Damiano Paolicelli1, Giuseppe Lucisano2, Alessia Manni3, Carlo Avolio4, Simona Bonavita5, Vincenzo Brescia Morra6, Marco Capobianco7, Eleonora Cocco8, Antonella Conte9,10, Giovanna De Luca11, Francesca De Robertis12, Claudio Gasperini13, Maurizia Gatto14, Paola Gazzola15, Giacomo Lus5, Antonio Iaffaldano3, Pietro Iaffaldano3, Davide Maimone16, Giulia Mallucci17, Giorgia T Maniscalco18, Girolama A Marfia19, Francesco Patti20, Ilaria Pesci21, Carlo Pozzilli22,23, Marco Rovaris24, Giuseppe Salemi25, Marco Salvetti26,27, Daniele Spitaleri28, Rocco Totaro29, Mauro Zaffaroni30, Giancarlo Comi31, Maria Pia Amato32,33, Maria Trojano3. 1. Department of Basic Medical Sciences, Neurosciences, and Sense Organs, Multiple Sclerosis Center, University of Bari "Aldo Moro", Bari, Italy. damiano.paolicelli@uniba.it. 2. Center for Outcomes Research and Clinical Epidemiology, Pescara, Italy. 3. Department of Basic Medical Sciences, Neurosciences, and Sense Organs, Multiple Sclerosis Center, University of Bari "Aldo Moro", Bari, Italy. 4. Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy. 5. Department of Advanced Medical and Surgical Sciences, University of Campania "Luigi Vanvitelli", Napoli, Italy. 6. Department of Neurosciences, Reproductive and Odontostomatological Sciences, "Federico II" University of Naples, Naples, Italy. 7. Department of Neurology and Regional Multiple Sclerosis Centre, University Hospital San Luigi, Orbassano, TO, Italy. 8. Department of Medical Science and Public Health, University of Cagliari and Multiple Sclerosis Center, Cagliari, Italy. 9. Department of Human Neurosciences, Sapienza, University of Rome, Rome, Italy. 10. IRCCS Neuromed, Pozzilli, IS, Italy. 11. Neurology Clinic, Multiple Sclerosis Centre, SS Annunziata Hospital, Chieti, Italy. 12. Department of Neurology, Vito Fazzi Hospital, ASL, Lecce, Italy. 13. Department of Neuroscience, San Camillo Hospital, Rome, Italy. 14. Neurology Unit, "F. Miulli" Hospital, Acquaviva delle Fonti BA, Italy. 15. Departemental Center for the Diagnosis and Treatment of Demyelinating Diseases, Sestri Ponente, Genoa, Italy. 16. Multiple Sclerosis Center, Garibaldi Hospital, Catania, Italy. 17. Multiple Sclerosis Center of IRCCS Mondino Foundation, Pavia, Italy. 18. Multiple Sclerosis Regional Center, A. Cardarelli Hospital, Naples, Italy. 19. Department of Systems Medicine, Multiple Sclerosis Clinical and Research Center, University of Rome Tor Vergata, Rome, Italy. 20. Department "G.F. Ingrassia", Multiple Sclerosis Center, University of Catania, Catania, Italy. 21. Multiple Sclerosis Center, Ospedale di Vaio (I.P.), Fidenza, PR, Italy. 22. Multiple Sclerosis Center, Sant'Andrea Hospital, Sapienza University of Rome, Rome, Italy. 23. Department of Neurology, University La Sapienza, Rome, Italy. 24. Multiple Sclerosis Center, IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy. 25. Department of Biomedicine, Neuroscience and Advanced Diagnostics, Palermo University, Palermo, Italy. 26. Department of Neuroscience, Mental Health and Sensory Organs, Sapienza University, Rome, Italy. 27. Istituto Neurologico Mediterraneo (INM) Neuromed, Pozzilli, Isernia, Italy. 28. UOC Neurology, AORN San G. Moscati, Avellino, Italy. 29. Department of Neurology, Demyelinating Disease Center, San Salvatore Hospital, L'Aquila, Italy. 30. Multiple Sclerosis Center, Hospital of Gallarate, Gallarate, Italy. 31. Department of Neurology, San Raffaele Hospital, Milan, Italy. 32. Department NEUROFARBA, University of Florence, Florence, Italy. 33. IRCCS and Fondazione Don Carlo Gnocchi, Florence, Italy.
