New generation of sphingosine 1-phosphate (S1P) receptor modulators in clinical practice: a real-world study from the Italian MS Registry
SYNOPSIS AND RESULTS
A second generation of sphingosine 1-phosphate (S1P) receptor modulators (siponimod, ozanimod and ponesimod), have been recently approved for the treatment of multiple sclerosis (MS). Siponimod and ozanimod are on the Italian commercial market since April 2021 and September 2021, respectively. Ponesimod is going to be on the Italian market. The efficacy and the safety profile of the second generation of S1P modulators were stated in randomized clinical trials (RCTs). RCTs are the gold standard for establishing efficacy, safety and tolerability profile of new drugs; however, they operate in a controlled setting and valuate the treatment profile in a limited and selected population. Post-marketing real-world studies, which are conducted on general population in a real-world setting, provide additional important insight into drugs’ profile. In particular, real-life data are more representative of the MS population than RCTs; they likely contribute to our knowledge about the use of novel drugs and help identifying which are the patients that will better respond to a treatment. The aim of this study is to collect data from the second generation of S1P modulators post-marketing, to give insights complementary to the RCTs data and to support neurologists in daily clinical practice.
Fondazione Italiana Sclerosi Multipla – FISM – Ente del Terzo Settore/ETS e, in forma abbreviata, FISM ETS. Iscrizione al RUNTS Rep. N° 89695 - Fondazione con Riconoscimento di Personalità Giuridica - C.F. 95051730109
New generation of sphingosine 1-phosphate (S1P) receptor modulators in clinical practice: a real-world study from the Italian MS Registry
A second generation of sphingosine 1-phosphate (S1P) receptor modulators (siponimod, ozanimod and ponesimod), have been recently approved for the treatment of multiple sclerosis (MS). Siponimod and ozanimod are on the Italian commercial market since April 2021 and September 2021, respectively. Ponesimod is going to be on the Italian market. The efficacy and the safety profile of the second generation of S1P modulators were stated in randomized clinical trials (RCTs). RCTs are the gold standard for establishing efficacy, safety and tolerability profile of new drugs; however, they operate in a controlled setting and valuate the treatment profile in a limited and selected population. Post-marketing real-world studies, which are conducted on general population in a real-world setting, provide additional important insight into drugs’ profile. In particular, real-life data are more representative of the MS population than RCTs; they likely contribute to our knowledge about the use of novel drugs and help identifying which are the patients that will better respond to a treatment.
The aim of this study is to collect data from the second generation of S1P modulators post-marketing, to give insights complementary to the RCTs data and to support neurologists in daily clinical practice.
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