Long-term effectiveness of natalizumab in secondary progressive multiple sclerosis: A propensity-matched study.

Autor:	Chisari CG; Department 'GF. Ingrassia'; Section of Neurosciences, University of Catania, Italy; UOS Sclerosi Multipla, AOU Policlinico 'G. Rodolico-San Marco', University of Catania, Catania, Italy., Aguglia U; Regional Epilepsy Centre, Great Metropolitan 'Bianchi-Melacrino-Morelli' Hospital, Reggio Calabria, Italy., Amato MP; Department NEUROFARBA, Section Neurosciences, University of Florence, Florence, Italy; IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy., Bergamaschi R; IRCCS Mondino Foundation, Pavia, Italy., Bertolotto A; Department of Neurology and Multiple Sclerosis Regional Referral Centre, AOU San Luigi Gonzaga, Orbassano, Turin, Italy., Bonavita S; Department of Advanced Medical and Surgical Sciences, University of Campania 'Luigi Vanvitelli' Naples, Italy., Morra VB; Multiple Sclerosis Centre, University Federico II, Naples, Italy., Cavalla P; Multiple Sclerosis Center, Department of Neuroscience and Mental Health, City of Health and Science University Hospital of Torino, Torino, Italy., Cocco E; Multiple Sclerosis Centre Binaghi Hospital, ATS Sardegna-University of Cagliari, Italy., Conte A; Department of Human Neurosciences, Sapienza University of Rome, Italy; IRCCS Neuromed Pozzili, Italy., Cottone S; Department of Neurology, A.R.N.A.S. Civico, Palermo, Italy., De Luca G; Multiple Sclerosis Center, Neurology Clinic, Policlinico SS Annunziata, University of Chieti-Pescara, Chieti, Italy., Di Sapio A; Department of Neurology and Multiple Sclerosis Regional Referral Centre, AOU San Luigi Gonzaga, Orbassano, Turin, Italy., Filippi M; Neuroimaging Research Unit, Division of Neuroscience, IRCCS San Raffaele Scientific Institute, Milan, Italy; Neurology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy; Neurorehabilitation Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy; Vita-Salute San Raffaele University, Milan, Italy; Neurophysiology Service, IRCCS San Raffaele Scientific Institute, Milan, Italy., Gallo A; Department of Advanced Medical and Surgical Sciences, University of Campania 'Luigi Vanvitelli' Naples, Italy., Gasperini C; Department of Neuroscience, UOC Neurology, San Camillo-Forlanini Hospital, Rome, Italy., Granella F; Neurosciences Unit, Department of Medicine and Surgery, University of Parma, Parma, Italy., Lus G; Department of Advanced Medical and Surgical Sciences, II Division of Neurology, Multiple Sclerosis Center, University of Campania 'L. Vanvitelli', Naples, Italy., Maimone D; Centro Sclerosi Multipla, UOC Neurologia, Azienda Ospedaliera Cannizzaro, Catania, Italy., Maniscalco GT; Multiple Sclerosis Center, Cardarelli Hospital, Naples, Italy., Marfia G; Multiple Sclerosis Clinical and Research Unit, Department of Systems Medicine, Tor Vergata University, Rome, Italy., Moiola L; Neurology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy., Paolicelli D; Department of Translational Biomedicines and Neurosciences University of Bari, A. Moro, Bari, Italy., Pesci I; Centro Sclerosi Multipla Unità Operativa Neurologia, Azienda Unità Sanitaria Locale, Ospedale Di Vaio, Fidenza, Parma, Italy., Ragonese P; Unit of Neurology, Department of Biomedicine, Neurosciences and Advanced Diagnostics, Palermo University, Palermo, Italy., Rovaris M; IRCCS Don C. Gnocchi Foundation ONLUS, Milan, Italy., Salemi G; Unit of Neurology, Department of Biomedicine, Neurosciences and Advanced Diagnostics, Palermo University, Palermo, Italy., Solaro C; Department of Rehabilitation, C.R.R.F. 'Mons. L. Novarese', Loc. Trompone, Moncrivello, (VC), Italy., Totaro R; Demyelinating Disease Center, Neurology Unit, University of L'Aquila, L'Aquila, Italy., Trojano M; School of Medicine, University 'Aldo Moro', Bari, Italy., Vianello M; OU Neurology, Cà Foncello Hospital, Treviso, Italy., Zaffaroni M; Multiple Sclerosis Center, ASST della Valle Olona, Ospedale di Gallarate, (VA), Italy., Lepore V; Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy., Patti F; Department 'GF. Ingrassia'; Section of Neurosciences, University of Catania, Italy; UOS Sclerosi Multipla, AOU Policlinico 'G. Rodolico-San Marco', University of Catania, Catania, Italy. Electronic address: patti@unict.it.
