Author Of 2 Presentations
P0143 - Real-World Experience in RRMS and SPMS Patients with Higher Disability and Substantial Lymphopenia Switching from Prior DMTs to Teriflunomide (ID 1818)
Teriflunomide is a once-daily oral immunomodulator approved for the treatment of relapsing forms of multiple sclerosis (MS).
To describe the patient characteristics and examine the effectiveness and safety of teriflunomide in patients who switched from other disease modifying therapies (DMTs).
A retrospective, observational, cohort study was conducted using medical charts on patients ≥ 18 years of age with diagnosis of RRMS or SPMS, who switched to teriflunomide from a prior DMT at a single MS center in the US. Data were extracted at 12 months prior (M-12), at baseline (M0), at 12 months post (M12), and at 24 months post (M24) initiating teriflunomide. Descriptive statistics were conducted for all outcome measures, including relapses, disability, MRI, and cognitive assessment.
Eighty patients (60% RRMS, 40% SPMS) were included in this analysis with a mean age of 44.0 ± 14.55, disease duration of 9.35 ± 6.37 years, baseline EDSS of 3.88 ± 1.76, and 30% with lymphopenia (ALC < 1000/mm3). The most common prior DMTs were dimethyl fumarate (22.5%), glatiramer acetate (18.8%), and natalizumab (16.3%). Mean number of relapses were reduced from 0.26 ±0.44 in the year prior to study entry to 0.18± 0.38 (M12) and 0.05 ± 0.22 (M24). Over the 24 months, mean (95% confidence interval) number of relapses decreased by -0.21 (-0.32, -0.11; P<0.0001), representing an 80.8% reduction. MRI was stable or improved in more patients at M12 (95.1%) and at M24 (97.6%), compared to baseline (92.5%). Mean EDSS score, Montreal Cognitive Assessment (MoCA) test score, and timed 25-foot walk (T25FW) remained stable throughout the study. The percent of patients with lymphopenia was reduced from 30.0% (M0) to 6.3% (M12) and 1.3% (M24). No unexpected or serious AEs were reported.
his real-world study evaluated a more challenging MS cohort with higher EDSS, including a substantial proportion with SPMS, and comorbidities including lymphopenia. Patients who switched to teriflunomide from a prior DMT demonstrated a significant decrease in relapses, and MRI was stable or improved in more patients after initiating teriflunomide compared to baseline. Mean EDSS, T25FW, and MoCA remained stable. In patients previously treated with other DMTs, the proportion of patients with lymphopenia substantially decreased with teriflunomide.
P1065 - Treatment Satisfaction Across Age Groups in Patients Who Switched to Teriflunomide: Analysis of the Real-world Teri-PRO Study (ID 814)
Teriflunomide is a once-daily oral immunomodulator approved for treating relapsing forms of MS (RMS) and relapsing-remitting MS, depending on the local label. In the phase 4, real-world Teri-PRO study (NCT01895335), patient-reported outcomes in RMS patients showed significantly improved satisfaction with teriflunomide versus prior disease-modifying therapy (DMT) at Week 48; safety was consistent with prior teriflunomide trials.
To assess changes in treatment satisfaction stratified by age in Teri-PRO patients who switched to teriflunomide 14 mg from prior DMTs.
Patients switching to teriflunomide 14 mg were stratified by age at baseline (≤35 years [n=85]; >35 to ≤45 years [n=167]; >45 to ≤55 years [n=175]; >55 years [n=129]). Assessment: Treatment Satisfaction Questionnaire for Medication (TSQM version 1.4 [4 domains: Global Satisfaction, Effectiveness, Side Effects, and Convenience; scores: 0-100, higher scores indicate improved satisfaction]) at baseline versus Week 48.
Compared with baseline, mean scores in each TSQM domain were significantly increased at Week 48 in patients aged >35 to ≤45 years (least-squares mean change [LS]: Global Satisfaction, 15.0, P<0.0001; Effectiveness, 6.3, P=0.0157; Side Effects, 20.6, P<0.0001; Convenience, 31.6, P<0.0001), >45 to ≤55 years (LS: Global Satisfaction, 15.4, P<0.0001; Effectiveness, 8.3, P<0.0001; Side Effects, 20.4, P<0.0001; Convenience, 31.0, P<0.0001), and >55 years (LS: Global Satisfaction, 11.3, P=0.0001; Effectiveness, 9.3, P=0.0001; Side Effects, 11.7, P<0.0001; Convenience, 29.8, P<0.0001). In patients aged ≤35 years, significantly improved mean TSQM scores at Week 48 versus baseline were observed in the Side Effects (LS: 26.2, P<0.0001) and Convenience (LS: 28.7, P<0.0001) domains. Across age groups, similar improvements in treatment satisfaction were also seen at Week 4 versus baseline, except for the Effectiveness domain in patients aged ≤35 years.
Over 48 weeks across age groups, patients aged >35 years who switched to teriflunomide 14 mg had significant improvements in all 4 TSQM domains versus baseline, and patients aged ≤35 years experienced significant improvements in the Side Effects and Convenience domains. These findings indicate teriflunomide improves treatment satisfaction regardless of age in RMS patients switching from other DMTs, with improvements occurring as early as Week 4 and persisting at Week 48 of treatment.
STUDY SUPPORT: Sanofi.