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Persistence on Therapy and Propensity Matched Outcome Comparison of Two Subcutaneous Interferon Beta 1a Dosages for Multiple Sclerosis

OBJECTIVES: To compare treatment persistence between two dosages of interferon β-1a in a large observational multiple sclerosis registry and assess disease outcomes of first line MS treatment at these dosages using propensity scoring to adjust for baseline imbalance in disease characteristics. METHO...

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Autores principales: Kalincik, Tomas, Spelman, Timothy, Trojano, Maria, Duquette, Pierre, Izquierdo, Guillermo, Grammond, Pierre, Lugaresi, Alessandra, Hupperts, Raymond, Cristiano, Edgardo, Van Pesch, Vincent, Grand’Maison, Francois, La Spitaleri, Daniele, Rio, Maria Edite, Flechter, Sholmo, Oreja-Guevara, Celia, Giuliani, Giorgio, Savino, Aldo, Amato, Maria Pia, Petersen, Thor, Fernandez-Bolanos, Ricardo, Bergamaschi, Roberto, Iuliano, Gerardo, Boz, Cavit, Lechner-Scott, Jeannette, Deri, Norma, Gray, Orla, Verheul, Freek, Fiol, Marcela, Barnett, Michael, van Munster, Erik, Santiago, Vetere, Moore, Fraser, Slee, Mark, Saladino, Maria Laura, Alroughani, Raed, Shaw, Cameron, Kasa, Krisztian, Petkovska-Boskova, Tatjana, den Braber-Moerland, Leontien, Chapman, Joab, Skromne, Eli, Herbert, Joseph, Poehlau, Dieter, Needham, Merrilee, Bacile, Elizabeth Alejandra Bacile, Arruda, Walter Oleschko, Paine, Mark, Singhal, Bhim, Vucic, Steve, Cabrera-Gomez, Jose Antonio, Butzkueven, Helmut, Roger, Elaine, Despault, Pierre, Marriott, Mark, Van der Walt, Anneke, King, John, Kilpatrick, Trevor, Buzzard, Katherine, Jokubaitis, Vilija, Byron, Jill, Morgan, Lisa, Skibina, Olga, Haartsen, Jodi, De Luca, Giovanna, Di Tommaso, Valeria, Travaglini, Daniela, Pietrolongo, Erika, di Ioia, Maria, Farina, Deborah, Mancinelli, Luca, Paolicelli, Damiano, Iaffaldano, Pietro, Ignacio Rojas, Juan, Patrucco, Liliana, Roullet, Etienne, Correale, Jorge, Ysrraelit, Celica, Elisabetta, Cartechini, Pucci, Eugenio, Williams, David, Dark, Lisa, Shaygannejad, Vahid, Zwanikken, Cees, Vella, Norbert, Sirbu, Carmen-Adella
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3660604/
https://www.ncbi.nlm.nih.gov/pubmed/23704913
http://dx.doi.org/10.1371/journal.pone.0063480
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author Kalincik, Tomas
Spelman, Timothy
Trojano, Maria
Duquette, Pierre
Izquierdo, Guillermo
Grammond, Pierre
Lugaresi, Alessandra
Hupperts, Raymond
Cristiano, Edgardo
Van Pesch, Vincent
Grand’Maison, Francois
La Spitaleri, Daniele
Rio, Maria Edite
Flechter, Sholmo
Oreja-Guevara, Celia
Giuliani, Giorgio
Savino, Aldo
Amato, Maria Pia
Petersen, Thor
Fernandez-Bolanos, Ricardo
Bergamaschi, Roberto
Iuliano, Gerardo
Boz, Cavit
Lechner-Scott, Jeannette
Deri, Norma
Gray, Orla
Verheul, Freek
Fiol, Marcela
Barnett, Michael
van Munster, Erik
Santiago, Vetere
Moore, Fraser
Slee, Mark
Saladino, Maria Laura
Alroughani, Raed
Shaw, Cameron
Kasa, Krisztian
Petkovska-Boskova, Tatjana
den Braber-Moerland, Leontien
Chapman, Joab
Skromne, Eli
Herbert, Joseph
Poehlau, Dieter
Needham, Merrilee
Bacile, Elizabeth Alejandra Bacile
Arruda, Walter Oleschko
Paine, Mark
Singhal, Bhim
Vucic, Steve
Cabrera-Gomez, Jose Antonio
Butzkueven, Helmut
Roger, Elaine
Despault, Pierre
Marriott, Mark
Van der Walt, Anneke
King, John
Kilpatrick, Trevor
Buzzard, Katherine
Jokubaitis, Vilija
Byron, Jill
Morgan, Lisa
Skibina, Olga
Haartsen, Jodi
De Luca, Giovanna
Di Tommaso, Valeria
Travaglini, Daniela
Pietrolongo, Erika
di Ioia, Maria
Farina, Deborah
Mancinelli, Luca
Paolicelli, Damiano
Iaffaldano, Pietro
Ignacio Rojas, Juan
Patrucco, Liliana
Roullet, Etienne
Correale, Jorge
Ysrraelit, Celica
Elisabetta, Cartechini
Pucci, Eugenio
Williams, David
Dark, Lisa
Shaygannejad, Vahid
