Save
Effect of teriflunomide in subgroups defined by prior treatment: pooled analysis of the phase 3 TEMSO, TOWER, and TENERE studies
Author(s): ,
G. Comi
Affiliations:
University Vita-Salute San Raffaele, Milan, Italy
,
M.S. Freedman
Affiliations:
University of Ottawa and the Ottawa Hospital Research Institute, Ottawa, ON, Canada
,
J. Meca-Lallana
Affiliations:
Hospital Virgen de la Arrixaca, Unidad de Esclerosis Múltiple, Cátedra de Neuroinmunología Clínica y Esclerosis Múltiple, UCAM Universidad Católica San Antonio de Murcia, Murcia, Spain
,
P. Vermersch
Affiliations:
University of Lille, CHU Lille, LIRIC - INSERM U995, FHU Imminent, Lille, France
,
B. Kim
Affiliations:
Department of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
,
A. Parajeles
Affiliations:
Hospital San Juan de Dios, San José, Costa Rica
,
K. Edwards
Affiliations:
Multiple Sclerosis Center of Northeastern New York, New York, NY, United States
,
R. Gold
Affiliations:
St Josef Hospital, Ruhr University Bochum, Bochum, Germany
,
J. Overell
Affiliations:
Institute of Neurological Sciences, Glasgow University, Glasgow, United Kingdom
,
H. Korideck
Affiliations:
Sanofi, Cambridge, MA
,
J. Chavin
Affiliations:
Sanofi, Cambridge, MA
,
E. Poole
Affiliations:
Sanofi, Cambridge, MA
P. Coyle
Affiliations:
Stony Brook MS Comprehensive Care Center, School of Medicine, Stony Brook University, Stony Brook, NY, United States
ECTRIMS Online Library. Comi G. Oct 12, 2018; 229045
Prof. Giancarlo Comi
Prof. Giancarlo Comi
Login now to access Regular content available to all registered users.

You may also access this content "anytime, anywhere" with the Free MULTILEARNING App for iOS and Android
Abstract
Discussion Forum (0)
Rate & Comment (0)

Abstract: P1205

Type: Poster Sessions

Abstract Category: Therapy - Immunomodulation/Immunosuppression

Background: Teriflunomide is a once-daily oral immunomodulator approved for the treatment of relapsing forms of MS. The efficacy and safety of teriflunomide have been established in a clinical trial program including a Phase 2 study (NCT01487096) and the Phase 3 TEMSO (NCT00134563), TOWER (NCT00751881), and TENERE (NCT00883337) studies.
Objective: To investigate the efficacy and safety of teriflunomide in subgroups defined by prior treatment in a pooled post hoc analysis of the Phase 2 study and the Phase 3 TEMSO, TOWER, and TENERE studies.
Methods: In the Phase 2 study and the Phase 3 TEMSO and TOWER studies, patients were randomized 1:1:1 to receive placebo, teriflunomide 7 mg, or teriflunomide 14 mg. In TENERE, patients were randomized 1:1:1 to receive subcutaneous interferon beta-1a (IFN), teriflunomide 7 mg, or teriflunomide 14 mg. Post hoc analysis of ARR was carried out for patients receiving placebo or teriflunomide (IFN-treated patients were not included) according to subgroups defined by prior MS treatment: Group 1, patients whose last prior DMT was discontinued within 6 months prior to randomization; Group 2, patients whose last prior DMT was discontinued 6 months to 2 years prior to randomization; and Group 3, patients who had received no prior DMT. Data reported here are for patients treated with teriflunomide 14 mg.
Results: There were a total of 2643 patients in the pooled population, of whom 348, 412, and 1883 were in Group 1, 2, and 3, respectively. ARR was statistically significantly lower in patients treated with teriflunomide 14 mg compared with placebo, regardless of prior treatment status: Group 1, 0.45 vs 0.81 (45% relative reduction; P=0.0029); Group 2, 0.53 vs 0.79, (34% relative reduction; P=0.0117), and Group 3, 0.33 vs 0.53 (38% relative reduction; P< 0.0001). Safety findings will be reported.
Conclusions: In a pooled analysis of Phase 2 and Phase 3 studies, the treatment effect of teriflunomide was consistent across subgroups of patients defined by prior MS treatment. Notably, treatment efficacy was not lost despite the higher disease activity in the subgroups of patients who had received prior DMTs.
Disclosure: GC: Compensation for consulting services and/or speaking activities from Almirall, Biogen, Celgene, Excemed, Forward Pharma, Genzyme, Merck, Novartis, Receptos, Roche, Sanofi, and Teva; fees for non-CME services from Almirall, Bayer, Biogen, Excemed, Genzyme, Merck Serono, Novartis, Receptos, Sanofi, SSIF, and Teva. MF: Research/educational grant support from Bayer and Genzyme; honoraria/consulting fees from Bayer, Biogen, EMD Canada, Novartis, Sanofi, and Teva; member of company advisory boards/board of directors/other similar group for Bayer, Biogen, Chugai, Merck Serono, Novartis, Opexa Therapeutics, Sanofi, and Teva. JML: Consulting fees from Almirall, Biogen, Merck Serono, Novartis, Sanofi, and Teva. PV: Honoraria, consulting fees from Almirall, Bayer, Biogen, Celgene, Genzyme, Sanofi, GSK, Merck Serono, Novartis, Servier, and Teva; research support from Bayer, Biogen, Genzyme, Sanofi, and Merck Serono. BK: Nothing to disclose. AP: Nothing disclosed. KE: Consulting fees from Biogen, Genzyme, EMD Serono; research support from Biogen, Eli Lilly, Genentech, Sanofi, and Hoffmann-La Roche, Novartis. RG: Consulting fees from Bayer, Biogen, Elan, Genzyme, Roche, and Teva; grant/research support from Bayer, Biogen, Genzyme, and Teva. JO: Speakers fees, advisory fees, travel, and hospitality from Roche, Biogen, Novartis, Teva, Merck, Medday, Allergan, Celgene, and Genzyme; Research and departmental funds from Novartis, Biogen, Roche, Genzyme, and Merck. HK: Employee of Sanofi with ownership interest. JC: Employee of Sanofi with ownership interest. EP: Employee of Sanofi with ownership interest. PC: Consulting fees from Accordant, Acorda, Bayer, Biogen, Celgene, Genentech, Roche, Genzyme, Sanofi, Novartis, Serono, and Teva; research support from Actelion, Alkermes, Genentech, Roche, MedDay, NINDS, and Novartis.
Study supported by Sanofi.

Code of conduct/disclaimer available in General Terms & Conditions
Anonymous User Privacy Preferences

Strictly Necessary Cookies (Always Active)

MULTILEARNING platforms and tools hereinafter referred as “MLG SOFTWARE” are provided to you as pure educational platforms/services requiring cookies to operate. In the case of the MLG SOFTWARE, cookies are essential for the Platform to function properly for the provision of education. If these cookies are disabled, a large subset of the functionality provided by the Platform will either be unavailable or cease to work as expected. The MLG SOFTWARE do not capture non-essential activities such as menu items and listings you click on or pages viewed.


Performance Cookies

Performance cookies are used to analyse how visitors use a website in order to provide a better user experience.



Google Analytics is used for user behavior tracking/reporting. Google Analytics works in parallel and independently from MLG’s features. Google Analytics relies on cookies and these cookies can be used by Google to track users across different platforms/services.


Save Settings