Comparative Effectiveness of Cladribine versus S1PR Modulators in Naive Patients with Relapsing-Remitting Multiple Sclerosis: An Observational Study
SYNOPSIS AND RESULTS
The primary objective of this study is to assess and compare the overall NEDA-3 status, as well as individual components of NEDA-3, treatment persistence, and safety profiles in patients diagnosed with RRMS, in patients who have undergone treatment with either Cladribine or S1PR modulators as their initial DMT, and who have a minimum follow-up period of at least 4 years. Inclusion Criteria: RRMS patients treated with Cladribine or S1PR modulators as their firstline DMT with at least 4 years follow-up since start of treatment. Exclusion Criteria: Patients with less than 4 years of follow-up, those with prior exposure to other DMTs, and individuals with contraindications to Cladribine or S1PR modulators. Data Collection: Clinical Data: Gathering relevant demographic information, baseline clinical characteristics, and medical history. Radiological Data: MRI scans analysis of new T2/FLAIR lesions, new gadolinium-enhancing lesions. Treatment Persistence: Evaluating the duration of treatment persistence and reasons for discontinuation. Outcome Measures: Primary Outcome: Calculation of NEDA-3 rates. Secondary Outcomes: NEDA-3 individual components analysis, analysis of treatment persistence rates and safety profiles, including monitoring and reporting adverse events. Statistical Analysis: Patient characteristics will be collected at baseline, and a 1:1 matching procedure will be performed using propensity scores. Cox proportional hazards models will be used for pairwise comparisons. The null hypothesis assumes no difference between Cladribine and S1PR modulators in NEDA-3 at year 4. Ethical Considerations: observational study. Expected Impact: This research aims to provide valuable insights into the long-term effectiveness, safety, and treatment persistence of Cladribine and S1PR modulators as first-line therapies for RRMS. The findings may inform clinical decision-making and contribute to optimizing treatment strategies for individuals diagnosed with RRMS.
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
Comparative Effectiveness of Cladribine versus S1PR Modulators in Naive Patients with Relapsing-Remitting Multiple Sclerosis: An Observational Study
The primary objective of this study is to assess and compare the overall NEDA-3 status, as well as individual components of NEDA-3, treatment persistence, and safety profiles in patients diagnosed with RRMS, in patients who have undergone treatment with either Cladribine or S1PR modulators as their initial DMT, and who have a minimum follow-up period of at least 4 years. Inclusion Criteria: RRMS patients treated with Cladribine or S1PR modulators as their firstline DMT with at least 4 years follow-up since start of treatment. Exclusion Criteria: Patients with less than 4 years of follow-up, those with prior exposure to other DMTs, and individuals with contraindications to Cladribine or S1PR modulators. Data Collection: Clinical Data: Gathering relevant demographic information, baseline clinical characteristics, and medical history. Radiological Data: MRI scans analysis of new T2/FLAIR lesions, new gadolinium-enhancing lesions. Treatment Persistence: Evaluating the duration of treatment persistence and reasons for discontinuation. Outcome Measures: Primary Outcome: Calculation of NEDA-3 rates. Secondary Outcomes: NEDA-3 individual components analysis, analysis of treatment persistence rates and safety profiles, including monitoring and reporting adverse events. Statistical Analysis: Patient characteristics will be collected at baseline, and a 1:1 matching procedure will be performed using propensity scores. Cox proportional hazards models will be used for pairwise comparisons. The null hypothesis assumes no difference between Cladribine and S1PR modulators in NEDA-3 at year 4. Ethical Considerations: observational study. Expected Impact: This research aims to provide valuable insights into the long-term effectiveness, safety, and treatment persistence of Cladribine and S1PR modulators as first-line therapies for RRMS. The findings may inform clinical decision-making and contribute to optimizing treatment strategies for individuals diagnosed with RRMS.
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