Advanced Neurosciences Institute

Author Of 1 Presentation

Patient-Reported Outcomes and Quality of Life Poster Presentation

P1047 - Quality of life (QoL) in treatment-refractory, disabled, multiple sclerosis (MS) during long-term repeated, alemtuzumab (ALE) as assessed by SF-36 (ID 1939)

Speakers
Presentation Number
P1047
Presentation Topic
Patient-Reported Outcomes and Quality of Life

Abstract

Background

Alemtuzumab (ALE) achieves effective protection against disability progression and often improvement in patients with severe multiple sclerosis (MS). The SF-36 health survey is a validated quality-of-life (QoL) outcome with multiple subscales, and has shown differences in low disability MS and short duration of disease in ALE trials..

Objectives

Using longitudinal linear multivariate models, assess changes in QoL in groups switching from other therapies to ALE, or undergoing additional therapy with ALE.

Methods

We prospectively measured changes in QoL with open-label ALE treatment using SF-36 in two arms: ALE-experienced (ALE-X) and ALE-naïve (ALE-N) cohorts with relapsing-remitting MS and secondary progressive MS with relapse, expanded disability status scale (EDSS)<7.0. ALE was given per standard protocols. 60 subjects were recruited and 55 completed the entire intent-to-treat prospective study. The SF-36 questionnaire was completed annually. Mean physical and emotional scores (PS, ES) were calculated from the respective subcategories of the SF-36. Longitudinal linear mixed models were used to test for an association between scores and the primary predictors of either total number of ALE treatments or study arm, with age, sex, EDSS, MS phenotype, and age at MS symptom onset as covariates. Study month was used as the random effect in the models.

Results

Differences of PS and ES between baseline and end of study were not significant, likely a preservation of QoL. Regarding absolute scores, MS phenotype was not associated with scores in any model tested. Total number of ALE treatments had no impact on PS, but covariates age and EDSS were significantly associated with PS. As EDSS increases, PS and ES are lower/worse without an effect of sex. Unexpectedly, PS were subtly but significantly with increasing age at ALE treatment and decreasing EDSS (older patients report higherincreased PS); more dramatic differences were seen for ES. ALE-X patients showed marginal significantly higher PS over ALE-N, possibly related to long-term therapy. ALE-X patients reported a significantly higher ES score than their ALE-N peers over the treatment course. ES also significantly increased with increasing ALE treatments (about 2% for each additional ALE treatment). Covariates of age at MS onset, sex, and EDSS were significantly associated with ES. Lower age at onset, females, and higher EDSS were associated with lower ES.

Conclusions

Both experienced and naïve ALE groups have relatively stable long-term QoL measures. As expected, QoL is negatively associated with EDSS. Older patients perceive greater physical health in our cohorts. Shorter disease duration, lower EDSS, males, and receiving greater ALE courses report better emotional health than those with longer disease duration, higher EDSS, females, or patients with fewer treatments, respectively. Greater QoL in experienced patients may reflect long-term benefit and treatment response.

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Presenter Of 1 Presentation

Patient-Reported Outcomes and Quality of Life Poster Presentation

P1047 - Quality of life (QoL) in treatment-refractory, disabled, multiple sclerosis (MS) during long-term repeated, alemtuzumab (ALE) as assessed by SF-36 (ID 1939)

Speakers
Presentation Number
P1047
Presentation Topic
Patient-Reported Outcomes and Quality of Life

Abstract

Background

Alemtuzumab (ALE) achieves effective protection against disability progression and often improvement in patients with severe multiple sclerosis (MS). The SF-36 health survey is a validated quality-of-life (QoL) outcome with multiple subscales, and has shown differences in low disability MS and short duration of disease in ALE trials..

Objectives

Using longitudinal linear multivariate models, assess changes in QoL in groups switching from other therapies to ALE, or undergoing additional therapy with ALE.

Methods

We prospectively measured changes in QoL with open-label ALE treatment using SF-36 in two arms: ALE-experienced (ALE-X) and ALE-naïve (ALE-N) cohorts with relapsing-remitting MS and secondary progressive MS with relapse, expanded disability status scale (EDSS)<7.0. ALE was given per standard protocols. 60 subjects were recruited and 55 completed the entire intent-to-treat prospective study. The SF-36 questionnaire was completed annually. Mean physical and emotional scores (PS, ES) were calculated from the respective subcategories of the SF-36. Longitudinal linear mixed models were used to test for an association between scores and the primary predictors of either total number of ALE treatments or study arm, with age, sex, EDSS, MS phenotype, and age at MS symptom onset as covariates. Study month was used as the random effect in the models.

Results

Differences of PS and ES between baseline and end of study were not significant, likely a preservation of QoL. Regarding absolute scores, MS phenotype was not associated with scores in any model tested. Total number of ALE treatments had no impact on PS, but covariates age and EDSS were significantly associated with PS. As EDSS increases, PS and ES are lower/worse without an effect of sex. Unexpectedly, PS were subtly but significantly with increasing age at ALE treatment and decreasing EDSS (older patients report higherincreased PS); more dramatic differences were seen for ES. ALE-X patients showed marginal significantly higher PS over ALE-N, possibly related to long-term therapy. ALE-X patients reported a significantly higher ES score than their ALE-N peers over the treatment course. ES also significantly increased with increasing ALE treatments (about 2% for each additional ALE treatment). Covariates of age at MS onset, sex, and EDSS were significantly associated with ES. Lower age at onset, females, and higher EDSS were associated with lower ES.

Conclusions

Both experienced and naïve ALE groups have relatively stable long-term QoL measures. As expected, QoL is negatively associated with EDSS. Older patients perceive greater physical health in our cohorts. Shorter disease duration, lower EDSS, males, and receiving greater ALE courses report better emotional health than those with longer disease duration, higher EDSS, females, or patients with fewer treatments, respectively. Greater QoL in experienced patients may reflect long-term benefit and treatment response.

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