Contributions
Abstract: P692
Type: Poster
Abstract Category: Therapy - disease modifying - Long-term treatment monitoring
Background: Teriflunomide is a once-daily oral immunomodulator for the treatment of relapsing-remitting MS. In the randomized, phase 3 TEMSO study (NCT00134563), patients with relapsing forms of MS (n=1086) received placebo or teriflunomide 7 mg or 14 mg for 108 weeks. Teriflunomide 14 mg significantly reduced annualized relapse rate (ARR) and risk of disability worsening confirmed for ≥12 weeks; 7 mg significantly reduced ARR. Patients completing TEMSO core study were eligible to enrol in an extension (NCT00803049), which continued until teriflunomide was locally reimbursed.
Objective(s): To report safety and efficacy outcomes from patients in the TEMSO extension study through to completion at 10.5 years of treatment.
Methods: Extension entry began in 2006 and ended in 2010. Upon entering the extension, teriflunomide-treated patients continued to receive their original blinded dose; the placebo group was rerandomized 1:1 to teriflunomide 7 mg or 14 mg (dose-blinded). Safety results are presented for the extension; efficacy results are presented for the total treatment period (core plus extension). Study magnetic resonance imaging (MRI) scans were performed annually until 2012.
Results: A total of 740 patients entered the extension. Cumulative teriflunomide exposures (from start of core study) were 811, 1639, 703, and 1687 patient-years for the placebo/7-mg, 7-mg/7-mg, placebo/14-mg, and 14-mg/14-mg groups, respectively. Median treatment duration was 7 years. During the extension, 92% of patients experienced adverse events (AEs), the majority of which were mild in intensity; AEs led to discontinuation in < 13% of patients. The nature and incidence of AEs were consistent with other teriflunomide studies. ARR remained low in each year of the extension (288/740 patients remained free from relapse) and Expanded Disability Status Scale scores remained stable throughout. The majority of patients (413/740) remained free from disability worsening confirmed for 12 weeks. Between baseline and Year 5, the volume and number of gadolinium-enhancing T1 lesions per MRI scan remained low.
Conclusions: Results from the completed TEMSO long-term extension study support previous observations that teriflunomide has a well-characterized and manageable long-term safety profile. ARR, rates of disability worsening, and MRI activity remained low throughout the extension, providing evidence that teriflunomide efficacy is maintained with long-term treatment.
Disclosure: Study supported by 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).
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).
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).
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).
CL-F: Consulting fees, honoraria, or scientific committee support (Allergan, Almirall, Bayer Schering, Biogen Idec, Genzyme, Merck Serono, Novartis, Sanofi, Teva).
PT: Employee of Sanofi Genzyme, with ownership interest.
AP: Employee of Sanofi Genzyme.
MB: Employee of Sanofi Genzyme.
JSW: Within the last 3 years, consulting agreements (AbbVie, Actelion, Alkermes, Athersys, Inc., Bayer HeathCare, EMD Serono, Forward Pharma, Genzyme, Novartis, Roche, Taketa, Teva, XenoPort); contracted research (Genzyme, National Institutes of Health, National MS Society); royalties (for monoclonal antibodies out-licensed to Chemicon International), through the University of Texas Health Science Center at Houston.
Abstract: P692
Type: Poster
Abstract Category: Therapy - disease modifying - Long-term treatment monitoring
Background: Teriflunomide is a once-daily oral immunomodulator for the treatment of relapsing-remitting MS. In the randomized, phase 3 TEMSO study (NCT00134563), patients with relapsing forms of MS (n=1086) received placebo or teriflunomide 7 mg or 14 mg for 108 weeks. Teriflunomide 14 mg significantly reduced annualized relapse rate (ARR) and risk of disability worsening confirmed for ≥12 weeks; 7 mg significantly reduced ARR. Patients completing TEMSO core study were eligible to enrol in an extension (NCT00803049), which continued until teriflunomide was locally reimbursed.
Objective(s): To report safety and efficacy outcomes from patients in the TEMSO extension study through to completion at 10.5 years of treatment.
Methods: Extension entry began in 2006 and ended in 2010. Upon entering the extension, teriflunomide-treated patients continued to receive their original blinded dose; the placebo group was rerandomized 1:1 to teriflunomide 7 mg or 14 mg (dose-blinded). Safety results are presented for the extension; efficacy results are presented for the total treatment period (core plus extension). Study magnetic resonance imaging (MRI) scans were performed annually until 2012.
Results: A total of 740 patients entered the extension. Cumulative teriflunomide exposures (from start of core study) were 811, 1639, 703, and 1687 patient-years for the placebo/7-mg, 7-mg/7-mg, placebo/14-mg, and 14-mg/14-mg groups, respectively. Median treatment duration was 7 years. During the extension, 92% of patients experienced adverse events (AEs), the majority of which were mild in intensity; AEs led to discontinuation in < 13% of patients. The nature and incidence of AEs were consistent with other teriflunomide studies. ARR remained low in each year of the extension (288/740 patients remained free from relapse) and Expanded Disability Status Scale scores remained stable throughout. The majority of patients (413/740) remained free from disability worsening confirmed for 12 weeks. Between baseline and Year 5, the volume and number of gadolinium-enhancing T1 lesions per MRI scan remained low.
Conclusions: Results from the completed TEMSO long-term extension study support previous observations that teriflunomide has a well-characterized and manageable long-term safety profile. ARR, rates of disability worsening, and MRI activity remained low throughout the extension, providing evidence that teriflunomide efficacy is maintained with long-term treatment.
Disclosure: Study supported by 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).
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).
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).
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).
CL-F: Consulting fees, honoraria, or scientific committee support (Allergan, Almirall, Bayer Schering, Biogen Idec, Genzyme, Merck Serono, Novartis, Sanofi, Teva).
PT: Employee of Sanofi Genzyme, with ownership interest.
AP: Employee of Sanofi Genzyme.
MB: Employee of Sanofi Genzyme.
JSW: Within the last 3 years, consulting agreements (AbbVie, Actelion, Alkermes, Athersys, Inc., Bayer HeathCare, EMD Serono, Forward Pharma, Genzyme, Novartis, Roche, Taketa, Teva, XenoPort); contracted research (Genzyme, National Institutes of Health, National MS Society); royalties (for monoclonal antibodies out-licensed to Chemicon International), through the University of Texas Health Science Center at Houston.