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Comparison of switch to fingolimod or interferon beta/glatiramer acetate in active multiple sclerosis.
JAMA Neurol. 2015 Apr; 72(4):405-13.JN

Abstract

IMPORTANCE

After multiple sclerosis (MS) relapse while a patient is receiving an injectable disease-modifying drug, many physicians advocate therapy switch, but the relative effectiveness of different switch decisions is often uncertain.

OBJECTIVE

To compare the effect of the oral immunomodulator fingolimod with that of all injectable immunomodulators (interferons or glatiramer acetate) on relapse rate, disability, and treatment persistence in patients with active MS.

DESIGN, SETTING, AND PARTICIPANTS

Matched retrospective analysis of data collected prospectively from MSBase, an international, observational cohort study. The MSBase cohort represents a population of patients with MS monitored at large MS centers. The analyzed data were collected between July 1996 and April 2014. Participants included patients with relapsing-remitting MS who were switching therapy to fingolimod or injectable immunomodulators up to 12 months after on-treatment clinical disease activity (relapse or progression of disability), matched on demographic and clinical variables. Median follow-up duration was 13.1 months (range, 3-80). Indication and attrition bias were controlled with propensity score matching and pairwise censoring, respectively. Head-to-head analyses of relapse and disability outcomes used paired, weighted, negative binomial models or frailty proportional hazards models adjusted for magnetic resonance imaging variables. Sensitivity analyses were conducted.

EXPOSURES

Patients had received fingolimod, interferon beta, or glatiramer acetate for a minimum of 3 months following a switch of immunomodulatory therapy.

MAIN OUTCOMES AND MEASURES

Annualized relapse rate and proportion of relapse-free patients, as well as the proportion of patients without sustained disability progression.

RESULTS

Overall, 379 patients in the injectable group were matched to 148 patients in the fingolimod group. The fingolimod group had a lower mean annualized relapse rate (0.31 vs 0.42; 95% CI, 0.02-0.19; P=.009), lower hazard of first on-treatment relapse (hazard ratio [HR], 0.74; 95% CI, 0.56-0.98; P=.04), lower hazard of disability progression (HR, 0.53; 95% CI, 0.31-0.91; P=.02), higher rate of disability regression (HR, 2.0; 95% CI, 1.2-3.3; P=.005), and lower hazard of treatment discontinuation (HR, 0.55; P=.04) compared with the injectable group.

CONCLUSIONS AND RELEVANCE

Switching from injectable immunomodulators to fingolimod is associated with fewer relapses, more favorable disability outcomes, and greater treatment persistence compared with switching to another injectable preparation following on-treatment activity of MS.

Authors+Show Affiliations

Department of Neurology, Royal Melbourne Hospital, Melbourne, Australia.Department of Medicine, University of Melbourne, Melbourne, Australia.Department of Medicine, University of Melbourne, Melbourne, Australia.Department of Neurology and Center of Clinical Neuroscience, General University Hospital, Prague, Czech Republic4Department of Neurology and Center for Clinical Neuroscience, Charles University, Prague, Czech Republic.Department of Neurology and Center of Clinical Neuroscience, General University Hospital, Prague, Czech Republic4Department of Neurology and Center for Clinical Neuroscience, Charles University, Prague, Czech Republic.Department of Basic Medical Sciences, Neuroscience, and Sense Organs, University of Bari, Bari, Italy.MS Center, Department of Neuroscience, Imaging, and Clinical Sciences, University G. d'Annunzio, Chienti, Italy.Department of Neurology, Hospital Universitario Virgen Macarena, Sevilla, Spain.Department of Neurology, Hotel-Dieu de Lévis, Lévis, Quebec, Canada.Department of Neurology, Hôpital Notre Dame, Montreal, Quebec, Canada.Department of Neurology, Hôpital Notre Dame, Montreal, Quebec, Canada.Neurology Unit, Azienda Sanitaria Unica Regionale Marche, Macerata, Italy.Department of Neurology, Ospedali Riuniti di Salerno, Salerno, Italy.Department of Neurology, Amiri Hospital, Kuwait City, Kuwait.Multiple Sclerosis Unit, University Hospital San Carlos, Madrid, Spain.Department of Neurology, Hospital Universitario Virgen de Valme, Seville, Spain.Neuro Rive-Sud, Hôpital Charles LeMoyne, Quebec City, Quebec, Canada.Department of Neurology, Nuovo Ospedale Civile San Agostino, Modena, Italy.Department of Neurology, Azienda Ospedaliera di Rilievo Nazionale, San Giuseppe Moscati, Avellino, Italy.Institute of Neurology, University of Parma, Parma, Italy.Medical Faculty, Department of Neurology, Ondokuz Mayis University, Samsun, Turkey.Department of Medicine, John Hunter Hospital, Newcastle, Australia21Hunter Medical Research Institute, University of Newcastle, Newcastle, Australia.Department of Neurology, Cliniques Universitaires Saint-Luc, Brussels, Belgium.Department of Neurology, Orbis Medical Center, Sittard, the Netherlands.Department of Neurology, Hospital de Galdakao-Usansolo, Galdakao, Spain.Department of Nephrology, Liverpool Hospital, Liverpool, Australia26Department of Neurology, Liverpool Hospital, Liverpool, Australia.Department of Neurology, Jahn Ferenc Teaching Hospital, Budapest, Hungary.Neurology Unit, Groen Hart Ziekenhuis, Gouda, the Netherlands.Department of Neurology, Royal Melbourne Hospital, Melbourne, Australia2Department of Medicine, University of Melbourne, Melbourne, Australia29Department of Neurology, Box Hill Hospital, Monash University, Melbourne, Australia.Department of Neurology, Royal Melbourne Hospital, Melbourne, Australia2Department of Medicine, University of Melbourne, Melbourne, Australia.No affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25665031

