Skip to main content
Top

Open Access 04-05-2024 | Ofatumumab | Original Communication

Ocrelizumab and ofatumumab comparison: an Italian real-world propensity score matched study

Authors: Aurora Zanghì, Giovanna Borriello, Simona Bonavita, Roberta Fantozzi, Elisabetta Signoriello, Stefania Barone, Gianmarco Abbadessa, Maria Cellerino, Vanessa Ziccone, Giuseppina Miele, Giacomo Lus, Paola Valentino, Sebastiano Bucello, Matilde Inglese, Diego Centonze, Carlo Avolio, Emanuele D’Amico

Published in: Journal of Neurology

Login to get access

Abstract

Background

The management of Multiple Sclerosis (MS) has undergone transformative evolution with the introduction of high-efficacy disease-modifying therapies (DMTs), specifically anti-CD20 monoclonal antibodies, such as ocrelizumab (OCR) and ofatumumab (OFA).

Materials and methods

This is an independent retrospective cohort study in Relapsing MS (RMS) patients followed at eight Italian MS centers who initiated treatment with OCR or OFA in the participating centers and with at least 12 months on therapy. A generalized linear regression model inverse probability of treatment weight (IPTW) PS-adjusted was performed to evaluate the relationship between annualized relapse rate (ARR) and treatment groups. No evidence of disease activity-NEDA-3 at 12-month score was also collected. Safety profile of the investigated DMTs was recorded.

Results

A total cohort of 396 RMS patients fulfilled the required criteria and were enrolled in the study. Out of them, 216 had a prescription of OCR and 180 of OFA. The mean follow-up was 13.2 ± 1.9 months. The estimated means for ARR did not show differences between the two groups, 0.059 for patients on OCR and 0.038 for patients on OFA (p = 0.185). The generalized regression model IPTW PS-adjusted did not reveal differences between patients on OCR and OFA (ExpBOFA 0.974, 95%CI 934–1.015, p = 0.207). NEDA-3 at 12 months was experienced by 199(92.1%) patients on OCR and 170(94.4%) patients on OFA (p = 0.368). Generally, both therapies exhibit good tolerability.

