Author Topic: (AAN abst.) Long-term outcomes in patients w/PPMS w/relapses...  (Read 64 times)

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Offline agate

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Presented at the annual AAN conference in Boston, April 2017.
Quote
Long-term Outcomes in Patients with Progressive MS with Relapses: Analysis of TEMSO and TOWER Extension Data

Flavia Nelson1, Christine Lebrun-Frenay2, William Camu3, Alexey Boyko4, Karthinathan Thangavelu5, Pascal Rufi5, Steve Cavalier5, Philippe Truffinet5, Jinjun Liang5, Fred Lublin6

1
University of Texas, Health Science Center at Houston, 2 Hôpital Pasteur, 3 Institute for Neurosciences Montpellier, 4 Russian State Medical University, NeuroClinica at the Usupov’s Hospital, 5 Sanofi Genzyme, 6 Mount
Sinai School of Medicine

Objective:

To analyze long-term outcomes in patients with progressive forms of MS with relapses, using data from ≤9 years’follow-up of TEMSO and TOWER and their extensions.

Background:

The pivotal phase 3 teriflunomide studies, TEMSO (NCT00134563) and TOWER (NCT00751881), included a small number of patients with progressive MS with relapses (secondary progressive MS [SPMS] or progressive relapsing MS [PRMS]).

Design/Methods:

Patients with relapsing forms of MS were randomized 1:1:1 to receive placebo or teriflunomide 7 mg or 14 mg for 108 (TEMSO) or ≥48 (TOWER) weeks. Patients completing the core studies were eligible to enter extensions. In TEMSO extension (NCT00803049), teriflunomide-treated patients continued as randomized; placebo-treated patients were re-randomized to teriflunomide 7 mg or 14 mg.

In TOWER extension, all patients received teriflunomide 14 mg.

TEMSO and TOWER data were pooled, irrespective of treatment allocation, to perform a post hoc analysis of disability worsening in all patients with progressive MS with relapses.

Results:

This analysis included 122 patients with progressive MS with relapses at randomization; 60 had SPMS and 62 had PRMS. Of these, 72 (59.0%) completed the core studies. During the analysis period of ≤9 years, 98 (80.3%) of these patients did not experience disability worsening confirmed for ≥12 weeks (Kaplan–Meier estimate of proportion not progressing, 0.694 [95% confidence interval, CI: 0.572, 0.787]).

No additional patients experienced confirmed disability worsening in Years 5–9 of the follow-up period. At baseline, median Expanded Disability
Status Scale (EDSS) score for patients with progressive MS with relapses was 4; at last follow-up (≤9 years), median change from baseline was 0. Further analysis of these patients will be discussed.

Conclusions:

These data from a small number of patients provide preliminary evidence that teriflunomide treatment may have a beneficial effect on accumulation of disability (as measured by EDSS) in some patients with progressive MS with
relapses.

____________________
Study Supported by: Sanofi Genzyme
MS Speaks--online for 12 years

SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010.

 

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