Contributions
Abstract: P1191
Type: Poster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background: Teriflunomide is a once-daily oral immunomodulator approved for the treatment of relapsing-remitting MS (RRMS) in 70 countries, and more than 71,000 patients are currently being treated with teriflunomide worldwide. Analysis of prespecified subgroups defined by baseline demographics and disease characteristics in the TEMSO (NCT00134563) and TOWER (NCT00751881) core studies demonstrated consistent outcomes with teriflunomide treatment on annualized relapse rates and confirmed disability worsening (CDW).
Objective: To examine long-term disability outcomes in subgroups of patients defined by baseline demographics and disease characteristics in a pooled dataset of the TEMSO and TOWER studies and their extensions.
Methods: In the core studies, patients with relapsing forms of MS (RMS) were randomized to placebo or teriflunomide 7mg or 14mg. In the TEMSO extension (NCT00803049), teriflunomide-treated patients continued on their original dose; placebo-treated patients were re-randomized to teriflunomide 7mg or 14mg. In the TOWER extension, all patients received teriflunomide 14mg. The risk of 12-week CDW (12-w CDW), determined using the Kaplan-Meier (KM) method, was evaluated in subgroups of patients defined by baseline demographics (gender, age) and disease characteristics (MS subtype, EDSS score, number of relapses before treatment, and previous use of disease-modifying therapies [DMTs]) in a pooled dataset of patients ever exposed to teriflunomide 14mg.
Results: Data from 1354 patients in the TEMSO and TOWER studies demonstrated that the probability of 12‑w CDW after treatment with teriflunomide 14mg was broadly similar across subgroups defined by demographics or disease characteristics. At Year 5, probability of 12-w CDW was comparable for male (0.344) and female (0.347) patients. Similar rates were observed within subgroups defined by age (< 38 years, 0.338; ≥38 years, 0.353) and among subgroups stratified by EDSS score (≤3.5, 0.349; >3.5, 0.340), number of previous relapses (≤1, 0.343; 2, 0.362) and MS subtype (progressive forms of RMS, 0.358; RRMS, 0.345). A slightly lower probability of 12-w CDW was observed in treatment-naïve patients (0.339) vs those previously exposed to another DMT (0.363).
Conclusions: These observations demonstrate long-term stability of EDSS score after treatment with teriflunomide and show that probability of longer-term CDW was generally similar across subgroups defined by demographics or baseline disease characteristics.
Disclosure: Study supported by Sanofi Genzyme.
PV: Honoraria, consulting fees (Almirall, Bayer, Biogen Idec, Genzyme/Sanofi, GSK, Merck Serono, Novartis, Servier, Teva); research support (Bayer, Biogen Idec, Genzyme/Sanofi, Merck Serono)
PT: Employee of Sanofi Genzyme with ownership interest.
EMP and MM: Employees 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: P1191
Type: Poster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background: Teriflunomide is a once-daily oral immunomodulator approved for the treatment of relapsing-remitting MS (RRMS) in 70 countries, and more than 71,000 patients are currently being treated with teriflunomide worldwide. Analysis of prespecified subgroups defined by baseline demographics and disease characteristics in the TEMSO (NCT00134563) and TOWER (NCT00751881) core studies demonstrated consistent outcomes with teriflunomide treatment on annualized relapse rates and confirmed disability worsening (CDW).
Objective: To examine long-term disability outcomes in subgroups of patients defined by baseline demographics and disease characteristics in a pooled dataset of the TEMSO and TOWER studies and their extensions.
Methods: In the core studies, patients with relapsing forms of MS (RMS) were randomized to placebo or teriflunomide 7mg or 14mg. In the TEMSO extension (NCT00803049), teriflunomide-treated patients continued on their original dose; placebo-treated patients were re-randomized to teriflunomide 7mg or 14mg. In the TOWER extension, all patients received teriflunomide 14mg. The risk of 12-week CDW (12-w CDW), determined using the Kaplan-Meier (KM) method, was evaluated in subgroups of patients defined by baseline demographics (gender, age) and disease characteristics (MS subtype, EDSS score, number of relapses before treatment, and previous use of disease-modifying therapies [DMTs]) in a pooled dataset of patients ever exposed to teriflunomide 14mg.
Results: Data from 1354 patients in the TEMSO and TOWER studies demonstrated that the probability of 12‑w CDW after treatment with teriflunomide 14mg was broadly similar across subgroups defined by demographics or disease characteristics. At Year 5, probability of 12-w CDW was comparable for male (0.344) and female (0.347) patients. Similar rates were observed within subgroups defined by age (< 38 years, 0.338; ≥38 years, 0.353) and among subgroups stratified by EDSS score (≤3.5, 0.349; >3.5, 0.340), number of previous relapses (≤1, 0.343; 2, 0.362) and MS subtype (progressive forms of RMS, 0.358; RRMS, 0.345). A slightly lower probability of 12-w CDW was observed in treatment-naïve patients (0.339) vs those previously exposed to another DMT (0.363).
Conclusions: These observations demonstrate long-term stability of EDSS score after treatment with teriflunomide and show that probability of longer-term CDW was generally similar across subgroups defined by demographics or baseline disease characteristics.
Disclosure: Study supported by Sanofi Genzyme.
PV: Honoraria, consulting fees (Almirall, Bayer, Biogen Idec, Genzyme/Sanofi, GSK, Merck Serono, Novartis, Servier, Teva); research support (Bayer, Biogen Idec, Genzyme/Sanofi, Merck Serono)
PT: Employee of Sanofi Genzyme with ownership interest.
EMP and MM: Employees 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).