Conclusions

The treatment with OCR and OFA resulted in comparable control of disease activity with good safety profile. Our results need further validation in larger multicentre studies with long-term follow-up.
Literature
3.
go back to reference Bar-Or A, O’Brien SM, Sweeney ML, Fox EJ, Cohen JA (2021) Clinical perspectives on the molecular and pharmacological attributes of anti-CD20 therapies for multiple sclerosis. CNS Drugs 35(9):985–997CrossRefPubMedPubMedCentral Bar-Or A, O’Brien SM, Sweeney ML, Fox EJ, Cohen JA (2021) Clinical perspectives on the molecular and pharmacological attributes of anti-CD20 therapies for multiple sclerosis. CNS Drugs 35(9):985–997CrossRefPubMedPubMedCentral
4.
go back to reference D’Amico E, Zanghì A, Gastaldi M, Patti F, Zappia M, Franciotta D (2019) Placing CD20-targeted B cell depletion in multiple sclerosis therapeutic scenario: present and future perspectives. Autoimmun Rev 18(7):665–672CrossRefPubMed D’Amico E, Zanghì A, Gastaldi M, Patti F, Zappia M, Franciotta D (2019) Placing CD20-targeted B cell depletion in multiple sclerosis therapeutic scenario: present and future perspectives. Autoimmun Rev 18(7):665–672CrossRefPubMed
6.
go back to reference Hauser SL, Bar-Or A, Comi G, Giovannoni G, Hartung H-P, Hemmer B et al (2016) Ocrelizumab versus interferon beta-1a in relapsing multiple sclerosis. N Engl J Med 376(3):221–234CrossRefPubMed Hauser SL, Bar-Or A, Comi G, Giovannoni G, Hartung H-P, Hemmer B et al (2016) Ocrelizumab versus interferon beta-1a in relapsing multiple sclerosis. N Engl J Med 376(3):221–234CrossRefPubMed
7.
go back to reference Kappos L, Li D, Calabresi PA, O’Connor P, Bar-Or A, Barkhof F et al (2011) Ocrelizumab in relapsing-remitting multiple sclerosis: a phase 2, randomised, placebo-controlled, multicentre trial. Lancet 378(9805):1779–1787CrossRefPubMed Kappos L, Li D, Calabresi PA, O’Connor P, Bar-Or A, Barkhof F et al (2011) Ocrelizumab in relapsing-remitting multiple sclerosis: a phase 2, randomised, placebo-controlled, multicentre trial. Lancet 378(9805):1779–1787CrossRefPubMed
9.
go back to reference Gärtner J, Hauser SL, Bar-Or A, Montalban X, Cohen JA, Cross AH et al (2022) Efficacy and safety of ofatumumab in recently diagnosed, treatment-naive patients with multiple sclerosis: results from ASCLEPIOS I and II. Multiple Sclerosis 28(10):1562–1575CrossRefPubMed Gärtner J, Hauser SL, Bar-Or A, Montalban X, Cohen JA, Cross AH et al (2022) Efficacy and safety of ofatumumab in recently diagnosed, treatment-naive patients with multiple sclerosis: results from ASCLEPIOS I and II. Multiple Sclerosis 28(10):1562–1575CrossRefPubMed
10.
go back to reference Hauser SL, Kappos L, Bar-Or A, Wiendl H, Paling D, Williams M et al (2023) The development of ofatumumab, a fully human anti-CD20 monoclonal antibody for practical use in relapsing multiple sclerosis treatment. Neurol Ther 12(5):1491–1515CrossRefPubMedPubMedCentral Hauser SL, Kappos L, Bar-Or A, Wiendl H, Paling D, Williams M et al (2023) The development of ofatumumab, a fully human anti-CD20 monoclonal antibody for practical use in relapsing multiple sclerosis treatment. Neurol Ther 12(5):1491–1515CrossRefPubMedPubMedCentral
11.
go back to reference Samjoo IA, Klotz L, Giovannoni G, Drudge C, Haltner A, Worthington E et al (2022) Simulated treatment comparison of efficacy outcomes for ofatumumab in ASCLEPIOS I/II versus ocrelizumab in OPERA I/II for the treatment of patients with relapsing multiple sclerosis. Multiple Sclerosis Related Disorders 66:104031CrossRefPubMed Samjoo IA, Klotz L, Giovannoni G, Drudge C, Haltner A, Worthington E et al (2022) Simulated treatment comparison of efficacy outcomes for ofatumumab in ASCLEPIOS I/II versus ocrelizumab in OPERA I/II for the treatment of patients with relapsing multiple sclerosis. Multiple Sclerosis Related Disorders 66:104031CrossRefPubMed
12.
go back to reference Samjoo IA, Worthington E, Drudge C, Zhao M, Cameron C, Häring DA et al (2020) Comparison of ofatumumab and other disease-modifying therapies for relapsing multiple sclerosis: a network meta-analysis. J Comparat Eff Res 9(18):1255–1274CrossRef Samjoo IA, Worthington E, Drudge C, Zhao M, Cameron C, Häring DA et al (2020) Comparison of ofatumumab and other disease-modifying therapies for relapsing multiple sclerosis: a network meta-analysis. J Comparat Eff Res 9(18):1255–1274CrossRef