Zwanikken, Cees
Vella, Norbert
Sirbu, Carmen-Adella
author_facet Kalincik, Tomas
Spelman, Timothy
Trojano, Maria
Duquette, Pierre
Izquierdo, Guillermo
Grammond, Pierre
Lugaresi, Alessandra
Hupperts, Raymond
Cristiano, Edgardo
Van Pesch, Vincent
Grand’Maison, Francois
La Spitaleri, Daniele
Rio, Maria Edite
Flechter, Sholmo
Oreja-Guevara, Celia
Giuliani, Giorgio
Savino, Aldo
Amato, Maria Pia
Petersen, Thor
Fernandez-Bolanos, Ricardo
Bergamaschi, Roberto
Iuliano, Gerardo
Boz, Cavit
Lechner-Scott, Jeannette
Deri, Norma
Gray, Orla
Verheul, Freek
Fiol, Marcela
Barnett, Michael
van Munster, Erik
Santiago, Vetere
Moore, Fraser
Slee, Mark
Saladino, Maria Laura
Alroughani, Raed
Shaw, Cameron
Kasa, Krisztian
Petkovska-Boskova, Tatjana
den Braber-Moerland, Leontien
Chapman, Joab
Skromne, Eli
Herbert, Joseph
Poehlau, Dieter
Needham, Merrilee
Bacile, Elizabeth Alejandra Bacile
Arruda, Walter Oleschko
Paine, Mark
Singhal, Bhim
Vucic, Steve
Cabrera-Gomez, Jose Antonio
Butzkueven, Helmut
Roger, Elaine
Despault, Pierre
Marriott, Mark
Van der Walt, Anneke
King, John
Kilpatrick, Trevor
Buzzard, Katherine
Jokubaitis, Vilija
Byron, Jill
Morgan, Lisa
Skibina, Olga
Haartsen, Jodi
De Luca, Giovanna
Di Tommaso, Valeria
Travaglini, Daniela
Pietrolongo, Erika
di Ioia, Maria
Farina, Deborah
Mancinelli, Luca
Paolicelli, Damiano
Iaffaldano, Pietro
Ignacio Rojas, Juan
Patrucco, Liliana
Roullet, Etienne
Correale, Jorge
Ysrraelit, Celica
Elisabetta, Cartechini
Pucci, Eugenio
Williams, David
Dark, Lisa
Shaygannejad, Vahid
Zwanikken, Cees
Vella, Norbert
Sirbu, Carmen-Adella
author_sort Kalincik, Tomas
collection PubMed
description OBJECTIVES: To compare treatment persistence between two dosages of interferon β-1a in a large observational multiple sclerosis registry and assess disease outcomes of first line MS treatment at these dosages using propensity scoring to adjust for baseline imbalance in disease characteristics. METHODS: Treatment discontinuations were evaluated in all patients within the MSBase registry who commenced interferon β-1a SC thrice weekly (n = 4678). Furthermore, we assessed 2-year clinical outcomes in 1220 patients treated with interferon β-1a in either dosage (22 µg or 44 µg) as their first disease modifying agent, matched on propensity score calculated from pre-treatment demographic and clinical variables. A subgroup analysis was performed on 456 matched patients who also had baseline MRI variables recorded. RESULTS: Overall, 4054 treatment discontinuations were recorded in 3059 patients. The patients receiving the lower interferon dosage were more likely to discontinue treatment than those with the higher dosage (25% vs. 20% annual probability of discontinuation, respectively). This was seen in discontinuations with reasons recorded as “lack of efficacy” (3.3% vs. 1.7%), “scheduled stop” (2.2% vs. 1.3%) or without the reason recorded (16.7% vs. 13.3% annual discontinuation rate, 22 µg vs. 44 µg dosage, respectively). Propensity score was determined by treating centre and disability (score without MRI parameters) or centre, sex and number of contrast-enhancing lesions (score including MRI parameters). No differences in clinical outcomes at two years (relapse rate, time relapse-free and disability) were observed between the matched patients treated with either of the interferon dosages. CONCLUSIONS: Treatment discontinuations were more common in interferon β-1a 22 µg SC thrice weekly. However, 2-year clinical outcomes did not differ between patients receiving the different dosages, thus replicating in a registry dataset derived from “real-world” database the results of the pivotal randomised trial. Propensity score matching effectively minimised baseline covariate imbalance between two directly compared sub-populations from a large observational registry.
