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Comparative effectiveness of glatiramer acetate and interferon beta formulations in relapsing-remitting multiple sclerosis.
Mult Scler. 2015 Aug; 21(9):1159-71.MS

Abstract

BACKGROUND

The results of head-to-head comparisons of injectable immunomodulators (interferon β, glatiramer acetate) have been inconclusive and a comprehensive analysis of their effectiveness is needed.

OBJECTIVE

We aimed to compare, in a real-world setting, relapse and disability outcomes among patients with multiple sclerosis (MS) treated with injectable immunomodulators.

METHODS

Pairwise analysis of the international MSBase registry data was conducted using propensity-score matching. The four injectable immunomodulators were compared in six head-to-head analyses of relapse and disability outcomes using paired mixed models or frailty proportional hazards models adjusted for magnetic resonance imaging variables. Sensitivity and power analyses were conducted.

RESULTS

Of the 3326 included patients, 345-1199 patients per therapy were matched (median pairwise-censored follow-up was 3.7 years). Propensity matching eliminated >95% of the identified indication bias. Slightly lower relapse incidence was found among patients treated with glatiramer acetate or subcutaneous interferon β-1a relative to intramuscular interferon β-1a and interferon β-1b (p≤0.001). No differences in 12-month confirmed progression of disability were observed.

CONCLUSION

Small but statistically significant differences in relapse outcomes exist among the injectable immunomodulators. MSBase is sufficiently powered to identify these differences and reflects practice in tertiary MS centres. While the present study controlled indication, selection and attrition bias, centre-dependent variance in data quality was likely.

Authors+Show Affiliations

Department of Medicine, University of Melbourne, Melbourne, Australia and Department of Neurology, Royal Melbourne Hospital, Melbourne, Australia tomas.kalincik@unimelb.edu.au.Department of Medicine, University of Melbourne, Melbourne, Australia and Department of Neurology, Royal Melbourne Hospital, Melbourne, Australia.Hospital Universitario Virgen Macarena, Sevilla, Spain.Hôpital Notre Dame, Montreal, Canada.Hôpital Notre Dame, Montreal, Canada.Hotel-Dieu de Levis, Quebec, Canada.MS Center, Neuroscience, Imaging and Clinical Sciences, University 'G. d'Annunzio', Chieti, Italy.University Hospital San Carlos, IdISSC, Madrid, Spain.National Neurological Institute C. Mondino, Pavia, Italy.Orbis Medical Center, Sittard, the Netherlands.Neuro Rive-Sud, Hôpital Charles LeMoyne, Quebec, Canada.Ospedale di Macerata, Macerata, Italy.Cliniques Universitaires Saint-Luc, Brussels, Belgium.Karadeniz Technical University, Trabzon, Turkey.Ospedali Riuniti di Salerno, Salerno, Italy.Hospital Universitario Virgen de Valme, Seville, Spain.Assaf Harofeh Medical Center, Beer-Yaakov, Israel.AORN San Giuseppe Moscati, Avellino, Italy.Hospital Italiano, Buenos Aires, Argentina.Groen Hart Ziekenhuis, Gouda, the Netherlands.John Hunter Hospital, Newcastle, Australia.Department NEUROFARBA, Section of Neurosciences, University of Florence, Florence, Italy.Centro Internacional de Restauracion Neurologica, Havana, Cuba.INEBA, Buenos Aires, Argentina.Flinders University and Medical Centre, Adelaide, Australia.Jewish General Hospital, Montreal, Canada.Craigavon Area Hospital, Portadown, UK.St Vincent's Hospital, Melbourne, Australia.Brain and Mind Research Institute, Sydney, Australia.Department of Neurology and Center of Clinical Neuroscience, 1st Faculty of Medicine, General University Hospital and Charles University in Prague, Czech Republic.Department of Neurology and Center of Clinical Neuroscience, 1st Faculty of Medicine, General University Hospital and Charles University in Prague, Czech Republic.Department of Medicine, University of Melbourne, Melbourne, Australia and Department of Neurology, Royal Melbourne Hospital, Melbourne, Australia.Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari, Bari, Italy/These authors contributed equally to the manuscript.Department of Medicine, University of Melbourne, Melbourne, Australia, Department of Neurology, Royal Melbourne Hospital, Melbourne, Australia, and Department of Neurology, Box Hill Hospital, Monash University, Box Hill, Australia.No affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