Jazyk:	angličtina
Zdroj:	Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics [Neurotherapeutics] 2024 Jul; Vol. 21 (4), pp. e00363. Date of Electronic Publication: 2024 May 07.
DOI:	10.1016/j.neurot.2024.e00363
Abstrakt:	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. Competing Interests: Declaration of competing interest CGC has received grants to attend scientific congresses or speaker honoraria from Biogen, Merck-Serono, Novartis, Roche, Sanofi/Genzyme, Teva. UA reports no disclosures relevant to the manuscript. MPA has received grants to attend scientific congresses or speaker honoraria from Biogen, Merck-Serono, Novartis, Roche, Sanofi/Genzyme, Teva. RB reports no disclosures relevant to the manuscript. AB has received grants to attend scientific congresses or speaker honoraria from Biogen, Merck-Serono, Novartis, Roche, Sanofi/Genzyme, Teva. SB served as speaker and/or advisory board fee, and/or travel grant from Novartis, Teva, Sanofi-Genzyme, Roche, Biogen-Idec, Merck-Serono. VBM received fees for consultancies or public speaking from Merck, Novartis, Biogen, Roche, Genzyme and Biogen. PC has served as an advisory board member for Almirall, Biogen, Merck-Serono, Sanofi-Genzyme, Roche, Teva; she has received grants to attend scientific congresses or speaker honoraria from Biogen, Merck-Serono, Novartis, Roche, Sanofi/Genzyme, Teva. EC reports no disclosures relevant to the manuscript. AC reports no disclosures relevant to the manuscript. SC has received grants to attend scientific congresses or speaker honoraria from Biogen, Merck-Serono, Novartis, Roche, Sanofi/Genzyme, Teva. GDL reports no disclosures relevant to the manuscript. ADS reports no disclosures relevant to the manuscript. MF is Editor-in-Chief of the Journal of Neurology; received compensation for consulting services and/or speaking activities from Biogen Idec, Merck-Serono, Novartis, Teva Pharmaceutical Industries; and receives research support from Biogen Idec, Merck-Serono, Novartis, Teva Pharmaceutical Industries, Roche, Italian Ministry of Health, Fondazione Italiana Sclerosi Multipla, and ARiSLA(Fondazione Italiana di Ricerca per la SLA). AG reports no disclosures relevant to the manuscript. CG reports no disclosures relevant to the manuscript. FG received grants to attend scientific congresses or speaker honoraria from Biogen, Merck-Serono, Novartis, Roche, Sanofi/Genzyme, Teva. GL reports no disclosures relevant to the manuscript. DM reports no disclosures relevant to the manuscript. GTM has received grants to attend scientific congresses or speaker honoraria from Biogen, Merck-Serono, Novartis, Roche, Sanofi/Genzyme, Teva. GAM has served as an advisory board member and received speaker honoraria, congress, travel and accommodation expense compensations from Merck, Teva, Mylan, Bayer, Novartis, Roche, Almirall, Biogen and Sanofi Genzyme. LM reports no disclosures relevant to the manuscript. DP has received grants to attend scientific congresses or speaker honoraria from Biogen, Merck-Serono, Novartis, Roche, Sanofi/Genzyme, Teva. IP reports no disclosures relevant to the manuscript. PR reports no disclosures relevant to the manuscript. MR received travel grants and fees for consulting and public speaking from Almirall, Biogen, Genzyme-Sanofi, Merck Serono, Mylan and Novartis. GS has received grants to attend scientific congresses or speaker honoraria from Biogen, Merck-Serono, Novartis, Roche, Sanofi/Genzyme, Teva. CS has received grants to attend scientific congresses or speaker honoraria from Biogen, Merck-Serono, Novartis, Roche, Sanofi/Genzyme, Teva. RT reports no disclosures relevant to the manuscript. ST reports no disclosures relevant to the manuscript. MT has received grants to attend scientific congresses or speaker honoraria from Biogen, Merck-Serono, Novartis, Roche, Sanofi/Genzyme, Teva. MV reports no disclosures relevant to the manuscript. VL reports no disclosures relevant to the manuscript. MZ has received grants to attend scientific congresses or speaker honoraria from Biogen, Merck-Serono, Novartis, Roche, Sanofi/Genzyme, Teva. FP has received honoraria for speaking activities by Almirall, Bayer Schering, Biogen Idec, Merck Serono, Novartis, Roche, Sanofi Genzyme, and TEVA; he also served as advisory board member the following companies: Bayer Schering, Biogen Idec, Merck Serono, Novartis, Roche, Sanofi Genzyme, and TEVA; he was also funded by Pfizer and FISM for epidemiological studies; he received grants for congress participation from Almirall, Bayer Shering, Biogen Idec, Merck Serono, Novartis, Roche, Sanofi Genzyme, and TEVA. (Copyright © 2024. Published by Elsevier Inc.)
Databáze:	MEDLINE
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