Inclusion of brain volume loss in a revised measure of 'no evidence of disease activity' (NEDA-4) in relapsing-remitting multiple sclerosis

'No evidence of disease activity' (NEDA), defined as absence of magnetic resonance imaging activity (T2 and/or gadolinium-enhanced T1 lesions), relapses and disability progression ('NEDA-3'), is used as a comprehensive measure of treatment response in relapsing multiple sclerosis...

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Vydáno v:	Multiple sclerosis Ročník 22; číslo 10; s. 1297 - 1305
Hlavní autoři:	Kappos, Ludwig, De Stefano, Nicola, Freedman, Mark S, Cree, Bruce Ac, Radue, Ernst-Wilhelm, Sprenger, Till, Sormani, Maria Pia, Smith, Terence, Häring, Dieter A, Piani Meier, Daniela, Tomic, Davorka
Médium:	Journal Article
Jazyk:	angličtina
Vydáno:	England 01.09.2016
Témata:	Adolescent Adult Atrophy Brain - diagnostic imaging Brain - pathology Clinical Trials, Phase III as Topic Female Fingolimod Hydrochloride - therapeutic use Humans Immunosuppressive Agents - therapeutic use Magnetic Resonance Imaging Male Middle Aged Multiple Sclerosis, Relapsing-Remitting - diagnostic imaging Multiple Sclerosis, Relapsing-Remitting - drug therapy Organ Size Treatment Outcome Young Adult Atrophy NEDA brain fingolimod multiple sclerosis
ISSN:	1477-0970
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Abstract	'No evidence of disease activity' (NEDA), defined as absence of magnetic resonance imaging activity (T2 and/or gadolinium-enhanced T1 lesions), relapses and disability progression ('NEDA-3'), is used as a comprehensive measure of treatment response in relapsing multiple sclerosis (RMS), but is weighted towards inflammatory activity. Accelerated brain volume loss (BVL) occurs in RMS and is an objective measure of disease worsening and progression. To assess the contribution of individual components of NEDA-3 and the impact of adding BVL to NEDA-3 ('NEDA-4') METHODS: We analysed data pooled from two placebo-controlled phase 3 fingolimod trials in RMS and assessed NEDA-4 using different annual BVL mean rate thresholds (0.2%-1.2%). At 2 years, 31.0% (217/700) of patients receiving fingolimod 0.5 mg achieved NEDA-3 versus 9.9% (71/715) on placebo (odds ratio (OR) 4.07; p < 0.0001). Adding BVL (threshold of 0.4%), the respective proportions of patients achieving NEDA-4 were 19.7% (139/706) and 5.3% (38/721; OR 4.41; p < 0.0001). NEDA-4 status favoured fingolimod across all BVL thresholds tested (OR 4.01-4.41; p < 0.0001). NEDA-4 has the potential to capture the impact of therapies on both inflammation and neurodegeneration, and deserves further evaluation across different compounds and in long-term studies.
AbstractList	BACKGROUND'No evidence of disease activity' (NEDA), defined as absence of magnetic resonance imaging activity (T2 and/or gadolinium-enhanced T1 lesions), relapses and disability progression ('NEDA-3'), is used as a comprehensive measure of treatment response in relapsing multiple sclerosis (RMS), but is weighted towards inflammatory activity. Accelerated brain volume loss (BVL) occurs in RMS and is an objective measure of disease worsening and progression.OBJECTIVETo assess the contribution of individual components of NEDA-3 and the impact of adding BVL to NEDA-3 ('NEDA-4') METHODS: We analysed data pooled from two placebo-controlled phase 3 fingolimod trials in RMS and assessed NEDA-4 using different annual BVL mean rate thresholds (0.2%-1.2%).RESULTSAt 2 years, 31.0% (217/700) of patients receiving fingolimod 0.5 mg achieved NEDA-3 versus 9.9% (71/715) on placebo (odds ratio (OR) 4.07; p < 0.0001). Adding BVL (threshold of 0.4%), the respective proportions of patients achieving NEDA-4 were 19.7% (139/706) and 5.3% (38/721; OR 4.41; p < 0.0001). NEDA-4 status favoured fingolimod across all BVL thresholds tested (OR 4.01-4.41; p < 0.0001).CONCLUSIONNEDA-4 has the potential to capture the impact of therapies on both inflammation and neurodegeneration, and deserves further evaluation across different compounds and in long-term studies. 'No evidence of disease activity' (NEDA), defined as absence of magnetic resonance imaging activity (T2 and/or gadolinium-enhanced T1 lesions), relapses and disability progression ('NEDA-3'), is used as a comprehensive measure of treatment response in relapsing multiple sclerosis (RMS), but is weighted towards inflammatory activity. Accelerated brain volume loss (BVL) occurs in RMS and is an objective measure of disease worsening and progression. To assess the contribution of individual components of NEDA-3 and the impact of adding BVL to NEDA-3 ('NEDA-4') METHODS: We analysed data pooled from two placebo-controlled phase 3 fingolimod trials in RMS and assessed NEDA-4 using different annual BVL mean rate thresholds (0.2%-1.2%). At 2 years, 31.0% (217/700) of patients receiving fingolimod 0.5 mg achieved NEDA-3 versus 9.9% (71/715) on placebo (odds ratio (OR) 4.07; p < 0.0001). Adding BVL (threshold of 0.4%), the respective proportions of patients achieving NEDA-4 were 19.7% (139/706) and 5.3% (38/721; OR 4.41; p < 0.0001). NEDA-4 status favoured fingolimod across all BVL thresholds tested (OR 4.01-4.41; p < 0.0001). NEDA-4 has the potential to capture the impact of therapies on both inflammation and neurodegeneration, and deserves further evaluation across different compounds and in long-term studies.
