Graziella Callari (Italy)
ircss giglio neurologyAuthor Of 1 Presentation
EXIT-STRATEGIES IN NATALIZUMAB RESPONDERS RRMS PATIENTS: AN ITALIAN COMPARISON AMONG OCRELIZUMAB, RETUXIMAB AND CLADRIBINE
- Emanuele D'Amico (Italy)
Abstract
Background and Aims:
The main aim of the study is to evaluate the efficacy and safety profile of Ocrelizumab (OCR), Rituximab (RTX), and Cladribine (CLA), employed as Natalizumab (NTZ) exit-strategies in Relapsing-Remitting Multiple Sclerosis (RRMS) patients at high-risk for progressive multifocal leukoencephalopathy (PML).
Methods:
This is a multicentre, retrospective, real-world study on consecutive RRMS patients from eleven tertiary Italian MS centres, who switched from NTZ to OCR, RTX and CLA from January 1st, 2019 to December 31st, 2019. The primary study outcomes were the annualized relapse rate (ARR) and Magnetic Resonance Imaging (MRI) outcome. Treatment effects were estimated by the inverse probability treatment weighting (IPTW), based on propensity score (PS) approach. Additional endpoint included confirmed disability progression (CDP) as measured by Expanded Disability Status Scale and adverse events (AEs).
Results:
Patients satisfying predefined inclusion and exclusion criteria were 120; 64 switched to OCR, 36 to RTX and 20 to CLA. Patients from the three groups did not shown differences for baseline characteristics, also after post-hoc analysis. The IPTW PS-adjusted models revealed that patients on OCR had a lower risk for ARR than patients on CLA (ExpB OCR 0.485, CI 95% 0.264-0.893, p=.020). This result was confirmed also for 12-months MRI activity (ExpB OCR 0.248 CI 95% 0.065-0.948, p=.042). No differences were found in other pairwise comparisons (OCR vs RTX and RTX vs CLA) for the investigated outcomes. AEs were similar among the three groups.
Conclusions:
Anti-CD20 drugs revealed to be effective and safe options as NTZ exit strategies. All investigated DMTs showed a good safety profile