Effectiveness of rituximab vs. ocrelizumab for the treatment of primary progressive multiple sclerosis: a real-world observational study

Introduction Ocrelizumab, an antiCD-20 antibody, is the only drug approved to treat patients with primary progressive multiple sclerosis (pwPPMS). Not all candidates receive this treatment due to prescription limitations. Rituximab, another antiCD-20 antibody, has been used off-label in pwPPMS befor...

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Published inJournal of neurology Vol. 269; no. 7; pp. 3676 - 3681
Main Authors Alcalá, Carmen, Quintanilla-Bordás, Carlos, Gascón, Francisco, Sempere, Ángel Perez, Navarro, Laura, Carcelén-Gadea, María, Landete, Lamberto, Mallada, Javier, Cañizares, Emmanuel, Belenguer, Antonio, Carratalá, Sara, Domínguez, José Andrés, Pérez-Miralles, Francisco Carlos, Gil-Perotín, Sara, Gasqué, Raquel, Cubas, Laura, Castillo, Jéssica, Casanova, Bonaventura
Format Journal Article
LanguageEnglish
Published Berlin/Heidelberg Springer Berlin Heidelberg 01.07.2022
Springer Nature B.V
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Abstract Introduction Ocrelizumab, an antiCD-20 antibody, is the only drug approved to treat patients with primary progressive multiple sclerosis (pwPPMS). Not all candidates receive this treatment due to prescription limitations. Rituximab, another antiCD-20 antibody, has been used off-label in pwPPMS before and after ocrelizumab approval. However, studies comparing effectiveness of both drugs are lacking. Objective To evaluate effectiveness of rituximab and ocrelizumab in pwPPMS under real-life conditions. Methods We conducted a multicentric observational study of pwPPMS that started ocrelizumab or rituximab according to clinical practice, with a minimum follow-up of 1 year. Data was collected prospectively and retrospectively. Primary outcome was time to confirmed disability progression at 3 months (CDW). Secondary outcome was serum neurofilament light chain levels (sNFL) at the end of follow-up. Results 95 out 111 pwPPMS fulfilled inclusion criteria and follow-up data availability: 49 (51.6%) received rituximab and 46 (48.4%) ocrelizumab. Rituximab-treated patients had significantly higher baseline EDSS, disease duration and history of previous disease-modifying treatment (DMT) than ocrelizumab-treated patients. After a mean follow-up of 18.3 months (SD 5.9), 26 patients experienced CDW (21.4%); 15 (30.6%) in the rituximab group; and 11 (23.9%) in the ocrelizumab group. Survival analysis revealed no differences in time to CDW . sNFL were measured in 60 patients and no differences between groups were found. Interpretation We provide real-world evidence of effectiveness of ocrelizumab and rituximab in pwPPMS. No differences in time to CDW were found between treatments. However, this study cannot establish equivalence of treatments and warrant clinical trial to confirm our findings.
AbstractList IntroductionOcrelizumab, an antiCD-20 antibody, is the only drug approved to treat patients with primary progressive multiple sclerosis (pwPPMS). Not all candidates receive this treatment due to prescription limitations. Rituximab, another antiCD-20 antibody, has been used off-label in pwPPMS before and after ocrelizumab approval. However, studies comparing effectiveness of both drugs are lacking.ObjectiveTo evaluate effectiveness of rituximab and ocrelizumab in pwPPMS under real-life conditions.MethodsWe conducted a multicentric observational study of pwPPMS that started ocrelizumab or rituximab according to clinical practice, with a minimum follow-up of 1 year. Data was collected prospectively and retrospectively. Primary outcome was time to confirmed disability progression at 3 months (CDW). Secondary outcome was serum neurofilament light chain levels (sNFL) at the end of follow-up.Results95 out 111 pwPPMS fulfilled inclusion criteria and follow-up data availability: 49 (51.6%) received rituximab and 46 (48.4%) ocrelizumab. Rituximab-treated patients had significantly higher baseline EDSS, disease duration and history of previous disease-modifying treatment (DMT) than ocrelizumab-treated patients. After a mean follow-up of 18.3 months (SD 5.9), 26 patients experienced CDW (21.4%); 15 (30.6%) in the rituximab group; and 11 (23.9%) in the ocrelizumab group. Survival analysis revealed no differences in time to CDW. sNFL were measured in 60 patients and no differences between groups were found.InterpretationWe provide real-world evidence of effectiveness of ocrelizumab and rituximab in pwPPMS. No differences in time to CDW were found between treatments. However, this study cannot establish equivalence of treatments and warrant clinical trial to confirm our findings.
