A comparison of natalizumab and ocrelizumab on disease progression in multiple sclerosis

Author:

Iaffaldano Pietro1ORCID,Lucisano Giuseppe2,Guerra Tommaso1,Paolicelli Damiano1,Portaccio Emilio3,Inglese Matilde45,Foschi Matteo6,Patti Francesco7,Granella Franco8,Romano Silvia9ORCID,Cavalla Paola10,De Luca Giovanna11,Gallo Paolo12,Bellantonio Paolo13,Gallo Antonio14,Montepietra Sara15,Di Sapio Alessia16,Vianello Marika17,Quatrale Rocco18,Spitaleri Daniele19,Clerici Raffaella20,Torri Clerici Valentina21,Cocco Eleonora22,Brescia Morra Vincenzo23,Marfia Girolama Alessandra24,Boccia Vincenzo Daniele4,Filippi Massimo25ORCID,Amato Maria Pia3,Trojano Maria1,

Affiliation:

1. Department of Translational Biomedicines and Neurosciences University of Bari Aldo Moro Bari Italy

2. CORESEARCH ‐ Center for Outcomes Research and Clinical Epidemiology Pescara Italy

3. Department of Neurofarba University of Florence Florence Italy

4. Dipartimento Di Neuroscienze, Riabilitazione, Oftalmologia, Genetica E Scienze Materno ‐ Infantili (DINOGMI) Università di Genova Genoa Italy

5. IRCCS Ospedale Policlinico San Martino Genoa Italy

6. Department of Neuroscience, Multiple Sclerosis Center‐Neurology Unit S. Maria delle Croci Hospital of Ravenna, AUSL Romagna Ravenna 48121 Italy

7. Dipartimento di Scienze Mediche e Chirurgiche e Tecnologie Avanzate, GF Ingrassia, Sez. Neuroscienze, Centro Sclerosi Multipla Università di Catania Catania Italy

8. Unit of Neurosciences, Department of Medicine and Surgery University of Parma Parma Italy

9. Department of Neurosciences, Mental Health and Sensory Organs, Centre for Experimental Neurological Therapies (CENTERS) Sapienza University of Rome Rome Italy

10. Multiple Sclerosis Center and 1 Neurology Unit, Department of Neurosciences and Mental Health AOU Città della Salute e della Scienza di Torino via Cherasco 15 Torino 10126 Italy

11. Centro Sclerosi Multipla Clinica Neurologica, Policlinico SS. Annunziata Chieti Italy

12. Department of Neurosciences, Multiple Sclerosis Centre‐Veneto Region (CeSMuV) University Hospital of Padua Padua Italy

13. Unit of Neurology and Neurorehabilitation IRCCS Neuromed Pozzilli Italy

14. Department of Advanced Medical and Surgical Sciences University of Campania “Luigi Vanvitelli” Naples Italy

15. Neurology Unit, Neuromotor and Rehabilitation Department AUSL‐IRCCS of Reggio Emilia Reggio Emilia Italy

16. Regional Referral MS Center, Neurological Unit Univ. Hospital San Luigi Orbassano Italy

17. Unit of Neurology Cà Foncello Hospital Treviso Italy

18. Ambulatorio Sclerosi Multipla ‐ Divisione di Neurologia Ospedale dell'Angelo Mestre Italy

19. Department of Neurology AORN San G. Moscati di Avellino Avellino Italy

20. Centro ad Alta Specializzazione per la diagnosi e la cura della sclerosi multipla Ospedale Generale di zona Valduce Como Italy

21. Foundation Neurological Institute C. Besta Milan Italy

22. Department of Medical Science and Public Health, Centro Sclerosi Multipla University of Cagliari Cagliari Italy

23. Department of Neuroscience (NSRO) Multiple Sclerosis Clinical Care and Research Center, Federico II University Naples Italy

24. Multiple Sclerosis Clinical and Research Unit University Hospital of Rome Tor Vergata Rome Italy

25. Neurology Unit and MS Center IRCCS San Raffaele Scientific Institute Milan Italy

Abstract

AbstractObjectiveNo direct comparisons of the effect of natalizumab and ocrelizumab on progression independent of relapse activity (PIRA) and relapse‐associated worsening (RAW) events are currently available. We aimed to compare the risk of achieving first 6 months confirmed PIRA and RAW events and irreversible Expanded Disability Status Scale (EDSS) 4.0 and 6.0 in a cohort of naïve patients treated with natalizumab or ocrelizumab from the Italian Multiple Sclerosis Register.MethodsPatients with a first visit within 1 year from onset, treated with natalizumab or ocrelizumab, and ≥3 visits were extracted. Pairwise propensity score‐matched analyses were performed. Risk of reaching the first PIRA, RAW, and EDSS 4.0 and 6.0 events were estimated using multivariable Cox proportional hazards models. Kaplan–Meier curves were used to show cumulative probabilities of reaching outcomes.ResultsIn total, 770 subjects were included (natalizumab = 568; ocrelizumab = 212) and the propensity score‐matching retrieved 195 pairs. No RAW events were found in natalizumab group and only 1 was reported in ocrelizumab group. A first PIRA event was reached by 23 natalizumab and 25 ocrelizumab exposed patients; 7 natalizumab‐ and 10 ocrelizumab‐treated patients obtained an irreversible EDSS 4.0, while 13 natalizumab‐ and 15 ocrelizumab‐treated patients reached an irreversible EDSS 6.0. No differences between the two groups were found in the risk (HR, 95%CI) of reaching a first PIRA (1.04, 0.59–1.84; p = 0.88) event, an irreversible EDSS 4.0 (1.23, 0.57–2.66; p = 0.60) and 6.0 (0.93, 0.32–2.68; p = 0.89).InterpretationBoth medications strongly suppress RAW events and, in the short term, the risk of achieving PIRA events, EDSS 4.0 and 6.0 milestones is not significantly different.

Publisher

Wiley

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