Abstract
BACKGROUND: The increase in disease-modifying drugs (DMDs) allows individualization of treatment in relapsing multiple sclerosis (RMS); however, the long-term impact of different treatment sequences is not well established. This is particularly relevant for MS patients who may need to postpone more aggressive DMD strategies. OBJECTIVE: To evaluate different therapeutic strategies and their long-term outcomes, measured as relapses and confirmed disability progression (CDP), in MS 'real-world' settings. METHODS: Multicentre, observational, retrospectively acquired cohort study evaluating the long-term impact of different treatment strategies on disability outcomes in patients with RMS in the Italian MS Register. RESULTS: We evaluated 1152 RMS-naïve patients after propensity-score adjustment. Patients included were receiving: interferon beta-1a (IFN-β1a) 44 µg switching to fingolimod (FTY; IFN-switchers; n = 97); FTY only (FTY-stayers; n = 157); IFN-β1a only (IFN-stayers; n = 849). CDP and relapses did not differ between FTY-stayers and IFN-switchers [HR (95% CI) 0.99 (0.48-2.04), p = 0.98 and 0.81 (0.42-1.58), p = 0.55, respectively]. However, IFN-stayers showed increased risk of relapses compared with FTY-stayers [HR (95% CI) 1.46 (1.00-2.12), p = 0.05]. CONCLUSION: The ideal treatment option for MS is becoming increasingly complex, with the need to balance benefit and risks. Our results suggest that starting with FTY affects the long-term disease outcome similarly to escalating from IFN-β1a to FTY.
BACKGROUND: The increase in disease-modifying drugs (DMDs) allows individualization of treatment in relapsing multiple sclerosis (RMS); however, the long-term impact of different treatment sequences is not well established. This is particularly relevant for MS patients who may need to postpone more aggressive DMD strategies. OBJECTIVE: To evaluate different therapeutic strategies and their long-term outcomes, measured as relapses and confirmed disability progression (CDP), in MS 'real-world' settings. METHODS: Multicentre, observational, retrospectively acquired cohort study evaluating the long-term impact of different treatment strategies on disability outcomes in patients with RMS in the Italian MS Register. RESULTS: We evaluated 1152 RMS-naïve patients after propensity-score adjustment. Patients included were receiving: interferon beta-1a (IFN-β1a) 44 µg switching to fingolimod (FTY; IFN-switchers; n = 97); FTY only (FTY-stayers; n = 157); IFN-β1a only (IFN-stayers; n = 849). CDP and relapses did not differ between FTY-stayers and IFN-switchers [HR (95% CI) 0.99 (0.48-2.04), p = 0.98 and 0.81 (0.42-1.58), p = 0.55, respectively]. However, IFN-stayers showed increased risk of relapses compared with FTY-stayers [HR (95% CI) 1.46 (1.00-2.12), p = 0.05]. CONCLUSION: The ideal treatment option for MS is becoming increasingly complex, with the need to balance benefit and risks. Our results suggest that starting with FTY affects the long-term disease outcome similarly to escalating from IFN-β1a to FTY.
Authors: Alexander Rae-Grant; Gregory S Day; Ruth Ann Marrie; Alejandro Rabinstein; Bruce A C Cree; Gary S Gronseth; Michael Haboubi; June Halper; Jonathan P Hosey; David E Jones; Robert Lisak; Daniel Pelletier; Sonja Potrebic; Cynthia Sitcov; Rick Sommers; Julie Stachowiak; Thomas S D Getchius; Shannon A Merillat; Tamara Pringsheim Journal: Neurology Date: 2018-04-24 Impact factor: 9.910
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Authors: Chris H Polman; Stephen C Reingold; Brenda Banwell; Michel Clanet; Jeffrey A Cohen; Massimo Filippi; Kazuo Fujihara; Eva Havrdova; Michael Hutchinson; Ludwig Kappos; Fred D Lublin; Xavier Montalban; Paul O'Connor; Magnhild Sandberg-Wollheim; Alan J Thompson; Emmanuelle Waubant; Brian Weinshenker; Jerry S Wolinsky Journal: Ann Neurol Date: 2011-02 Impact factor: 10.422
Authors: Ludwig Kappos; Paul O'Connor; Ernst-Wilhelm Radue; Chris Polman; Reinhard Hohlfeld; Krzysztof Selmaj; Shannon Ritter; Rolf Schlosshauer; Philipp von Rosenstiel; Lixin Zhang-Auberson; Gordon Francis Journal: Neurology Date: 2015-03-20 Impact factor: 9.910
Authors: Maria Trojano; Roberto Bergamaschi; Maria Pia Amato; Giancarlo Comi; Angelo Ghezzi; Vito Lepore; Maria Giovanna Marrosu; Paola Mosconi; Francesco Patti; Michela Ponzio; Paola Zaratin; Mario Alberto Battaglia Journal: Neurol Sci Date: 2018-11-13 Impact factor: 3.307