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spelling pubmed-36606042013-05-23 Persistence on Therapy and Propensity Matched Outcome Comparison of Two Subcutaneous Interferon Beta 1a Dosages for Multiple Sclerosis Kalincik, Tomas Spelman, Timothy Trojano, Maria Duquette, Pierre Izquierdo, Guillermo Grammond, Pierre Lugaresi, Alessandra Hupperts, Raymond Cristiano, Edgardo Van Pesch, Vincent Grand’Maison, Francois La Spitaleri, Daniele Rio, Maria Edite Flechter, Sholmo Oreja-Guevara, Celia Giuliani, Giorgio Savino, Aldo Amato, Maria Pia Petersen, Thor Fernandez-Bolanos, Ricardo Bergamaschi, Roberto Iuliano, Gerardo Boz, Cavit Lechner-Scott, Jeannette Deri, Norma Gray, Orla Verheul, Freek Fiol, Marcela Barnett, Michael van Munster, Erik Santiago, Vetere Moore, Fraser Slee, Mark Saladino, Maria Laura Alroughani, Raed Shaw, Cameron Kasa, Krisztian Petkovska-Boskova, Tatjana den Braber-Moerland, Leontien Chapman, Joab Skromne, Eli Herbert, Joseph Poehlau, Dieter Needham, Merrilee Bacile, Elizabeth Alejandra Bacile Arruda, Walter Oleschko Paine, Mark Singhal, Bhim Vucic, Steve Cabrera-Gomez, Jose Antonio Butzkueven, Helmut Roger, Elaine Despault, Pierre Marriott, Mark Van der Walt, Anneke King, John Kilpatrick, Trevor Buzzard, Katherine Jokubaitis, Vilija Byron, Jill Morgan, Lisa Skibina, Olga Haartsen, Jodi De Luca, Giovanna Di Tommaso, Valeria Travaglini, Daniela Pietrolongo, Erika di Ioia, Maria Farina, Deborah Mancinelli, Luca Paolicelli, Damiano Iaffaldano, Pietro Ignacio Rojas, Juan Patrucco, Liliana Roullet, Etienne Correale, Jorge Ysrraelit, Celica Elisabetta, Cartechini Pucci, Eugenio Williams, David Dark, Lisa Shaygannejad, Vahid Zwanikken, Cees Vella, Norbert Sirbu, Carmen-Adella PLoS One Research Article OBJECTIVES: To compare treatment persistence between two dosages of interferon β-1a in a large observational multiple sclerosis registry and assess disease outcomes of first line MS treatment at these dosages using propensity scoring to adjust for baseline imbalance in disease characteristics. METHODS: Treatment discontinuations were evaluated in all patients within the MSBase registry who commenced interferon β-1a SC thrice weekly (n = 4678). Furthermore, we assessed 2-year clinical outcomes in 1220 patients treated with interferon β-1a in either dosage (22 µg or 44 µg) as their first disease modifying agent, matched on propensity score calculated from pre-treatment demographic and clinical variables. A subgroup analysis was performed on 456 matched patients who also had baseline MRI variables recorded. RESULTS: Overall, 4054 treatment discontinuations were recorded in 3059 patients. The patients receiving the lower interferon dosage were more likely to discontinue treatment than those with the higher dosage (25% vs. 20% annual probability of discontinuation, respectively). This was seen in discontinuations with reasons recorded as “lack of efficacy” (3.3% vs. 1.7%), “scheduled stop” (2.2% vs. 1.3%) or without the reason recorded (16.7% vs. 13.3% annual discontinuation rate, 22 µg vs. 44 µg dosage, respectively). Propensity score was determined by treating centre and disability (score without MRI parameters) or centre, sex and number of contrast-enhancing lesions (score including MRI parameters). No differences in clinical outcomes at two years (relapse rate, time relapse-free and disability) were observed between the matched patients treated with either of the interferon dosages. CONCLUSIONS: Treatment discontinuations were more common in interferon β-1a 22 µg SC thrice weekly. However, 2-year clinical outcomes did not differ between patients receiving the different dosages, thus replicating in a registry dataset derived from “real-world” database the results of the pivotal randomised trial. Propensity score matching effectively minimised baseline covariate imbalance between two directly compared sub-populations from a large observational registry. Public Library of Science 2013-05-21 /pmc/articles/PMC3660604/ /pubmed/23704913 http://dx.doi.org/10.1371/journal.pone.0063480 Text en © 2013 Kalincik et al http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are properly credited.
