TY - JOUR
T1 - Exit Strategies in Natalizumab-Treated RRMS at High Risk of Progressive Multifocal Leukoencephalopathy: a Multicentre Comparison Study
AU - Zanghì, Aurora
AU - Gallo, Antonio
AU - Avolio, Carlo
AU - Capuano, Rocco
AU - Lucchini, Matteo
AU - Petracca, Maria
AU - Bonavita, Simona
AU - Lanzillo, Roberta
AU - Ferraro, Diana
AU - Curti, Erica
AU - Buccafusca, Maria
AU - Callari, Graziella
AU - Barone, Stefania
AU - Pontillo, Giuseppe
AU - Abbadessa, Gianmarco
AU - Di Francescantonio, Valeria
AU - Signoriello, Elisabetta
AU - Lus, Giacomo
AU - Sola, Patrizia
AU - Granella, Franco
AU - Valentino, Paola
AU - Mirabella, Massimiliano
AU - Patti, Francesco
AU - D’Amico, Emanuele
PY - 2021
Y1 - 2021
N2 - 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). 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). Patients satisfying predefined inclusion and exclusion criteria were 120; 64 switched to OCR, 36 to RTX, and 20 to CLA. Patients from the 3 groups did not show 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 (ExpBOCR 0.485, CI 95% 0.264-0.893, p=0.020). This result was confirmed also for 12-month MRI activity (ExpBOCR 0.248 CI 95% 0.065-0.948, p=0.042). No differences were found in other pairwise comparisons (OCR vs RTX and RTX vs CLA) for the investigated outcomes. AEs were similar among the 3 groups. Anti-CD20 drugs were revealed to be effective and safe options as NTZ exit strategies. All investigated DMTs showed a good safety profile.
AB - 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). 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). Patients satisfying predefined inclusion and exclusion criteria were 120; 64 switched to OCR, 36 to RTX, and 20 to CLA. Patients from the 3 groups did not show 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 (ExpBOCR 0.485, CI 95% 0.264-0.893, p=0.020). This result was confirmed also for 12-month MRI activity (ExpBOCR 0.248 CI 95% 0.065-0.948, p=0.042). No differences were found in other pairwise comparisons (OCR vs RTX and RTX vs CLA) for the investigated outcomes. AEs were similar among the 3 groups. Anti-CD20 drugs were revealed to be effective and safe options as NTZ exit strategies. All investigated DMTs showed a good safety profile.
KW - Cladribine
KW - Disease activity
KW - Exit strategy
KW - Natalizumab
KW - Ocrelizumab
KW - Rituximab
KW - Cladribine
KW - Disease activity
KW - Exit strategy
KW - Natalizumab
KW - Ocrelizumab
KW - Rituximab
UR - http://hdl.handle.net/10807/176941
U2 - 10.1007/s13311-021-01037-2
DO - 10.1007/s13311-021-01037-2
M3 - Article
SN - 1933-7213
VL - 2021
SP - N/A-N/A
JO - Neurotherapeutics
JF - Neurotherapeutics
ER -