13.
go back to reference Filippi M, Preziosa P, Banwell BL, Barkhof F, Ciccarelli O, De Stefano N et al (2019) Assessment of lesions on magnetic resonance imaging in multiple sclerosis: practical guidelines. Brain J Neurol 142(7):1858–1875CrossRef Filippi M, Preziosa P, Banwell BL, Barkhof F, Ciccarelli O, De Stefano N et al (2019) Assessment of lesions on magnetic resonance imaging in multiple sclerosis: practical guidelines. Brain J Neurol 142(7):1858–1875CrossRef
14.
go back to reference Thompson AJ, Baranzini SE, Geurts J, Hemmer B, Ciccarelli O (2018) Multiple sclerosis. Lancet 391(10130):1622–1636CrossRefPubMed Thompson AJ, Baranzini SE, Geurts J, Hemmer B, Ciccarelli O (2018) Multiple sclerosis. Lancet 391(10130):1622–1636CrossRefPubMed
17.
go back to reference Amin M et al. Real-world effectiveness, tolerability, and safety of ofatumumab at 12-month follow-up. Poster presented at the 9th Joint ECTRIMS-ACTRIMS Meeting, 11–13 October 2023 Milan, Italy Amin M et al. Real-world effectiveness, tolerability, and safety of ofatumumab at 12-month follow-up. Poster presented at the 9th Joint ECTRIMS-ACTRIMS Meeting, 11–13 October 2023 Milan, Italy
19.
go back to reference Mathias A, Pantazou V, Perriot S, Canales M, Jones S, Oberholster L et al (2023) Ocrelizumab impairs the phenotype and function of memory CD8+ T cells. Neurol Neuroimmunol Neuroinflammat 10(2):200084CrossRef Mathias A, Pantazou V, Perriot S, Canales M, Jones S, Oberholster L et al (2023) Ocrelizumab impairs the phenotype and function of memory CD8+ T cells. Neurol Neuroimmunol Neuroinflammat 10(2):200084CrossRef
20.
go back to reference Capasso N, Nozzolillo A, Scalia G, Lanzillo R, Carotenuto A, De Angelis M et al (2021) Ocrelizumab depletes T-lymphocytes more than rituximab in multiple sclerosis. Multiple Sclerosis Related Disorders 49:102802CrossRefPubMed Capasso N, Nozzolillo A, Scalia G, Lanzillo R, Carotenuto A, De Angelis M et al (2021) Ocrelizumab depletes T-lymphocytes more than rituximab in multiple sclerosis. Multiple Sclerosis Related Disorders 49:102802CrossRefPubMed
22.
go back to reference D’Amico E, Zanghì A, Fantozzi R, Centonze D, Avolio C (2023) Ofatumumab and early immunological cells subset characterization in naïve relapsing multiple sclerosis patients: a real-world study. Curr Neuropharmacol 21(12):2563–2566CrossRefPubMedPubMedCentral D’Amico E, Zanghì A, Fantozzi R, Centonze D, Avolio C (2023) Ofatumumab and early immunological cells subset characterization in naïve relapsing multiple sclerosis patients: a real-world study. Curr Neuropharmacol 21(12):2563–2566CrossRefPubMedPubMedCentral
23.
go back to reference Cellerino M, Boffa G, Lapucci C, Tazza F, Sbragia E, Mancuso E et al (2021) Predictors of ocrelizumab effectiveness in patients with multiple sclerosis. Neurotherapeutics J Am Soc Exp NeuroTherapeutics 18(4):2579–2588CrossRef Cellerino M, Boffa G, Lapucci C, Tazza F, Sbragia E, Mancuso E et al (2021) Predictors of ocrelizumab effectiveness in patients with multiple sclerosis. Neurotherapeutics J Am Soc Exp NeuroTherapeutics 18(4):2579–2588CrossRef
Metadata
Title
Ocrelizumab and ofatumumab comparison: an Italian real-world propensity score matched study
Authors
Aurora Zanghì
Giovanna Borriello
Simona Bonavita
Roberta Fantozzi
Elisabetta Signoriello
Stefania Barone
Gianmarco Abbadessa
Maria Cellerino
Vanessa Ziccone
Giuseppina Miele
Giacomo Lus
Paola Valentino
Sebastiano Bucello
Matilde Inglese
Diego Centonze
Carlo Avolio
Emanuele D’Amico
Publication date
04-05-2024
Publisher
Springer Berlin Heidelberg
Published in
Journal of Neurology
Print ISSN: 0340-5354
Electronic ISSN: 1432-1459
DOI
https://doi.org/10.1007/s00415-024-12360-x
Live Webinar | 27-06-2024 | 18:00 (CEST)

Keynote webinar | Spotlight on medication adherence

Live: Thursday 27th June 2024, 18:00-19:30 (CEST)

WHO estimates that half of all patients worldwide are non-adherent to their prescribed medication. The consequences of poor adherence can be catastrophic, on both the individual and population level.

Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.

Prof. Kevin Dolgin
Prof. Florian Limbourg
Prof. Anoop Chauhan
Developed by: Springer Medicine