Contributions
Abstract: EP1715
Type: ePoster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background: In both phase 3 clinical trials (TEMSO, NCT00134563; TOWER, NCT00751881) teriflunomide significantly reduced the risk of disability worsening confirmed for ≥12 weeks in patients with relapsing forms of MS (RMS).
Objective: To assess long-term disability outcomes in a pooled analysis of the TEMSO and TOWER core and extension studies.
Methods: In TEMSO and TOWER, patients with RMS were randomized 1:1:1 to placebo, teriflunomide
7 mg, or 14 mg. Patients received treatment for 2 years in TEMSO; in TOWER, study duration was variable ending 48 weeks after the last patient was randomized. In the TEMSO extension (NCT00803049), patients randomized to teriflunomide 7 mg or 14 mg continued treatment; those previously receiving placebo were re-randomized 1:1 to teriflunomide 7 mg or 14 mg. All patients received teriflunomide 14 mg in the TOWER extension. Disability worsening was assessed using the Expanded Disability Status Scale (EDSS) and Functional System Scores (FSS). In this pooled analysis of the TEMSO and TOWER core and extension studies (intent-to-treat [ITT] population), EDSS scores were categorized based on change over 1 year, as stable (change from baseline of 0.5 points) or improved (reduction from baseline of 1 point or greater), or worsened (increase from baseline of 1 point or greater); change from baseline at Year 5 is reported for each FSS.
Results: The proportion of patients with stable or improved EDSS scores in the overall pooled ITT population remained consistently high over 5 years of treatment with teriflunomide 14 mg (Year 5, 73.6%). This trend was observed in both patients with relapsing-remitting MS (Year 5, 74.0%) and progressive forms of relapsing MS (Year 5, 61.5%). Consistent with these observations of EDSS scores, changes in individual FSS were stable over 5 years (mean [SD] change from baseline at Week 252: Brainstem, 0.05 [0.73]; Bowel & Bladder, 0.12 [0.94]; Cerebellar, 0.20 [0.88]; Cerebral, -0.06 [0.89]; Pyramidal,
0.12 [0.92]; Sensory, 0.18 [1.11]; Visual, 0.01 [0.82]). Disability outcomes were consistent for patients treated with teriflunomide 7 mg.
Conclusions: Long-term disability remained stable or improved with teriflunomide in the majority of patients, regardless of MS subtype, which was also reflected in stability across different functional systems. Disability outcomes as measured by FSS were consistent with EDSS outcomes observed in the teriflunomide clinical development programme.
Disclosure: Study supported by Sanofi Genzyme.
FL: Consulting agreements, advisory board/DSMB membership (Abbott, Acorda, Actelion, Allozyne, Avanir, Bayer HealthCare, Biogen Idec, Celgene, EMD Serono, Genmab, Johnson & Johnson, Medicinova, MorphoSys, Novartis, Pfizer, Questcor, Roche, Sanofi, Teva Neuroscience); Speaker bureaus/honoraria (EMD Serono, Teva Neuroscience); stock ownership (Cognition Pharmaceuticals); research support (Acorda Therapeutics, Biogen Idec, Genzyme, National Institutes of Health, National MS Society, Novartis, Sanofi, Teva Neuroscience).
AM: Consulting fees (Accordant Health Services, Acorda Therapeutics, Alkermes, Biogen Idec, EMD Serono, Genentech/Roche, Genzyme, GSK, Mallinckrodt Pharmaceuticals [Questcor], Novartis, Roche, Teva); contracted research (Biogen Idec, Genentech, Novartis, Questcor, Roche, Sanofi).
PT: Employee of Sanofi Genzyme with ownership interests.
KT and MM: Employee of Sanofi Genzyme.
MSF: Research/educational grant support (Bayer HealthCare, Genzyme); honoraria/consulting fees (Bayer HealthCare, Biogen Idec, EMD Canada, Novartis, Sanofi, Teva Canada Innovation); member of company advisory boards/board of directors/other similar group (Bayer HealthCare, Biogen Idec, Chugai, Merck Serono, Novartis, Opexa Therapeutics, Sanofi, Teva Canada Innovation).
