Neurology and Therapy (Oct 2023)

Effectiveness and Safety of Teriflunomide in Relapsing–Remitting Multiple Sclerosis and Improvements in Quality of Life: Results from the Real-World TERICARE Study

  • José E. Meca-Lallana,
  • José M. Prieto González,
  • Ana B. Caminero Rodríguez,
  • Javier Olascoaga Urtaza,
  • Ana M. Alonso,
  • Eduardo Durán Ferreras,
  • Raúl Espinosa,
  • Julio Dotor,
  • Mercedes Romera,
  • Adrián Ares Luque,
  • Domingo Pérez Ruiz,
  • Carmen Calles,
  • Miguel A. Hernández,
  • Miguel Hervás García,
  • Amelia Mendoza Rodríguez,
  • Yasmina Berdei Montero,
  • Nieves Téllez,
  • Nicolás Herrera Varó,
  • Javier Sotoca,
  • Silvia Presas-Rodríguez,
  • Luis A. Querol Gutierrez,
  • Mariona Hervás Pujol,
  • Jordi Batlle Nadal,
  • Gisela Martín Ozaeta,
  • Laura Gubieras Lillo,
  • Sergio Martínez Yélamos,
  • Lluís Ramió-Torrentà,
  • Javier Mallada Frechin,
  • Antonio Belenguer Benavides,
  • Francisco Gascón-Giménez,
  • Bonaventura Casanova,
  • Lamberto Landete Pascual,
  • Leticia Berenguer,
  • Laura Navarro,
  • Montserrat Gómez Gutierrez,
  • Carmen Durán,
  • Ana Rodríguez Regal,
  • Elena Álvarez,
  • Daniel A. García-Estévez,
  • Ana M. López Real,
  • Miguel A. Llaneza González,
  • María E. Marzo Sola,
  • José L. Sánchez-Menoyo,
  • Agustín Oterino,
  • Ramón Villaverde González,
  • Tamara Castillo-Triviño,
  • Amaya Álvarez de Arcaya,
  • Cristina Llarena

DOI
https://doi.org/10.1007/s40120-023-00557-7
Journal volume & issue
Vol. 12, no. 6
pp. 2177 – 2193

Abstract

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Abstract Introduction Teriflunomide is a once-daily oral immunomodulator approved for relapsing forms of multiple sclerosis (MS) or relapsing–remitting multiple sclerosis (RRMS; depending on the local label), based on extensive evidence from clinical trials and a real-world setting on efficacy, tolerability and patient-reported benefits. The TERICARE study assessed the impact of teriflunomide treatment over 2 years on health-related quality of life (HRQoL) and some of the most common and disabling symptoms of MS, such as fatigue and depression. Methods This prospective observational study in Spain included RRMS patients treated with teriflunomide for ≤ 4 weeks. The following patient-reported outcomes (PROs) were collected at baseline and every 6 months for 2 years: the 29-item Multiple Sclerosis Impact Scale version 2 (MSIS-29), the 21-item Modified Fatigue Impact Scale (MFIS-21), the Beck Depression Inventory (BDI-II), the Short Form (SF)-Qualiveen and the Treatment Satisfaction Questionnaire for Medication v1.4 (TSQM). Annualised relapse rate (ARR), disability progression according to the Expanded Disability Status Scale (EDSS), and no evidence of disease activity (NEDA-3) were also assessed. Results A total of 325 patients were analysed. Patients had a mean (SD) age of 43.2 years (10.4), a mean baseline EDSS score of 1.75 (1.5), a mean number of relapses in the past 2 years of 1.5 (0.7), and 64% had received prior disease-modifying therapy (DMT). Patients showed significant improvements in the psychological domain of MSIS-29 from 35.9 (26.6) at baseline to 29.4 (25.5) at 18 months (p = 0.004) and 29.0 (24.6) at 24 months (p = 0.002). Levels of fatigue and depression were also reduced. After 2 years of treatment with teriflunomide, ARR was reduced to 0.17 (95% CI 0.14–0.21) from the baseline of 0.42 (95% CI 0.38–0.48), representing a 60.1% reduction. Mean EDSS scores remained stable during the study, and 79.9% of patients showed no disability progression. 54.7% of patients achieved NEDA-3 in the first 12 months, which increased to 61.4% during months 12–24. Patients reported increased satisfaction with treatment over the course of the study, regardless of whether they were DMT naive or not. Conclusion Teriflunomide improves psychological aspects of HRQoL and maintains low levels of fatigue and depression. Treatment with teriflunomide over 2 years is effective in reducing ARR and disability progression.

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