Ricerc@Sapienza

Multiple Sclerosis (MS) is a chronic, progressive and debilitating disease that places a high burden on young patients and on society. Being disability the main contributor to the burden of MS, the reduction of its progressive accumulation is a major running objective in MS care.
Nowadays, several clinical tests have high sensitivity to evaluate disability in progressive MS (PMS). Expanded Disability Status Scale (EDSS) is the most well know clinical measure, though with some limitations. Other measures, such as Multiple Sclerosis Functional Composite (MSFC) or Brief International Cognitive Assessment for MS (BICAMS), are usually combined with EDSS and contribute to increase the informativeness of PMS evaluation.
In 2011 an original efficacy outcome, Clinical Disability Improvement (CDI - defined as at least 1-point EDSS score decrease sustained for 6 months, in patients with baseline score ¿ 2.0) was used in several studies as a measure to evaluate the efficacy of recent therapies to improve pre-existing disability.
The aim of our study is to evaluate if Siponimod, a selective sphingosine-1-phosphate receptor modulator, recently approved for Secondary Progressive MS (SPMS), can reach CDI. This outcome measure will be integrated by the other motor and cognitive scales (MSFC, BICAMS) to evaluate its effects against disability accumulation, and by some Patient Reported Outcomes (PROs), to evaluate also patient perceptions. To this aim, we will carry out a real-world study, controlled-group, on SPMS patients consecutively referred to our MS Clinic with approved indications for Siponimod treatment. Over a 2 years-period of follow-up we will apply the above scales at two time points, 0 and 12 months. This study may contribute to both extend and refine the clinical evaluation of PMS patients, and to explore new outcome measures dealing with disability changes.