Carmen Alcalá1, Carlos Quintanilla-Bordás2, Francisco Gascón3, Ángel Perez Sempere4, Laura Navarro5, María Carcelén-Gadea6, Lamberto Landete7, Javier Mallada8, Emmanuel Cañizares9, Antonio Belenguer10, Sara Carratalá1, José Andrés Domínguez3, Francisco Carlos Pérez-Miralles1, Sara Gil-Perotín1, Raquel Gasqué1, Laura Cubas1, Jéssica Castillo1, Bonaventura Casanova1. 1. Neuroimmunology Unit, Polytechnic and University Hospital La Fe València, Avda. Fernando Abril Martorell, 106, 46026, Valencia, Spain. 2. Neuroimmunology Unit, Polytechnic and University Hospital La Fe València, Avda. Fernando Abril Martorell, 106, 46026, Valencia, Spain. carlosqb@gmail.com. 3. Neurology Service, Clinic University Hospital of València, Valencia, Spain. 4. Neurology Service, University General Hospital of Alacant, Alicante, Spain. 5. Neurology Service, University General Hospital of Elx, Elche, Spain. 6. Neurology Service, University General Hospital of València, Valencia, Spain. 7. Neurology Service, University Dr. Peset University Hospital of València, Valencia, Spain. 8. Neurology Service, University General Hospital of Elda, Elda, Spain. 9. Neurology Unit, La Ribera University Hospital, Alzira, Spain. 10. Neurology Service, University General Hospital of Castelló, Castelló de la Plana, Spain.
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.
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.
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