Outcome of T1 hypodensities in patients with early forms of multiple sclerosis randomised to Betaseron® or Copaxone® and followed prospectively by monthly 3T MRI for up to 2 years:: preliminary analysis of the BECOME study

INTRODUCTION: BECOME is the first rater- blinded, randomized,prospective study comparing the efficacy by MRI of standard dosesof Betaseron (Interferon beta 1b) vs. Glatiramer acetate (Copaxone) inpatients with relapsing forms of multiple sclerosis (MS). An importantradiological outcome of treatment for MS is the burden of T1hypointensities, referred to as black holes (BH). There is evidencesuggesting that treatment with Copaxone decreases the evolution ofnew lesions to BH, but whether a similar effect occurs with InterferonBeta remains to be determined. Until the BECOME study therehas never been a head-to-head comparison of these treatments. OBJECTIVES: One of the secondary outcome measures of the BECOMEstudy is a comparison of the evolution of T1 hypointensities after ran-domization to either Betaseron or Copaxone in an intention to treatanalysis. METHODS: All MRI for the BECOME study were performed aton a single 3T dedicated head unit at New Jersey Medical School. Pa-tients were recruited from the MS Centers at New Jersey Medical Schooland Holy Name Hospital, both in New Jersey. For this preliminaryanalysis we compared the evolution of T1 hypointensity in the two treat-ment groups by (1) Visual analysis of percentage of new lesions thatevolved into BH 6 and 12 months after onset in each treatment group,and (2) Volumetric analysis of change in volume of T1 hypointensityfrom baseline to 12 months post-treatment using Analyze † (Lenexa,KS). RESULTS: For the percentage of new lesions evolving into BH,masked examiners analyze new enhancing lesions (NEL) on follow upT1W MRIs without fat suppression 6 and 12 months after onset to deter-mine whether they persist as hypointense. Of 661 lesions that have beenanalyzed, 42 (6.4%) and 21 (3.2%) remain as BH after 6 and 12 months offollow up, respectively. The volume of lesions that evolved to BH wassignificantly larger than in the lesions that did not (mean volumes 510and 84 mm3, respectively; pB/0.001 for both). Volumetric analysis ofchange in T1 hypodensity after 1 year is in progress. CONCLUSIONS: Inthis preliminary analysis less than 4% of NEL evolved into BH. Largernew lesions have a higher likelihood of becoming BH. The results of thevolumetric analysis and the percentage of NEL evolving to BH after 6 and12 months of randomization to either Betaseron or Copaxone will bepresented at the meeting. Funding. Supported by an investigator-initiated grant from Berlex/Shering AG to UMDNJ.