Abstract: Long-Term Outcomes for Subgroup of Patients with a Primary Presentation of Optic Neuritis in the TOPIC Extension Study (2017 Annual Meeting of the Consortium of Multiple Sclerosis Centers)

DX37
Long-Term Outcomes for Subgroup of Patients with a Primary Presentation of Optic Neuritis in the TOPIC Extension Study

Thursday, May 25, 2017

B2 (New Orleans Convention Center)

Jiwon Oh, MD , St. Michael's Hospital, University of Toronto, Toronto, ON, Canada

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

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

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

Jerome de Seze, MD PhD , University Hospital of Strasbourg, Strasbourg, France

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

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:

TOPIC (NCT00622700) evaluated the efficacy and safety of teriflunomide, a once-daily oral immunomodulator, in patients with a first clinical episode suggestive of MS (N=614). Teriflunomide 14 mg significantly reduced the risk of relapse determining conversion to clinically definite MS (CDMS; primary endpoint), including in those patients with a primary presentation of optic neuritis (ON; P=0.0458). Patients completing TOPIC, still on-study at completion, or experiencing relapse determining conversion to CDMS, were eligible to enroll in an extension.

Objectives:

To report clinical outcomes for a subgroup of patients with a primary presentation of ON over the course of the TOPIC extension study through to completion.

Methods:

In TOPIC, patients received placebo or teriflunomide 7 mg or 14 mg for ≤108 weeks. In the extension, teriflunomide-treated patients continued to receive their original dose; placebo-treated patients were re-randomized 1:1 to teriflunomide 7 mg or 14 mg. Statistical analyses were performed using time-to-event methods.

Results:

Of the 614 patients in TOPIC, 200 (32.6%) had a primary presentation of ON. Demographic and baseline disease characteristics were comparable across the overall TOPIC and ON subgroups. At Year 6, the risk of relapse determining conversion to CDMS for the overall TOPIC population treated with teriflunomide 14 mg was reduced by 35.6% vs patients initially randomized to placebo (P=0.0151). Similarly, at Year 6, the risk of relapse for patients in the ON subgroup treated with teriflunomide 14 mg was reduced by 51.5% vs placebo (P=0.0462). The majority of patients with ON presented with monofocal status (n=148); in this additional subgroup, the risk of relapse determining conversion to CDMS at Year 6 was reduced by 70% for patients treated with teriflunomide 14 mg vs placebo (P=0.0394). In patients with multifocal presentation (n=52), the teriflunomide 14-mg group demonstrated a 44% reduction in risk of relapse vs placebo, but this was not significant (P=0.2432), likely because of the small subgroup size. Safety results in the TOPIC trial were consistent with those from other clinical trials of teriflunomide, and no unexpected adverse events were observed.

Conclusions:

Together with data from studies in patients with relapsing forms of MS, observations in this population of patients with early MS demonstrate consistent efficacy and safety outcomes with long-term teriflunomide treatment, including in patients presenting with ON as their first clinical episode.

DX37 Long-Term Outcomes for Subgroup of Patients with a Primary Presentation of Optic Neuritis in the TOPIC Extension Study

DX37
Long-Term Outcomes for Subgroup of Patients with a Primary Presentation of Optic Neuritis in the TOPIC Extension Study