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. Teri-CARE is a real-world study investigating quality of life and clinical outcomes in patients with RRMS treated with teriflunomide 14 mg in Spain.
To evaluate effectiveness of teriflunomide in Relapsing Remitting Multiple Sclerosis (RRMS) and its impact on quality of life, fatigue and depression.
Prospective multicenter study in RRMS patients treated with teriflunomide for ≤4 weeks. Clinical data and questionnaires were completed during the inclusion visit and every 6 months for 2 years: MSIS-29 (MS-Impact Scale), MFIS (Modified Fatigue-Impact Scale), BDI (Beck Depression Inventory).
325 patients with RRMS (36% naive, 71% female) were included. Median±SD age was 43,2±10,4, MS duration was 7,2±7,3 years, EDSS was 1,75±1,52, annualized relapse rate (ARR) was 0,4. 30% of patients presented T1Gd+ lesions (2,1±1,8). 49% reduction on ARR was observed on year 1 (0,22) and 60% on year 2 (0,17). EDSS was maintained stable after 2 years (1,83±1,66; p=0,081) and 80% of the patients did not show disability progression. T1Gd+ median lesion decreased at year 1 (1,5±0,7) and at year 2 (1,2±0,6). Nineteen patients reported 20 serious adverse events and no death was reported. After 2 years of treatment, a significant reduction in the psychological impact of MS was observed in the MSIS-29 (32,4±25,4 vs 28,8±24,5; p=0,001), but not in the physical component. At baseline, patients presented a mild grade of fatigue (MFIS: 26,4±21,1) and depression (BDI: 12,3±10,0), which were maintained at year 2 without significant changes.
Long term treatment with teriflunomide significantly reduces relapses and maintains disability progression stable. Teriflunomide improves aspects of quality of life and seems to delay the MS impact on fatigue and emotional well-being.