25480857

Citation

Kalincik, Tomas, et al. "Comparative Effectiveness of Glatiramer Acetate and Interferon Beta Formulations in Relapsing-remitting Multiple Sclerosis." Multiple Sclerosis (Houndmills, Basingstoke, England), vol. 21, no. 9, 2015, pp. 1159-71.
Kalincik T, Jokubaitis V, Izquierdo G, et al. Comparative effectiveness of glatiramer acetate and interferon beta formulations in relapsing-remitting multiple sclerosis. Mult Scler. 2015;21(9):1159-71.
Kalincik, T., Jokubaitis, V., Izquierdo, G., Duquette, P., Girard, M., Grammond, P., Lugaresi, A., Oreja-Guevara, C., Bergamaschi, R., Hupperts, R., Grand'Maison, F., Pucci, E., Van Pesch, V., Boz, C., Iuliano, G., Fernandez-Bolanos, R., Flechter, S., Spitaleri, D., Cristiano, E., ... Butzkueven, H. (2015). Comparative effectiveness of glatiramer acetate and interferon beta formulations in relapsing-remitting multiple sclerosis. Multiple Sclerosis (Houndmills, Basingstoke, England), 21(9), 1159-71. https://doi.org/10.1177/1352458514559865
Kalincik T, et al. Comparative Effectiveness of Glatiramer Acetate and Interferon Beta Formulations in Relapsing-remitting Multiple Sclerosis. Mult Scler. 2015;21(9):1159-71. PubMed PMID: 25480857.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparative effectiveness of glatiramer acetate and interferon beta formulations in relapsing-remitting multiple sclerosis. AU - Kalincik,Tomas, AU - Jokubaitis,Vilija, AU - Izquierdo,Guillermo, AU - Duquette,Pierre, AU - Girard,Marc, AU - Grammond,Pierre, AU - Lugaresi,Alessandra, AU - Oreja-Guevara,Celia, AU - Bergamaschi,Roberto, AU - Hupperts,Raymond, AU - Grand'Maison,Francois, AU - Pucci,Eugenio, AU - Van Pesch,Vincent, AU - Boz,Cavit, AU - Iuliano,Gerardo, AU - Fernandez-Bolanos,Ricardo, AU - Flechter,Shlomo, AU - Spitaleri,Daniele, AU - Cristiano,Edgardo, AU - Verheul,Freek, AU - Lechner-Scott,Jeannette, AU - Amato,Maria Pia, AU - Cabrera-Gomez,Jose Antonio, AU - Saladino,Maria Laura, AU - Slee,Mark, AU - Moore,Fraser, AU - Gray,Orla, AU - Paine,Mark, AU - Barnett,Michael, AU - Havrdova,Eva, AU - Horakova,Dana, AU - Spelman,Timothy, AU - Trojano,Maria, AU - Butzkueven,Helmut, AU - ,, Y1 - 2014/12/05/ PY - 2014/07/07/received PY - 2014/10/22/accepted PY - 2014/12/7/entrez PY - 2014/12/7/pubmed PY - 2016/5/5/medline KW - Multiple sclerosis KW - disability KW - patient registry KW - propensity score KW - real-world date KW - relapses KW - treatment outcomes SP - 1159 EP - 71 JF - Multiple sclerosis (Houndmills, Basingstoke, England) JO - Mult. Scler. VL - 21 IS - 9 N2 - BACKGROUND: The results of head-to-head comparisons of injectable immunomodulators (interferon β, glatiramer acetate) have been inconclusive and a comprehensive analysis of their effectiveness is needed. OBJECTIVE: We aimed to compare, in a real-world setting, relapse and disability outcomes among patients with multiple sclerosis (MS) treated with injectable immunomodulators. METHODS: Pairwise analysis of the international MSBase registry data was conducted using propensity-score matching. The four injectable immunomodulators were compared in six head-to-head analyses of relapse and disability outcomes using paired mixed models or frailty proportional hazards models adjusted for magnetic resonance imaging variables. Sensitivity and power analyses were conducted. RESULTS: Of the 3326 included patients, 345-1199 patients per therapy were matched (median pairwise-censored follow-up was 3.7 years). Propensity matching eliminated >95% of the identified indication bias. Slightly lower relapse incidence was found among patients treated with glatiramer acetate or subcutaneous interferon β-1a relative to intramuscular interferon β-1a and interferon β-1b (p≤0.001). No differences in 12-month confirmed progression of disability were observed. CONCLUSION: Small but statistically significant differences in relapse outcomes exist among the injectable immunomodulators. MSBase is sufficiently powered to identify these differences and reflects practice in tertiary MS centres. While the present study controlled indication, selection and attrition bias, centre-dependent variance in data quality was likely. SN - 1477-0970 UR - https://www.unboundmedicine.com/medline/citation/25480857/Comparative_effectiveness_of_glatiramer_acetate_and_interferon_beta_formulations_in_relapsing_remitting_multiple_sclerosis_ L2 - http://journals.sagepub.com/doi/full/10.1177/1352458514559865?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -