Efficacy of Natalizumab Therapy in Patients of African Descent With Relapsing Multiple Sclerosis

Abstract

Background: Patients with multiple sclerosis (MS) who are of African descent experience a more aggressive disease course than patients who are of white race/ethnicity. In phase 3 clinical trials (Natalizumab Safety and Efficacy in Relapsing Remitting Multiple Sclerosis [AFFIRM] and Safety and Efficacy of Natalizumab in Combination With Interferon Beta-1a in Patients With Relapsing Remitting Multiple Sclerosis [SENTINEL]), natalizumab use significantly improved clinical and magnetic resonance imaging outcomes over 2 years in patients with relapsing MS. Because patients of African descent may be less responsive to interferon beta treatment than patients of white race/ ethnicity, the efficacy of natalizumab therapy in this population is clinically important. Objective: To evaluate the efficacy of natalizumab use in patients of African descent with relapsing MS.

Pharmacokinetics/pharmacodynamics by Race: Analysis of a Peginterferon β-1a Phase I Study

“…11 Evidence is mixed from studies of other DMTs, including high-efficacy DMTs such as natalizumab and ocrelizumab, with some studies suggesting a poorer response to treatment in Black compared with White patients, 26 and others reporting a finding of no difference. 10, 12, 31 Interpretation of the previous studies is limited by the low proportion of Black patients included, which ranged from 1.9% to 13.9%. In contrast, this study enrolled greater than 50% Black participants, alongside a similar proportion of White participants.…”

Pharmacokinetics/pharmacodynamics by Race: Analysis of a Peginterferon β-1a Phase I Study

“…11 Evidence is mixed from studies of other DMTs, including high-efficacy DMTs such as natalizumab and ocrelizumab, with some studies suggesting a poorer response to treatment in Black compared with White patients, 26 and others reporting a finding of no difference. 10, 12, 31 Interpretation of the previous studies is limited by the low proportion of Black patients included, which ranged from 1.9% to 13.9%. In contrast, this study enrolled greater than 50% Black participants, alongside a similar proportion of White participants.…”

Long-Term Effectiveness and Safety of Natalizumab in African American and Hispanic/Latino Patients with Early Relapsing–Remitting Multiple Sclerosis: STRIVE Data Analysis

“…Only two high-efficacy DMTs, natalizumab and ocrelizumab, have published post hoc analyses of their phase III pivotal trials examining efficacy in patients of African descent [1,2]. Both analyses found that the treatment reduced clinical and MRI activity versus placebo/interferon beta-1a in patients of African descent [1,2]. Although these results are promising, authors of both publications stated further research was needed.…”

Real-World Safety and Effectiveness of Dimethyl Fumarate in Black or African American Patients with Multiple Sclerosis: 3-Year Results from ESTEEM

“…Conversely, more recent subgroup analyses from an observational study of the safety and effectiveness of pegylated IFNβ-1a in a small cohort ( n = 38) of AA patients demonstrated low relapse rates; however, the sample size was small and, similarly to the present study, these patients were selected for IFN therapy and were not randomized [ 20 ]. Natalizumab has also been shown to significantly lower both relapse rate and the accumulation of brain lesions in patients of African descent with relapsing–remitting multiple sclerosis ( n = 49) [ 21 ]. These subanalyses are once again limited by the small numbers of participants, which affect the generalizability of the results.…”

Pharmacokinetics/pharmacodynamics by Race: Analysis of a Peginterferon β-1a Phase I Study

“…11 Evidence is mixed from studies of other DMTs, including high-efficacy DMTs such as natalizumab and ocrelizumab, with some studies suggesting a poorer response to treatment in Black compared with White patients, 26 and others reporting a finding of no difference. 10, 12, 31 Interpretation of the previous studies is limited by the low proportion of Black patients included, which ranged from 1.9% to 13.9%. In contrast, this study enrolled greater than 50% Black participants, alongside a similar proportion of White participants.…”

Long-Term Effectiveness and Safety of Natalizumab in African American and Hispanic/Latino Patients with Early Relapsing–Remitting Multiple Sclerosis: STRIVE Data Analysis

“…Only two high-efficacy DMTs, natalizumab and ocrelizumab, have published post hoc analyses of their phase III pivotal trials examining efficacy in patients of African descent [1,2]. Both analyses found that the treatment reduced clinical and MRI activity versus placebo/interferon beta-1a in patients of African descent [1,2]. Although these results are promising, authors of both publications stated further research was needed.…”

Real-World Safety and Effectiveness of Dimethyl Fumarate in Black or African American Patients with Multiple Sclerosis: 3-Year Results from ESTEEM

“…Conversely, more recent subgroup analyses from an observational study of the safety and effectiveness of pegylated IFNβ-1a in a small cohort ( n = 38) of AA patients demonstrated low relapse rates; however, the sample size was small and, similarly to the present study, these patients were selected for IFN therapy and were not randomized [ 20 ]. Natalizumab has also been shown to significantly lower both relapse rate and the accumulation of brain lesions in patients of African descent with relapsing–remitting multiple sclerosis ( n = 49) [ 21 ]. These subanalyses are once again limited by the small numbers of participants, which affect the generalizability of the results.…”

Pharmacokinetics/pharmacodynamics by Race: Analysis of a Peginterferon β-1a Phase I Study

“…11 Evidence is mixed from studies of other DMTs, including high-efficacy DMTs such as natalizumab and ocrelizumab, with some studies suggesting a poorer response to treatment in Black compared with White patients, 26 and others reporting a finding of no difference. 10, 12, 31 Interpretation of the previous studies is limited by the low proportion of Black patients included, which ranged from 1.9% to 13.9%. In contrast, this study enrolled greater than 50% Black participants, alongside a similar proportion of White participants.…”

Long-Term Effectiveness and Safety of Natalizumab in African American and Hispanic/Latino Patients with Early Relapsing–Remitting Multiple Sclerosis: STRIVE Data Analysis

“…Only two high-efficacy DMTs, natalizumab and ocrelizumab, have published post hoc analyses of their phase III pivotal trials examining efficacy in patients of African descent [1,2]. Both analyses found that the treatment reduced clinical and MRI activity versus placebo/interferon beta-1a in patients of African descent [1,2]. Although these results are promising, authors of both publications stated further research was needed.…”

Real-World Safety and Effectiveness of Dimethyl Fumarate in Black or African American Patients with Multiple Sclerosis: 3-Year Results from ESTEEM

“…Conversely, more recent subgroup analyses from an observational study of the safety and effectiveness of pegylated IFNβ-1a in a small cohort ( n = 38) of AA patients demonstrated low relapse rates; however, the sample size was small and, similarly to the present study, these patients were selected for IFN therapy and were not randomized [ 20 ]. Natalizumab has also been shown to significantly lower both relapse rate and the accumulation of brain lesions in patients of African descent with relapsing–remitting multiple sclerosis ( n = 49) [ 21 ]. These subanalyses are once again limited by the small numbers of participants, which affect the generalizability of the results.…”