Teri-LIFE: an observational study of quality of life in patients with relapsing remitting multiple sclerosis treated with teri-flunomide in the Nordic region

Title (max. 250 characters including spaces): 151 Teri-LIFE: An observational study of quality of life in patients with relapsing remitting multiple sclerosis treated with teriflunomide in the Nordic region Authors: Hestvik AL,1 Frederiksen J,2 Nielsen HH,3 Torkildsen Ø,4 Eek C,5 Huang-Link Y,6 Haghighi S,7 Poole EM,8 Tsai JA,9 Kant M3 1Sanofi, Lysaker, Norway 2University of Copenhagen, Copenhagen, Denmark 3University of Southern Denmark, Odense, Denmark 4Haukeland University Hospital, Bergen, Norway 5Drammen Hospital, Drammen, Norway 6 Linköping University Hospital, Linköping, Sweden 7Department of Neurology, Motala Hospital, Motala, Sweden 8Sanofi, Cambridge, MA, USA 9Sanofi, Stockholm, Sweden Abstract character count (max. 2500 including spaces, excluding disclosures): 2441 Introduction Teriflunomide is a once-daily oral immunomodulator approved for the treatment of relapsing forms of multiple sclerosis (MS) or relapsing remitting MS (RRMS), depending on the local label. Objective To report the results of Teri-LIFE, a non-interventional, real-world study of quality of life (QoL) in patients with RRMS treated with teriflunomide in the Nordic region. Methods Teri-LIFE recruited patients from Norway, Sweden, and Denmark between June 2015 and December 2016. Patients ≥18 years of age with RRMS who had already chosen to initiate treatment with teriflunomide 14 mg were eligible. Patients were followed per routine clinical practice for 24 months, with follow-up every 6 months. The primary endpoint was QoL measured by the Short Form-36 (SF-36) questionnaire. Secondary endpoints included clinical efficacy, safety, and adherence. Results Two hundred patients were recruited, 68% were treatment-naïve. The majority (71%) were female, mean (standard deviation [SD]) age was 44.1 (10.4) years. Mean (SD) time since diagnosis was 3.6 (5.9) years. Median (upper quartile, lower quartile) Expanded Disability Status Scale score was 2.0 (1.0, 2.5). Mean (SD) number of relapses in the prior 2 years was 0.8 (0.7); 69/197 (35%) patients reported no relapses during this time. A total of 118 (59%) patients remained on teriflunomide during the 24-month study period; 22% discontinued due to adverse events (AEs), 9% due to lack of efficacy, and 10% due to other reasons. Mean (SD) SF-36 scores at baseline and months 6, 12, 18 and 24 were 46.5 (10.0), 46.7 (10.4), 47.5 (9.7), 47.6 (10.5), and 47.7 (10.4), respectively, for the physical component score (PCS), and 46.6 (11.8), 48.6 (11.9), 48.4 (11.1), 48.4 (11.2), and 48.8 (10.3), respectively, for the mental component score (MCS). A repeated measures analysis of covariance showed no significant change except for baseline to 24 months on the PCS (P=0.0038). The on-treatment annualised relapse rate (95% confidence interval) was 0.17 (0.13, 0.23); 79% of patients experienced no relapses. AEs were reported by 93.5% of patients, the most common being hair thinning (26.5%), diarrhoea (23%), and fatigue (20%). Serious AEs were reported by 11% of patients. Conclusions QoL was stable over 24 months in teriflunomide-treated patients. The benefit–risk ratio, and safety and tolerability profile of teriflunomide were consistent with those observed in clinical trials. Disclosures: ALH: Employee of Sanofi JF: Served on scientific advisory boards for and received funding for travel related to these activities as well as honoraria from Biogen Idec, Merck Serono, Sanofi-Aventis, Teva, Novartis and Almirall. Received speaker honoraria from Biogen Idec, Teva and Novartis. HHN: Accepted financial compensation and travel reimbursements from Teva, Biogen Idec, Sanofi-Genzyme, Novartis and Roche. ØT: Served on the scientific advisory boards for and received speaker honoraria from Novartis, Biogen, Genzyme, Roche and Merck. CE: Received honorarium from Merck and contributed to sponsored research. YL: Financial support from Sanofi for research (Teri-LIFE study) SH: The Teri-LIFE project received financial support from Sanofi. EMP: Employee of Sanofi with ownership interest JAT: Employee of Sanofi with ownership interest MK: Support for congress participation from Biogen, Genzyme, Teva, Roche, and Novartis Study supported by Sanofi Submission details Type: Oral or poster presentation Abstract category: Clinical aspects of MS 1. Diagnosis and differential diagnosis 2. MS Variants 3. Paediatric MS 4. Progressive MS 5. Natural course 6. Epidemiology 7. MS and gender 8. Pregnancy in MS 9. MS symptoms 10. Clinical assessment tools 11. Patient reported outcomes 12. Economic burden 13. Neuro-ophthalmology 14. Comorbidity Pathology and pathogenesis of MS 15. Pathology 16. Experimental models 17. Genetics/ Epigenetics 18. Immunology 19. Microbiology and virology 20. Environmental factors 21. Neurobiology 22. Neurodegeneration 23. Repairing mechanisms 24. MRI and PET 25. OCT 26. Neuropsychology 27. Biomarkers Therapy 28. Immunomodulation/ Immunosuppression 29. Neuroprotection & repair 30. Long-term treatment monitoring 31. Risk management for disease modifying treatments 32. Tools for detecting therapeutic response 33. Symptomatic treatment 34. Others RIMS 35. Multi-disciplinary rehabilitation 36. Symptoms management (including cognition, fatigue, imbalance) 37. Neurobiology & rehabilitation Presenting author details: Anne Lise Hestvik, Sanofi, Prof Kohtsvei 5–17, 1366 Lysaker, Norway. Email: annelise.hestvik@sanofi.com. Telephone: +47 97 48 99 64.