Contributions
Abstract: EP1394
Type: ePoster
Abstract Category: Clinical aspects of MS - 8 Clinical assessment tools
Background: In patients with multiple sclerosis, disease and treatment history, early magnetic resonance imaging (MRI) lesion activity, and/or relapses may predict long-term clinical outcomes.
Objectives: To assess the ability of variables at baseline and during the 1-year TRANSFORMS trial to predict long-term disability worsening during the study extension.
Methods: This was a post hoc analysis of data from the 36-month follow-up to the randomized, double-blind TRANSFORMS study comparing fingolimod and intramuscular (IM) interferon (IFN) beta-1a. During follow-up, patients randomized to IFN beta-1a IM were switched to fingolimod. Multiple logistic regression was used to assess which patient or disease characteristics from baseline to month (M) 12 predicted two disability outcome measures (6-month confirmed disability progression [6MCDP]; Expanded Disability Status Scale [EDSS] score >6) during M12‒48. Baseline variables included sex, age, duration of MS since diagnosis, previous treatment for MS, number of relapses in the previous 2 years, EDSS score, number of gadolinium-enhancing [Gd+] lesions, T1 hypointense volume and total volume of T2 lesions. Baseline to M12 variables included the number of confirmed relapses, EDSS score change, presence of new T2 lesions and presence of MRI lesion activity.
Results: In total, 1292 patients were randomized in TRANSFORMS (analysis sets for the multiple regression analysis: 6MCDP, n=758; EDSS score >6, n=934). Predictors of both outcomes were baseline EDSS score (odds ratio [95% confidence interval]: 6MCDP: 1.353 [1.138-1.609], p=0.0006; EDSS score >6: 3.335 [2.530-4.396], p< 0.0001) and the presence of MRI lesion activity during M0-12 (≥1 Gd+ or ≥2 new T2 lesions, 6MCDP: 1.854 [1.038-3.310], p=0.0369; EDSS score >6: 3.434 [1.292-9.128], p=0.0134). Change in EDSS score during M0-12 (2.794 [1.990-3.921], p< 0.0001) and T1 hypointense lesion volume at baseline (1.297 [1.082-1.555], p=0.0049) were predictors of EDSS score >6 only.
Conclusions: In TRANSFORMS, baseline EDSS score and MRI lesion activity during
M0-12 were predictors of both disability outcomes in the long term. Change in EDSS score during M0-12 and T1 hypointense lesion volume at baseline were predictors of patients reaching an EDSS score >6. These findings support early review of treatment regimens to help to prevent worsening disability.
Disclosure:
Pavle Repovic: Acorda Therapeutics, Biogen Idec, EMD Serono, Genzyme, Novartis Pharmaceuticals Corporation, Pfizer and Teva Pharmaceuticals (multiple sources).
Aaron Boster: Acorda Therapeutics, Actelion Pharmaceuticals, Biogen Idec, CNS Therapeutics, Genzyme, Jazz Pharmaceuticals, Medtronic, Novartis Pharmaceuticals, Roche, Serono, Questcor Pharmaceuticals and Teva Pharmaceuticals.
Shannon Ritter, Xiangyi Meng: Novartis Pharmaceuticals Corporation (employees).
Davorka Tomic, Daniela Piani Meier: Novartis Pharma AG (employees).
Till Sprenger: Actelion, Allergan, ATI Pharma, Biogen Idec, ElectroCore, Novartis, Sanofi Genzyme and Teva.
Frederik Barkhof: Biogen Idec, Bayer Schering Pharma, Genzyme, Janssen Alzheimer Immunotherapy, Lundbeck, MediciNova, Merck Serono, Novartis Pharmaceuticals Corporation, Roche, Sanofi-Aventis and Synthon (multiple sources).
Abstract: EP1394
Type: ePoster
Abstract Category: Clinical aspects of MS - 8 Clinical assessment tools
Background: In patients with multiple sclerosis, disease and treatment history, early magnetic resonance imaging (MRI) lesion activity, and/or relapses may predict long-term clinical outcomes.
Objectives: To assess the ability of variables at baseline and during the 1-year TRANSFORMS trial to predict long-term disability worsening during the study extension.
Methods: This was a post hoc analysis of data from the 36-month follow-up to the randomized, double-blind TRANSFORMS study comparing fingolimod and intramuscular (IM) interferon (IFN) beta-1a. During follow-up, patients randomized to IFN beta-1a IM were switched to fingolimod. Multiple logistic regression was used to assess which patient or disease characteristics from baseline to month (M) 12 predicted two disability outcome measures (6-month confirmed disability progression [6MCDP]; Expanded Disability Status Scale [EDSS] score >6) during M12‒48. Baseline variables included sex, age, duration of MS since diagnosis, previous treatment for MS, number of relapses in the previous 2 years, EDSS score, number of gadolinium-enhancing [Gd+] lesions, T1 hypointense volume and total volume of T2 lesions. Baseline to M12 variables included the number of confirmed relapses, EDSS score change, presence of new T2 lesions and presence of MRI lesion activity.
Results: In total, 1292 patients were randomized in TRANSFORMS (analysis sets for the multiple regression analysis: 6MCDP, n=758; EDSS score >6, n=934). Predictors of both outcomes were baseline EDSS score (odds ratio [95% confidence interval]: 6MCDP: 1.353 [1.138-1.609], p=0.0006; EDSS score >6: 3.335 [2.530-4.396], p< 0.0001) and the presence of MRI lesion activity during M0-12 (≥1 Gd+ or ≥2 new T2 lesions, 6MCDP: 1.854 [1.038-3.310], p=0.0369; EDSS score >6: 3.434 [1.292-9.128], p=0.0134). Change in EDSS score during M0-12 (2.794 [1.990-3.921], p< 0.0001) and T1 hypointense lesion volume at baseline (1.297 [1.082-1.555], p=0.0049) were predictors of EDSS score >6 only.
Conclusions: In TRANSFORMS, baseline EDSS score and MRI lesion activity during
M0-12 were predictors of both disability outcomes in the long term. Change in EDSS score during M0-12 and T1 hypointense lesion volume at baseline were predictors of patients reaching an EDSS score >6. These findings support early review of treatment regimens to help to prevent worsening disability.
Disclosure:
Pavle Repovic: Acorda Therapeutics, Biogen Idec, EMD Serono, Genzyme, Novartis Pharmaceuticals Corporation, Pfizer and Teva Pharmaceuticals (multiple sources).
Aaron Boster: Acorda Therapeutics, Actelion Pharmaceuticals, Biogen Idec, CNS Therapeutics, Genzyme, Jazz Pharmaceuticals, Medtronic, Novartis Pharmaceuticals, Roche, Serono, Questcor Pharmaceuticals and Teva Pharmaceuticals.
Shannon Ritter, Xiangyi Meng: Novartis Pharmaceuticals Corporation (employees).
Davorka Tomic, Daniela Piani Meier: Novartis Pharma AG (employees).
Till Sprenger: Actelion, Allergan, ATI Pharma, Biogen Idec, ElectroCore, Novartis, Sanofi Genzyme and Teva.
Frederik Barkhof: Biogen Idec, Bayer Schering Pharma, Genzyme, Janssen Alzheimer Immunotherapy, Lundbeck, MediciNova, Merck Serono, Novartis Pharmaceuticals Corporation, Roche, Sanofi-Aventis and Synthon (multiple sources).