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Efficacy of daclizumab beta versus intramuscular interferon beta-1a on disability progression across patient demographic and disease activity subgroups in DECIDE.
Mult Scler. 2018 12; 24(14):1883-1891.MS

Abstract

BACKGROUND

Demonstration of clinical benefits on disability progression measures is an important attribute of effective multiple sclerosis (MS) treatments.

OBJECTIVE

Examine efficacy of daclizumab beta versus intramuscular (IM) interferon beta-1a on measures of disability progression in patient subgroups from DECIDE.

METHODS

Twenty-four-week confirmed disability progression (CDP), 24-week sustained worsening on a modified Multiple Sclerosis Functional Composite (MSFCS) where 3-Second Paced Auditory Serial Addition Test was replaced by Symbol Digit Modalities Test, and proportion of patients with clinically meaningful worsening in 29-Item Multiple Sclerosis Impact Scale physical impact subscale (MSIS-29 PHYS) score from baseline to week 96 were examined in the overall population and subgroups defined by baseline demographic/disease characteristics.

RESULTS

Daclizumab beta significantly reduced risk of 24-week CDP (hazard ratio (HR), 0.73; 95% confidence interval (95% CI), 0.55-0.98), risk of 24-week sustained MSFCS progression (HR, 0.80; 95% CI, 0.67-0.95), and odds of clinically meaningful worsening in MSIS-29 PHYS (odds ratio, 0.76; 95% CI, 0.60-0.95) versus IM interferon beta-1a. Point estimates showed trends favoring daclizumab beta over IM interferon beta-1a across several patient subgroups for all three outcome measures.

CONCLUSION

Daclizumab beta showed consistent benefit versus IM interferon beta-1a across measures assessing patient disability/function and across a range of clinical baseline characteristics in patients with relapsing-remitting MS.

Links

Publisher Full Text
ncbi.nlm.nih.gov
journals.sagepub.com
PMC Free PDF

Authors+Show Affiliations

Cohan S
Providence Multiple Sclerosis Center, Providence Brain and Spine Institute, Providence St. Joseph Health, Portland, OR, USA.
Kappos L
Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research and Biomedical Engineering, University Hospital and University of Basel, Basel, Switzerland.
Giovannoni G
Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University London, London, UK.
Wiendl H
Department of Neurology, University of Münster, Münster, Germany.
Selmaj K
Department of Neurology, Medical University of Lodz, Lodz, Poland.
Havrdová EK
Department of Neurology and Center for Clinical Neuroscience, First Faculty of Medicine, Charles University, Prague, Czech Republic.
Rose J
Department of Neurology, University of Utah and Neurovirology Research Laboratory VASLCHCS, Imaging and Neuroscience Center, Salt Lake City, UT, USA.
Greenberg S
AbbVie Inc., North Chicago, IL, USA.
Phillips G
Biogen, Cambridge, MA, USA.
Ma W
Biogen, Cambridge, MA, USA.
Wang P
Biogen, Cambridge, MA, USA.
Lima G
Biogen, Cambridge, MA, USA.
Sabatella G
Biogen, Cambridge, MA, USA.

MeSH

AdultAntibodies, Monoclonal, HumanizedDaclizumabDisease ProgressionFemaleHumansImmunoglobulin GImmunosuppressive AgentsInterferon beta-1aMaleMiddle AgedMultiple SclerosisTreatment Outcome

Pub Type(s)

