Abstract Details

Title Efficacy and Safety of Teriflunomide in Patients of Differing Ages: Analysis of Pooled Clinical Trials

Topic Multiple Sclerosis

Presentation(s) P4 - Poster Session 4 (5:30 PM-6:30 PM)

Poster/Presentation
Number 15-047

Objective To report long-term safety and efficacy in subgroups defined by age in a pooled analysis of the Phase 2 (NCT01487096), and the Phase 3 TEMSO (NCT00134563; NCT00803049), TOWER (NCT00751881), TOPIC (NCT00622700), and TENERE (NCT00883337) core and extension studies.

Background

MS affects individuals of all ages, and it is unknown whether the efficacy and safety of teriflunomide differs by age.

Design/Methods

Efficacy data (annualized relapse rate [ARR]) were pooled from the Phase 2 study (patients aged 18–65 years), TEMSO (18–55 years), TOWER (18–55 years), and TENERE (18+ years). Safety analyses (adverse events [AEs]) also included TOPIC (18–55 years). Patients receiving placebo or teriflunomide 14 mg in the core+extension studies were included and stratified by age at study entry (≤25, >25–≤35, >35–≤45, and >45 years).

Results In the core period, ARR was reduced significantly with teriflunomide vs placebo in all age groups: risk reduction (RR)=0.445, P=0.0005 (≤25 years); RR=0.732, P=0.0148 (>25–≤35 years); RR=0.641, P=0.0002 (>35–≤45 years); and RR=0.642, P=0.0096 (>45 years). The mean age (SD) was 36.8 (9.3). In the core+extension period, unadjusted ARR (95% CI) was 0.228 (0.216, 0.241) overall in patients receiving teriflunomide, and in subgroups by age were: 0.269 (0.220, 0.317; ≤25 years), 0.303 (0.275, 0.330; >25–≤35 years), 0.201 (0.182, 0.219; >35–≤45 years), and 0.181 (0.159, 0.202; >45 years). The proportion of patients experiencing AEs across all age groups in the core and core+extension periods was 82.6% and 88.0% (≤25 years), 87.5% and 87.0%, (>25–≤35 years), 90.3% and 90.7%, (>35–≤45 years), and 91.1 and 89.3, (>45 years), respectively. Approximately 60% of patients completed the study.

Conclusions

Teriflunomide 14 mg significantly reduced ARRs across all age groups vs placebo in the core studies. Similar safety outcomes were observed in teriflunomide-treated patients regardless of age in core+extension studies.

Authors/Disclosures
Mariana Espinosa-Polanco PRESENTER	No disclosure on file
Sandra Vukusic, MD (Hopital Neurologique Pierre Wertheimer)	The institution of Dr. Vukusic has received research support from Biogen. The institution of Dr. Vukusic has received research support from Janssen. The institution of Dr. Vukusic has received research support from Merck. The institution of Dr. Vukusic has received research support from Novartis. The institution of Dr. Vukusic has received research support from Roche.
Klaus Tiel-Wilck, MD (Neurolog.Facharztzentrum Berlin)	No disclosure on file
Mauro Zaffaroni (Teva Pharma Italia)	No disclosure on file
Stanley L. Cohan, MD, PhD, FAAN	Dr. Cohan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen. Dr. Cohan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for AbbVie. Dr. Cohan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Cohan has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche Genentech. Dr. Cohan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Bristol Myers Squibb (Celgene). Dr. Cohan has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Icometrix. Dr. Cohan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for EMD Serono. Dr. Cohan has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. Dr. Cohan has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for sanofi genzyme. Dr. Cohan has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Novartis. Dr. Cohan has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Roche Genentech. Dr. Cohan has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Bristol Myers Squibb. Dr. Cohan has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for EMD Serono. Dr. Cohan has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Icometrix.
Jihad S. Inshasi, MD, MBBS, FAAN (Rashid Hospital)	Dr. Inshasi has nothing to disclose.
David Rog, MBBS	Dr. Rog has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Rog has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi Genzyme. Dr. Rog has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Novartis. Dr. Rog has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Roche. Dr. Rog has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Merck. Dr. Rog has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Neuraxpharm. Dr. Rog has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Teva. The institution of Dr. Rog has received research support from Merck. The institution of Dr. Rog has received research support from Novartis. The institution of Dr. Rog has received research support from TG Therapeutics. Dr. Rog has received research support from Janssen-Cilag.
Darren P. Baker, PhD (Sanofi Genzyme)	Dr. Baker has received personal compensation for serving as an employee of Sanofi. Dr. Baker has received stock or an ownership interest from Sanofi.
Kathleen C. Somera-Molina, PhD	Dr. Somera-Molina has received personal compensation for serving as an employee of Biogen. Dr. Somera-Molina has received stock or an ownership interest from Biogen.
Yelena G. Pyatkevich, MD (Takeda Pharmaceutical)	Dr. Pyatkevich has received personal compensation for serving as an employee of Takeda. Dr. Pyatkevich has stock in Takeda.
Elizabeth Poole	No disclosure on file
Keith R. Edwards, MD, FAAN (MS Center of Northeastern New York)	No disclosure on file

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