Реальные результаты лечения чернокожих, испаноязычных, азиатов и белых пациентов с множественным склерозом лечатся с Натализумбом.

Key Points

This was a retrospective analysis of the Komodo Health Claims Database to evaluate the effectiveness of natalizumab (NTZ) on relapse rate and onset, and to assess multiple sclerosis (MS)-related healthcare encounters and costs in Black, Hispanic, Asian, and White people with MS (PwMS); the largest study on the effects of NTZ in PwMS in racial and ethnic populations. Differences in baseline clinical characteristics of Black and Hispanic PwMS, and discrepancies in healthcare access compared with White counterparts, suggest that race, ethnicity, genetic factors, comorbidity, and social determinants of health may influence MS outcomes. All racial and ethnic groups experienced a significant reduction in annualized relapse rate after 12 months of NTZ treatment compared with pre-index levels; > 84% of PwMS in these groups remained relapse-free at 2 years.

Introduction

Multiple sclerosis (MS) is a complex neurological disease that affects approximately 2.9 million people globally, including nearly 1 million in the US [ 1 , 2 ]. Although MS was once considered to primarily impact White individuals of European descent, more recent studies have shown that MS is prevalent across a diverse racial and ethnic population [ 3 , 4 ]. In the United States, the prevalence of MS among various racial subgroups may vary geographically; the incidence rates among Black individuals has been growing in recent decades [ 4 , 5 ]. Nationally, MS remains most prevalent among White individuals, followed by Black individuals, Hispanic individuals, and individuals in the other non-Hispanic racial categories [ 5 ]. It is noteworthy that MS remains inadequately studied in racial and ethnic minorities, as clinical trials typically enroll low percentages of these populations [ 6 ].

In addition to incidence and prevalence of MS, racial disparities may also influence diagnosis, disease course, disease-modifying therapy (DMT) utilization, and clinical outcomes [ 3 , 4 , 7 – 10 ]. Black people with MS (PwMS) tend to experience a more aggressive disease course with increased risk for disability; Hispanic PwMS often have earlier-onset MS with increased disability at an earlier age [ 8 , 11 ]. There has been accumulating evidence that early use of high-efficacy MS DMTs is associated with greater reduction of inflammatory activity and disease progression in PwMS compared with delayed use of these agents [ 12 – 15 ]. However, certain racial and ethnic groups may encounter barriers toward accessing and optimizing treatment [ 3 , 16 , 17 ], as the use of high-efficacy DMTs is lower in Black and Hispanic PwMS compared with White PwMS [ 18 ]. Furthermore, data on high-efficacy DMTs in racial and ethnic minorities are limited.

Natalizumab (TYSABRI ® ; NTZ) is an infusible, high-efficacy DMT approved for treating relapsing forms of MS [ 19 ] based on the demonstrated efficacy and safety profile in the phase III AFFIRM and SENTINEL trials [ 20 , 21 ]. Due to the limited Black and Hispanic participants in AFFIRM, data for Black and Hispanic patients from AFFIRM and SENTINEL were combined in a post-hoc analysis, showing significant reduction in annualized relapse rate (ARR) for both minority patient populations [ 22 ]. More recently, a post-hoc analysis of a 4-year observational study (STRIVE) evaluating clinical and magnetic resonance imaging outcomes in participants with relapsing-remitting MS showed long-term effectiveness and safety of NTZ treatment in Black/African American and Hispanic/Latino patients when administered early in the disease course [ 23 ]. Although these previous studies provide insights into the use and efficacy of NTZ in minority patient populations, they were limited by small racial/ethnic subgroups; further studies with larger patient populations are needed.

Understanding the racial and ethnic heterogeneity of MS has been challenging due to historically low representation of minority populations in clinical trials [ 24 – 26 ]. A systematic review of 45 phase III MS trials from 1995 to June 2020 revealed that nearly 70% of these trials either did not report race/ethnicity or, when reported, race/ethnicity was only mentioned as a proportion of White participants [ 25 ]. In recent years, claims data analyses have become valuable for studying real-world racial/ethnic variations in MS prevalence, disease activity, treatment responses, and healthcare utilization. By utilizing a claims database with a larger racial/ethnic minority population (relative to clinical trials), this study aimed first to evaluate the effectiveness of NTZ on relapse rate and onset in Black, Hispanic, Asian, and White PwMS; and second, to assess MS-related healthcare encounters and healthcare costs across racial and ethnic groups.

