Efficacy of daclizumab beta versus intramuscular interferon beta-1a on disability progression across patient demographic and disease activity subgroups in DECIDE

. 2018 Dec ; 24 (14) : 1883-1891. [epub] 20171006

Jazyk angličtina Země Velká Británie, Anglie Médium print-electronic

Typ dokumentu klinická studie, časopisecké články, práce podpořená grantem

Perzistentní odkaz   https://www.medvik.cz/link/pmid28984179

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.

Zobrazit více v PubMed

Ebers GC, Heigenhauser L, Daumer M, et al. Disability as an outcome in MS clinical trials. Neurology 2008; 71: 624–631. PubMed

Wiendl H, Meuth SG. Pharmacological approaches to delaying disability progression in patients with multiple sclerosis. Drugs 2015; 75: 947–977. PubMed PMC

Kurtzke JF. Rating neurologic impairment in multiple sclerosis: An expanded disability status scale (EDSS). Neurology 1983; 33: 1444–1452. PubMed

Lavery AM, Verhey LH, Waldman AT. Outcome measures in relapsing-remitting multiple sclerosis: Capturing disability and disease progression in clinical trials. Mult Scler Int 2014; 2014: 262350. PubMed PMC

Balcer LJ. Clinical outcome measures for research in multiple sclerosis. J Neuroophthalmol 2001; 21: 296–301. PubMed

Cohen JA, Reingold SC, Polman CH, et al. Disability outcome measures in multiple sclerosis clinical trials: Current status and future prospects. Lancet Neurol 2012; 11: 467–476. PubMed

Polman CH, Rudick RA. The multiple sclerosis functional composite: A clinically meaningful measure of disability. Neurology 2010; 74(Suppl. 3): S8–S15. PubMed

Rudick RA, Polman CH, Cohen JA, et al. Assessing disability progression with the Multiple Sclerosis Functional Composite. Mult Scler 2009; 15: 984–997. PubMed

Drake AS, Weinstock-Guttman B, Morrow SA, et al. Psychometrics and normative data for the Multiple Sclerosis Functional Composite: Replacing the PASAT with the Symbol Digit Modalities Test. Mult Scler 2010; 16: 228–237. PubMed

Lopez-Gongora M, Querol L, Escartin A. A one-year follow-up study of the Symbol Digit Modalities Test (SDMT) and the Paced Auditory Serial Addition Test (PASAT) in relapsing-remitting multiple sclerosis: An appraisal of comparative longitudinal sensitivity. BMC Neurol 2015; 15: 40. PubMed PMC

Strober LB, Rao SM, Lee JC, et al. Cognitive impairment in multiple sclerosis: An 18 year follow-up study. Mult Scler Relat Disord 2014; 3: 473–481. PubMed

Cohen JA, Cutter GR, Fischer JS, et al. Use of the Multiple Sclerosis Functional Composite as an outcome measure in a phase 3 clinical trial. Arch Neurol 2001; 58: 961–967. PubMed

Kappos L, Wiendl H, Selmaj K, et al. Daclizumab HYP versus Interferon Beta-1a in Relapsing Multiple Sclerosis. N Engl J Med 2015; 373: 1418–1428. PubMed

Liu Y, Vollmer T, Havrdova E, et al. Impact of daclizumab versus interferon beta-1a on patient-reported outcomes in relapsing-remitting multiple sclerosis. Mult Scler Relat Disord 2017; 11: 18–24. PubMed

Rudick RA. MS clinical trials: What can subgroup analyses teach us? Lancet Neurol 2012; 11: 386–388. PubMed

Lucchinetti C, Bruck W, Parisi J, et al. Heterogeneity of Multiple Sclerosis Lesions: Implications for the Pathogenesis of Demyelination. Ann Neurol 2000; 47: 707–717. PubMed

International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. ICH harmonised tripartite guideline: Guideline for good clinical practice, http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf (1996, accessed 2 February 2015).

Kappos L. Definitions for a standardised, quantified neurological examination and assessment of Kurtzke’s Functional Systems and Expanded Disability Status Scale in Multiple Sclerosis, https://www.neurostatus.net/media/specimen/Definitions_0309_specimen.pdf (2009, accessed 4 May 2017).

Benedict RH, Morrow S, Rodgers J, et al. Characterizing cognitive function during relapse in multiple sclerosis. Mult Scler 2014; 20: 1745–1752. PubMed

Phillips GA, Wyrwich KW, Guo S, et al. Responder definition of the Multiple Sclerosis Impact Scale physical impact subscale for patients with physical worsening. Mult Scler 2014; 20: 1753–1760. PubMed PMC

Rubin DB. Multiple imputation for nonresponse in surveys. New York: John Wiley & Sons, 1987.

Karabudak R, Dahdaleh M, Aljumah M, et al. Functional clinical outcomes in multiple sclerosis: Current status and future prospects. Mult Scler Relat Disord 2015; 4: 192–201. PubMed

European Medicines Agency. Guideline on clinical investigation of medicinal products for the treatment of Multiple Sclerosis, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/03/WC500185161.pdf (2015, accessed 16 September 2016).

Hobart J, Lamping D, Fitzpatrick R, et al. The Multiple Sclerosis Impact Scale (MSIS-29): A new patient-based outcome measure. Brain 2001; 124: 962–973. PubMed

Costelloe L, O’Rourke K, McGuigan C, et al. The longitudinal relationship between the patient-reported Multiple Sclerosis Impact Scale and the clinician-assessed Multiple Sclerosis Functional Composite. Mult Scler 2008; 14: 255–258. PubMed

Zobrazit více v PubMed

ClinicalTrials.gov
NCT01064401

Najít záznam

Citační ukazatele

Nahrávání dat ...

Možnosti archivace

Nahrávání dat ...