Abstract: EP1715
Type: ePoster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background: In both phase 3 clinical trials (TEMSO, NCT00134563; TOWER, NCT00751881) teriflunomide significantly reduced the risk of disability worsening confirmed for ≥12 weeks in patients with relapsing forms of MS (RMS).
Objective: To assess long-term disability outcomes in a pooled analysis of the TEMSO and TOWER core and extension studies.
Methods: In TEMSO and TOWER, patients with RMS were randomized 1:1:1 to placebo, teriflunomide
7 mg, or 14 mg. Patients received treatment for 2 years in TEMSO; in TOWER, study duration was variable ending 48 weeks after the last patient was randomized. In the TEMSO extension (NCT00803049), patients randomized to teriflunomide 7 mg or 14 mg continued treatment; those previously receiving placebo were re-randomized 1:1 to teriflunomide 7 mg or 14 mg. All patients received teriflunomide 14 mg in the TOWER extension. Disability worsening was assessed using the Expanded Disability Status Scale (EDSS) and Functional System Scores (FSS). In this pooled analysis of the TEMSO and TOWER core and extension studies (intent-to-treat [ITT] population), EDSS scores were categorized based on change over 1 year, as stable (change from baseline of 0.5 points) or improved (reduction from baseline of 1 point or greater), or worsened (increase from baseline of 1 point or greater); change from baseline at Year 5 is reported for each FSS.
Results: The proportion of patients with stable or improved EDSS scores in the overall pooled ITT population remained consistently high over 5 years of treatment with teriflunomide 14 mg (Year 5, 73.6%). This trend was observed in both patients with relapsing-remitting MS (Year 5, 74.0%) and progressive forms of relapsing MS (Year 5, 61.5%). Consistent with these observations of EDSS scores, changes in individual FSS were stable over 5 years (mean [SD] change from baseline at Week 252: Brainstem, 0.05 [0.73]; Bowel & Bladder, 0.12 [0.94]; Cerebellar, 0.20 [0.88]; Cerebral, -0.06 [0.89]; Pyramidal,
0.12 [0.92]; Sensory, 0.18 [1.11]; Visual, 0.01 [0.82]). Disability outcomes were consistent for patients treated with teriflunomide 7 mg.
Conclusions: Long-term disability remained stable or improved with teriflunomide in the majority of patients, regardless of MS subtype, which was also reflected in stability across different functional systems. Disability outcomes as measured by FSS were consistent with EDSS outcomes observed in the teriflunomide clinical development programme.
Disclosure: Study supported by Sanofi Genzyme.
FL: Consulting agreements, advisory board/DSMB membership (Abbott, Acorda, Actelion, Allozyne, Avanir, Bayer HealthCare, Biogen Idec, Celgene, EMD Serono, Genmab, Johnson & Johnson, Medicinova, MorphoSys, Novartis, Pfizer, Questcor, Roche, Sanofi, Teva Neuroscience); Speaker bureaus/honoraria (EMD Serono, Teva Neuroscience); stock ownership (Cognition Pharmaceuticals); research support (Acorda Therapeutics, Biogen Idec, Genzyme, National Institutes of Health, National MS Society, Novartis, Sanofi, Teva Neuroscience).
AM: Consulting fees (Accordant Health Services, Acorda Therapeutics, Alkermes, Biogen Idec, EMD Serono, Genentech/Roche, Genzyme, GSK, Mallinckrodt Pharmaceuticals [Questcor], Novartis, Roche, Teva); contracted research (Biogen Idec, Genentech, Novartis, Questcor, Roche, Sanofi).
PT: Employee of Sanofi Genzyme with ownership interests.
KT and MM: Employee of Sanofi Genzyme.
MSF: Research/educational grant support (Bayer HealthCare, Genzyme); honoraria/consulting fees (Bayer HealthCare, Biogen Idec, EMD Canada, Novartis, Sanofi, Teva Canada Innovation); member of company advisory boards/board of directors/other similar group (Bayer HealthCare, Biogen Idec, Chugai, Merck Serono, Novartis, Opexa Therapeutics, Sanofi, Teva Canada Innovation).