Neurotherapeutics (Jul 2024)
Long-term effectiveness of natalizumab in secondary progressive multiple sclerosis: A propensity-matched study
- Clara G. Chisari,
- Umberto Aguglia,
- Maria Pia Amato,
- Roberto Bergamaschi,
- Antonio Bertolotto,
- Simona Bonavita,
- Vincenzo Brescia Morra,
- Paola Cavalla,
- Eleonora Cocco,
- Antonella Conte,
- Salvatore Cottone,
- Giovanna De Luca,
- Alessia Di Sapio,
- Massimo Filippi,
- Antonio Gallo,
- Claudio Gasperini,
- Franco Granella,
- Giacomo Lus,
- Davide Maimone,
- Giorgia Teresa Maniscalco,
- Girolama Marfia,
- Lucia Moiola,
- Damiano Paolicelli,
- Ilaria Pesci,
- Paolo Ragonese,
- Marco Rovaris,
- Giuseppe Salemi,
- Claudio Solaro,
- Rocco Totaro,
- Maria Trojano,
- Marika Vianello,
- Mauro Zaffaroni,
- Vito Lepore,
- Francesco Patti,
- Carlo Avolio,
- Roberto Balgera,
- Paola Banfi,
- Paolo Bellantonio,
- Placido Bramanti,
- Lorenzo Capone,
- Guido Cavalletti,
- Luca Chiveri,
- Raffaella Clerici,
- Marinella Clerico,
- Francesco Corea,
- Vincenzo Dattola,
- Francesca De Robertis,
- Giancarlo Di Battista,
- Simonetta Galgani,
- Maurizia Gatto,
- Maria Grazia Grasso,
- Matilde Inglese,
- Lorenzo Lo Russo,
- Francesco Ottavio Logullo,
- Renato Mantegazza,
- Alessandra Protti,
- Monica Rezzonico,
- Mariarosa Rottoli,
- Marco Salvetti,
- Elio Scarpini,
- Leonardo Sinisi,
- Maddalena Sparaco,
- Daniele Spitaleri,
- Tiziana Tassinari,
- Simone Tonietti,
- Paola Valentino,
- Franco Valzania,
- Simonetta Venturi
Affiliations
- Clara G. Chisari
- Department “GF. Ingrassia”; Section of Neurosciences, University of Catania, Italy; UOS Sclerosi Multipla, AOU Policlinico “G. Rodolico-San Marco”, University of Catania, Catania, Italy
- Umberto Aguglia
- Regional Epilepsy Centre, Great Metropolitan “Bianchi-Melacrino-Morelli” Hospital, Reggio Calabria, Italy
- Maria Pia Amato
- Department NEUROFARBA, Section Neurosciences, University of Florence, Florence, Italy; IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy
- Roberto Bergamaschi
- IRCCS Mondino Foundation, Pavia, Italy
- Antonio Bertolotto
- Department of Neurology and Multiple Sclerosis Regional Referral Centre, AOU San Luigi Gonzaga, Orbassano, Turin, Italy
- Simona Bonavita
- Department of Advanced Medical and Surgical Sciences, University of Campania “Luigi Vanvitelli” Naples, Italy
- Vincenzo Brescia Morra
- Multiple Sclerosis Centre, University Federico II, Naples, Italy
- Paola Cavalla
- Multiple Sclerosis Center, Department of Neuroscience and Mental Health, City of Health and Science University Hospital of Torino, Torino, Italy
- Eleonora Cocco
- Multiple Sclerosis Centre Binaghi Hospital, ATS Sardegna-University of Cagliari, Italy
- Antonella Conte
- Department of Human Neurosciences, Sapienza University of Rome, Italy; IRCCS Neuromed Pozzili, Italy
- Salvatore Cottone
- Department of Neurology, A.R.N.A.S. Civico, Palermo, Italy
- Giovanna De Luca
- Multiple Sclerosis Center, Neurology Clinic, Policlinico SS Annunziata, University of Chieti-Pescara, Chieti, Italy
- Alessia Di Sapio
- Department of Neurology and Multiple Sclerosis Regional Referral Centre, AOU San Luigi Gonzaga, Orbassano, Turin, Italy
- Massimo Filippi
- Neuroimaging Research Unit, Division of Neuroscience, IRCCS San Raffaele Scientific Institute, Milan, Italy; Neurology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy
- Antonio Gallo
- Department of Advanced Medical and Surgical Sciences, University of Campania “Luigi Vanvitelli” Naples, Italy
- Claudio Gasperini
- Department of Neuroscience, UOC Neurology, San Camillo-Forlanini Hospital, Rome, Italy
- Franco Granella
- Neurosciences Unit, Department of Medicine and Surgery, University of Parma, Parma, Italy
- Giacomo Lus
- Department of Advanced Medical and Surgical Sciences, II Division of Neurology, Multiple Sclerosis Center, University of Campania ‘L. Vanvitelli’, Naples, Italy
- Davide Maimone
- Centro Sclerosi Multipla, UOC Neurologia, Azienda Ospedaliera Cannizzaro, Catania, Italy
- Giorgia Teresa Maniscalco
- Multiple Sclerosis Center, Cardarelli Hospital, Naples, Italy
- Girolama Marfia
- Multiple Sclerosis Clinical and Research Unit, Department of Systems Medicine, Tor Vergata University, Rome, Italy
