Brigham and Women's Hospital
Neurology

Author Of 2 Presentations

Observational Studies Poster Presentation

P0871 - Efficacy and safety of dimethyl fumarate in progressive multiple sclerosis (ID 1547)

Presentation Number
P0871
Presentation Topic
Observational Studies

Abstract

Background

Dimethyl fumarate (DMF) is an FDA approved drug for relapsing forms of multiple sclerosis. Currently, there is limited data analyzing the safety and efficacy of DMF in progressive multiple sclerosis (PMS) population. A combination of immunomodulatory and neuroprotective effects demonstrated with DMF could theoretically benefit this subset of patients.

Objectives

To analyze the safety and efficacy of dimethyl fumarate in patients diagnosed with progressive forms of multiple sclerosis.

Methods

We conducted a single-center retrospective observational analysis of patients with PMS assessing the safety and efficacy of DMF. We used Cox proportional hazards models to compare the time to sustained worsening and improvement on the Expanded Disability Status Scale (EDSS) and timed 25-foot walk (T25FW) between patients treated with DMF and glatiramer acetate (GA) for at least one year. A multivariable analysis adjusting for age, sex, disease duration, and baseline EDSS was also performed.

Results

Eighty-eight patients were included in this study, 46 patients in the DMF group and 42 in the GA group. Safety and tolerability of GA and DMF were consistent with established profiles. There was a non-significant reduction in sustained EDSS and T25FW progression in the DMF group compared to the GA group after adjustment (HR=0.74; 95% CI: 0.32, 1.70; p=0.46 and HR=0.51; 95% CI: 0.21, 1.21; p=0.12, respectively). Sustained EDSS improvement showed a significant difference in the DMF group compared to the GA group (HR=4.23; 95% CI: 1.09, 16.42; p=0.04) after adjustment.

Conclusions

In a well-characterized PMS population, DMF showed a consistent though non-significant reduction of disease progression metrics and a significant increase in proportion of patients experiencing sustained EDSS improvement compared to patients treated with GA. The small sample precluded definitive determination though suggested that further study of DMF in PMS is warranted.

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Observational Studies Poster Presentation

P0918 - Teriflunomide safety and efficacy in advanced progressive multiple sclerosis (ID 1541)

Presentation Number
P0918
Presentation Topic
Observational Studies

Abstract

Background

Teriflunomide is an FDA approved medication for relapsing-remitting multiple sclerosis. The efficacy of teriflunomide in progressive multiple sclerosis is not well characterized.

Objectives

To explore the safety and efficacy profile of teriflunomide in patients diagnosed with progressive multiple sclerosis.

Methods

We conducted a single-center retrospective observational analysis of a progressive multiple sclerosis population, assessing safety and efficacy in patients treated at least one year with teriflunomide or glatiramer acetate. Sustained progression of expanded disability status scale (EDSS) and sustained worsening of timed 25-foot walk (T25FW) were compared using a cox proportional hazards model.

Results

Teriflunomide group (n=29) mean characteristics: age=58 years (SD±7.6), disease duration=16.7 years (SD±9.5), EDSS =5.9 (SD±1.3), follow-up=32.4 months (SD±13.6). Glatiramer acetate group (n=30) mean characteristics: age=52.4 years (SD±11.3), disease duration=15.1 years (SD±10.4), EDSS =5.7 (SD±1.6), follow-up=46.9 months (SD±43.9). Both treatments were well tolerated without serious side effects. After adjustment for age, sex, and baseline EDSS, sustained EDSS progression did not differ between groups (Hazard Ratio =1.17; 95% Confidence Interval: 0.45, 3.08; p=0.75). Sustained T25FW worsening after adjustment also did not differ (Hazard Ratio =0.56; 95% Confidence Interval: 0.2, 1.53; p=0.26).

Conclusions

In an advanced progressive multiple sclerosis population no substantial differences in tolerability, safety, sustained EDSS progression, or sustained T25FW worsening over time were observed between glatiramer acetate and teriflunomide treated groups.