Author	Freedman, Mark S Radue, Ernst-Wilhelm Sormani, Maria Pia Häring, Dieter A Cree, Bruce Ac Tomic, Davorka Sprenger, Till De Stefano, Nicola Smith, Terence Piani Meier, Daniela Kappos, Ludwig
Author_xml	– sequence: 1 givenname: Ludwig surname: Kappos fullname: Kappos, Ludwig email: ludwig.kappos@usb.ch organization: Neurology, Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital Basel, Basel, Switzerland ludwig.kappos@usb.ch – sequence: 2 givenname: Nicola surname: De Stefano fullname: De Stefano, Nicola organization: Department of Medicine, Surgery and Neuroscience, University of Siena, Siena, Italy – sequence: 3 givenname: Mark S surname: Freedman fullname: Freedman, Mark S organization: University of Ottawa and Ottawa Hospital Research Institute, Ottawa, ON, Canada – sequence: 4 givenname: Bruce Ac surname: Cree fullname: Cree, Bruce Ac organization: Multiple Sclerosis Center, University of California, San Francisco, CA, USA – sequence: 5 givenname: Ernst-Wilhelm surname: Radue fullname: Radue, Ernst-Wilhelm organization: Medical Image Analysis Centre, University of Basel, University Hospital Basel, Basel, Switzerland – sequence: 6 givenname: Till surname: Sprenger fullname: Sprenger, Till organization: Medical Image Analysis Centre, University of Basel, University Hospital Basel, Basel, Switzerland; Department of Neurology, DKD Helios Klinik Wiesbaden, Wiesbaden, Germany – sequence: 7 givenname: Maria Pia surname: Sormani fullname: Sormani, Maria Pia organization: Biostatistics Unit, Department of Health Sciences, University of Genoa, Genoa, Italy – sequence: 8 givenname: Terence surname: Smith fullname: Smith, Terence organization: Oxford PharmaGenesis, Oxford, UK – sequence: 9 givenname: Dieter A surname: Häring fullname: Häring, Dieter A organization: Novartis Pharma AG, Basel, Switzerland – sequence: 10 givenname: Daniela surname: Piani Meier fullname: Piani Meier, Daniela organization: Novartis Pharma AG, Basel, Switzerland – sequence: 11 givenname: Davorka surname: Tomic fullname: Tomic, Davorka organization: Novartis Pharma AG, Basel, Switzerland
BackLink	https://www.ncbi.nlm.nih.gov/pubmed/26585439$$D View this record in MEDLINE/PubMed
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PublicationYear	2016
References	24446248 - CNS Drugs. 2014 Feb;28(2):147-56 23524331 - J Neurol Neurosurg Psychiatry. 2013 Oct;84(10):1082-91 25551571 - BMC Neurol. 2014 Dec 31;14:240 24022270 - Mult Scler. 2014 Apr;20(4):464-70 19221291 - Neurology. 2009 Feb 17;72(7):586-7 24507512 - Handb Clin Neurol. 2014;122:15-58 21444901 - Neurology. 2011 Mar 29;76(13):1161-7 23424159 - Ann Neurol. 2013 Mar;73(3):327-40 12427893 - Neurology. 2002 Nov 12;59(9):1412-20 22751847 - Arch Neurol. 2012 Oct;69(10):1259-69 10727480 - J Neurol Neurosurg Psychiatry. 2000 Apr;68(4):450-7 24006277 - Ann Neurol. 2014 Jan;75(1):43-9 24685276 - Lancet Neurol. 2014 Jun;13(6):545-56 20625068 - Arch Neurol. 2010 Nov;67(11):1329-35 19201654 - Lancet Neurol. 2009 Mar;8(3):254-60 16230320 - Brain. 2005 Nov;128(Pt 11):2705-12 22441196 - Lancet Neurol. 2012 Apr;11(4):349-60 19339255 - Brain. 2009 May;132(Pt 5):1175-89 20089952 - N Engl J Med. 2010 Feb 4;362(5):387-401 25877624 - Mult Scler Relat Disord. 2013 Apr;2(2):65-7 25662353 - Mult Scler. 2015 Jun;21(7):916-24 24395449 - JAMA Neurol. 2014 Mar;71(3):269-70 19168190 - J Neurol Sci. 2009 Jul 15;282(1-2):112-9 24470325 - Glia. 2014 Nov;62(11):1816-30 25414048 - Adv Ther. 2014 Nov;31(11):1134-54 25531931 - JAMA Neurol. 2015 Feb;72(2):152-8 21397565 - Lancet Neurol. 2011 Apr;10(4):329-37 25904813 - J Neurol Neurosurg Psychiatry. 2016 Jan;87(1):93-9 25632085 - Neurology. 2015 Feb 24;84(8):784-93 20089954 - N Engl J Med. 2010 Feb 4;362(5):402-15 21828195 - Mult Scler. 2012 Jan;18(1):64-71
