Real-World Assessment of Quality of Life in Patients with Relapsing Remitting Multiple Sclerosis Treated with Teriflunomide for Two Years: Patient-Reported Outcomes from the AURELIO Study in Greece

Abstract

Introduction Multiple sclerosis (MS) is a highly heterogeneous inflammatory disease of the central nervous system. Patient-reported outcomes (PROs) in a real-world clinical setting can provide detailed information about MS from the patient's perspective. PROs were used here to assess quality of life (QoL), treatment satisfaction, clinical efficacy, and safety outcomes in a Greek cohort of relapsing remitting MS (RRMS) patients treated with oral teriflunomide (14 mg/day). Methods AURELIO was a 2-year, prospective, observational study whose QoL primary endpoint was assessed with the Multiple Sclerosis Impact Scale (MSIS-29). Secondary endpoints included analyses of Patient Determined Disease Steps (PDDS), Treatment Satisfaction Questionnaire for Medication (TSQM), Expanded Disability Status Scale (EDSS), annualized relapse rate (ARR), adherence, and safety outcomes. Results AURELIO enrolled 282 patients (62.8% female; mean age 44.8 [SD ± 11] years; EDSS 2.0 [SD ± 1.6]; 44.6% treatment-naïve), with 212 patients (75%) remaining on treatment at study end. MSIS-29 total scores remained stable, while the MSIS-29 psychological scale showed significant improvement ( p = 0.0015) at 2 years vs. baseline. TSQM scores at 2 years showed significant improvements in effectiveness (+ 6.6, p = 0.0001), convenience (+ 1.9, p = 0.0256), and global satisfaction (+ 8.1, p = 0.0001) vs. baseline. Disease progression was stable as indicated by non-significant changes in PDDS and EDSS vs. baseline. The ARR was low at 0.065, with a slightly higher ARR in previously treated (0.070) vs. naïve patients (0.058). Adherence was high at > 90%. Overall, 91 patients (32.3%) in the study reported a total of 215 safety events (32 serious, of which 21 were classified as mild–moderate). No new safety signals were observed. Conclusions These data highlight the importance of PROs to facilitate personalized treatment strategies in MS. In line with other teriflunomide studies, AURELIO showed stable QoL, efficacy and safety outcomes, and good treatment satisfaction both in treatment-naïve and previously treated patients in this Greek cohort of patients with RRMS. Supplementary Information The online version contains supplementary material available at 10.1007/s40120-022-00384-2.

The 7-year follow-up of the Hungarian BICAMS validation cohort implies that cognitive performance may improve in multiple sclerosis patients

“…clinical studies with a follow-up period of 2 years on teriflunomidetreated patients can be found so far. They all agree that after 2 years of treatment, there is an improvement compared to the baseline cognitive state in patients who are in a stable condition with therapy, which is related to the effect of treatment [30][31][32]. Our results also imply some role of therapy escalation; however, the significant impact could only be measured in case of BVMT-R scores, unlike in the teriflunomide follow-up cohorts.…”

“…Regarding the prevalence of definitive CI, while 44.2% of the patients were cognitively impaired at baseline, the proportion was reduced to 27.9% after 5 years and 19% by the end of the study. The earlier mentioned validation cohort follow-ups and shorter duration follow-up studies with patients on teriflunomide treatment have also yielded similar results [27][28][29][30][31][32]. There are multiple possible reasons behind these aforementioned outcomes.…”

Neutrophil Nanovesicle Protects against Experimental Autoimmune Encephalomyelitis through Enhancing Myelin Clearance by Microglia

“…4−6 Accordingly, disease-modifying therapies (DMTs) approved by the U.S. Food and Drug Administration (FDA) mainly focus on inhibiting lymphocytes proliferation, including interferon beta (IFN-β), 7 glatiramer acetate (GA), 8 monoclonal antibodies (natalizumab, alemtuzumab, daclizumab and ocrelizumab), 9−11 mitoxantrone, 12 fingolimode, 13 dimethyl fumarates, 14 and teriflunomide. 15 Although these drugs reduce disease recurrence, they do not repair damaged myelin.…”

“…MS patients or experimental models (i.e., experimental autoimmune encephalomyelitis, EAE) are characterized by T cell-mediated demyelination. , The blood–brain barrier (BBB) in MS patients is compromised, resulting in an uncontrolled influx of peripheral immune cells . Specifically, myelin-specific T cells infiltrate into the central nervous system (CNS) and attack myelin sheath to induce neuronal injury. − Accordingly, disease-modifying therapies (DMTs) approved by the U.S. Food and Drug Administration (FDA) mainly focus on inhibiting lymphocytes proliferation, including interferon beta (IFN-β), glatiramer acetate (GA), monoclonal antibodies (natalizumab, alemtuzumab, daclizumab and ocrelizumab), − mitoxantrone, fingolimode, dimethyl fumarates, and teriflunomide . Although these drugs reduce disease recurrence, they do not repair damaged myelin.…”