Erica Curti1, Elena Tsantes2, Eleonora Baldi3, Luisa Maria Caniatti3, Diana Ferraro4, Patrizia Sola5, Franco Granella6. 1. Neurosciences Unit, Department of Medicine and Surgery, University of Parma, via Gramsci 14, Parma 43126, Italy. Electronic address: ericacurti1984@gmail.com. 2. Neurosciences Unit, Department of Medicine and Surgery, University of Parma, via Gramsci 14, Parma 43126, Italy. 3. Neurology Unit, Department of Neuroscience/Rehabilitation, Azienda Ospedaliera-Universitaria S. Anna, via Moro 8, Cona, Ferrara 44124, Italy. 4. Department of Neurosciences, Ospedale Civile, Azienda Ospedaliero-Universitaria, via Giardini 1355, Baggiovara, Modena 41126, Italy; Department of Biomedical, Metabolic and Neurosciences, University of Modena and Reggio Emilia, Modena, Italy. Electronic address: diana.ferraro@unimore.it. 5. Department of Neurosciences, Ospedale Civile, Azienda Ospedaliero-Universitaria, via Giardini 1355, Baggiovara, Modena 41126, Italy. Electronic address: p.sola@ausl.mo.it. 6. Neurosciences Unit, Department of Medicine and Surgery, University of Parma, via Gramsci 14, Parma 43126, Italy. Electronic address: franco.granella@unipr.it.
Abstract
BACKGROUND: Both natalizumab and fingolimod are highly effective in the treatment of relapsing-remitting MS (RRMS). In the absence of head-to-head trials, some observational studies have compared their efficacy with conflicting results. OBJECTIVES: To investigate the efficacy of natalizumab and fingolimod in a cohort of RRMS patients in an observational, retrospective study. METHODS: We included all consecutive RRMS patients who started natalizumab or fingolimod in three MS centres with a follow-up to 24 months and analysed clinical and brain MRI data after propensity score (PS) matching. RESULTS: After 1:1 PS-matching, we retained 102 patients in both groups, with similar baseline features. After 24 months, although both drugs resulted highly effective, patients treated with natalizumab had a lower relapse risk (HR 0.59 CI 95% 0.35-1.00, p = 0.048) and higher time to first relapse. MRI-combined-unique-activity was found in 31.8% of natalizumab vs 43.2% of fingolimod treated patients (p = 0.28). We found a higher proportion of patients with confirmed regression of disability (19.2 vs 6.7%, p = 0.03) and 2-year no evidence of disease activity (NEDA-3, 39.0% vs 22.0%, p = 0.04) in the natalizumab group. CONCLUSIONS: Both drugs were highly effective in our cohort. Natalizumab proved superior in inducing regression of disability and 2-year-NEDA-3.
BACKGROUND: Both natalizumab and fingolimod are highly effective in the treatment of relapsing-remitting MS (RRMS). In the absence of head-to-head trials, some observational studies have compared their efficacy with conflicting results. OBJECTIVES: To investigate the efficacy of natalizumab and fingolimod in a cohort of RRMS patients in an observational, retrospective study. METHODS: We included all consecutive RRMS patients who started natalizumab or fingolimod in three MS centres with a follow-up to 24 months and analysed clinical and brain MRI data after propensity score (PS) matching. RESULTS: After 1:1 PS-matching, we retained 102 patients in both groups, with similar baseline features. After 24 months, although both drugs resulted highly effective, patients treated with natalizumab had a lower relapse risk (HR 0.59 CI 95% 0.35-1.00, p = 0.048) and higher time to first relapse. MRI-combined-unique-activity was found in 31.8% of natalizumab vs 43.2% of fingolimod treated patients (p = 0.28). We found a higher proportion of patients with confirmed regression of disability (19.2 vs 6.7%, p = 0.03) and 2-year no evidence of disease activity (NEDA-3, 39.0% vs 22.0%, p = 0.04) in the natalizumab group. CONCLUSIONS: Both drugs were highly effective in our cohort. Natalizumab proved superior in inducing regression of disability and 2-year-NEDA-3.
Authors: Juan S Lasa; Pablo A Olivera; Stefanos Bonovas; Silvio Danese; Laurent Peyrin-Biroulet Journal: Drug Saf Date: 2021-03-05 Impact factor: 5.606
Authors: Georgina Arrambide; Ellen Iacobaeus; Maria Pia Amato; Tobias Derfuss; Sandra Vukusic; Bernhard Hemmer; Lou Brundin; Mar Tintore Journal: Mult Scler Date: 2020-06-12 Impact factor: 6.312
Authors: Helmut Butzkueven; Stephanie Licata; Douglas Jeffery; Douglas L Arnold; Massimo Filippi; Jeroen Jg Geurts; Sourav Santra; Nolan Campbell; Pei-Ran Ho Journal: BMJ Open Date: 2020-10-20 Impact factor: 2.692