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Consistent efficacy of daclizumab beta across patient demographic and disease activity subgroups in patients with relapsing-remitting multiple sclerosis.
Mult Scler Relat Disord. 2017 Oct; 17:32-40.MS

Abstract

BACKGROUND

Daclizumab beta is a humanized monoclonal antibody specific for the human interleukin-2 receptor alpha chain (CD25). In two pivotal studies in relapsing multiple sclerosis (MS), patients treated with daclizumab beta exhibited lower annualized relapse rates (ARR) when compared with placebo or with intramuscular (IM) interferon beta-1a.

OBJECTIVES

To determine if the efficacy of daclizumab beta demonstrated in the phase 2 SELECT study and the phase 3 DECIDE study was consistent in patient subgroups.

METHODS

In the SELECT study, patients received daclizumab beta 150 or 300mg administered subcutaneously every 4 weeks for 52 weeks, and were compared with patients who received placebo. In the DECIDE study, patients received daclizumab beta 150mg administered subcutaneously every 4 weeks for 96-144 weeks, and were compared with patients who received IM interferon beta-1a 30µg. Subgroups were defined by sex, age, the number of relapses in the year before the study, disease duration, baseline disability measured by EDSS, presence of Gd-enhancing lesions, T2 hyperintense lesion volume at baseline, and previous interferon beta-1a use.

RESULTS

Treatment with daclizumab beta was associated with relative lower ARR, with 95% confidence intervals (CIs) below 1 in 13 of 15 subgroups (SELECT study) compared with placebo and in all 17 subgroups compared with interferon beta-1a (DECIDE study). In 2 subgroups in the SELECT study (patients who were older than 35 years of age or who had a disease duration of 10 or more years), the rate ratio point estimate for the ARR was in favor of daclizumab beta but the 95% CI overlapped with 1. The clinical benefits in ARR achieved with daclizumab beta treatment compared with placebo or interferon beta-1a across subgroups were similarly supported by reductions in lesion activity on magnetic resonance images (MRIs).

CONCLUSIONS

These findings suggest that treatment with daclizumab beta is consistently effective among clinically important patient subgroups and support its potential as a viable therapeutic option across the spectrum of relapsing MS.

Authors+Show Affiliations

Department of Neurology, University of Utah, Neurovirology Research Laboratory VASLCHCS, Imaging and Neuroscience Center, 175 North Medical Drive East, Salt Lake City, UT 84132, USA. Electronic address: jrose@genetics.utah.edu.Department of Neurology, Queen Mary University London, The London School of Medicine and Dentistry, 4 Newark St, London, England, United Kingdom. Electronic address: g.giovannoni@qmul.ac.uk.Department of Neurology, University of Münster, Schlossplatz 2, 48149 Münster, Germany. Electronic address: sekretariat.neurologie@ukmuenster.de.Department of Neurology, Ruhr-University Bochum, Gudrunstr. 56, 44791 Bochum, Germany. Electronic address: ralf.gold@rub.de.Department of Neurology, First Faculty of Medicine, Charles University in Prague, Kateřinská 30, 12821 Prague, Czech Republic. Electronic address: eva.havrdova@lf1.cuni.cz.Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University of Basel, Petersgraben 4, 4031 Basel, Switzerland. Electronic address: ludwig.kappos@usb.ch.Department of Neurology, Medical University of Łódź, Al. Kościuszki 4, 90-419 Łódź, Poland. Electronic address: kselmaj@afazja.am.lodz.pl.AbbVie Inc., 1400 Sheridan Rd, North Chicago, IL 60064, USA. Electronic address: zhao.jun@abbvie.com.Biogen, 225 Binney St, Cambridge, MA 02142, USA. Electronic address: katherine.riester@biogen.com.AbbVie Biotherapeutics Inc., 1500 Seaport Blvd, Redwood City, CA 94063, USA. Electronic address: ctsao@pcyc.com.AbbVie Inc., 1400 Sheridan Rd, North Chicago, IL 60064, USA. Electronic address: steven.greenberg@AbbVie.com.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

