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Effects of High- and Low-Efficacy Therapy in Secondary Progressive Multiple Sclerosis
Izanne Roos1, Emmanuelle Leray1, Romain Casey1
1From the CORe (I.R., C.M., T.K.), Department of Medicine, University of Melbourne; Melbourne MS Centre (I.R., K.B., C.M., T.K.), Department of Neurology, Royal Melbourne Hospital, Australia; Rennes University (E.L.), EHESP, REPERES EA 7449; Univ Rennes (E.L.), CHU Rennes, Inserm, CIC 1414 (Centre d'Investigation Clinique de Rennes); Université de Lyon (R.C.), Université Claude Bernard Lyon 1; Hospices Civils de Lyon (R.C.), Service de Neurologie, sclérose en plaques, pathologies de la myéline et neuro-inflammation, Bron; Observatoire Français de la Sclérose en Plaques (R.C.), Centre de Recherche en Neurosciences de Lyon, INSERM 1028 et CNRS UMR 5292; EUGENE DEVIC EDMUS Foundation Against Multiple Sclerosis (R.C.), state-approved foundation, Bron, France; Department of Neurology and Center of Clinical Neuroscience (D.H., E.H.), First Faculty of Medicine, Charles University; General University Hospital (D.H., E.H.), Prague, Czech Republic; Hospital Universitario Virgen Macarena (G.I., S.E.M.), Sevilla, Spain; Department of Medical and Surgical Sciences and Advanced Technologies (F.P.), GF Ingrassia; Multiple Sclerosis Center (F.P.), University of Catania, Italy; Centre hospitalier universitaire de Rennes (G.E.), Hôpital Pontchaillou, Service de neurologie, CIC1414 INSERM; Nancy University Hospital (M.D.), Department of Neurology; Université de Lorraine (M.D.), APEMAC, Nancy, France; Aix Marseille Univ (J.P.), APHM, Hôpital de la Timone, Pôle de Neurosciences Cliniques, Service de Neurologie, France; Dokuz Eylul University (S.O.), Konak/Izmir, Turkey; Department of Neurosciences, Psychology, Drugs and Child Health Area (NEUROFARBA) (M.P.A.), Section Neurosciences, University of Florence, Italy; CHU Clermont-Ferrand (P.C.), Department of Neurology; Université Clermont Auvergne (P.C.), Inserm, Neuro-Dol, Clermont-Ferrand, France; CISSS Chaudière-Appalache (P.G.), Lévis, Canada; KTU Medical Faculty Farabi Hospital (C.B.), Trabzon, Turkey; Department of Neurology (K.B., O.S., H.B.), Box Hill Hospital, Monash University; The Alfred Hospital (O.S.), Melbourne, Australia; CHU de Toulouse (J.C.), Hôpital Pierre-Paul Riquet, Department of Neurology, CRC-SEP, Toulouse Cedex 9, France; Department of Neurology (O.G.), Zuyderland Medical Center, Sittard-Geleen, the Netherlands; Neuro Rive-Sud (F.G.), Quebec, Canada; School of Medicine and Public Health (J.L.-S.), University Newcastle; Department of Neurology (J.L.-S.), John Hunter Hospital, Hunter New England Health, Newcastle; Central Clinical School (H.B.), Monash University; Department of Neurology (H.B.), The Alfred Hospital, Melbourne, Australia; Service de neurologie (S.V.), sclérose en plaques, pathologies de la myéline et neuro-inflammation; Hôpital Neurologique Pierre Wertheimer (S.V.), Hospices Civils de Lyon, Lyon/Bron; France Centre des Neurosciences de Lyon (S.V.), Observatoire Français de la Sclérose en Plaques, INSERM 1028 et CNRS UMR5292; and Université Claude Bernard Lyon 1 (S.V.), Faculté de médecine Lyon Est, France.
Objective:
To compare the clinical effectiveness of high- and low-efficacy treatments in patients with recently active and inactive secondary progressive multiple sclerosis (SPMS) after accounting for therapeutic lag.
Methods:
Patients treated with high-efficacy (natalizumab, alemtuzumab, mitoxantrone, ocrelizumab, rituximab, cladribine, fingolimod) or low-efficacy (interferon beta, glatiramer acetate, teriflunomide) therapies after SPMS onset were selected from MSBase and Observatoire Français de la Sclérose en Plaques (OFSEP), 2 large observational cohorts. Therapeutic lag was estimated for each patient from their demographic and clinical characteristics. Propensity score was used to match patients treated with high- and low-efficacy therapies. Outcomes after the period of therapeutic lag was disregarded were compared in paired, pairwise-censored analyses.
Results:
One thousand patients were included in the primary analysis. Patients with active SPMS treated with high-efficacy therapy experienced less frequent relapses than those on low-efficacy therapy (hazard ratio [HR] 0.7, p = 0.006). In patients with inactive SPMS, there was no evidence for a difference in relapse frequency between groups (HR 0.8, p = 0.39). No evidence for a difference in the risk of disability progression was observed.
Conclusion:
In treated patients with SPMS, high-efficacy therapy is superior to low-efficacy therapy in reducing relapses in patients with active but not those with inactive SPMS. However, more potent therapies do not offer an advantage in reducing disability progression in this patient group.
Classification Of Evidence:
This study provides Class III evidence that high-efficacy therapy is superior to low-efficacy therapy in reducing relapses in patients with active SPMS, although we did not find a difference in disability progression between patients treated with high- and low-efficacy therapy.
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