Methods

Study Design and Participants

This is a retrospective, observational analysis of the Komodo Health Claims Database to evaluate the effectiveness of NTZ in Black, Hispanic, Asian, and White PwMS. The Komodo Health Claims Database is one of the largest claims databases in the US that is based on proprietary partnerships with > 150 key national payers and consortia. Komodo’s Healthcare Map captures 5 years of payer-complete patient encounters, as well as an additional 15 million new patient encounters per day from other data sources [ 27 ]. It has > 260 million patients with self-identified race and ethnicity [ 27 ].

Eligible patients were 18–64 years old at index date with one or more claims for a diagnosis of MS ( International Classification of Diseases, Tenth Revision, Clinical Modification [ICD-10-CM] code G35) during the study period (01 January 2016 to 31 August 2022) who had a claim for NTZ between 01 January 2017 to 31 May 2022. Access to the Komodo Health Claims Database included only commercial claims data; the lack of Medicare data limits the availability of information on patients aged 65 years and older. Index date was defined as the date of the first claim of a paid prescription fill date for NTZ. Patients were included if they had (i) continuous medical and pharmacy enrollment from closed claims sources for ≥ 12 months pre-index (≤ 45-day gap) and for ≥ 3 months post-index (≤ 45-day gap), and (ii) continuous exposure to NTZ for ≥ 3 months post-index (≤ 45-day gap). Those who had multiple DMTs on the same day as the NTZ index date were excluded. Follow-up was from the index date to the first occurrence of (i) end of study, (ii) end of insurance eligibility, (iii) gap in NTZ > 45 days, or (iv) switch from NTZ to another DMT.

Data on race and ethnicity were collected for patients who had an outpatient, inpatient, or emergency room visit and who chose to report race/ethnicity. The Komodo Health Claims Database consolidated the reported race and ethnicity data for consistency. The designations were as follows: (i) Black, including individuals who identified as Black or African American; (ii) Hispanic, including those who identified as Hispanic or Latino; (iii) Asian, including those who identified as Asian or Pacific Islander, defined as those with origins in East Asia, Southeast Asia, the Indian subcontinent, or the Pacific Islands (such as Hawaii, Guam, and Samoa); and (iv) White, including those who identified as non-Hispanic White.

Outcomes

The primary outcome was the change in ARR from 12 months pre-index to post-index NTZ within racial and ethnic groups. The secondary outcomes were the time to first post-index relapse (up to Month 24) and the change in pre-/post-index MS-related healthcare encounters and costs. DMT-related events/costs (i.e., DMT infusion) were not included in MS-related healthcare encounters and costs. Relapse outcomes, as well as MS-related healthcare encounters and costs, were also assessed across racial and ethnic strata compared with White PwMS.

Relapses were defined as an MS-related inpatient claim with a primary diagnosis of MS (ICD 10 code G35) or an outpatient MS-related diagnosis plus a prescription claim for an intravenous (IV) steroid (not including IV steroids that were administered on the same day as an IV MS DMT such as NTZ, adrenocorticotropic hormone, total plasma exchange, or a high-dose oral corticosteroid (≥ 500 mg/day prednisone or equivalent) ≤7 days after the outpatient visit. Healthcare encounters and costs that were associated with a diagnosis code for MS (ICD 9/10 codes 340/G35) were considered MS-related events. Annualized outcomes were calculated as the total number of events observed divided by the total number of patient-years observed.

Statistical Analyses

Patient demographics and baseline characteristics were summarized descriptively. Kaplan-Meier and adjusted Cox proportional hazards models were used to assess the probability of relapse-free survival following initiation of NTZ across race groups. Within racial groups, pre/post NTZ initiation ARR and encounter rates were estimated from Poisson generalized linear models (GLMs) adjusted for repeated measures correlation and offset for time. Pre-/post-annualized healthcare costs were estimated similarly with gamma GLMs. These GLMs were also used for across-racial group analyses evaluating post-index outcomes during the on-NTZ follow-up period. These models included an offset term for on-treatment follow-up time and were adjusted for age, sex, baseline relapses, MS severity score, Charlson comorbidity index, high poverty state, and insurance plan type. Comparisons were made with the White racial group as the reference.

