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.
P0419 - Racial inequalities in multiple sclerosis research participation: underreporting and underrepresentation (ID 1751)
Abstract
Background
MS affects minority communities differently with more rapid disability accumulation described in African American and Hispanic patients. These patients are also negatively impacted by social determinants of health further worsening disparities in outcomes. To best care for minority patients, the safety and efficacy of MS treatments in these populations must be known and reliably reported.
Objectives
To evaluate how representation of minority patients in manufacturer-sponsored phase 3 trials is reported in medical journals and on patient- and healthcare provider (HCP)-facing websites for approved disease-modifying therapies (DMTs). To assess the representation of minority patients in DMT trials and trends over time.
Methods
The Medline and clinicialtrials.gov databases were searched from 1995 to 1 June 2020, to identify manufacturer-sponsored phase 3 trials for FDA-approved MS DMTs. We explored how race and ethnicity were reported in the trial outcomes publications. Using studies where information was available, we analyzed representation of minority patients. Additionally, we reviewed patient-and HCP-facing websites of available DMTs to assess the availability of information on racial representation in trials. Finally, we searched for publications presenting either post-hoc analyses of clinical trial data or post-marketing studies aiming to evaluate safety and efficacy of DMTs in minority patients.
Results
A total of 41 phase 3 trials were reviewed, among which 14 (34%) did not report race, 15 (37%) reported race as proportion of white participants only, and 12 (29%) reported detailed information on race. People identifying as black were underrepresented in all trials, with decreased representation over time. Ethnicity was only reported in 1/41 publication, and trends in representation of Hispanics could not be assessed. No patient- or HCP-facing website reported demographic data on race and ethnicity. Four post-hoc analyses and three post-marketing studies that addressed DMT efficacy and safety in minority patients were found.
Conclusions
Race is underreported in phase 3 trial outcomes publications for MS DMTs and race/ethnicity representation is omitted from patient- and HCP-facing websites. When available, data show that minority patients are underrepresented in MS trials. Finally, few post-marketing studies assessed safety and efficacy of DMTs in minority populations. The availability of this information is crucial for patients and their HCPs to make informed decisions about their care.