Citation

He, Anna, et al. "Comparison of Switch to Fingolimod or Interferon Beta/glatiramer Acetate in Active Multiple Sclerosis." JAMA Neurology, vol. 72, no. 4, 2015, pp. 405-13.
He A, Spelman T, Jokubaitis V, et al. Comparison of switch to fingolimod or interferon beta/glatiramer acetate in active multiple sclerosis. JAMA Neurol. 2015;72(4):405-13.
He, A., Spelman, T., Jokubaitis, V., Havrdova, E., Horakova, D., Trojano, M., Lugaresi, A., Izquierdo, G., Grammond, P., Duquette, P., Girard, M., Pucci, E., Iuliano, G., Alroughani, R., Oreja-Guevara, C., Fernandez-Bolaños, R., Grand'Maison, F., Sola, P., Spitaleri, D., ... Kalincik, T. (2015). Comparison of switch to fingolimod or interferon beta/glatiramer acetate in active multiple sclerosis. JAMA Neurology, 72(4), 405-13. https://doi.org/10.1001/jamaneurol.2014.4147
He A, et al. Comparison of Switch to Fingolimod or Interferon Beta/glatiramer Acetate in Active Multiple Sclerosis. JAMA Neurol. 2015;72(4):405-13. PubMed PMID: 25665031.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparison of switch to fingolimod or interferon beta/glatiramer acetate in active multiple sclerosis. AU - He,Anna, AU - Spelman,Tim, AU - Jokubaitis,Vilija, AU - Havrdova,Eva, AU - Horakova,Dana, AU - Trojano,Maria, AU - Lugaresi,Alessandra, AU - Izquierdo,Guillermo, AU - Grammond,Pierre, AU - Duquette,Pierre, AU - Girard,Marc, AU - Pucci,Eugenio, AU - Iuliano,Gerardo, AU - Alroughani,Raed, AU - Oreja-Guevara,Celia, AU - Fernandez-Bolaños,Ricardo, AU - Grand'Maison,Francois, AU - Sola,Patrizia, AU - Spitaleri,Daniele, AU - Granella,Franco, AU - Terzi,Murat, AU - Lechner-Scott,Jeannette, AU - Van Pesch,Vincent, AU - Hupperts,Raymond, AU - Sánchez-Menoyo,José Luis, AU - Hodgkinson,Suzanne, AU - Rozsa,Csilla, AU - Verheul,Freek, AU - Butzkueven,Helmut, AU - Kalincik,Tomas, AU - ,, PY - 2015/2/10/entrez PY - 2015/2/11/pubmed PY - 2015/7/16/medline SP - 405 EP - 13 JF - JAMA neurology JO - JAMA Neurol VL - 72 IS - 4 N2 - IMPORTANCE: After multiple sclerosis (MS) relapse while a patient is receiving an injectable disease-modifying drug, many physicians advocate therapy switch, but the relative effectiveness of different switch decisions is often uncertain. OBJECTIVE: To compare the effect of the oral immunomodulator fingolimod with that of all injectable immunomodulators (interferons or glatiramer acetate) on relapse rate, disability, and treatment persistence in patients with active MS. DESIGN, SETTING, AND PARTICIPANTS: Matched retrospective analysis of data collected prospectively from MSBase, an international, observational cohort study. The MSBase cohort represents a population of patients with MS monitored at large MS centers. The analyzed data were collected between July 1996 and April 2014. Participants included patients with relapsing-remitting MS who were switching therapy to fingolimod or injectable immunomodulators up to 12 months after on-treatment clinical disease activity (relapse or progression of disability), matched on demographic and clinical variables. Median follow-up duration was 13.1 months (range, 3-80). Indication and attrition bias were controlled with propensity score matching and pairwise censoring, respectively. Head-to-head analyses of relapse and disability outcomes used paired, weighted, negative binomial models or frailty proportional hazards models adjusted for magnetic resonance imaging variables. Sensitivity analyses were conducted. EXPOSURES: Patients had received fingolimod, interferon beta, or glatiramer acetate for a minimum of 3 months following a switch of immunomodulatory therapy. MAIN OUTCOMES AND MEASURES: Annualized relapse rate and proportion of relapse-free patients, as well as the proportion of patients without sustained disability progression. RESULTS: Overall, 379 patients in the injectable group were matched to 148 patients in the fingolimod group. The fingolimod group had a lower mean annualized relapse rate (0.31 vs 0.42; 95% CI, 0.02-0.19; P=.009), lower hazard of first on-treatment relapse (hazard ratio [HR], 0.74; 95% CI, 0.56-0.98; P=.04), lower hazard of disability progression (HR, 0.53; 95% CI, 0.31-0.91; P=.02), higher rate of disability regression (HR, 2.0; 95% CI, 1.2-3.3; P=.005), and lower hazard of treatment discontinuation (HR, 0.55; P=.04) compared with the injectable group. CONCLUSIONS AND RELEVANCE: Switching from injectable immunomodulators to fingolimod is associated with fewer relapses, more favorable disability outcomes, and greater treatment persistence compared with switching to another injectable preparation following on-treatment activity of MS. SN - 2168-6157 UR - https://www.unboundmedicine.com/medline/citation/25665031/Comparison_of_switch_to_fingolimod_or_interferon_beta/glatiramer_acetate_in_active_multiple_sclerosis_ L2 - https://jamanetwork.com/journals/jamaneurology/fullarticle/10.1001/jamaneurol.2014.4147 DB - PRIME DP - Unbound Medicine ER -