are important indicators of MS progression. Encouragingly, the trial found that biosim-NTZ worked similarly to ref-NTZ in reducing the formation of new lesions in the brain by the 24th week of treatment.
The difference in the number of new lesions between the groups receiving biosim-NTZ and ref-NTZ fell within the expected range, indicating that both treatments had a comparable effect on reducing new lesion formation. Other measurements, such as how often relapses occurred and the level of disability, also did not show significant differences between the two treatments.
One critical aspect of the trial was assessing the safety and side effects of biosim-NTZ compared to ref-NTZ. Fortunately, both treatments showed similar safety profiles throughout the trial. No major differences were observed in the occurrence of side effects or in laboratory tests monitoring patients' health. Moreover, the development of specific antibodies related to MS or the medication itself was not significantly different between the two groups.