Introduction Ocrelizumab, an antiCD-20 antibody, is the only drug approved to treat patients with primary progressive multiple sclerosis (pwPPMS). Not all candidates receive this treatment due to prescription limitations. Rituximab, another antiCD-20 antibody, has been used off-label in pwPPMS before and after ocrelizumab approval. However, studies comparing effectiveness of both drugs are lacking. Objective To evaluate effectiveness of rituximab and ocrelizumab in pwPPMS under real-life conditions. Methods We conducted a multicentric observational study of pwPPMS that started ocrelizumab or rituximab according to clinical practice, with a minimum follow-up of 1 year. Data was collected prospectively and retrospectively. Primary outcome was time to confirmed disability progression at 3 months (CDW). Secondary outcome was serum neurofilament light chain levels (sNFL) at the end of follow-up. Results 95 out 111 pwPPMS fulfilled inclusion criteria and follow-up data availability: 49 (51.6%) received rituximab and 46 (48.4%) ocrelizumab. Rituximab-treated patients had significantly higher baseline EDSS, disease duration and history of previous disease-modifying treatment (DMT) than ocrelizumab-treated patients. After a mean follow-up of 18.3 months (SD 5.9), 26 patients experienced CDW (21.4%); 15 (30.6%) in the rituximab group; and 11 (23.9%) in the ocrelizumab group. Survival analysis revealed no differences in time to CDW . sNFL were measured in 60 patients and no differences between groups were found. Interpretation We provide real-world evidence of effectiveness of ocrelizumab and rituximab in pwPPMS. No differences in time to CDW were found between treatments. However, this study cannot establish equivalence of treatments and warrant clinical trial to confirm our findings.
Ocrelizumab, an antiCD-20 antibody, is the only drug approved to treat patients with primary progressive multiple sclerosis (pwPPMS). Not all candidates receive this treatment due to prescription limitations. Rituximab, another antiCD-20 antibody, has been used off-label in pwPPMS before and after ocrelizumab approval. However, studies comparing effectiveness of both drugs are lacking. To evaluate effectiveness of rituximab and ocrelizumab in pwPPMS under real-life conditions. We conducted a multicentric observational study of pwPPMS that started ocrelizumab or rituximab according to clinical practice, with a minimum follow-up of 1 year. Data was collected prospectively and retrospectively. Primary outcome was time to confirmed disability progression at 3 months (CDW). Secondary outcome was serum neurofilament light chain levels (sNFL) at the end of follow-up. 95 out 111 pwPPMS fulfilled inclusion criteria and follow-up data availability: 49 (51.6%) received rituximab and 46 (48.4%) ocrelizumab. Rituximab-treated patients had significantly higher baseline EDSS, disease duration and history of previous disease-modifying treatment (DMT) than ocrelizumab-treated patients. After a mean follow-up of 18.3 months (SD 5.9), 26 patients experienced CDW (21.4%); 15 (30.6%) in the rituximab group; and 11 (23.9%) in the ocrelizumab group. Survival analysis revealed no differences in time to CDW. sNFL were measured in 60 patients and no differences between groups were found. We provide real-world evidence of effectiveness of ocrelizumab and rituximab in pwPPMS. No differences in time to CDW were found between treatments. However, this study cannot establish equivalence of treatments and warrant clinical trial to confirm our findings.
Author Mallada, Javier
Belenguer, Antonio
Castillo, Jéssica
Gil-Perotín, Sara
Carcelén-Gadea, María
Gasqué, Raquel
Domínguez, José Andrés
Casanova, Bonaventura
Landete, Lamberto
Cañizares, Emmanuel
Carratalá, Sara
Navarro, Laura
Cubas, Laura
Alcalá, Carmen
Quintanilla-Bordás, Carlos
Sempere, Ángel Perez
Gascón, Francisco
Pérez-Miralles, Francisco Carlos
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2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.
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M Komori (10989_CR24) 2016; 3
AH Cross (10989_CR19) 2006; 180
S Gingele (10989_CR10) 2020; 15
E Schuh (10989_CR9) 2016; 197
C Klein (10989_CR11) 2012; 5
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J Bergman (10989_CR23) 2018; 91
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10989_CR4
SL Hauser (10989_CR1) 2008; 358
RT Naismith (10989_CR3) 2010; 74
R Ahdab (10989_CR25) 2009; 111
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L Piccio (10989_CR20) 2010; 67
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EG Kamburova (10989_CR14) 2013; 13
10989_CR17
A Bar-Or (10989_CR2) 2008; 63
F Morschhauser (10989_CR12) 2010; 21
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AC Londoño (10989_CR22) 2018; 7
HF Petereit (10989_CR13) 2009; 15
L Bell (10989_CR16) 2020; 10
S Boyer-Suavet (10989_CR8) 2020
RM Brand (10989_CR27) 2021
MDP Martin (10989_CR18) 2009; 66
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Snippet Introduction Ocrelizumab, an antiCD-20 antibody, is the only drug approved to treat patients with primary progressive multiple sclerosis (pwPPMS). Not all...
Ocrelizumab, an antiCD-20 antibody, is the only drug approved to treat patients with primary progressive multiple sclerosis (pwPPMS). Not all candidates...
IntroductionOcrelizumab, an antiCD-20 antibody, is the only drug approved to treat patients with primary progressive multiple sclerosis (pwPPMS). Not all...
INTRODUCTIONOcrelizumab, an antiCD-20 antibody, is the only drug approved to treat patients with primary progressive multiple sclerosis (pwPPMS). Not all...
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StartPage 3676
SubjectTerms Immunotherapy
Medicine
Medicine & Public Health
Monoclonal antibodies
Multiple sclerosis
Neurology
Neuroradiology
Neurosciences
Observational studies
Original Communication
Patients
Rituximab
Survival analysis
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Title Effectiveness of rituximab vs. ocrelizumab for the treatment of primary progressive multiple sclerosis: a real-world observational study
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