spellingShingle Research Article
Kalincik, Tomas
Spelman, Timothy
Trojano, Maria
Duquette, Pierre
Izquierdo, Guillermo
Grammond, Pierre
Lugaresi, Alessandra
Hupperts, Raymond
Cristiano, Edgardo
Van Pesch, Vincent
Grand’Maison, Francois
La Spitaleri, Daniele
Rio, Maria Edite
Flechter, Sholmo
Oreja-Guevara, Celia
Giuliani, Giorgio
Savino, Aldo
Amato, Maria Pia
Petersen, Thor
Fernandez-Bolanos, Ricardo
Bergamaschi, Roberto
Iuliano, Gerardo
Boz, Cavit
Lechner-Scott, Jeannette
Deri, Norma
Gray, Orla
Verheul, Freek
Fiol, Marcela
Barnett, Michael
van Munster, Erik
Santiago, Vetere
Moore, Fraser
Slee, Mark
Saladino, Maria Laura
Alroughani, Raed
Shaw, Cameron
Kasa, Krisztian
Petkovska-Boskova, Tatjana
den Braber-Moerland, Leontien
Chapman, Joab
Skromne, Eli
Herbert, Joseph
Poehlau, Dieter
Needham, Merrilee
Bacile, Elizabeth Alejandra Bacile
Arruda, Walter Oleschko
Paine, Mark
Singhal, Bhim
Vucic, Steve
Cabrera-Gomez, Jose Antonio
Butzkueven, Helmut
Roger, Elaine
Despault, Pierre
Marriott, Mark
Van der Walt, Anneke
King, John
Kilpatrick, Trevor
Buzzard, Katherine
Jokubaitis, Vilija
Byron, Jill
Morgan, Lisa
Skibina, Olga
Haartsen, Jodi
De Luca, Giovanna
Di Tommaso, Valeria
Travaglini, Daniela
Pietrolongo, Erika
di Ioia, Maria
Farina, Deborah
Mancinelli, Luca
Paolicelli, Damiano
Iaffaldano, Pietro
Ignacio Rojas, Juan
Patrucco, Liliana
Roullet, Etienne
Correale, Jorge
Ysrraelit, Celica
Elisabetta, Cartechini
Pucci, Eugenio
Williams, David
Dark, Lisa
Shaygannejad, Vahid
Zwanikken, Cees
Vella, Norbert
Sirbu, Carmen-Adella
Persistence on Therapy and Propensity Matched Outcome Comparison of Two Subcutaneous Interferon Beta 1a Dosages for Multiple Sclerosis
title Persistence on Therapy and Propensity Matched Outcome Comparison of Two Subcutaneous Interferon Beta 1a Dosages for Multiple Sclerosis
title_full Persistence on Therapy and Propensity Matched Outcome Comparison of Two Subcutaneous Interferon Beta 1a Dosages for Multiple Sclerosis
title_fullStr Persistence on Therapy and Propensity Matched Outcome Comparison of Two Subcutaneous Interferon Beta 1a Dosages for Multiple Sclerosis
title_full_unstemmed Persistence on Therapy and Propensity Matched Outcome Comparison of Two Subcutaneous Interferon Beta 1a Dosages for Multiple Sclerosis
title_short Persistence on Therapy and Propensity Matched Outcome Comparison of Two Subcutaneous Interferon Beta 1a Dosages for Multiple Sclerosis
title_sort persistence on therapy and propensity matched outcome comparison of two subcutaneous interferon beta 1a dosages for multiple sclerosis
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3660604/
https://www.ncbi.nlm.nih.gov/pubmed/23704913
http://dx.doi.org/10.1371/journal.pone.0063480
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