Real-world effectiveness of natalizumab and fingolimod compared with self-injectable drugs in non-responders and in treatment-naïve patients with multiple sclerosis
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In this independent, multicentre post-marketing study we directly compared the effectiveness of natalizumab (NTZ), fingolimod (FNG) and self-injectable drugs (INJ), in non-responders to first immunomodulating treatment and in highly active treatment-naïve patients with multiple sclerosis. As main outcome measure we considered the proportions of patients with no evidence of disease activity (NEDA-3), defined as absence of relapses, disability worsening and radiological activity. A total of 567 non-responders to interferon beta (IFNB) or glatiramer acetate (GA) [dataset A] and 216 highly active treatment-naïves [dataset B] were followed up to 24 months from the beginning of NTZ, FNG or INJ, i.e. switching from IFNB to GA or viceversa (in the case of non-responders) or starting high-dose IFNB (in the case of highly active treatment-naïves). Propensity score matching in a 1:1:1 ratio was used to select only patients with similar baseline characteristics, retaining 330 and 120 patients in dataset A and B, respectively. In dataset A, the 24-month proportion with NEDA-3 was greater in both NTZ group (67%) and FNG group (42%) than in INJ group (35%) (p ≤ 0.016); however, NTZ was superior to FNG in promoting the attainment of NEDA-3 status (p = 0.034). In dataset B, the 24-month proportion with NEDA-3 was greater in NTZ group (75%) and FNG group (67%) than in INJ group (40%), but the small cohort sizes most likely prevented the detection of any statistically significant difference. Our study provides real-world evidence that NTZ was more effective than both FNG and INJ in non-responders, while it could seem that, in highly active treatment-naïves, NTZ was as effective as FNG and both were superior to INJ.
KeywordsMultiple sclerosis Propensity score NEDA Disease-modifying drugs
Compliance with ethical standards
Conflicts of interest
No conflict of interest.
No external source of funding was required.
LP received consulting fees from Biogen and Novartis; speaker honoraria from Biogen, Genzyme, Novartis and Teva; travel Grants from Biogen, Genzyme, Novartis and Teva; research Grants from the Italian MS Society (Associazione Italiana Sclerosi Multipla) and Genzyme. He also acts as member of steering committee AIFA (Agenzia Italiana del Farmaco) on natalizumab. FS received personal compensation from Novartis, Forward Pharma, Almirall, Genzyme, and Teva for public speaking, editorial work and advisory boards. CC received consulting fees from Novartis and Merk Serono. AC ha nothing to disclose. FB received funding for traveling from Novartis, Teva, Merck Serono, Almirall, Biogen. SP received fees by Almirall, Biogen, Teva, and Genzyme and travel Grants by CSL Behring, Genzyme, Novartis, Teva, Kedrion. AB has nothing to disclose. SR received speaking honoraria from Merck Serono and Teva. SH has nothing to disclose. VBM received compensation for public speaking and advisory boards from Biogen, Merk Serono, Bayer, Genzyme, Almirall, Novartis, and Teva. RC received consulting fees from Novartis, Biogen and lecture fees and/or travel Grants from Novartis, Biogen, Genzyme and Sanofi-Aventis. DC acted as an Advisory Board member of Merck Serono, Teva, Bayer Schering, Biogen, Novartis, Almirall, GW Pharmaceuticals, Genzyme, Roche, and received funding for traveling and honoraria for speaking or consultation fees from Merck Serono, Teva, Novartis, Bayer Schering, Sanofi-Aventis, Biogen, Almirall, Genzyme. He also acts as member of steering committee AIFA (Agenzia Italiana del Farmaco) on natalizumab. GDB received speaker honoraria from Merck Serono, Biogen Idec, Sanofi-Aventis and Bayer Shering Pharma; received support for participation to National and International Congresses from Bayer-Schering, Biogen-Idec, Merck Serono, Novartis, Sanofi-Aventis and Teva. EF has nothing to disclose. AF received honoraria for lecturing and compensation for travel expenses from Merck Serono, Teva, Novartis, Bayer Schering, Sanofi-Aventis, and Biogen. SG has received fees as invited speaker or travel expenses for attending meeting from Biogen, Merck Serono, Teva, Almirall, Sanofi-Aventis, Novartis, Genzyme. CG received lecture fees and/or consulting fees from Merck Serono, Biogen, Teva, Bayer Schering and Novartis. EM received funding for traveling and speaking honoraria from Novartis and Teva. MM received honoraria from Biogen, Genzyme, Novartis, Merck Serono, Almirall and Teva. CP has received consulting and/or lecture fees and/or research funding and travel Grant from Almirall, Bayer Schering, Biogen, Genzyme, Merck Serono, Novartis, Roche and Teva.
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