Results

Baseline Characteristics

Overall, there were 439,928 patients with one or more claims for a diagnosis of MS (ICD 10 code G35) and one or more DMT claim between 01 January 2016 and 31 May 2022. After applying exclusion criteria, the study included 3244 PwMS with known race/ethnicity and who received NTZ, including 632 Black, 382 Hispanic, 49 Asian, and 2181 White PwMS (Supplementary Fig. S1 , see electronic supplementary material [ESM]). Baseline characteristics are shown in Table 1 . Over 55% of patients were 30–49 years old. The average post-index duration (months [SD]) of NTZ exposure was 15.8 (12.8) in Black, 17.1 (14.3) in Hispanic, 15.5 (12.9) in Asian, and 19.2 (15.1) in White PwMS. Baseline mean (SD) MS severity score was higher in Black (7.78 [4.42]) and Hispanic (7.98 [4.32]) PwMS compared with White (7.21 [4.04]). Similarly, the pre-index relapse rates were higher in Black (0.380) and Hispanic (0.442) PwMS compared with White (0.323) PwMS.

Table 1 Patient demographics and baseline characteristics Demographic/characteristic Black, N = 632 Hispanic, N = 382 Asian, N = 49 White, N = 2181 Female, n (%) 518 (82.0) 282 (73.8) 37 (75.5) 1685 (77.3) Age, years, mean (SD) 39.7 (10.9) 37.5 (10.1) 40.3 (12.1) 42.6 (10.9) Age group, years, n (%)  18–29 117 (18.5) 94 (24.6) 9 (18.4) 274 (12.6)  30–49 379 (60.0) 232 (60.7) 28 (57.1) 1275 (58.5)  50–64 136 (21.5) 56 (14.7) 12 (24.5) 632 (28.9) Insurance type, n (%)  Commercial 256 (40.5) 214 (56.0) 35 (71.4) 1430 (65.6)  Medicaid 262 (41.5) 123 (32.2) 11 (22.4) 436 (20.0)  Medicare 114 (18.0) 45 (11.8) 3 (6.1) 315 (14.4) Region, n (%)  MW 110 (17.4) 43 (11.3) 10 (20.4) 530 (24.3)  NE 109 (17.2) 97 (25.4) 8 (16.3) 509 (23.3)  SO 355 (56.2) 117 (30.6) 14 (28.6) 769 (35.3)  WE 44 (7.0) 113 (29.6) 15 (30.6) 348 (16.0)  UNK 14. (2.2) 12 (3.1) 2 (4.1) 25 (1.1) Reside in state with high level of poverty, n  (%) a 213 (33.7) 105 (27.5) 10 (20.4) 558 (25.6) ARR 1-year pre-index b,c 0.380 0.442 0.286 0.323 MS severity score, mean (SD) 7.78 (4.42) 7.98 (4.32) 6.12 (3.28) 7.21 (4.04) MS severity, n (%)  Low 151 (24.0) 89 (23.4) 20 (40.8) 577 (26.6)  Moderate 338 (53.8) 204 (53.5) 22 (44.9) 1247 (57.4)  High 139 (22.1) 88 (23.1) 7 (14.3) 348 (16.0) Quan-Charlson comorbidity index, mean (SD) 0.76 (1.36) 0.75 (1.26) 0.41 (1.00) 0.60 (1.14)  Charlson comorbidities ≥ 5%, n (%)  Chronic pulmonary disease 115 (18.2) 70 (18.3) 6 (12.2) 268 (12.3)  Diabetes without complications 75 (11.9) 31 (8.1) 4 (8.2) 161 (7.4)  Diabetes with complications 37 (5.9) 16 (4.2) 2 (4.1) 67 (3.1)  Cerebrovascular disease 62 (9.8) 43 (11.3) 2 (4.1) 129 (5.9)  Paraplegia and hemiplegia 68 (10.8) 41 (10.7) 3 (6.1) 155 (7.1)  Peripheral vascular disease 20 (3.2) 13 (3.4) 4 (8.2) 64 (2.9)  Mild liver disease 22 (3.5) 21 (5.5) 2 (4.1) 112 (5.1) No DMT in prior 12 months, n (%) 384 (60.8) 211 (55.2) 27 (55.1) 1197 (54.9) Charlson comorbidity index is an assessment tool designed specifically to predict long-term mortality; MS severity score is a combination of Expanded Disability Status Scale and disease duration ARR annualized relapse rate, DMT disease-modifying therapy, MS multiple sclerosis, MW Midwest, NE Northeast, NTZ natalizumab, SD standard deviation, SO South, UNK unknown, WE West a State ranks in the top quartile for the proportion of residents who live in poverty based on 2021 US Census Bureau of Statistics (LA, MS, NM, DC, WV, AL, KY, OK, SC, GA, TX, NV, NY) b ARR calculated as the total number of relapses observed divided by the total number of patient-years observed. Estimated via Poisson model adjusting for repeated measures correlation c Relapses were defined as an MS-related inpatient claim with a primary diagnosis of MS, or an outpatient MS-related diagnosis and prescription claim for an intravenous steroid, adrenocorticotropic hormone, total plasma exchange, or a high-dose oral corticosteroid ≤7 days after the outpatient visit

