Patricia K Coyle1, Bhupendra Khatri2, Keith R Edwards3, José E Meca-Lallana4, Steve Cavalier5, Pascal Rufi6, Myriam Benamor6, Karthinathan Thangavelu5, Miqun Robinson7, Ralf Gold8. 1. Department of Neurology, HSC T12-020, Stony Brook University, 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 South 16th St, Milwaukee, WI 53215, USA. Electronic address: bokhatri@aol.com. 3. Multiple Sclerosis Center of Northeastern New York, 1182 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, Murcia 30120, Spain; Cátedra de Neuroinmunología Clínica y Esclerosis Múltiple, UCAM Universidad Católica San Antonio de Murcia, Campus de los Jerónimos, Guadalupe, Murcia 30107, Spain. Electronic address: pmecal@gmail.com. 5. Sanofi, 500 Kendall Street, Cambridge, MA 02142, USA. Electronic address: steven.cavalier@sanofi.com. 6. Sanofi, 1 Avenue Pierre Brossolette, Chilly-Mazarin 91385, France. Electronic address: pascal.rufi@sanofi.com. 7. Sanofi, 55 Corporate Drive, Bridgewater, NJ 08807, USA. Electronic address: miqun.robinson@sanofi.com. 8. St Josef Hospital, Ruhr University Bochum, 5092414 Gudrunstrasse 56, Bochum D-44791, Germany. Electronic address: ralf.gold@ruhr-uni-bochum.de.
Abstract
BACKGROUND: Patient-reported outcomes (PROs) can assist clinicians in understanding the impact of disease-modifying therapy (DMT) on the daily lives of patients with multiple sclerosis (MS). With an increased number of DMTs becoming available, patients are now switching treatments more frequently in clinical practice. The effects of switching DMTs on a patient's daily life and their disease course may be reflected in PROs. The global, multicenter, open-label, phase 4 Teri-PRO study (NCT01895335), which was conducted in routine clinical practice, previously showed statistically and clinically significant increases in patient-reported treatment satisfaction in patients switching to teriflunomide from other DMTs. The impact of switching to teriflunomide from other DMTs on treatment satisfaction and a range of additional PROs was also evaluated. METHODS: Patients with relapsing forms of MS (N = 1000) received teriflunomide for 48 weeks per local labeling. Outcomes assessed in this analysis included treatment satisfaction (as measured by Treatment Satisfaction Questionnaire for Medication [Version 1.4]), disability worsening (as measured using the Expanded Disability Status Scale [EDSS] score, the Patient-Determined Disease Steps scale, and the Multiple Sclerosis Performance Scale), cognition (as measured using the Symbol Digit Modalities Test [SDMT]), treated relapses, quality of life (as measured by the Multiple Sclerosis International Quality of Life [MusiQoL] questionnaire and the Stern Leisure Activity Scale), and safety/tolerability over the course of the study in the subgroup of patients switching to teriflunomide from another DMT (n = 594). RESULTS: Patients reported significant improvements in treatment satisfaction scores following the switch to teriflunomide regardless of the reason for treating with teriflunomide (Global Satisfaction, disease worsening: baseline, 46.0, Week 48, 65.1; convenience: baseline, 57.4, Week 48, 72.4; intolerance: baseline, 50.9, Week 48, 71.1; side effects: baseline, 49.7, Week 48, 67.2; P < 0.0001 in all comparisons). These patients also showed improvement or stability in PROs evaluating disability worsening, cognition, and quality of life (EDSS: baseline, 3.1, Week 48, 3.0; SDMT: baseline, 0.975, Week 48, 0.978; MusiQoL: baseline, 67.5, Week 48, 69.5). The safety and tolerability profile of teriflunomide was consistent with that observed in other teriflunomide clinical trials. CONCLUSION: This analysis of the Teri-PRO study demonstrates the value of switching to teriflunomide from other DMTs in a real-world, clinical practice setting. The high levels of treatment satisfaction associated with teriflunomide in Teri-PRO may lead to improved adherence and thus improved outcomes.
BACKGROUND:Patient-reported outcomes (PROs) can assist clinicians in understanding the impact of disease-modifying therapy (DMT) on the daily lives of patients with multiple sclerosis (MS). With an increased number of DMTs becoming available, patients are now switching treatments more frequently in clinical practice. The effects of switching DMTs on a patient's daily life and their disease course may be reflected in PROs. The global, multicenter, open-label, phase 4 Teri-PRO study (NCT01895335), which was conducted in routine clinical practice, previously showed statistically and clinically significant increases in patient-reported treatment satisfaction in patients switching to teriflunomide from other DMTs. The impact of switching to teriflunomide from other DMTs on treatment satisfaction and a range of additional PROs was also evaluated. METHODS:Patients with relapsing forms of MS (N = 1000) received teriflunomide for 48 weeks per local labeling. Outcomes assessed in this analysis included treatment satisfaction (as measured by Treatment Satisfaction Questionnaire for Medication [Version 1.4]), disability worsening (as measured using the Expanded Disability Status Scale [EDSS] score, the Patient-Determined Disease Steps scale, and the Multiple Sclerosis Performance Scale), cognition (as measured using the Symbol Digit Modalities Test [SDMT]), treated relapses, quality of life (as measured by the Multiple Sclerosis International Quality of Life [MusiQoL] questionnaire and the Stern Leisure Activity Scale), and safety/tolerability over the course of the study in the subgroup of patients switching to teriflunomide from another DMT (n = 594). RESULTS:Patients reported significant improvements in treatment satisfaction scores following the switch to teriflunomide regardless of the reason for treating with teriflunomide (Global Satisfaction, disease worsening: baseline, 46.0, Week 48, 65.1; convenience: baseline, 57.4, Week 48, 72.4; intolerance: baseline, 50.9, Week 48, 71.1; side effects: baseline, 49.7, Week 48, 67.2; P < 0.0001 in all comparisons). These patients also showed improvement or stability in PROs evaluating disability worsening, cognition, and quality of life (EDSS: baseline, 3.1, Week 48, 3.0; SDMT: baseline, 0.975, Week 48, 0.978; MusiQoL: baseline, 67.5, Week 48, 69.5). The safety and tolerability profile of teriflunomide was consistent with that observed in other teriflunomide clinical trials. CONCLUSION: This analysis of the Teri-PRO study demonstrates the value of switching to teriflunomide from other DMTs in a real-world, clinical practice setting. The high levels of treatment satisfaction associated with teriflunomide in Teri-PRO may lead to improved adherence and thus improved 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: Michael Guger; Michael Matthias Ackerl; Martin Heine; Christiane Hofinger-Renner; Heinrich Karl Spiss; Andrea Taut; Karin Unger; Fritz Leutmezer Journal: eNeurologicalSci Date: 2022-03-07