Patricia K Coyle1, Bhupendra Khatri2, Keith R Edwards3, José E Meca-Lallana4, Steve Cavalier5, Pascal Rufi6, Myriam Benamor7, Sandrine Brette8, Miqun Robinson9, Ralf Gold10. 1. Department of Neurology, Stony Brook University, HSC T12-020, Stony Brook, NY 11794-8121, USA. Electronic address: Patricia.Coyle@stonybrookmedicine.edu. 2. The Regional MS Center, Center for Neurological Disorders, Wheaton Franciscan Health Care, 3237 S 16th St, Milwaukee, WI 53215, USA. Electronic address: bokhatri@aol.com. 3. Multiple Sclerosis Center of Northeastern New York, 1205 Troy-Schenectady Rd, Ste 105, Latham, NY 12110, USA. Electronic address: kedwards@tristateneuro.com. 4. Hospital Virgen de la Arrixaca, Ctra., Madrid-Cartagena, s/n, 30120 Murcia, Spain; Cátedra de Neuroinmunología Clínica y Esclerosis Múltiple, UCAM Universidad Católica San Antonio de Murcia, Campus de los Jerónimos, Guadalupe, 30107 Murcia, Spain. Electronic address: pmecal@gmail.com. 5. Sanofi Genzyme, 500 Kendall Street, 6th Floor, Cambridge, MA 02142, USA. Electronic address: steven.cavalier@sanofi.com. 6. Sanofi Genzyme, 1 Avenue Pierre Brossolette, 91385 Chilly-Mazarin, France. Electronic address: pascal.rufi@sanofi.com. 7. Sanofi Genzyme, 1 Avenue Pierre Brossolette, 91385 Chilly-Mazarin, France. 8. Aixial, 4 Rue Barthelemy Danjou, 92100 Boulogne-Billancourt, France. Electronic address: Sandrine.brette@sanofi.com. 9. Sanofi, 55 Corporate Drive, Bridgewater, NJ 08807, USA. Electronic address: Miqun.Robinson@sanofi.com. 10. St Josef Hospital, Ruhr University Bochum, 5092414 Gudrunstrasse 56, D-44791 Bochum, Germany. Electronic address: ralf.gold@ruhr-uni-bochum.de.
Abstract
BACKGROUND: Patient-reported outcomes (PROs) provide clinicians with further understanding of the impact of treatment on patients' daily lives. In addition, real-world studies, which employ broader inclusion criteria than randomized trials, may help to inform prescribing decisions when selecting a disease-modifying therapy (DMT) to treat relapsing forms of MS (RMS). We sought to use PROs to determine patient treatment satisfaction and other treatment outcomes, and report safety and tolerability associated with teriflunomide, in the global, phase 4 Teri-PRO study (NCT01895335). METHODS: Patients with RMS (N = 1000) received teriflunomide for 48 weeks per local labeling. The primary endpoint was Global Satisfaction with teriflunomide treatment measured by the Treatment Satisfaction Questionnaire for Medication (TSQM, V1.4). Secondary endpoints included TSQM scores at Week (W)48 vs baseline in patients switching to teriflunomide from other DMTs ('switchers'), additional PROs, and safety. RESULTS: Mean TSQM Global Satisfaction score at W48 was high (68.2). Switchers reported significant improvements across all four TSQM domains at W48 vs baseline (all p < 0.0001). Adverse events were consistent with teriflunomide clinical trials. CONCLUSION: Patients reported high treatment satisfaction with teriflunomide, with switchers also reporting improved treatment satisfaction vs baseline. High treatment satisfaction in patients with RMS may lead to improved adherence, and hence treatment outcomes.
BACKGROUND:Patient-reported outcomes (PROs) provide clinicians with further understanding of the impact of treatment on patients' daily lives. In addition, real-world studies, which employ broader inclusion criteria than randomized trials, may help to inform prescribing decisions when selecting a disease-modifying therapy (DMT) to treat relapsing forms of MS (RMS). We sought to use PROs to determine patient treatment satisfaction and other treatment outcomes, and report safety and tolerability associated with teriflunomide, in the global, phase 4 Teri-PRO study (NCT01895335). METHODS:Patients with RMS (N = 1000) received teriflunomide for 48 weeks per local labeling. The primary endpoint was Global Satisfaction with teriflunomide treatment measured by the Treatment Satisfaction Questionnaire for Medication (TSQM, V1.4). Secondary endpoints included TSQM scores at Week (W)48 vs baseline in patients switching to teriflunomide from other DMTs ('switchers'), additional PROs, and safety. RESULTS: Mean TSQM Global Satisfaction score at W48 was high (68.2). Switchers reported significant improvements across all four TSQM domains at W48 vs baseline (all p < 0.0001). Adverse events were consistent with teriflunomide clinical trials. CONCLUSION:Patients reported high treatment satisfaction with teriflunomide, with switchers also reporting improved treatment satisfaction vs baseline. High treatment satisfaction in patients with RMS may lead to improved adherence, and hence treatment outcomes.
Authors: Todd A Hardy; John Parratt; Heidi Beadnall; Stefan Blum; Richard Macdonell; Roy G Beran; Neil Shuey; Andrew Lee; William Carroll; Cameron Shaw; Richard Worrell; Jana Moody; Mamdouh Sedhom; Michael Barnett; Steve Vucic Journal: BMJ Neurol Open Date: 2022-07-04
Authors: Diego Centonze; Roberta Fantozzi; Fabio Buttari; Luigi Maria Edoardo Grimaldi; Rocco Totaro; Francesco Corea; Maria Giovanna Marrosu; Paolo Confalonieri; Salvatore Cottone; Maria Trojano; Valentina Zipoli Journal: Front Neurol Date: 2021-04-22 Impact factor: 4.003
Authors: Jiwon Oh; Sandra Vukusic; Klaus Tiel-Wilck; Jihad Said Inshasi; David Rog; Darren P Baker; Yelena Pyatkevich; Elizabeth M Poole; Patrick Vermersch Journal: J Cent Nerv Syst Dis Date: 2021-07-29