Patient demographics and baseline characteristics

Charlson comorbidity index is an assessment tool designed specifically to predict long-term mortality; MS severity score is a combination of Expanded Disability Status Scale and disease duration

ARR annualized relapse rate, DMT disease-modifying therapy, MS multiple sclerosis, MW Midwest, NE Northeast, NTZ natalizumab, SD standard deviation, SO South, UNK unknown, WE West

a State ranks in the top quartile for the proportion of residents who live in poverty based on 2021 US Census Bureau of Statistics (LA, MS, NM, DC, WV, AL, KY, OK, SC, GA, TX, NV, NY)

b ARR calculated as the total number of relapses observed divided by the total number of patient-years observed. Estimated via Poisson model adjusting for repeated measures correlation

c Relapses were defined as an MS-related inpatient claim with a primary diagnosis of MS, or an outpatient MS-related diagnosis and prescription claim for an intravenous steroid, adrenocorticotropic hormone, total plasma exchange, or a high-dose oral corticosteroid ≤7 days after the outpatient visit

Racial/ethnic groups with MS in this study lived in various regions within the US; notably, > 50% of the Black cohort resided in the south. A higher proportion of Black (33.7%) and Hispanic (27.5%) PwMS resided in a state with a high level of poverty compared with White (25.6%) PwMS as designated by the 2021 US Census [ 28 ]. The baseline mean (SD) Charlson comorbidity index was higher in Black (0.76 [1.36]) and Hispanic (0.75 [1.26]) PwMS compared with White PwMS (0.60 [1.14]). Compared with White PwMS (65.6%), a lower proportion of Black (40.5%) and Hispanic (56.0%) PwMS were on commercial insurance plans (Table 1 ).

Effectiveness Outcomes

Compared with the 12 months pre-index, ARR was significantly reduced in the post-index period across all racial/ethnic groups ( p  ≤ 0.001; Fig. 1 ). The pre-index versus post-index ARR ratio was 0.36 (95% confidence interval [CI]: 0.28–0.47) for Black PwMS, 0.25 (95% CI: 0.17–0.37) for Hispanic PwMS, 0.11 (95% CI: 0.03–0.43) for Asian PwMS, and 0.55 (95% CI: 0.42–0.71) for White PwMS. In the comparison of the Black, Hispanic, and Asian PwMS versus the White PwMS, the adjusted post-index ARR ratio was 0.77 (95% CI: 0.57–1.04) for Black PwMS, 0.66 (95% CI: 0.45–0.96) for Hispanic PwMS, and 0.24 (95% CI: 0.04–0.97) for Asian PwMS. Although Black, Hispanic, and Asian PwMS had a rate ratio <1, only Hispanic PwMS had a statistically significant difference ( p  = 0.028), indicating a more favorable outcome compared with White PwMS (Fig. 2 ). The adjusted Kaplan-Meier estimated proportion of relapse-free PwMS at 2 years (95% CI) were 84.3% (80.4–88.1) for Black PwMS, 88.2% (84.0–92.4) for Hispanic PwMS, 95.2% (88.9–100) for Asian PwMS, and 84.1% (82.1–86.1) for White PwMS. There were no statistically significant differences between the Black, Hispanic, and Asian PwMS versus the White PwMS (Fig. 3 ).

