Contributions
Abstract: P691
Type: Poster
Abstract Category: Therapy - disease modifying - Long-term treatment monitoring
Background: Teriflunomide is a once-daily oral immunomodulator approved for relapsing-remitting MS. In 2 pivotal phase 3 clinical trials in patients with relapsing forms of MS (RMS; TEMSO [NCT00134563], and TOWER [NCT00751881]), teriflunomide 14 mg consistently and significantly reduced risk of disability worsening confirmed for ≥12 weeks. Advancement to Expanded Disability Status Scale (EDSS) score ≥6 has been associated with poorer health-related quality of life and may also be associated with an increased burden on healthcare resources as patients become less independent.
Objective(s): To evaluate impact of long-term treatment with teriflunomide 14 mg on risk of advancing to EDSS score ≥6 and ≥7 using pooled data from 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 (385-765 days) ending 48 weeks after last patient randomized. Patients completing the core studies were eligible to enter the extensions. In the TEMSO extension (NCT00803049), patients originally randomized to teriflunomide 7 mg or 14 mg continued treatment; those previously receiving placebo were rerandomized 1:1 to teriflunomide 7 mg or 14 mg. All patients received teriflunomide 14 mg in the TOWER extension. Patients who received teriflunomide 14 mg at any point during TEMSO, TOWER, and their extensions are included in this analysis. 12-week confirmed disability worsening was analyzed in patients treated with teriflunomide 14 mg in TEMSO, TOWER, and their extensions. Probability of advancement to EDSS score ≥6 or ≥7 was derived from Kaplan-Meier estimates.
Results: After 6 years" follow-up of patients with baseline EDSS score < 6 and treatment with teriflunomide 14 mg, 93.7% (n=1316) had not advanced to EDSS score ≥6. Over the same period, 99.5% (n=1336) of patients entering the studies with baseline EDSS score < 7 had not advanced to EDSS score ≥7. No patients treated with teriflunomide 14 mg in the core studies reached EDSS score ≥7 in the extension studies.
Conclusions: A high proportion of patients receiving long-term treatment with teriflunomide 14 mg did not advance to EDSS score ≥6 or ≥7. These results are consistent with the efficacy of teriflunomide vs placebo in reducing risk of disability worsening in the core studies, and support the long-term efficacy in patients continuing teriflunomide.
Disclosure: Study supported by Sanofi Genzyme.
FR: Research support (Acorda Therapeutics, Biogen Idec, Genzyme, National Institutes of Health, National MS Society, Novartis, Sanofi, Teva Neuroscience); 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).
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).
GC: Consulting fees (Almirall, Bayer, Chugai, Excemed, Genzyme, Merck Serono, Novartis, Receptos, Sanofi, Serono Symposia International Foundation [SSIF], Teva); fees from non-CME services (Almirall, Bayer, Biogen, Excemed, Genzyme, Merck Serono, Novartis, Receptos, Sanofi, SSIF, Teva).
AEM: Consulting fees (Accordant Health Services, Acorda Therapeutics, Alkermes, Biogen Idec, EMD Serono, Genentech, Genzyme, GSK, Mallinckrodt Pharmaceuticals [Questcor], Novartis, Roche, Teva); contracted research (Biogen Idec, Genentech, Novartis, Questcor, Roche, Sanofi).
KT: Employee of Sanofi Genzyme.
PT: Employee of Sanofi Genzyme, with ownership interest.
LK: Author´s institution (University Hospital Basel) has received in last 3 years and used exclusively for research support: steering committee, advisory board, and consultancy fees (Actelion, Addex, Bayer HealthCare, Biogen Idec, Biotica, Genzyme, Lilly, Merck, Mitsubishi, Novartis, Ono Pharma, Pfizer, Receptos, Sanofi, Santhera, Siemens, Teva, UCB, XenoPort); speaker fees (Bayer HealthCare, Biogen Idec, Merck, Novartis, Sanofi, Teva); support of educational activities (Bayer HealthCare, Biogen, CSL Behring, Genzyme, Merck, Novartis, Sanofi, Teva); royalties (Neurostatus Systems GmbH); grants (Bayer HealthCare, Biogen Idec, European Union, Merck, Novartis, Roche Research Foundation, Swiss MS Society, Swiss National Research Foundation).
