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• W2053898472 abstract "We read with interest the report on the Betaferon Efficacy Yielding Outcomes of a New Dose (BEYOND) study, which compared clinical and MRI outcomes in treatment-naive patients with relapsing-remitting multiple sclerosis (RRMS) who were randomised to standard dose (250 μg) interferon beta-1b, double-dose (500 μg) interferon beta-1b, or glatiramer acetate (20 mg).1O'Connor P Filippi M Arnason B et al.250 μg or 500 μg interferon beta-1b versus 20 mg glatiramer acetate in relapsing-remitting multiple sclerosis: a prospective, randomised, multicentre study.Lancet Neurol. 2009; 8: 889-897Summary Full Text Full Text PDF PubMed Scopus (343) Google Scholar At baseline, patients had a mean disease duration of 5·3 years, a mean expanded disability status scale score of 2·3, and relapsed an average of 1·6 times in the past year. 85% (1902/2244) of the patients had more than 14 T2 hyperintense brain lesions, and 45% (1020/2244) had gadolinium-enhancing lesions. By all these conventional measures, the BEYOND study included typical patients with RRMS. We found the MRI data presented in figure 2 surprising and inconsistent with results from previous clinical trials. Figure 2A showed that T2 lesion volume increased in each of the 3 years for both interferon beta-1b doses and for glatiramer acetate. This finding differs qualitatively from previous published clinical trials of subcutaneous interferon beta for RRMS,2Paty D Li D Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. II. MRI results of a multicenter, randomized, double-blind, placebo-controlled trial.Neurology. 1993; 43: 662-667Crossref PubMed Google Scholar, 3Li DK Paty DW Magnetic resonance imaging results of the PRISMS trial: a randomized, double-blind, placebo-controlled study of interferon-beta1a in relapsing-remitting multiple sclerosis. Prevention of relapses and disability by interferon-beta1a subcutaneously in multiple sclerosis.Ann Neurol. 1999; 46: 197-206Crossref PubMed Scopus (340) Google Scholar or clinically isolated syndrome,4Barkhof F Polman CH Radue EW et al.Magnetic resonance imaging effects of interferon beta-1b in the BENEFIT study: integrated 2-year results.Arch Neurol. 2007; 64: 1292-1298Crossref PubMed Scopus (47) Google Scholar which reported decreased T2 lesion volume during the first treatment year. A recent trial of interferon beta-1a versus alemtuzumab5Coles AJ Compston DA Selmaj KW et al.Alemtuzumab vs. interferon beta-1a in early multiple sclerosis.N Engl J Med. 2008; 359: 1786-1801Crossref PubMed Scopus (824) Google Scholar also reported reduced T2 lesion volume with interferon beta-1a treatment. In a clinical trial of natalizumab, which was a contemporary clinical trial with entry criteria and baseline features similar to the BEYOND study, reduced T2 lesion volume with active treatment was reported.6Miller DH Soon D Fernando KT et al.MRI outcomes in a placebo-controlled trial of natalizumab in relapsing MS.Neurology. 2007; 68: 1390-1401Crossref PubMed Scopus (260) Google Scholar The possible reasons why T2 volume increased in each of the 3 years in the BEYOND study, in contrast to previously published studies, was not discussed in the paper. Furthermore, as expected and seen repeatedly with anti-inflammatory drugs, brain volume decreased during year 1 for all three groups (figure 2B). However, during years 2 and 3, the mean brain volume increased. Brain atrophy has been consistently and repeatedly documented in patients with RRMS, and no previous clinical trials of interferon beta or glatiramer acetate have reported cessation of brain atrophy. Because brain atrophy has been repeatedly shown to be the best MRI correlate of MS-related neurological disability, the finding of complete cessation of brain volume loss is difficult to accept alongside the disability data presented in the same paper: as expected, 21–27% of the patients had sustained increases in their expanded disability status scale scores during the trial. Is there a technical or methodological explanation for the differences seen in the BEYOND study compared with previous studies? Can the reported changes in lesion volume and brain volume be explained? Can the authors reconcile the brain atrophy findings with the disability progression results presented in table 3? RR has received consulting fees or speaking fees from Biogen Idec, Genzyme, Millennium Pharmaceuticals, Novartis, Teva, and Wyeth. EF has received research funding or honoraria for speaking from Biogen Idec, Millennium Pharmaceuticals, Teva, and Wyeth. Do interferon beta-1b and glatiramer acetate grow brain? – Authors' replyWe would like to thank Rudick and Fisher for their correspondence, and to Coles for his insightful comments.1 We would like to clarify the primary purpose of the Betaferon Efficacy Yielding Outcomes of a New Dose (BEYOND) trial:2 this study was a head-to-head comparative trial, designed to investigate the upper end of the dose–response curve for interferon beta-1b (US standard dose), with glatiramer acetate serving as an additional control. While annualised relapse rates were lower than expected (0·33–0·36; on average, one relapse every 3 years) they were not as low as mentioned by Coles. Full-Text PDF" @default.
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• W2053898472 title "Do interferon beta-1b and glatiramer acetate grow brain?" @default.
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• W2053898472 doi "https://doi.org/10.1016/s1474-4422(09)70312-6" @default.
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