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

被引：2

作者：

Chisari, Clara G. ^{[1
,2
]}

Aguglia, Umberto ^{[3
]}

Amato, Maria Pia ^{[4
,5
]}

Bergamaschi, Roberto ^{[6
]}

Bertolotto, Antonio ^{[7
]}

Bonavita, Simona ^{[8
]}

Morra, Vincenzo Brescia ^{[9
]}

Cavalla, Paola ^{[10
]}

Cocco, Eleonora ^{[11
]}

Conte, Antonella ^{[11
,12
,13
]}

Cottone, Salvatore ^{[14
]}

De Luca, Giovanna ^{[15
]}

Di Sapio, Alessia ^{[6
,7
]}

Filippi, Massimo ^{[16
,17
,18
,19
,20
]}

Gallo, Antonio ^{[7
,8
]}

Gasperini, Claudio ^{[21
]}

Granella, Franco ^{[22
]}

Lus, Giacomo ^{[23
]}

Maimone, Davide ^{[24
]}

Maniscalco, Giorgia Teresa ^{[25
]}

Marfia, Girolama ^{[26
]}

Moiola, Lucia ^{[17
]}

Paolicelli, Damiano ^{[27
]}

Pesci, Ilaria ^{[28
]}

Ragonese, Paolo ^{[29
]}

Rovaris, Marco ^{[30
]}

Salemi, Giuseppe ^{[29
]}

Solaro, Claudio ^{[31
]}

Totaro, Rocco ^{[32
]}

Trojano, Maria ^{[33
]}

Vianello, Marika ^{[34
]}

Zaffaroni, Mauro ^{[35
]}

Lepore, Vito ^{[36
]}

Patti, Francesco ^{[1
,2
]}

机构：

[1] Univ Catania, Sect Neurosci, Catania, Italy

[2] Univ Catania, UOS Sclerosi Multipla, AOU Policlin G Rodol San Marco, Catania, Italy

[3] Great Metropolitan Bianchi Melacrino Morelli Hosp, Reg Epilepsy Ctr, Reggio Di Calabria, Italy

[4] Univ Florence, Sect Neurosci, Dept NEUROFARBA, Florence, Italy

[5] IRCCS Fdn Don Carlo Gnocchi, Florence, Italy

[6] IRCCS Mondino Fdn, Pavia, Italy

[7] AOU San Luigi Gonzaga, Multiple Sclerosis Reg Referral Ctr, Dept Neurol, Turin, Italy

[8] Univ Campania Luigi Vanvitelli, Dept Adv Med & Surg Sci, Naples, Italy

[9] Univ Federico II, Multiple Sclerosis Ctr, Naples, Italy

[10] City Hlth & Sci Univ Hosp Torino, Multiple Sclerosis Ctr, Dept Neurosci & Mental Hlth, Turin, Italy

[11] ATS Sardegna Univ Cagliari, Multiple Sclerosis Ctr, Binaghi Hosp, Cagliari, Italy

[12] Sapienza Univ Rome, Dept Human Neurosci, Rome, Italy

[13] IRCCS Neuromed Pozzili, Pozzilli, Italy

[14] ARNAS Civico, Dept Neurol, Palermo, Italy

[15] Univ G dAnnunzio, Multiple Sclerosis Ctr, Neurol Clin, Policlin SS Annunziata, Chieti, Pescara, Italy

[16] IRCCS San Raffaele Sci Inst, Div Neurosci, Neuroimaging Res Unit, Milan, Italy

[17] IRCCS San Raffaele Sci Inst, Neurol Unit, Milan, Italy

[18] IRCCS San Raffaele Sci Inst, Neurorehabil Unit, Milan, Italy

[19] Univ Vita Salute San Raffaele, Milan, Italy

[20] IRCCS San Raffaele Sci Inst, Neurophysiol Serv, Milan, Italy

[21] San Camillo Forlanini Hosp, UOC Neurol, Dept Neurosci, I-00152 Rome, Italy

[22] Univ Parma, Dept Med & Surg, Neurosci Unit, Parma, Italy

[23] Univ Campania L Vanvitelli, Multiple Sclerosis Ctr, Dept Adv Med & Surg Sci, Div Neurol 2, Naples, Italy

[24] UOC Neurol, Ctr Sclerosi Multipla, Azienda Osped Cannizzaro, Catania, Italy

[25] Cardarelli Hosp, Multiple Sclerosis Ctr, Naples, Italy

[26] Tor Vergata Univ, Dept Syst Med, Multiple Sclerosis Clin & Res Unit, Rome, Italy

[27] Univ Bari A Moro, Dept Translat Biomed & Neurosci, Bari, Italy

[28] Osped Vaio, Ctr Sclerosi Multipla Unit Operativa Neurol, Azienda Unit Sanit Locale, Fidenza, Parma, Italy

[29] Palermo Univ, Dept Biomed Neurosci & Adv Diagnost, Unit Neurol, Palermo, Italy

[30] IRCCS Don C Gnocchi Fdn ONLUS, Milan, Italy

[31] CRRF Mons L Novarese, Rehabil Dept, Moncrivello, VC, Italy

[32] Univ Aquila, Demyelinating Dis Ctr, Neurol Unit, Laquila, Italy

[33] Univ Aldo Moro, Sch Med, Bari, Italy

[34] Ca Foncello Hosp, OU Neurol, Treviso, Italy

[35] Osped Gallarate, Multiple Sclerosis Ctr, ASST Valle Olona, Gallarate, VA, Italy

[36] Ist Ric Farmacolog Mario Negri IRCCS, Milan, Italy

来源：

NEUROTHERAPEUTICS | 2024年 / 21卷 / 04期

关键词：

Natalizumab; Interferon beta 1b; Secondary progressive multiple sclerosis; Disability progression; EUROPEAN MULTICENTER TRIAL; INTERFERON BETA-1B; DISABILITY; DISEASE; RELAPSE; CXCL13; EDSS; MS;

D O I：

10.1016/j.neurot.2024.e00363

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

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 nonrandomization, 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.

引用

页数：8

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