Switching multiple sclerosis patients with breakthrough disease to second-line therapy.

BACKGROUND: Multiple sclerosis (MS) patients with breakthrough disease on immunomodulatory drugs are frequently offered to switch to natalizumab or immunosuppressants. The effect of natalizumab monotherapy in patients with breakthrough disease is unknown. METHODS: This is an open-label retrospective...

Full description

Bibliographic Details
Main Authors: Tamara Castillo-Trivino, Ellen M Mowry, Alberto Gajofatto, Dorothee Chabas, Elizabeth Crabtree-Hartman, Bruce A Cree, Douglas S Goodin, Ari J Green, Darin T Okuda, Daniel Pelletier, Scott S Zamvil, Eric Vittinghoff, Emmanuelle Waubant
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2011-01-01
Series:PLoS ONE
Online Access:http://europepmc.org/articles/PMC3033401?pdf=render
_version_ 1819261649810358272
author Tamara Castillo-Trivino
Ellen M Mowry
Alberto Gajofatto
Dorothee Chabas
Elizabeth Crabtree-Hartman
Bruce A Cree
Douglas S Goodin
Ari J Green
Darin T Okuda
Daniel Pelletier
Scott S Zamvil
Eric Vittinghoff
Emmanuelle Waubant
author_facet Tamara Castillo-Trivino
Ellen M Mowry
Alberto Gajofatto
Dorothee Chabas
Elizabeth Crabtree-Hartman
Bruce A Cree
Douglas S Goodin
Ari J Green
Darin T Okuda
Daniel Pelletier
Scott S Zamvil
Eric Vittinghoff
Emmanuelle Waubant
author_sort Tamara Castillo-Trivino
collection DOAJ
description BACKGROUND: Multiple sclerosis (MS) patients with breakthrough disease on immunomodulatory drugs are frequently offered to switch to natalizumab or immunosuppressants. The effect of natalizumab monotherapy in patients with breakthrough disease is unknown. METHODS: This is an open-label retrospective cohort study of 993 patients seen at least four times at the University of California San Francisco MS Center, 95 had breakthrough disease on first-line therapy (60 patients switched to natalizumab, 22 to immunosuppressants and 13 declined the switch [non-switchers]). We used Poisson regression adjusted for potential confounders to compare the relapse rate within and across groups before and after the switch. RESULTS: In the within-group analyses, the relapse rate decreased by 70% (95% CI 50,82%; p<0.001) in switchers to natalizumab and by 77% (95% CI 59,87%; p<0.001) in switchers to immunosuppressants; relapse rate in non-switchers did not decrease (6%, p =  0.87). Relative to the reduction among non-switchers, the relapse rate was reduced by 68% among natalizumab switchers (95% CI 19,87%; p = 0.017) and by 76% among the immunosuppressant switchers (95% CI 36,91%; p = 0.004). CONCLUSIONS: Switching to natalizumab or immunosuppressants in patients with breakthrough disease is effective in reducing clinical activity of relapsing MS. The magnitude of the effect and the risk-benefit ratio should be evaluated in randomized clinical trials and prospective cohort studies.
first_indexed 2024-12-23T19:45:10Z
format Article
id doaj.art-726577013d33407794589ca26be706fa
institution Directory Open Access Journal
issn 1932-6203
language English
last_indexed 2024-12-23T19:45:10Z
publishDate 2011-01-01
publisher Public Library of Science (PLoS)
record_format Article
series PLoS ONE
spelling doaj.art-726577013d33407794589ca26be706fa2022-12-21T17:33:33ZengPublic Library of Science (PLoS)PLoS ONE1932-62032011-01-0162e1666410.1371/journal.pone.0016664Switching multiple sclerosis patients with breakthrough disease to second-line therapy.Tamara Castillo-TrivinoEllen M MowryAlberto GajofattoDorothee ChabasElizabeth Crabtree-HartmanBruce A CreeDouglas S GoodinAri J GreenDarin T OkudaDaniel PelletierScott S ZamvilEric VittinghoffEmmanuelle WaubantBACKGROUND: Multiple sclerosis (MS) patients with breakthrough disease on immunomodulatory drugs are frequently offered to switch to natalizumab or immunosuppressants. The effect of natalizumab monotherapy in patients with breakthrough disease is unknown. METHODS: This is an open-label retrospective cohort study of 993 patients seen at least four times at the University of California San Francisco MS Center, 95 had breakthrough disease on first-line therapy (60 patients switched to natalizumab, 22 to immunosuppressants and 13 declined the switch [non-switchers]). We used Poisson regression adjusted for potential confounders to compare the relapse rate within and across groups before and after the switch. RESULTS: In the within-group analyses, the relapse rate decreased by 70% (95% CI 50,82%; p<0.001) in switchers to natalizumab and by 77% (95% CI 59,87%; p<0.001) in switchers to immunosuppressants; relapse rate in non-switchers did not decrease (6%, p =  0.87). Relative to the reduction among non-switchers, the relapse rate was reduced by 68% among natalizumab switchers (95% CI 19,87%; p = 0.017) and by 76% among the immunosuppressant switchers (95% CI 36,91%; p = 0.004). CONCLUSIONS: Switching to natalizumab or immunosuppressants in patients with breakthrough disease is effective in reducing clinical activity of relapsing MS. The magnitude of the effect and the risk-benefit ratio should be evaluated in randomized clinical trials and prospective cohort studies.http://europepmc.org/articles/PMC3033401?pdf=render
spellingShingle Tamara Castillo-Trivino
Ellen M Mowry
Alberto Gajofatto
Dorothee Chabas
Elizabeth Crabtree-Hartman
Bruce A Cree
Douglas S Goodin
Ari J Green
Darin T Okuda
Daniel Pelletier
Scott S Zamvil
Eric Vittinghoff
Emmanuelle Waubant
Switching multiple sclerosis patients with breakthrough disease to second-line therapy.
PLoS ONE
title Switching multiple sclerosis patients with breakthrough disease to second-line therapy.
title_full Switching multiple sclerosis patients with breakthrough disease to second-line therapy.
title_fullStr Switching multiple sclerosis patients with breakthrough disease to second-line therapy.
title_full_unstemmed Switching multiple sclerosis patients with breakthrough disease to second-line therapy.
title_short Switching multiple sclerosis patients with breakthrough disease to second-line therapy.
title_sort switching multiple sclerosis patients with breakthrough disease to second line therapy
url http://europepmc.org/articles/PMC3033401?pdf=render
work_keys_str_mv AT tamaracastillotrivino switchingmultiplesclerosispatientswithbreakthroughdiseasetosecondlinetherapy
AT ellenmmowry switchingmultiplesclerosispatientswithbreakthroughdiseasetosecondlinetherapy
AT albertogajofatto switchingmultiplesclerosispatientswithbreakthroughdiseasetosecondlinetherapy
AT dorotheechabas switchingmultiplesclerosispatientswithbreakthroughdiseasetosecondlinetherapy
AT elizabethcrabtreehartman switchingmultiplesclerosispatientswithbreakthroughdiseasetosecondlinetherapy
AT bruceacree switchingmultiplesclerosispatientswithbreakthroughdiseasetosecondlinetherapy
AT douglassgoodin switchingmultiplesclerosispatientswithbreakthroughdiseasetosecondlinetherapy
AT arijgreen switchingmultiplesclerosispatientswithbreakthroughdiseasetosecondlinetherapy
AT darintokuda switchingmultiplesclerosispatientswithbreakthroughdiseasetosecondlinetherapy
AT danielpelletier switchingmultiplesclerosispatientswithbreakthroughdiseasetosecondlinetherapy
AT scottszamvil switchingmultiplesclerosispatientswithbreakthroughdiseasetosecondlinetherapy
AT ericvittinghoff switchingmultiplesclerosispatientswithbreakthroughdiseasetosecondlinetherapy
AT emmanuellewaubant switchingmultiplesclerosispatientswithbreakthroughdiseasetosecondlinetherapy