Interferon beta-1b reduces black holes in a randomised trial of clinically isolated syndrome

Nagtegaal, G. J. A.; Pohl, Christoph; Wattjes, Mike P.; Hulst, Hanneke E.; Freedman, Mark S.; Hartung, Hans‐Peter; Miller, David H.; Montalbán, Xavier; Kappos, Ludwig; Edan, Gilles; Pleimes, Dirk; Beckman, K; Stemper, Brigitte; Polman, C.; Sandbrink, Rupert; Barkhof, Frederik

doi:10.1177/1352458513494491

Cited by 19 publications

(25 citation statements)

References 30 publications

(73 reference statements)

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“…24,25 In addition to contrast enhancing and active T2 lesions to measure acute MS related inflammation, several MRI markers of focal neurodegeneration should be considered, such as chronic T1 hypointense lesions ('black holes') that persist longer than 6 months. [26][27][28][29] This imaging finding may hold promise for predicting disability progression and monitoring remyelination, and represents a possible new outcome marker for MS therapies. 30,31 Global brain volume changes The pathological hallmark of MS is the presence of multi ple focal demyelinating lesions in the cerebral white and grey matter, but substantial brain atrophy can also occur.…”

Section: Focal Lesionsmentioning

confidence: 99%

MAGNIMS consensus guidelines on the use of MRI in multiple sclerosis—establishing disease prognosis and monitoring patients

2015

Nat Rev Neurol

402

147

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Section: Focal Lesionsmentioning

confidence: 99%

MAGNIMS consensus guidelines on the use of MRI in multiple sclerosis—establishing disease prognosis and monitoring patients

2015

Nat Rev Neurol

402

147

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“…Conventional MRI techniques are of limited value in monitoring remyelination. However, the measurement of the evolution of transient T1 hypointense lesions (black holes, BH) as a potential marker is a well-established concept and is increasingly being applied in clinical treatment trials [45]. However, there is broad spectrum of advanced imaging techniques available allowing a more specific in vivo evaluation of the myelin content.…”

Section: Resultsmentioning

confidence: 99%

MRI in the Diagnosis and Monitoring of Multiple Sclerosis: An Update

2015

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“…Placebo‐controlled studies have shown that, over a 6‐12 month period, approximately 25‐40% of active MS lesions will evolve into T1H lesions 6, 79, 10, 11, 12 …”

Section: Introductionmentioning

confidence: 99%

The Effect of Three Times a Week Glatiramer Acetate on Cerebral T1 Hypointense Lesions in Relapsing‐Remitting Multiple Sclerosis

Zivadinov

Dwyer

Ramasamy

et al. 2015

Journal of Neuroimaging

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BACKGROUND AND PURPOSETwo definitions of T1 hypointense (T1H) lesions can be derived from pre‐contrast images: those that may or may not have a corresponding gadolinium‐enhancing correlate on post‐contrast images (T1H total), and those that are simultaneously non‐gadolinium‐enhancing on post‐contrast scans (T1H non‐enhancing). To determine the differences in lesion evolution between these two T1H definitions, we examined the effect of glatiramer acetate 40 mg/mL three times weekly subcutaneous injection (GA40) on the number of new or enlarging T1H total and T1H non‐enhancing lesions in patients with relapsing‐remitting multiple sclerosis (RRMS).METHODSThe Phase III GALA study randomized 1404 RRMS subjects 2:1 to receive GA40 or placebo for 12 months. MRI scans were obtained at baseline and at months 6 and 12. Cumulative numbers of T1H total and of T1H non‐enhancing lesions were analyzed using an adjusted negative binomial regression model. A total of 1,357 patients had MRI data collected at either the month 6 or month 12 visit.RESULTSAmong the 1,357 patients with MRI scans performed at either the month 6 or month 12 visit, 883 treated with GA40 developed an adjusted cumulative mean of 1.72 T1H total lesions versus 2.62 in 440 placebo controls (risk ratio, .66; 95% CI, .54‐.80; P < .0001). On T1H non‐enhanced scans, GA40‐treated patients developed an adjusted cumulative mean of 1.35 T1H non‐enhancing lesions versus 1.91 in placebo controls (risk ratio, .71; CI, .58‐.87; P = .0009).CONCLUSIONSGA40 significantly reduced the number of new or enlarging T1H total lesions and T1H non‐enhancing lesions compared with placebo. Although the treatment effect magnitude was comparable with both definitions, the use of T1H non‐enhancing lesions may be more relevant for more uniform standardization in future clinical trials.

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Interferon beta-1b reduces black holes in a randomised trial of clinically isolated syndrome

Abstract: NCT00544037.

Cited by 19 publications

References 30 publications

MAGNIMS consensus guidelines on the use of MRI in multiple sclerosis—establishing disease prognosis and monitoring patients

MAGNIMS consensus guidelines on the use of MRI in multiple sclerosis—establishing disease prognosis and monitoring patients

MRI in the Diagnosis and Monitoring of Multiple Sclerosis: An Update

The Effect of Three Times a Week Glatiramer Acetate on Cerebral T1 Hypointense Lesions in Relapsing‐Remitting Multiple Sclerosis

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