- Lucia Moiola
- Neurology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy
- Damiano Paolicelli
- Department of Translational Biomedicines and Neurosciences University of Bari, A. Moro, Bari, Italy
- Ilaria Pesci
- Centro Sclerosi Multipla Unità Operativa Neurologia, Azienda Unità Sanitaria Locale, Ospedale Di Vaio, Fidenza, Parma, Italy
- Paolo Ragonese
- Unit of Neurology, Department of Biomedicine, Neurosciences and Advanced Diagnostics, Palermo University, Palermo, Italy
- Marco Rovaris
- IRCCS Don C. Gnocchi Foundation ONLUS, Milan, Italy
- Giuseppe Salemi
- Unit of Neurology, Department of Biomedicine, Neurosciences and Advanced Diagnostics, Palermo University, Palermo, Italy
- Claudio Solaro
- Department of Rehabilitation, C.R.R.F. “Mons. L. Novarese”, Loc. Trompone, Moncrivello, (VC), Italy
- Rocco Totaro
- Demyelinating Disease Center, Neurology Unit, University of L'Aquila, L'Aquila, Italy
- Maria Trojano
- School of Medicine, University “Aldo Moro”, Bari, Italy
- Marika Vianello
- OU Neurology, Cà Foncello Hospital, Treviso, Italy
- Mauro Zaffaroni
- Multiple Sclerosis Center, ASST della Valle Olona, Ospedale di Gallarate, (VA), Italy
- Vito Lepore
- Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy
- Francesco Patti
- Department “GF. Ingrassia”; Section of Neurosciences, University of Catania, Italy; UOS Sclerosi Multipla, AOU Policlinico “G. Rodolico-San Marco”, University of Catania, Catania, Italy; Corresponding author.
- Carlo Avolio
- Roberto Balgera
- Paola Banfi
- Paolo Bellantonio
- Placido Bramanti
- Lorenzo Capone
- Guido Cavalletti
- Luca Chiveri
- Raffaella Clerici
- Marinella Clerico
- Francesco Corea
- Vincenzo Dattola
- Francesca De Robertis
- Giancarlo Di Battista
- Simonetta Galgani
- Maurizia Gatto
- Maria Grazia Grasso
- Matilde Inglese
- Lorenzo Lo Russo
- Francesco Ottavio Logullo
- Renato Mantegazza
- Alessandra Protti
- Monica Rezzonico
- Mariarosa Rottoli
- Marco Salvetti
- Elio Scarpini
- Leonardo Sinisi
- Maddalena Sparaco
- Daniele Spitaleri
- Tiziana Tassinari
- Simone Tonietti
- Paola Valentino
- Franco Valzania
- Simonetta Venturi
- Journal volume & issue
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Vol. 21,
no. 4
p. e00363
Abstract
Treatment options for secondary progressive MS (SPMS) are limited, especially considering that the new drugs recently approved are licensed for actively relapsing patients. We aimed to compare the disability progression in a real-world cohort of SPMS patients treated with natalizumab (NTZ) or interferon beta-1b (IFNb-1b). This multicenter retrospective enrolled patients with a diagnosis of SPMS according to 2014 Lublin criteria, who received NTZ or IFNb-1b for at least 48 months between the 1st June 2012 and the 15th May 2018 at 33 Italian MS centers contributing to the Italian MS Registry NTZ or IFNb-1b. Confirmed Expanded Disability Status Scale worsening (CEW) and progression independent of relapse (PIRA) were evaluated. In order to correct for non-randomization, a propensity score matching of the groups was performed. Out of 5206 MS patients identified at the time of data extraction, 421 SPMS patients treated with NTZ (224 [53.2%] females, mean age 45.3 ± 25.4 years) and 353 with IFNb-1b (133 [37.8%] females, mean age 48.5 ± 19.8 years) were enrolled. After applying the matching procedure, 102 patients were retained in the NTZ group and 98 in the IFNb-2b group. The proportion of patients who reached the 48-month 1-point CEW was significantly higher in IFNb-1b compared to NTZ group (58.2% versus 30.4%, p = 0.01). The proportion of patients who developed PIRA at 48 months were significantly higher in IFNb-1b compared to NTZ (72.4% versus 40.2%, p = 0.01). EDSS before treatment initiation and SPMS duration were risk factors for disability progression in terms of PIRA (HR 2.54, 25%CI 1.67–5.7; p = 0.006 and HR 2.04, 25%CI 1.22–3.35; p = 0.01, respectively). Patients treated with IFNb-1b were 1.64 times more to likely to develop PIRA (HR 1.64, 25%CI 1.04–4.87; p = 0.001). Treatment with NTZ in SPMS patients showed more favorable disability outcomes compared to IFNb-1b with beneficial effects over 48 months.
