Abstract: Final Outcomes from the Teriflunomide TOWER Extension Study: Up to 6 Years of Follow-up (Core Plus Extension) in Patients with Relapsing Forms of MS (2016 CMSC Annual Meeting)

DX48
Final Outcomes from the Teriflunomide TOWER Extension Study: Up to 6 Years of Follow-up (Core Plus Extension) in Patients with Relapsing Forms of MS

Thursday, June 2, 2016

Exhibit Hall

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

Ludwig Kappos, MD , University Hospital Basel, Basel, Switzerland

Giancarlo Comi, MD , University Vita-Salute San Raffaele, Milan, Italy

Aaron E Miller, MD , Icahn School of Medicine at Mount Sinai, New York, NY

Jerry Wolinsky, MD , University of Texas Health Science Center at Houston, Houston, TX

Karthinathan Thangavelu, PhD , Genzyme, a Sanofi company, Cambridge, MA

Philippe Truffinet, MD , Genzyme, a Sanofi company, Chilly-Mazarin, France

Myriam Benamor, MD , Genzyme, a Sanofi company, Chilly-Mazarin, France

Pascal Rufi, MD , Genzyme, a Sanofi company, Chilly-Mazarin, France

Paul O'Connor, MD , University of Toronto, Toronto, ON, Canada

Background:

Teriflunomide is a once-daily oral immunomodulator approved for relapsing forms of MS (RMS). In the randomized placebo-controlled phase 3 TOWER study (NCT00751881), patients with RMS (n=1165) received placebo or teriflunomide 7 mg or 14 mg once daily for ≥48 weeks. TOWER confirmed consistent efficacy on annualized relapse rate (ARR) and disability, and safety profile, observed in other teriflunomide trials. Patients completing the core study could enroll in an open-label extension and continue treatment until teriflunomide was commercially available in their country.

Objectives:

To report final long-term efficacy and safety outcomes from patients treated with teriflunomide in the TOWER core study and its extension.

Methods:

All patients entering the extension received teriflunomide 14 mg regardless of core study treatment. Efficacy data are reported for the intent-to-treat (ITT) population. The safety population included all randomized patients exposed to medication, analyzed according to treatment received.

Results:

In total, 751 patients entered the extension (safety population: placebo/14 mg, n=251; 7 mg/14 mg, n=267; 14 mg/14 mg, n=233). Of these, 549 patients (73%) completed the study treatment period; cumulative durations of teriflunomide exposure for patients across the core study and extension were 529 (placebo/14 mg), 1088 (7 mg/14 mg), and 951 (14 mg/14 mg) patient-years.

In the ITT population (placebo/14 mg, n=253; 7 mg/14 mg, n=265; 14 mg/14 mg, n=233), the adjusted ARR in the extension was 0.193. At Month 60 after core study baseline, mean changes in Expanded Disability Status Scale (EDSS) scores from baseline were <0.03 in all treatment groups.

In the extension, percentages of patients reporting adverse events (AEs, 79%) or AEs leading to treatment discontinuation (7.2%) were similar across treatment groups; the nature of AEs was consistent with those seen in the core study. Serious AEs were reported by <13% of patients in each treatment group. Six deaths were reported: pulmonary tuberculosis (Belarus), pulmonary embolism (China), hematemesis (Tunisia), sepsis (Philippines), and suicide (Romania and USA).

Conclusions:

Most patients (73%) entering the TOWER extension completed the study (follow-up period of up to 6 years). EDSS remained stable in the core and extension, and ARR remained <0.2 in the extension; AEs reported were consistent with those in the core study. These data further support the positive benefit-risk profile of long-term teriflunomide treatment for RMS.

DX48 Final Outcomes from the Teriflunomide TOWER Extension Study: Up to 6 Years of Follow-up (Core Plus Extension) in Patients with Relapsing Forms of MS

DX48
Final Outcomes from the Teriflunomide TOWER Extension Study: Up to 6 Years of Follow-up (Core Plus Extension) in Patients with Relapsing Forms of MS