A plain language summary on clinical and mechanistic effects of cladribine in relapsing multiple sclerosis: 2-year results from the MAGNIFY-MS study.

What is this summary about?This summary looks at how cladribine tablets work in people with relapsing multiple sclerosis (MS). Cladribine tablets are a medicine taken by mouth for relapsing MS. They are taken over short periods at the start of Years 1 and 2 of treatment followed by 2 years without treatment. Cladribine tablets work by lowering the number of active immune cells. This allows the immune system to recover in a manner that is less harmful. The treatment helps reduce relapses, prevents disability from getting worse (also referred to as progression), and reduces areas of nerve damage seen on magnetic resonance imaging (MRI) scans.What were the results?This summary shares the 2 year results from the MAGNIFY-MS study, which looked at how cladribine affected symptoms, daily abilities, and signs of inflammation and nerve damage inside the body. Researchers looked at how cladribine affects both clinical outcomes (what people with MS experience) and biomarkers (signs of inflammation and nerve damage inside the body). The study design has been described by de Stefano et al. and can be seen at https://doi.org/10.1212/NXI.0000000000001187The study looked at how many participants showed no evidence of disease activity (NEDA-3) or no evidence of progression or active disease (NEPAD) by using a standard neurological exam, a timed walking test, and a test of hand coordination. It also looked at biomarkers in the blood and the fluid surrounding the spinal cord and brain to better understand inflammation, disease activity, and nerve damage. Biomarkers in the fluid around the brain and spinal cord were assessed in a smaller group of participants, as was nerve damage, which was evaluated using eye scans and vision tests with letter charts. The study also looked at results according to whether a participant had previously received a different treatment that might slow down the progress of MS or not.What do the results mean?The results showed that cladribine tablets help to improve or stabilise symptoms in people with MS, especially when given as the first treatment. In addition, the biomarker results showed that inflammation was reduced and nerve cells were protected. However, these biomarker results were only looked at in a small group of the participants, so the evidence is not as strong for these findings as for the effects on symptoms of MS.Clinical trial number: NCT03364036,NCT04783935.