Comparison of 2-year Teriflunomide Outcomes between DMT-naive and switch patients with Relapsing MS: subanalysis of the Real-World TERICARE study (P6-3.003)

Abstract

<h3>Objective:</h3> To evaluate the effect of teriflunomide on clinical and patient-reported outcomes (PROs) in disease-modifying therapy (DMT)-naive and previously treated (switch) patients with relapsing-remitting multiple sclerosis (RRMS). <h3>Background:</h3> Clinical trials and real-world evidence have shown that patients with RRMS benefit from teriflunomide regardless of prior exposure to DMT. <h3>Design/Methods:</h3> TERICARE was a multicentre, observational and prospective study in Spain. RRMS patients with no relapses within the last 30 days before the inclusion received teriflunomide for 2-years. This analysis compared the annualized relapse rate (ARR), Expanded Disability Status Scale (EDSS), disability worsening, quality of life (Multiple Sclerosis Impact Scale, MSIS-29), fatigue (Modified Fatigue Impact Scale-5), and depression (Beck Depression Inventory-II) between DMT-naive and switch patients. <h3>Results:</h3> Of 325 patients included, 117 were DMT-naive and 208 switch patients. At baseline, DMT-naive was younger than switch patients (40.9 <i>vs</i> 44.4 years; p=0.003), had shorter disease duration (3.1 <i>vs</i> 9.5 years; p&lt;0.001), lower EDSS score (1.3 <i>vs</i> 2.0; p&lt;0.001), higher number of relapses in the last 2 years (1.3 <i>vs</i> 0.6; p&lt;0.001) and ARR (95% CI) (0.63 [0.53–0.74] <i>vs</i> 0.31 [0.26–0.37]; p&lt;0.001). The ARR was significantly reduced in both groups after 12 months (DMT-naive=0.24; p&lt;0.001; switch=0.21; p=0.032) and 24 months (DMT-naive=0.19; switch=0.16; p&lt;0.001, both groups). A greater reduction of ARR was observed in DMT-naive both at 12 (63% <i>vs</i> 33%) and 24 months (70% <i>vs</i> 49%). Mean change in EDSS score did not vary between groups, nor the percentage of patients with disability worsening at 12 (20% <i>vs</i> 13.2%; p=0.167) and 24 months (24.2% <i>vs</i> 17.6%; p=0.246). DMT-naive experienced a greater and significant reduction (improvement) in psychological MSIS-29 score at month 24 compared to switch group (−7.11 <i>vs</i> −1.48; p=0.019). <h3>Conclusions:</h3> Teriflunomide shows effectiveness in both DMT-naive and switch RRMS patients with a trend towards better relapse and quality of life outcomes in DMT-naive. <b>Disclosure:</b> Dr. Meca Lallana has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Dr. Meca Lallana has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Meca Lallana has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. Dr. Meca Lallana has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sandoz. Dr. Meca Lallana has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen. Dr. Meca Lallana has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bristol Myers Squibb. Dr. Meca Lallana has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Meca Lallana has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen. Dr. Meca Lallana has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Bristol-Myers-Squibb. Dr. Meca Lallana has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck. Dr. Meca Lallana has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Dr. Meca Lallana has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. Dr. Meca Lallana has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi. The institution of Dr. Meca Lallana has received research support from Merck. The institution of Dr. Meca Lallana has received research support from Novartis. The institution of Dr. Meca Lallana has received research support from Roche. The institution of Dr. Meca Lallana has received research support from Sanofi. The institution of Dr. Meca Lallana has received research support from Biogen. Dr. Prieto has nothing to disclose. Dr. Caminero Rodriguez has nothing to disclose. Javier Olaskoaga has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Sanofi-Genzyme. Rosa Casademont Portell has received personal compensation for serving as an employee of Sanofi. Mrs. Forner has received personal compensation for serving as an employee of Sanofi.