Author Of 2 Presentations
P0176 - Treatment and care management, clinical outcomes and mobility impairment in people with or without MS aged ≥ 50 years: observational 6-year analysis (ID 832)
Abstract
Background
Although multiple sclerosis (MS) is often described as a disease of young adults, a recent study conducted by the National Multiple Sclerosis Society showed that, in the US, people with MS have a median age of 52 years. Limited data are available in the older MS population.
Objectives
To characterize clinical outcomes, mobility impairment, treatment and care management patterns in people with MS ≥50 years of age (PwMS) compared with a cohort of adults ≥50 years of age without MS (AwoMS) from the general population.
Methods
Administrative US claims data from Truven Health MarketScan® Commercial and Medicare Databases 2011-2017 were analysed. PwMS included 3 claims with MS diagnoses (ICD9/10 340/G35) OR 1 MS diagnosis + 1 disease-modifying drug (DMD) within 1-year of each other, AND 1st diagnosis or DMD in 2012 as index; continuous enrollment 1-year pre-index (baseline), and ≥3 years follow-up; aged ≥50. AwoMS included those continuously enrolled from 2011 to minimum 2015, up to 2017, aged ≥50 and never diagnosed with MS, with July 1st 2012 used as index for baseline characteristics. A 1:1 matched cohort was created using propensity scores calculated from baseline covariates (age, sex, region, health plan and comorbidities). Multivariable models were used to compare infection and malignancy rates, treatment and care patterns including utilization of magnetic resonance imaging (MRI), skilled nursing facilities (SNF), and time to mobility aids (cane/walker or wheelchair use) between matched PwMS and AwoMS.
Results
Inclusion criteria were met by 10,746 PwMS and 3,521,326 AwoMS (10,746 matched to PwMS). Over the average 5-year follow-up, PwMS had a higher infection rate than AwoMS (0.738 vs. 0.247 per patient, respectively; rate ratio [RR]: 2.977 [with 95% confidence interval of [2.849-3.111]), a higher rate of MRI use (0.684 vs. 0.157 per patient, respectively; RR: 4.234 [4.016-4.464]), most being brain and spine MRIs, and a higher use of SNF (0.658 vs. 0.098 per patient, respectively; RR: 6.920 [6.487-7.385]). Having MS showed no significant association with the odds of developing a malignancy (odds ratio: 1.006 [0.940-1.076]). MS was associated with a shorter time to cane/walker or wheelchair use (hazard ratios: 2.374 [2.140-2.634] and 7.600 [6.516-8.863], respectively).
Conclusions
Compared with AwoMS, PwMS showed higher rates of infections, MRI utilization and SNF use, shorter time to cane/walker or wheelchair use, and similar rates of malignancies.
P0310 - Cladribine tablets in patients with RRMS and active SPMS after suboptimal response to prior DMD (MASTER-2 and CLICK-MS): initial baseline demographics (ID 129)
Abstract
Background
Although the efficacy and safety of cladribine tablets (CT) 10 mg (3.5 mg/kg cumulative dose over 2 years [yrs]) have been shown in patients (pts) with relapsing forms of multiple sclerosis (MS) in Phase 3 trials, real world data are limited.
Objectives
To examine real-world effectiveness, safety, and pt reported outcomes (PROs) in pts with relapsing-remitting MS (RRMS) and active secondary progressive MS (SPMS) who transition to CT after suboptimal response to prior disease-modifying drugs (DMDs).
Methods
MASTER-2 and CLICK-MS are single arm, observational, 30-month (mo), Phase 4 trials in the US (Timeline: 2019–2023). Eligible pts are adults with RRMS or active SPMS, with suboptimal response to an oral/infusion (MASTER-2) or injectable (CLICK-MS) DMD, meeting criteria for CT 3.5 mg/kg treatment (US Prescribing Information). The primary outcome is 24-mo annualized relapse rate (ARR). Key secondary outcomes are PROs, treatment adherence and satisfaction, ARR in prior 24 mos, MS treatment pattern prior to transition and follow-up if CT are discontinued, and adverse events (AEs). Planned enrollment per study is 200 pts across 50 sites.
Results
Pt enrollment is ongoing for both trials. As of May 2020, 52 pts (mean [standard deviation {SD}] age: 50 [10.6] yrs; 75% female) have baseline data available in MASTER-2 (data not shown for CLICK-MS). Mean (SD) time since diagnosis was 11.8 (7.71) yrs. Most recent DMDs used included teriflunomide (23.1%), dimethyl fumarate (23.1%), fingolimod (19.2%), ocrelizumab (13.5%), natalizumab (9.6%) and alemtuzumab (1.9%). Sixteen pts had 21 relapses within 24 mos prior to enrollment (mean [SD] ARR: 0.21 [0.351]). Mean (SD) baseline PRO scores before starting CT were 50.7 (25.11) for 14-Item Treatment Satisfaction Questionnaire for Medication (Global Satisfaction), 50.0 (9.57) and 41.4 (11.56) for 36-Item Short Form Health Survey (mental and physical component summaries, respectively), 1.4 (1.71) for Beck-Depression Inventory-Fast Screen, 8.9 (4.79) for the Fatigue Impact Scale, and 2.7 (2.31) for Patient Determined Disability Steps scale. Thirty-six treatment emergent AEs (2 serious, but unrelated) were seen in 12 pts in 9.97 pt-yrs to date. Additional MASTER-2 and CLICK-MS pt baseline data will be shown in the presentation.
Conclusions
These studies will report real-world effectiveness and safety data of cladribine tablets in pts with RRMS and active SPMS with suboptimal response to prior oral, infusion, or injectable DMDs.