ARR pre-index vs post-index by race/ethnicity. ARR annualized relapse rate, CI confidence interval. a Calculated as the total number of relapses observed divided by the total number of patient-years observed. Estimated via Poisson model adjusting for repeated measures correlation. Rate ratio < 1 favors the post-index period

Adjusted ARR ratio vs White PwMS. ARR annualized relapse rate, CI confidence interval, PwMS people with multiple sclerosis. a Adjusted ARR is based on the negative binomial model adjusting for baseline relapse rate, age, sex, and MS severity score. Rate ratio > 1 favors the White racial group

Proportion of relapse-free a patients. CI confidence interval, HR hazard ratio. a Relapses were defined as an MS-related inpatient claim with a primary diagnosis of MS or an outpatient MS-related diagnosis and prescription claim for an intravenous steroid, adrenocorticotropic hormone, total plasma exchange, or a high-dose oral corticosteroid ≤ 7 days after the outpatient visit

Healthcare Encounters and Costs

The pre-index versus post-index annualized MS-related encounter rate ratio (95% CI) was 0.99 (0.94–1.07) for Black PwMS, 1.03 (0.94–1.12) for Hispanic PwMS, 1.19 (0.93–1.53) for Asian PwMS, and 1.03 (0.98–1.07) for White PwMS (Fig. 4 A). There were no statistically significant differences in pre-index versus post-index annualized MS-related encounter rate ratios across the racial/ethnic groups ( p > 0.05). However, a statistically significant difference in annualized MS-related healthcare cost rates (95% CI) before and after NTZ initiation was observed across the racial/ethnic groups: Black PwMS 0.63 (0.53–0.76; p  < 0.001), Hispanic PwMS 0.56 (0.42–0.75; p  < 0.001), Asian PwMS 0.56 (0.38–0.83; p  = 0.004), and White PwMS 0.84 (0.72–0.98; p  = 0.002) (Fig. 4 B).

A Pre-index vs post-index annualized MS-related healthcare encounter rates and B Annualized MS-related encounter cost rates. CI confidence interval, MS multiple sclerosis. a Calculated as the total number of MS encounters observed divided by the total number of patient-years observed. Estimated via Poisson model adjusting for repeated measures correlation. Rate ratio < 1 favors the post-index period. b Calculated as the total sum of MS-related encounter costs observed divided by the total number of patient-years observed. Estimated via gamma model adjusting for repeated measures correlation. Rate ratio < 1 favors the post-index period

There was a statistically significant reduction in inpatient MS-related encounter rates ( p  < 0.05) for Black, Hispanic, and White PwMS before versus after NTZ initiation (Fig. 5 ). Inpatient MS-related encounters in the pre-index period contributed to a small proportion of the total all-location MS encounters for Black (8.0%), Hispanic (8.9%), Asian (9.6%), and White (4.8%) PwMS (Supplementary Table S1 , see ESM). However, these events contributed to a substantial proportion of the accrued pre-index all-location MS-related costs: Black (44.0%), Hispanic (56.5%), Asian (50.6%), and White (33.8%) (Supplementary Table S1 , see ESM).

Inpatient annualized MS-related encounter rate. CI confidence interval, MS multiple sclerosis. a Calculated as the total number of MS encounters observed divided by the total number of patient-years observed. Estimated via Poisson model adjusting for repeated measures correlation. Rate ratio < 1 favors the post-index period

The adjusted annualized MS-related encounter rate ratios compared with White PwMS (95% CI) were 0.99 (0.94–1.04) for Black PwMS, 1.02 (0.96–1.09) for Hispanic PwMS, and 1.19 (1.01–1.40) for Asian PwMS (Fig. 6 ). Although Asian PwMS were observed to have higher encounter rates compared with White PwMS ( p  = 0.03), these results should be interpreted with caution due to the small sample size of the Asian group. No significant difference in MS-related healthcare costs were observed in Black, Hispanic, or Asian PwMS compared with White PwMS (Table 2 ).

