Abstract: Efficacy and Safety of Teriflunomide in Asian Patients with Relapsing Forms of MS: A Subgroup Analysis of the Phase 3 TOWER Study (2017 Annual Meeting of the Consortium of Multiple Sclerosis Centers)

DX59
Efficacy and Safety of Teriflunomide in Asian Patients with Relapsing Forms of MS: A Subgroup Analysis of the Phase 3 TOWER Study

Thursday, May 25, 2017

B2 (New Orleans Convention Center)

Richard AL Macdonell, MD , Austin Health, Heidelberg, Australia

Mark S Freedman, MD , University of Ottawa and the Ottawa Hospital Research Institute, Ottawa, ON, Canada

Xianhao Xu, MD , Beijing Hospital, Beijing, China

Steve Vucic, MD , University of Sydney, Sydney, Australia

Philippe Truffinet, MD , Sanofi, Chilly-Mazarin, France

Myriam Benamor, MD , Sanofi, Chilly-Mazarin, France

Karthinathan Thangavelu, PhD , Sanofi Genzyme, Cambridge, MA

Aaron E Miller, MD , Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai, New York, NY

Heather St Michael, BSc , Fishawack, Abingdon, United Kingdom

Background: Teriflunomide is a once-daily oral immunomodulator approved for the treatment of relapsing-remitting MS. TOWER (NCT00751881), a phase 3 placebo-controlled study in patients with relapsing forms of MS, was conducted in 26 countries including China. Teriflunomide 14 mg significantly reduced annualized relapse rate (ARR; 36.3%, P=0.0001) and the risk of disability worsening confirmed for ≥12 weeks (12w-CDW) by 31.5% vs placebo (P=0.0442).

Objectives: To report efficacy and safety outcomes associated with teriflunomide treatment in a subgroup of Asian patients enrolled into TOWER.

Methods: Patients were randomized 1:1:1 to placebo, or teriflunomide 7 mg or 14 mg, for ≥48 weeks. The primary and key secondary endpoints were ARR and 12w-CDW, respectively. Incidence of adverse events (AEs) were monitored throughout the study up to completion.

Results: The mean (SD) duration of study treatment for the TOWER core and its extension was 211.27 (56.95) weeks. Of the 1165 patients randomized and treated in TOWER, 168 (14.4%) were of Asian descent. Demographic and baseline disease characteristics of this population were comparable to the non-Asian TOWER population, although Asian patients had a shorter time since first symptoms of MS (mean [SD]: 5 [5.20] years vs non-Asian, 8.5 [6.83] years), and a smaller proportion had received another disease-modifying therapy within the last 2 years (3.6% vs non-Asian, 37.9%). No significant treatment-by-subgroup interaction based on Asian race was observed for patients treated with teriflunomide 14 mg with respect to ARR or 12w-CDW. Within the Asian subpopulation, treatment with teriflunomide 14 mg reduced the ARR and risk of 12w-CDW by 68.8% (P=0.0015) and 49.2% (P=0.3172) vs placebo, respectively. The incidence of AEs was similar across treatment groups in both Asian and non-Asian populations; serious AEs and AEs leading to treatment discontinuation were consistent with the overall TOWER population.

Conclusions: Efficacy outcomes in Asians enrolled in the TOWER study were consistent with the non-Asian population. Safety was also similar to that seen in non-Asian treated patients, with no new or unexpected safety findings observed.

DX59 Efficacy and Safety of Teriflunomide in Asian Patients with Relapsing Forms of MS: A Subgroup Analysis of the Phase 3 TOWER Study

DX59
Efficacy and Safety of Teriflunomide in Asian Patients with Relapsing Forms of MS: A Subgroup Analysis of the Phase 3 TOWER Study