References_xml	– reference: 10727480 - J Neurol Neurosurg Psychiatry. 2000 Apr;68(4):450-7 – reference: 25877624 - Mult Scler Relat Disord. 2013 Apr;2(2):65-7 – reference: 24022270 - Mult Scler. 2014 Apr;20(4):464-70 – reference: 24507512 - Handb Clin Neurol. 2014;122:15-58 – reference: 21828195 - Mult Scler. 2012 Jan;18(1):64-71 – reference: 20089954 - N Engl J Med. 2010 Feb 4;362(5):402-15 – reference: 16230320 - Brain. 2005 Nov;128(Pt 11):2705-12 – reference: 24685276 - Lancet Neurol. 2014 Jun;13(6):545-56 – reference: 22751847 - Arch Neurol. 2012 Oct;69(10):1259-69 – reference: 19168190 - J Neurol Sci. 2009 Jul 15;282(1-2):112-9 – reference: 24470325 - Glia. 2014 Nov;62(11):1816-30 – reference: 19201654 - Lancet Neurol. 2009 Mar;8(3):254-60 – reference: 24395449 - JAMA Neurol. 2014 Mar;71(3):269-70 – reference: 25632085 - Neurology. 2015 Feb 24;84(8):784-93 – reference: 25414048 - Adv Ther. 2014 Nov;31(11):1134-54 – reference: 24446248 - CNS Drugs. 2014 Feb;28(2):147-56 – reference: 20089952 - N Engl J Med. 2010 Feb 4;362(5):387-401 – reference: 23524331 - J Neurol Neurosurg Psychiatry. 2013 Oct;84(10):1082-91 – reference: 19339255 - Brain. 2009 May;132(Pt 5):1175-89 – reference: 25531931 - JAMA Neurol. 2015 Feb;72(2):152-8 – reference: 25551571 - BMC Neurol. 2014 Dec 31;14:240 – reference: 19221291 - Neurology. 2009 Feb 17;72(7):586-7 – reference: 20625068 - Arch Neurol. 2010 Nov;67(11):1329-35 – reference: 23424159 - Ann Neurol. 2013 Mar;73(3):327-40 – reference: 21444901 - Neurology. 2011 Mar 29;76(13):1161-7 – reference: 24006277 - Ann Neurol. 2014 Jan;75(1):43-9 – reference: 25904813 - J Neurol Neurosurg Psychiatry. 2016 Jan;87(1):93-9 – reference: 21397565 - Lancet Neurol. 2011 Apr;10(4):329-37 – reference: 12427893 - Neurology. 2002 Nov 12;59(9):1412-20 – reference: 25662353 - Mult Scler. 2015 Jun;21(7):916-24 – reference: 22441196 - Lancet Neurol. 2012 Apr;11(4):349-60
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Snippet	'No evidence of disease activity' (NEDA), defined as absence of magnetic resonance imaging activity (T2 and/or gadolinium-enhanced T1 lesions), relapses and... BACKGROUND'No evidence of disease activity' (NEDA), defined as absence of magnetic resonance imaging activity (T2 and/or gadolinium-enhanced T1 lesions),...
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SubjectTerms	Adolescent Adult Atrophy Brain - diagnostic imaging Brain - pathology Clinical Trials, Phase III as Topic Female Fingolimod Hydrochloride - therapeutic use Humans Immunosuppressive Agents - therapeutic use Magnetic Resonance Imaging Male Middle Aged Multiple Sclerosis, Relapsing-Remitting - diagnostic imaging Multiple Sclerosis, Relapsing-Remitting - drug therapy Organ Size Treatment Outcome Young Adult
Title	Inclusion of brain volume loss in a revised measure of 'no evidence of disease activity' (NEDA-4) in relapsing-remitting multiple sclerosis
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