Adjusted annualized per-patient per-year MS-related encounters rate. ARR annualized relapse rate, CI confidence interval, MS multiple sclerosis. a ARR rate is based on the negative binomial model adjusting for age, sex, baseline relapses, MS severity score, Quan-Charlson comorbidity index, state with high poverty, and insurance plan type. Rate ratio > 1 favors the White racial group

Table 2 Post-index MS-related healthcare costs Healthcare costs Black, N = 632 Hispanic, N = 382 Asian, N = 49 White, N = 2181 Adjusted annualized per-patient per-year costs rate $4219 ($3534–$5038) $5285 ($4249–$6574) $4217 ($2301–$7726) $5450 ($4859–$6111) Rate ratio (95% CI) a 0.774 (0.599–1.00) 0.97 (0.718–1.31) 0.774 (0.343–1.75) Reference p value 0.052 0.999 0.999 Reference CI confidence interval, MS multiple sclerosis a Estimated via generalized linear model with gamma distribution weighted by follow-up time (exposure) adjusting for age, sex, baseline relapses, MS severity score, Charlson comorbidity index, state with high poverty, and insurance plan type. Rate ratio > 1 favors the White racial group

Post-index MS-related healthcare costs

CI confidence interval, MS multiple sclerosis

a Estimated via generalized linear model with gamma distribution weighted by follow-up time (exposure) adjusting for age, sex, baseline relapses, MS severity score, Charlson comorbidity index, state with high poverty, and insurance plan type. Rate ratio > 1 favors the White racial group

Discussion

Historically, racial and ethnic minorities have been underrepresented in clinical trials, making it difficult to fully understand the effects of MS and treatment outcomes in these populations. This lack of representation limits insights into how disease activity and responses to DMTs may vary across different groups. However, the Komodo Health Claims Database and its inclusion of self-reported race and ethnicity information provides a valuable alternative for studying MS in diverse populations. By leveraging real-world data, it allows for a more comprehensive assessment of DMT effectiveness among racial and ethnic minorities, helping to address the data gap left by controlled clinical trials.

At baseline, Black and Hispanic PwMS in this study showed greater MS severity and higher relapse rates compared with White PwMS, consistent with previous research indicating more severe disease in these populations. Also in this study, Black and Hispanic PwMS had a higher comorbidity index, which may correspond with their higher relapse rates prior to NTZ initiation. This finding is consistent with other studies that have shown a link between comorbidities and increased relapse rates [ 29 ]. Additionally, Black and Hispanic PwMS were more likely to reside in a state with a higher poverty rate and were less likely to be on a commercial insurance plan. In fact, Black and Hispanic PwMS were nearly twice as likely to be on federally funded insurance (i.e., Medicaid, Medicare) than White PwMS. These collective findings allude to the fact that race, ethnicity, genetic factors, comorbidity, and social determinants of health may play a part in influencing MS outcomes.

Although Black and Hispanic PwMS had higher pre-index ARR compared with Asian and White PwMS, all racial and ethnic groups experienced a significant reduction in ARR after 12 months of NTZ treatment compared with pre-treatment levels, with ARR reductions of 64% for Black, 75% for Hispanic, 89% for Asian, and 45% for White PwMS. Hispanic PwMS had a greater reduction in ARR compared with White PwMS, whereas the Black and Asian PwMS did not demonstrate a statistically significant difference versus White PwMS. In addition, > 84% of PwMS in these groups remained relapse-free at 2 years. This is consistent with findings from the post-hoc analysis of the AFFIRM and SENTINEL studies, which showed that natalizumab therapy significantly reduced the ARR in Black/African American PwMS [ 22 ]. Similarly, a 4-year observational study showed that ARR was reduced by 90.2% and 91.3% in Black PwMS and Hispanic PwMS, respectively, after the initiation of NTZ treatment [ 23 ].

