Effectiveness of rituximab vs. ocrelizumab for the treatment of primary progressive multiple sclerosis: a real-world observational study
Por:
Alcalá C, Quintanilla-Bordás C, Gascón F, Sempere ÁP, Navarro L, Carcelén-Gadea M, Landete L, Mallada J, Cañizares E, Belenguer A, Carratalá S, Domínguez JA, Pérez-Miralles FC, Gil-Perotín S, Gasqué R, Cubas L, Castillo J and Casanova B
Publicada:
1 jul 2022
Ahead of Print:
1 feb 2022
Resumen:
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.
Filiaciones:
Alcalá C:
Neuroimmunology Unit, Polytechnic and University Hospital La Fe València, Avda. Fernando Abril Martorell, 106, 46026, Valencia, Spain
Quintanilla-Bordás C:
Neuroimmunology Unit, Polytechnic and University Hospital La Fe València, Avda. Fernando Abril Martorell, 106, 46026, Valencia, Spain.
Gascón F:
Neurology Service, Clinic University Hospital of València, Valencia, Spain
Sempere ÁP:
Neurology Service, University General Hospital of Alacant, Alicante, Spain
:
Neurology Service, University General Hospital of Elx, Elche, Spain
Carcelén-Gadea M:
Neurology Service, University General Hospital of València, Valencia, Spain
:
Neurology Service, University Dr. Peset University Hospital of València, Valencia, Spain
:
Neurology Service, University General Hospital of Elda, Elda, Spain
Cañizares E:
Neurology Unit, La Ribera University Hospital, Alzira, Spain
:
Neurology Service, University General Hospital of Castelló, Castelló de la Plana, Spain
Carratalá S:
Neuroimmunology Unit, Polytechnic and University Hospital La Fe València, Avda. Fernando Abril Martorell, 106, 46026, Valencia, Spain
Domínguez JA:
Neurology Service, Clinic University Hospital of València, Valencia, Spain
Pérez-Miralles FC:
Neuroimmunology Unit, Polytechnic and University Hospital La Fe València, Avda. Fernando Abril Martorell, 106, 46026, Valencia, Spain
Gil-Perotín S:
Neuroimmunology Unit, Polytechnic and University Hospital La Fe València, Avda. Fernando Abril Martorell, 106, 46026, Valencia, Spain
Gasqué R:
Neuroimmunology Unit, Polytechnic and University Hospital La Fe València, Avda. Fernando Abril Martorell, 106, 46026, Valencia, Spain
Cubas L:
Neuroimmunology Unit, Polytechnic and University Hospital La Fe València, Avda. Fernando Abril Martorell, 106, 46026, Valencia, Spain
Castillo J:
Neuroimmunology Unit, Polytechnic and University Hospital La Fe València, Avda. Fernando Abril Martorell, 106, 46026, Valencia, Spain
Casanova B:
Neuroimmunology Unit, Polytechnic and University Hospital La Fe València, Avda. Fernando Abril Martorell, 106, 46026, Valencia, Spain
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