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Presenter Of 2 Presentations

Observational Studies Poster Presentation

P0871 - Efficacy and safety of dimethyl fumarate in progressive multiple sclerosis (ID 1547)

Presentation Number
P0871
Presentation Topic
Observational Studies

Abstract

Background

Dimethyl fumarate (DMF) is an FDA approved drug for relapsing forms of multiple sclerosis. Currently, there is limited data analyzing the safety and efficacy of DMF in progressive multiple sclerosis (PMS) population. A combination of immunomodulatory and neuroprotective effects demonstrated with DMF could theoretically benefit this subset of patients.

Objectives

To analyze the safety and efficacy of dimethyl fumarate in patients diagnosed with progressive forms of multiple sclerosis.

Methods

We conducted a single-center retrospective observational analysis of patients with PMS assessing the safety and efficacy of DMF. We used Cox proportional hazards models to compare the time to sustained worsening and improvement on the Expanded Disability Status Scale (EDSS) and timed 25-foot walk (T25FW) between patients treated with DMF and glatiramer acetate (GA) for at least one year. A multivariable analysis adjusting for age, sex, disease duration, and baseline EDSS was also performed.

Results

Eighty-eight patients were included in this study, 46 patients in the DMF group and 42 in the GA group. Safety and tolerability of GA and DMF were consistent with established profiles. There was a non-significant reduction in sustained EDSS and T25FW progression in the DMF group compared to the GA group after adjustment (HR=0.74; 95% CI: 0.32, 1.70; p=0.46 and HR=0.51; 95% CI: 0.21, 1.21; p=0.12, respectively). Sustained EDSS improvement showed a significant difference in the DMF group compared to the GA group (HR=4.23; 95% CI: 1.09, 16.42; p=0.04) after adjustment.

Conclusions

In a well-characterized PMS population, DMF showed a consistent though non-significant reduction of disease progression metrics and a significant increase in proportion of patients experiencing sustained EDSS improvement compared to patients treated with GA. The small sample precluded definitive determination though suggested that further study of DMF in PMS is warranted.

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Observational Studies Poster Presentation

P0918 - Teriflunomide safety and efficacy in advanced progressive multiple sclerosis (ID 1541)

Presentation Number
P0918
Presentation Topic
Observational Studies

Abstract

Background

Teriflunomide is an FDA approved medication for relapsing-remitting multiple sclerosis. The efficacy of teriflunomide in progressive multiple sclerosis is not well characterized.

Objectives

To explore the safety and efficacy profile of teriflunomide in patients diagnosed with progressive multiple sclerosis.

Methods

We conducted a single-center retrospective observational analysis of a progressive multiple sclerosis population, assessing safety and efficacy in patients treated at least one year with teriflunomide or glatiramer acetate. Sustained progression of expanded disability status scale (EDSS) and sustained worsening of timed 25-foot walk (T25FW) were compared using a cox proportional hazards model.

Results

Teriflunomide group (n=29) mean characteristics: age=58 years (SD±7.6), disease duration=16.7 years (SD±9.5), EDSS =5.9 (SD±1.3), follow-up=32.4 months (SD±13.6). Glatiramer acetate group (n=30) mean characteristics: age=52.4 years (SD±11.3), disease duration=15.1 years (SD±10.4), EDSS =5.7 (SD±1.6), follow-up=46.9 months (SD±43.9). Both treatments were well tolerated without serious side effects. After adjustment for age, sex, and baseline EDSS, sustained EDSS progression did not differ between groups (Hazard Ratio =1.17; 95% Confidence Interval: 0.45, 3.08; p=0.75). Sustained T25FW worsening after adjustment also did not differ (Hazard Ratio =0.56; 95% Confidence Interval: 0.2, 1.53; p=0.26).

Conclusions

In an advanced progressive multiple sclerosis population no substantial differences in tolerability, safety, sustained EDSS progression, or sustained T25FW worsening over time were observed between glatiramer acetate and teriflunomide treated groups.

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