Patricia K Coyle1, Bhupendra Khatri2, Keith R Edwards3, José E Meca-Lallana4, Steve Cavalier5, Pascal Rufi6, Myriam Benamor7, Elizabeth M Poole8, Miqun Robinson9, Ralf Gold10. 1. Stony Brook University Medical Center, Department of Neurology, HSC T12-020, SUNY at Stony Brook, Stony Brook, NY 11794-8121, USA. Electronic address: Patricia.Coyle@stonybrookmedicine.edu. 2. The Regional MS Center, Center for Neurological Disorders at Wheaton Franciscan Healthcare, Milwaukee, WI 3237, USA. Electronic address: milwaukee4145@gmail.com. 3. MS Center of Northeastern New York, 1182 Troy-Schenectady Road, Suite 203, Latham, NY 12110, USA. Electronic address: kedwards@tristateneuro.com. 4. National Multiple Sclerosis Reference Center (CSUR), Hospital Virgen de la Arrixaca, Ctra. Madrid-Cartagena, s/n, 30120, Murcia, Spain; Clinical Neuroimmunology and Multiple Sclerosis Cathedra. UCAM. Universidad Católica San Antonio. Campus de los Jerónimos, Guadalupe, Murcia 30107, Spain. Electronic address: pmecal@gmail.com. 5. Sanofi, 50 Binney 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, 1 Avenue Pierre Brossolette, Chilly-Mazarin 91385, France. Electronic address: Myriam.Benamor@sanofi.com. 8. Sanofi, 50 Binney Street, Cambridge, MA 02142, USA. Electronic address: Elizabeth.Poole@sanofi.com. 9. Sanofi, 55 Corporate Drive, Bridgewater, NJ 08807, USA. Electronic address: miqun.robinson@sanofi.com. 10. St. Josef-Hospital, Ruhr University Bochum, Gudrunstrasse 56, Bochum D-44791, Germany. Electronic address: Ralf.Gold@ruhr-uni-bochum.de.
Abstract
BACKGROUND: The demographics and management of patients with multiple sclerosis (MS) differ across geographical regions, but it is unclear whether/how these differences affect treatment outcomes. The aim of this post-hoc analysis was to assess teriflunomide use and patient-reported outcomes in the United States (US) and the rest of the world (ROW) in the phase 4 Teri-PRO study (NCT01895335). METHODS: In the phase 4, real-world, Teri-PRO study, patients with relapsing forms of MS received teriflunomide for 48 weeks according to local labeling. The primary endpoint was treatment satisfaction measured using the Treatment Satisfaction Questionnaire for Medication Version 1.4 (TSQM 1.4). Secondary endpoints included scores on the Expanded Disability Status Scale (EDSS), Multiple Sclerosis Performance Scale (MSPS), and Patient-Determined Disease Steps (PDDS), and occurrence of adverse events. Primary and secondary endpoints were assessed at baseline and Week 48. An exploratory subgroup analysis assessed PROs in the black patient population. RESULTS: The US and ROW groups included 545 and 455 patients, respectively. The mean age of patients in the ROW group was lower, they had a shorter mean time since first symptoms of MS, and had lower mean EDSS scores at baseline, compared with the US group (all p < 0.0001). Black patients made up 9% of US patients vs 0.2% of ROW patients. TSQM global satisfaction scores and effectiveness, side effects, and convenience subscale scores were significantly improved from baseline to Week 48 (all p < 0.0001). Disability measures were stable from baseline to Week 48 for both groups, despite different baseline level scores between the two groups. The overall proportion of patients who experienced an AE was similar across both groups. Fewer patients in the US group vs the ROW group reported hair thinning (16.1% vs 31.2%). Black patients showed comparable baseline demographics and disease characteristics and similar change over time in PROs compared with the overall US group. CONCLUSION: Patient differences observed at baseline between the US and ROW groups suggest variation in teriflunomide prescribing practices in the real-world Teri-PRO study. Improvement in treatment satisfaction and stability of disability measures were comparable between patients in the US and ROW. This suggests that teriflunomide was effective despite differences in baseline demographics and possible cultural and management differences between these geographical regions.
BACKGROUND: The demographics and management of patients with multiple sclerosis (MS) differ across geographical regions, but it is unclear whether/how these differences affect treatment outcomes. The aim of this post-hoc analysis was to assess teriflunomide use and patient-reported outcomes in the United States (US) and the rest of the world (ROW) in the phase 4 Teri-PRO study (NCT01895335). METHODS: In the phase 4, real-world, Teri-PRO study, patients with relapsing forms of MS received teriflunomide for 48 weeks according to local labeling. The primary endpoint was treatment satisfaction measured using the Treatment Satisfaction Questionnaire for Medication Version 1.4 (TSQM 1.4). Secondary endpoints included scores on the Expanded Disability Status Scale (EDSS), Multiple Sclerosis Performance Scale (MSPS), and Patient-Determined Disease Steps (PDDS), and occurrence of adverse events. Primary and secondary endpoints were assessed at baseline and Week 48. An exploratory subgroup analysis assessed PROs in the black patient population. RESULTS: The US and ROW groups included 545 and 455 patients, respectively. The mean age of patients in the ROW group was lower, they had a shorter mean time since first symptoms of MS, and had lower mean EDSS scores at baseline, compared with the US group (all p < 0.0001). Black patients made up 9% of US patients vs 0.2% of ROW patients. TSQM global satisfaction scores and effectiveness, side effects, and convenience subscale scores were significantly improved from baseline to Week 48 (all p < 0.0001). Disability measures were stable from baseline to Week 48 for both groups, despite different baseline level scores between the two groups. The overall proportion of patients who experienced an AE was similar across both groups. Fewer patients in the US group vs the ROW group reported hair thinning (16.1% vs 31.2%). Black patients showed comparable baseline demographics and disease characteristics and similar change over time in PROs compared with the overall US group. CONCLUSION:Patient differences observed at baseline between the US and ROW groups suggest variation in teriflunomide prescribing practices in the real-world Teri-PRO study. Improvement in treatment satisfaction and stability of disability measures were comparable between patients in the US and ROW. This suggests that teriflunomide was effective despite differences in baseline demographics and possible cultural and management differences between these geographical regions.
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