Abstract: P691
Type: Poster
Abstract Category: Therapy - disease modifying - Long-term treatment monitoring
Background: Teriflunomide is a once-daily oral immunomodulator approved for relapsing-remitting MS. In 2 pivotal phase 3 clinical trials in patients with relapsing forms of MS (RMS; TEMSO [NCT00134563], and TOWER [NCT00751881]), teriflunomide 14 mg consistently and significantly reduced risk of disability worsening confirmed for ≥12 weeks. Advancement to Expanded Disability Status Scale (EDSS) score ≥6 has been associated with poorer health-related quality of life and may also be associated with an increased burden on healthcare resources as patients become less independent.
Objective(s): To evaluate impact of long-term treatment with teriflunomide 14 mg on risk of advancing to EDSS score ≥6 and ≥7 using pooled data from 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 (385-765 days) ending 48 weeks after last patient randomized. Patients completing the core studies were eligible to enter the extensions. In the TEMSO extension (NCT00803049), patients originally randomized to teriflunomide 7 mg or 14 mg continued treatment; those previously receiving placebo were rerandomized 1:1 to teriflunomide 7 mg or 14 mg. All patients received teriflunomide 14 mg in the TOWER extension. Patients who received teriflunomide 14 mg at any point during TEMSO, TOWER, and their extensions are included in this analysis. 12-week confirmed disability worsening was analyzed in patients treated with teriflunomide 14 mg in TEMSO, TOWER, and their extensions. Probability of advancement to EDSS score ≥6 or ≥7 was derived from Kaplan-Meier estimates.
Results: After 6 years" follow-up of patients with baseline EDSS score < 6 and treatment with teriflunomide 14 mg, 93.7% (n=1316) had not advanced to EDSS score ≥6. Over the same period, 99.5% (n=1336) of patients entering the studies with baseline EDSS score < 7 had not advanced to EDSS score ≥7. No patients treated with teriflunomide 14 mg in the core studies reached EDSS score ≥7 in the extension studies.
Conclusions: A high proportion of patients receiving long-term treatment with teriflunomide 14 mg did not advance to EDSS score ≥6 or ≥7. These results are consistent with the efficacy of teriflunomide vs placebo in reducing risk of disability worsening in the core studies, and support the long-term efficacy in patients continuing teriflunomide.
Disclosure: Study supported by Sanofi Genzyme.
FR: Research support (Acorda Therapeutics, Biogen Idec, Genzyme, National Institutes of Health, National MS Society, Novartis, Sanofi, Teva Neuroscience); 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).
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).
GC: Consulting fees (Almirall, Bayer, Chugai, Excemed, Genzyme, Merck Serono, Novartis, Receptos, Sanofi, Serono Symposia International Foundation [SSIF], Teva); fees from non-CME services (Almirall, Bayer, Biogen, Excemed, Genzyme, Merck Serono, Novartis, Receptos, Sanofi, SSIF, Teva).
AEM: Consulting fees (Accordant Health Services, Acorda Therapeutics, Alkermes, Biogen Idec, EMD Serono, Genentech, Genzyme, GSK, Mallinckrodt Pharmaceuticals [Questcor], Novartis, Roche, Teva); contracted research (Biogen Idec, Genentech, Novartis, Questcor, Roche, Sanofi).
KT: Employee of Sanofi Genzyme.
PT: Employee of Sanofi Genzyme, with ownership interest.
LK: Author´s institution (University Hospital Basel) has received in last 3 years and used exclusively for research support: steering committee, advisory board, and consultancy fees (Actelion, Addex, Bayer HealthCare, Biogen Idec, Biotica, Genzyme, Lilly, Merck, Mitsubishi, Novartis, Ono Pharma, Pfizer, Receptos, Sanofi, Santhera, Siemens, Teva, UCB, XenoPort); speaker fees (Bayer HealthCare, Biogen Idec, Merck, Novartis, Sanofi, Teva); support of educational activities (Bayer HealthCare, Biogen, CSL Behring, Genzyme, Merck, Novartis, Sanofi, Teva); royalties (Neurostatus Systems GmbH); grants (Bayer HealthCare, Biogen Idec, European Union, Merck, Novartis, Roche Research Foundation, Swiss MS Society, Swiss National Research Foundation).