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

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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.

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Funding

This work has been supported by a grant from the Health Institute Carlos III (PI20/01446) and FEDER funding.

Author information

Author notes

  1. Carmen Alcalá and Carlos Quintanilla-Bordás have contributed equally to this work.

Authors and Affiliations

  1. Neuroimmunology Unit, Polytechnic and University Hospital La Fe València, Avda. Fernando Abril Martorell, 106, 46026, Valencia, Spain

    Carmen Alcalá, Carlos Quintanilla-Bordás, Sara Carratalá, Francisco Carlos Pérez-Miralles, Sara Gil-Perotín, Raquel Gasqué, Laura Cubas, Jéssica Castillo & Bonaventura Casanova

  2. Neurology Service, Clinic University Hospital of València, Valencia, Spain

    Francisco Gascón & José Andrés Domínguez

  3. Neurology Service, University General Hospital of Alacant, Alicante, Spain

    Ángel Perez Sempere

  4. Neurology Service, University General Hospital of Elx, Elche, Spain

    Laura Navarro

  5. Neurology Service, University General Hospital of València, Valencia, Spain

    María Carcelén-Gadea

  6. Neurology Service, University Dr. Peset University Hospital of València, Valencia, Spain

    Lamberto Landete

  7. Neurology Service, University General Hospital of Elda, Elda, Spain

    Javier Mallada

  8. Neurology Unit, La Ribera University Hospital, Alzira, Spain

    Emmanuel Cañizares

  9. Neurology Service, University General Hospital of Castelló, Castelló de la Plana, Spain

    Antonio Belenguer

Authors
  1. Carmen Alcalá
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  2. Carlos Quintanilla-Bordás
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  3. Francisco Gascón
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  4. Ángel Perez Sempere
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  5. Laura Navarro
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  6. María Carcelén-Gadea
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  7. Lamberto Landete
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  8. Javier Mallada
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  9. Emmanuel Cañizares
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  10. Antonio Belenguer
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  11. Sara Carratalá
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  13. Francisco Carlos Pérez-Miralles
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  14. Sara Gil-Perotín
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  15. Raquel Gasqué
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  16. Laura Cubas
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  17. Jéssica Castillo
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  18. Bonaventura Casanova
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Contributions

CA and BC for conception and design of the study, acquisition and analysis of data and critical revision of the manuscript. CQ-B por drafting the manuscript, acquisition and analysis of data. FG, APS, LN, MC, LL, JM, EC, AB, SC, JAD, FCP-M, SG-P, RG, LC, JC for acquisition of data and critical revision of the manuscript.

Corresponding author

Correspondence to Carlos Quintanilla-Bordás.

Ethics declarations

Conflicts of interest

B Casanova has received consulting fees form Merck, Sanofi-Genzyme, Biogen-Idec, Novartis, and Roche. AP Sempere has received consulting and speaking fees from Biogen, Merck Serono, Novartis, Teva and Roche. F Gascon has received consulting fees and grants for travel from Teva, Merck-Serono, Biogen, Bayer, Novartis, Sanofi-Genzyme, Almirall and Roche. L Navarro has received consulting and speaking fees from Sanofi-Genzyme, Merk, Biogen-Idec and Roche.

Ethical standard statement

The study was conducted in accordance with local ethical standards and approved by the ethics committee.

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Alcalá, C., Quintanilla-Bordás, C., Gascón, F. et al. Effectiveness of rituximab vs. ocrelizumab for the treatment of primary progressive multiple sclerosis: a real-world observational study. J Neurol 269, 3676–3681 (2022). https://doi.org/10.1007/s00415-022-10989-0

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  • DOI: https://doi.org/10.1007/s00415-022-10989-0

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