BACKGROUND: In a phase 2b study in patients with relapsing-remitting MS (RRMS), BG-12 240 mg three times daily significantly reduced the number of new gadolinium-enhanced (Gd+) lesions from weeks 12 to 24 (primary end point) by 69% compared with placebo. OBJECTIVE: In this analysis, the effect of BG-12 240 mg three times daily on the number of Gd+ lesions from weeks 12 to 24 was evaluated in subgroups based on baseline disease characteristics and demographics. METHODS:Two hundred and fifty-seven patients were randomized equally to receive BG-12 (120 mg once daily or three times daily or 240 mg three times daily) or placebo. RESULTS:BG-12 240 mg three times daily significantly reduced the number of new Gd+ lesions compared with placebo in the following subgroups: Expanded Disability Status Scale (EDSS) score ≤ 2.5 (74%), EDSS score > 2.5 (63%), no Gd+ lesions (80%), ≥ 1 Gd+ lesion (55%), age < 40 years (49%), age ≥ 40 years (89%), female patients (81%), disease duration ≤ 6 years (81%) and disease duration > 6 years (54%) (all comparisons p < 0.05). CONCLUSION:BG-12 demonstrated efficacy in patients with RRMS by decreasing new Gd+ lesion development across a range of subgroups defined by baseline disease characteristics or demographics.
RCT Entities:
BACKGROUND: In a phase 2b study in patients with relapsing-remitting MS (RRMS), BG-12 240 mg three times daily significantly reduced the number of new gadolinium-enhanced (Gd+) lesions from weeks 12 to 24 (primary end point) by 69% compared with placebo. OBJECTIVE: In this analysis, the effect of BG-12 240 mg three times daily on the number of Gd+ lesions from weeks 12 to 24 was evaluated in subgroups based on baseline disease characteristics and demographics. METHODS: Two hundred and fifty-seven patients were randomized equally to receive BG-12 (120 mg once daily or three times daily or 240 mg three times daily) or placebo. RESULTS:BG-12 240 mg three times daily significantly reduced the number of new Gd+ lesions compared with placebo in the following subgroups: Expanded Disability Status Scale (EDSS) score ≤ 2.5 (74%), EDSS score > 2.5 (63%), no Gd+ lesions (80%), ≥ 1 Gd+ lesion (55%), age < 40 years (49%), age ≥ 40 years (89%), female patients (81%), disease duration ≤ 6 years (81%) and disease duration > 6 years (54%) (all comparisons p < 0.05). CONCLUSION:BG-12 demonstrated efficacy in patients with RRMS by decreasing new Gd+ lesion development across a range of subgroups defined by baseline disease characteristics or demographics.
Authors: Claudio Gasperini; Luca Prosperini; Mar Tintoré; Maria Pia Sormani; Massimo Filippi; Jordi Rio; Jacqueline Palace; Maria A Rocca; Olga Ciccarelli; Frederik Barkhof; Jaume Sastre-Garriga; Hugo Vrenken; Jette L Frederiksen; Tarek A Yousry; Christian Enzinger; Alex Rovira; Ludwig Kappos; Carlo Pozzilli; Xavier Montalban; Nicola De Stefano Journal: Neurology Date: 2018-12-26 Impact factor: 9.910
Authors: Amit Bar-Or; Ralf Gold; Ludwig Kappos; Douglas L Arnold; Gavin Giovannoni; Krzysztof Selmaj; John O'Gorman; Monica Stephan; Katherine T Dawson Journal: J Neurol Date: 2013-09 Impact factor: 4.849
Authors: Michael Hutchinson; Robert J Fox; David H Miller; J Theodore Phillips; Mariko Kita; Eva Havrdova; John O'Gorman; Ray Zhang; Mark Novas; Vissia Viglietta; Katherine T Dawson Journal: J Neurol Date: 2013-06-08 Impact factor: 4.849
Authors: Amnon A Berger; Emily R Sottosanti; Ariel Winnick; Jonathan Izygon; Kevin Berardino; Elyse M Cornett; Alan D Kaye; Giustino Varrassi; Omar Viswanath; Ivan Urits Journal: Neurol Int Date: 2021-05-19