Contributions
Abstract: EP1537
Type: ePoster
Abstract Category: Therapy - disease modifying - Tools for detecting therapeutic response
Background: In EVIDENCE, patients (pts) with relapsing-remitting multiple sclerosis (RRMS) were randomly assigned to interferon beta-1a (IFN β-1a) 44 µg subcutaneously 3x/week (SC tiw; n=339) or IFN β-1a 30 µg intramuscularly 1x/week (IM qw; n=338).
Goals: Examine the predictive value of early magnetic resonance imaging (MRI) lesions for achieving longer term no evidence of disease activity (NEDA) in pts treated with IFN β-1a.
Methods: T2 and pre-/post-contrast T1 scans were performed at screening, Study Day 1, and every 4 weeks to Week (W) 24, with additional T2 scans at W48/72. This post hoc analysis assessed whether early lesions predicted NEDA status from W8 up to W48/72 (no relapses or disability worsening [≥1 point increase in Expanded Disability Status Scale (EDSS) score confirmed at W12 (last EDSS before/at W8)] from W8 to W48/72 and no active T2 lesions from W8 up to W48/72). Unadjusted and adjusted logistic analyses were performed based on baseline combined unique active (CUA) lesions, in addition to other common baseline factors.
Results: By W8, mean gadolinium-enhancing (Gd+) lesions/pt/scan (all scans up to W8) were 0.79 with IFN β-1a SC tiw vs 1.34 with IFN β-1a IM qw (p=0.002). From W8 up to W48/72, more pts receiving IFN β-1a SC tiw vs IFN β-1a IM qw achieved NEDA status ([adjusted for baseline CUA lesions] 43% vs 26%, p=0.0001 and 33% vs 16%, p< 0.0001, respectively). Absence (vs presence) of Gd+ lesions at W8 predicted NEDA status from W8 up to W48/72 with IFN β-1a SC tiw (odds ratio [OR] 3.58 [95% confidence interval (CI) 1.86-6.88], p=0.0001; 3.27 [1.59-6.73], p=0.0013, respectively); when adjusted for baseline CUA lesions, W8 Gd+ lesions still predicted NEDA status (OR 2.65 [95% CI 1.27-5.53], p=0.010; 2.72 [1.21-6.15], p=0.016, respectively).
Absence (vs presence) of Gd+ lesions at W8 predicted NEDA status from W8 up to W48/72 with IFN β-1a IM qw (3.80 [1.86-7.75], p=0.0002; 4.33 [1.61-11.65], p=0.0037, respectively); when adjusted for baseline CUA lesions, W8 Gd+ lesions no longer predicted NEDA status. Absence (vs presence) of Gd+ lesions at baseline also predicted NEDA up to W48/72.
Conclusions: Pts treated with IFN β-1a SC tiw had a higher likelihood of achieving longer term NEDA status vs IFN β-1a IM qw regardless of early Gd+ lesions. While early Gd+ lesions predicted longer term NEDA status in both treatment groups, Gd+ lesions at W8 remained predictive only in the IFN β-1a SC tiw group when adjusting for baseline CUA lesions.
Disclosure: Patricia K Coyle has received consulting fees from AbbVie, Accordant, Acorda, Bayer, Biogen, EMD Serono, Inc., Genentech/Roche, Genzyme/Sanofi, Mylan, Novartis, and Teva Pharmaceuticals, and has received fees for contracted research with Actelion, Genzyme/Sanofi, Novartis, and Opexa. Mark S Freedman has received honoraria or consulting fees from Actelion, Bayer HealthCare, Biogen, Chugai, EMD Serono (Canada), Genzyme, Hoffmann-La Roche, Merck Serono, Novartis, Sanofi-Aventis and Teva Canada Innovation; has served on an advisory board or board of directors for Actelion, Bayer HealthCare, Biogen, Hoffmann-La Roche, Merck Serono, Novartis, Opexa, and Sanofi-Aventis; and has served on a speakers bureau for Genzyme. Hao Zhang is an employee of EMD Serono, Inc., Rockland, MA, USA (a business of Merck KGaA, Darmstadt, Germany). Fernando Dangond is an employee of EMD Serono, Inc., Billerica, MA, USA (a business of Merck KGaA, Darmstadt, Germany). Anthony T Reder has received consulting fees from Acorda, Bayer, Biogen, EMD Serono, Inc., Genzyme, Novartis, Pfizer, Questcor, Sanofi, and Teva Pharmaceuticals.