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

Language

eng

PubMed ID

28984179

Clinical Trial Links

Clinical trial which this article describes

Citation

Cohan, Stanley, et al. "Efficacy of Daclizumab Beta Versus Intramuscular Interferon Beta-1a On Disability Progression Across Patient Demographic and Disease Activity Subgroups in DECIDE." Multiple Sclerosis (Houndmills, Basingstoke, England), vol. 24, no. 14, 2018, pp. 1883-1891.
Cohan S, Kappos L, Giovannoni G, et al. Efficacy of daclizumab beta versus intramuscular interferon beta-1a on disability progression across patient demographic and disease activity subgroups in DECIDE. Mult Scler. 2018;24(14):1883-1891.
Cohan, S., Kappos, L., Giovannoni, G., Wiendl, H., Selmaj, K., Havrdová, E. K., Rose, J., Greenberg, S., Phillips, G., Ma, W., Wang, P., Lima, G., & Sabatella, G. (2018). Efficacy of daclizumab beta versus intramuscular interferon beta-1a on disability progression across patient demographic and disease activity subgroups in DECIDE. Multiple Sclerosis (Houndmills, Basingstoke, England), 24(14), 1883-1891. https://doi.org/10.1177/1352458517735190
Cohan S, et al. Efficacy of Daclizumab Beta Versus Intramuscular Interferon Beta-1a On Disability Progression Across Patient Demographic and Disease Activity Subgroups in DECIDE. Mult Scler. 2018;24(14):1883-1891. PubMed PMID: 28984179.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy of daclizumab beta versus intramuscular interferon beta-1a on disability progression across patient demographic and disease activity subgroups in DECIDE. AU - Cohan,Stanley, AU - Kappos,Ludwig, AU - Giovannoni,Gavin, AU - Wiendl,Heinz, AU - Selmaj,Krzysztof, AU - Havrdová,Eva Kubala, AU - Rose,John, AU - Greenberg,Steven, AU - Phillips,Glenn, AU - Ma,Wei, AU - Wang,Ping, AU - Lima,Gabriel, AU - Sabatella,Guido, Y1 - 2017/10/06/ PY - 2017/10/7/pubmed PY - 2020/7/9/medline PY - 2017/10/7/entrez KW - Daclizumab beta KW - disability progression KW - efficacy KW - interferon beta-1a KW - relapsing-remitting multiple sclerosis KW - subgroup analysis SP - 1883 EP - 1891 JF - Multiple sclerosis (Houndmills, Basingstoke, England) JO - Mult Scler VL - 24 IS - 14 N2 - BACKGROUND: Demonstration of clinical benefits on disability progression measures is an important attribute of effective multiple sclerosis (MS) treatments. OBJECTIVE: Examine efficacy of daclizumab beta versus intramuscular (IM) interferon beta-1a on measures of disability progression in patient subgroups from DECIDE. METHODS: Twenty-four-week confirmed disability progression (CDP), 24-week sustained worsening on a modified Multiple Sclerosis Functional Composite (MSFCS) where 3-Second Paced Auditory Serial Addition Test was replaced by Symbol Digit Modalities Test, and proportion of patients with clinically meaningful worsening in 29-Item Multiple Sclerosis Impact Scale physical impact subscale (MSIS-29 PHYS) score from baseline to week 96 were examined in the overall population and subgroups defined by baseline demographic/disease characteristics. RESULTS: Daclizumab beta significantly reduced risk of 24-week CDP (hazard ratio (HR), 0.73; 95% confidence interval (95% CI), 0.55-0.98), risk of 24-week sustained MSFCS progression (HR, 0.80; 95% CI, 0.67-0.95), and odds of clinically meaningful worsening in MSIS-29 PHYS (odds ratio, 0.76; 95% CI, 0.60-0.95) versus IM interferon beta-1a. Point estimates showed trends favoring daclizumab beta over IM interferon beta-1a across several patient subgroups for all three outcome measures. CONCLUSION: Daclizumab beta showed consistent benefit versus IM interferon beta-1a across measures assessing patient disability/function and across a range of clinical baseline characteristics in patients with relapsing-remitting MS. SN - 1477-0970 UR - https://www.unboundmedicine.com/medline/citation/28984179/Efficacy_of_daclizumab_beta_versus_intramuscular_interferon_beta_1a_on_disability_progression_across_patient_demographic_and_disease_activity_subgroups_in_DECIDE_ L2 - https://journals.sagepub.com/doi/10.1177/1352458517735190?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -