Switching Multiple Sclerosis Patients with Breakthrough Disease to Second-Line Therapy

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. This is an open-label retrospective cohort study of 993...

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Veröffentlicht in:PloS one Jg. 6; H. 2; S. e16664
Hauptverfasser: Castillo-Trivino, Tamara, Mowry, Ellen M., Gajofatto, Alberto, Chabas, Dorothee, Crabtree-Hartman, Elizabeth, Cree, Bruce A., Goodin, Douglas S., Green, Ari J., Okuda, Darin T., Pelletier, Daniel, Zamvil, Scott S., Vittinghoff, Eric, Waubant, Emmanuelle
Format: Journal Article
Sprache:Englisch
Veröffentlicht: United States Public Library of Science 03.02.2011
Public Library of Science (PLoS)
Schlagworte:
Adult
Algorithms
Analysis
Antibodies, Monoclonal - therapeutic use
Antibodies, Monoclonal, Humanized
Autoimmune diseases
Care and treatment
Chemotherapy, Adjuvant
Clinical trials
Cohort analysis
Cohort Studies
Disease Progression
Drug dosages
Drug Substitution - methods
Drugs
Female
Humans
Immunologic Factors - therapeutic use
Immunomodulation
Immunosuppressive agents
Immunosuppressive Agents - therapeutic use
Interferon
Leukemia
Male
Medical research
Medicine
Middle Aged
Monoclonal antibodies
Multiple sclerosis
Multiple Sclerosis, Relapsing-Remitting - drug therapy
Multiple Sclerosis, Relapsing-Remitting - pathology
Natalizumab
Neurology
Patients
Poisson density functions
Recurrence
Regression analysis
Retrospective Studies
Rheumatoid arthritis
Statistical analysis
Switching
Therapy
United States > US
San Francisco California
California
ISSN:1932-6203, 1932-6203
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Beschreibung
Zusammenfassung: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. 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. 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). 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.
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Conceived and designed the experiments: TC-T EMM DC AJG EV EW. Analyzed the data: TC-T EV. Wrote the paper: TC-T EMM AG EC-H BAC DSG AJG DTO DP SSZ EV EW.
ISSN:1932-6203
1932-6203
DOI:10.1371/journal.pone.0016664