Abstract: EP1537
Type: ePoster
Abstract Category: Therapy - disease modifying - Tools for detecting therapeutic response
Background: In EVIDENCE, patients (pts) with relapsing-remitting multiple sclerosis (RRMS) were randomly assigned to interferon beta-1a (IFN β-1a) 44 µg subcutaneously 3x/week (SC tiw; n=339) or IFN β-1a 30 µg intramuscularly 1x/week (IM qw; n=338).
Goals: Examine the predictive value of early magnetic resonance imaging (MRI) lesions for achieving longer term no evidence of disease activity (NEDA) in pts treated with IFN β-1a.
Methods: T2 and pre-/post-contrast T1 scans were performed at screening, Study Day 1, and every 4 weeks to Week (W) 24, with additional T2 scans at W48/72. This post hoc analysis assessed whether early lesions predicted NEDA status from W8 up to W48/72 (no relapses or disability worsening [≥1 point increase in Expanded Disability Status Scale (EDSS) score confirmed at W12 (last EDSS before/at W8)] from W8 to W48/72 and no active T2 lesions from W8 up to W48/72). Unadjusted and adjusted logistic analyses were performed based on baseline combined unique active (CUA) lesions, in addition to other common baseline factors.
Results: By W8, mean gadolinium-enhancing (Gd+) lesions/pt/scan (all scans up to W8) were 0.79 with IFN β-1a SC tiw vs 1.34 with IFN β-1a IM qw (p=0.002). From W8 up to W48/72, more pts receiving IFN β-1a SC tiw vs IFN β-1a IM qw achieved NEDA status ([adjusted for baseline CUA lesions] 43% vs 26%, p=0.0001 and 33% vs 16%, p< 0.0001, respectively). Absence (vs presence) of Gd+ lesions at W8 predicted NEDA status from W8 up to W48/72 with IFN β-1a SC tiw (odds ratio [OR] 3.58 [95% confidence interval (CI) 1.86-6.88], p=0.0001; 3.27 [1.59-6.73], p=0.0013, respectively); when adjusted for baseline CUA lesions, W8 Gd+ lesions still predicted NEDA status (OR 2.65 [95% CI 1.27-5.53], p=0.010; 2.72 [1.21-6.15], p=0.016, respectively).
Absence (vs presence) of Gd+ lesions at W8 predicted NEDA status from W8 up to W48/72 with IFN β-1a IM qw (3.80 [1.86-7.75], p=0.0002; 4.33 [1.61-11.65], p=0.0037, respectively); when adjusted for baseline CUA lesions, W8 Gd+ lesions no longer predicted NEDA status. Absence (vs presence) of Gd+ lesions at baseline also predicted NEDA up to W48/72.
Conclusions: Pts treated with IFN β-1a SC tiw had a higher likelihood of achieving longer term NEDA status vs IFN β-1a IM qw regardless of early Gd+ lesions. While early Gd+ lesions predicted longer term NEDA status in both treatment groups, Gd+ lesions at W8 remained predictive only in the IFN β-1a SC tiw group when adjusting for baseline CUA lesions.
Disclosure: Patricia K Coyle has received consulting fees from AbbVie, Accordant, Acorda, Bayer, Biogen, EMD Serono, Inc., Genentech/Roche, Genzyme/Sanofi, Mylan, Novartis, and Teva Pharmaceuticals, and has received fees for contracted research with Actelion, Genzyme/Sanofi, Novartis, and Opexa. Mark S Freedman has received honoraria or consulting fees from Actelion, Bayer HealthCare, Biogen, Chugai, EMD Serono (Canada), Genzyme, Hoffmann-La Roche, Merck Serono, Novartis, Sanofi-Aventis and Teva Canada Innovation; has served on an advisory board or board of directors for Actelion, Bayer HealthCare, Biogen, Hoffmann-La Roche, Merck Serono, Novartis, Opexa, and Sanofi-Aventis; and has served on a speakers bureau for Genzyme. Hao Zhang is an employee of EMD Serono, Inc., Rockland, MA, USA (a business of Merck KGaA, Darmstadt, Germany). Fernando Dangond is an employee of EMD Serono, Inc., Billerica, MA, USA (a business of Merck KGaA, Darmstadt, Germany). Anthony T Reder has received consulting fees from Acorda, Bayer, Biogen, EMD Serono, Inc., Genzyme, Novartis, Pfizer, Questcor, Sanofi, and Teva Pharmaceuticals.