A small portion of total all-location MS-related healthcare encounters, both pre- and post-index, was attributable to inpatient MS encounters across racial and ethnic groups. Despite a reduction in inpatient encounters for Black, Hispanic, and White groups, no significant change was observed in overall MS encounters following NTZ initiation. However, a statistically significant reduction in total MS-related healthcare costs across all racial groups was observed. This was due to a reduction in the proportion of overall costs contributed by MS-related inpatient events after NTZ initiation when compared with pre-index. These reductions in inpatient encounters are encouraging, as they may suggest fewer and/or less costly relapse-related hospitalizations. Higher MS-related healthcare encounter rates were observed in the Asian group compared with the Black, Hispanic/Latino, and White groups; however, this finding should be interpreted with caution due to the small sample size of the Asian cohort. No significant difference in MS-related healthcare costs were observed between Black, Hispanic, and Asian PwMS compared with White PwMS.

Limitations

This study has limitations including those that are inherent in claims data analyses, such as lack of randomization, possible coding errors (without the possibility of verifying reported diagnoses), and potential variabilities in the documentation of MS disease severity. In addition, mild relapses that do not prompt a patient to interact with the healthcare system would not have been captured in claims data—that is, relapses are only captured if they result in a patient having an outpatient visit with their MS clinician, an inpatient hospital stay, or an emergency room visit. Salient limitations of this study using a claims database are the variability in terminology used in the documentation of race and ethnicity (e.g., Hispanic, Latino, LatinX, etc.), particularly when self-reported as in this study. In addition, since the Komodo database is limited to US patients, conclusions in this study may not be generalizable for global MS populations.

Conclusions

To date, this is the largest study on the effects of NTZ in PwMS in racial and ethnic populations. This study demonstrates the effectiveness of NTZ across Black, Hispanic, and Asian PwMS. The NTZ-associated relapse outcomes and the statistically significant reduction in total MS-related healthcare costs across all racial groups after NTZ initiation (associated with a reduction in MS-related inpatient events) has clinical and policy implications. Moreover, access to NTZ has the potential to reduce disparities in clinical outcomes of PwMS among racial subgroups. The findings in this study are consistent with prior reports demonstrating the efficacy of NTZ across racial and ethnic patient populations with MS.

Supplementary Information

Below is the link to the electronic supplementary material.

Supplementary file1 (PDF 225 KB)

Acknowledgements

Medical writing support was provided by Bess Reinoso, PhD, on behalf of Excel Medical Affairs, and the manuscript was edited by Cara Farrell.

Declarations

Funding

This study was funded by Biogen (Cambridge, MA, USA). Biogen provided funding for medical writing support (development of tables, figures, copyediting) in the development of this manuscript, and the decision to submit for publication. All authors had full access to study data, had full editorial control, and approved the final version. The corresponding author had final responsibility for the decision to submit for publication.

Conflicting Interests

K. Blitz-Shabbir: consultant fees from Biogen and Genentech; A. Banks and H. Garg: nothing to disclose; F. Nelson: consultant fee from Novartis; S. Shah: honoraria from Novartis and TG Therapeutics; N. Belviso, J.P. Mendoza, R.L. Avila, B. Bian, and K. Fong: employees of Biogen and may hold stock in the company.

Ethical Approval

This retrospective database analysis used de-identified claims data from the Komodo Health Claims Database in accordance with the Health Insurance Portability and Accountability Act to protect patient privacy.

Consent to Participate

The analysis in this manuscript was based on claims data which precludes the capacity to obtain patients’ consent to participate in the study.

Consent for Publication

Not applicable.

Availability of Data and Material

The claims database details analyzed in this study are not publicly available as this is proprietary information. Researchers can purchase the data through a licensing agreement with Komodo Health.

Code Availability

Not applicable.

Authors’ Contribution

Conceptualization and investigation: all; methodology, validation, and data curation: NB, JPM, RLA, BB, KF; supervision: KF, NB; writing and visualization of original draft: all; review and editing of drafts: all. All authors read and approved the final version of the manuscript.

References

Associated Data

Supplementary Materials

Supplementary file1 (PDF 225 KB)