29055471

Citation

Rose, John W., et al. "Consistent Efficacy of Daclizumab Beta Across Patient Demographic and Disease Activity Subgroups in Patients With Relapsing-remitting Multiple Sclerosis." Multiple Sclerosis and Related Disorders, vol. 17, 2017, pp. 32-40.
Rose JW, Giovannoni G, Wiendl H, et al. Consistent efficacy of daclizumab beta across patient demographic and disease activity subgroups in patients with relapsing-remitting multiple sclerosis. Mult Scler Relat Disord. 2017;17:32-40.
Rose, J. W., Giovannoni, G., Wiendl, H., Gold, R., Havrdová, E., Kappos, L., Selmaj, K. W., Zhao, J., Riester, K., Tsao, L. C., & Greenberg, S. J. (2017). Consistent efficacy of daclizumab beta across patient demographic and disease activity subgroups in patients with relapsing-remitting multiple sclerosis. Multiple Sclerosis and Related Disorders, 17, 32-40. https://doi.org/10.1016/j.msard.2017.06.006
Rose JW, et al. Consistent Efficacy of Daclizumab Beta Across Patient Demographic and Disease Activity Subgroups in Patients With Relapsing-remitting Multiple Sclerosis. Mult Scler Relat Disord. 2017;17:32-40. PubMed PMID: 29055471.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Consistent efficacy of daclizumab beta across patient demographic and disease activity subgroups in patients with relapsing-remitting multiple sclerosis. AU - Rose,John W, AU - Giovannoni,Gavin, AU - Wiendl,Heinz, AU - Gold,Ralf, AU - Havrdová,Eva, AU - Kappos,Ludwig, AU - Selmaj,Krzysztof W, AU - Zhao,Jun, AU - Riester,Katherine, AU - Tsao,L Claire, AU - Greenberg,Steven J, Y1 - 2017/06/19/ PY - 2016/11/28/received PY - 2017/05/22/revised PY - 2017/06/16/accepted PY - 2017/10/23/entrez PY - 2017/10/23/pubmed PY - 2018/2/8/medline KW - Annualized relapse rate KW - Daclizumab beta KW - Interferon beta-1a KW - Relapsing-remitting multiple sclerosis KW - Subgroup analysis SP - 32 EP - 40 JF - Multiple sclerosis and related disorders JO - Mult Scler Relat Disord VL - 17 N2 - BACKGROUND: Daclizumab beta is a humanized monoclonal antibody specific for the human interleukin-2 receptor alpha chain (CD25). In two pivotal studies in relapsing multiple sclerosis (MS), patients treated with daclizumab beta exhibited lower annualized relapse rates (ARR) when compared with placebo or with intramuscular (IM) interferon beta-1a. OBJECTIVES: To determine if the efficacy of daclizumab beta demonstrated in the phase 2 SELECT study and the phase 3 DECIDE study was consistent in patient subgroups. METHODS: In the SELECT study, patients received daclizumab beta 150 or 300mg administered subcutaneously every 4 weeks for 52 weeks, and were compared with patients who received placebo. In the DECIDE study, patients received daclizumab beta 150mg administered subcutaneously every 4 weeks for 96-144 weeks, and were compared with patients who received IM interferon beta-1a 30µg. Subgroups were defined by sex, age, the number of relapses in the year before the study, disease duration, baseline disability measured by EDSS, presence of Gd-enhancing lesions, T2 hyperintense lesion volume at baseline, and previous interferon beta-1a use. RESULTS: Treatment with daclizumab beta was associated with relative lower ARR, with 95% confidence intervals (CIs) below 1 in 13 of 15 subgroups (SELECT study) compared with placebo and in all 17 subgroups compared with interferon beta-1a (DECIDE study). In 2 subgroups in the SELECT study (patients who were older than 35 years of age or who had a disease duration of 10 or more years), the rate ratio point estimate for the ARR was in favor of daclizumab beta but the 95% CI overlapped with 1. The clinical benefits in ARR achieved with daclizumab beta treatment compared with placebo or interferon beta-1a across subgroups were similarly supported by reductions in lesion activity on magnetic resonance images (MRIs). CONCLUSIONS: These findings suggest that treatment with daclizumab beta is consistently effective among clinically important patient subgroups and support its potential as a viable therapeutic option across the spectrum of relapsing MS. SN - 2211-0356 UR - https://www.unboundmedicine.com/medline/citation/29055471/Consistent_efficacy_of_daclizumab_beta_across_patient_demographic_and_disease_activity_subgroups_in_patients_with_relapsing_remitting_multiple_sclerosis_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S2211-0348(17)30139-6 DB - PRIME DP - Unbound Medicine ER -