TY - JOUR
T1 - Impact of peginterferon beta-1a and disease factors on quality of life in multiple sclerosis
AU - Newsome, S. D.
AU - Guo, S.
AU - Altincatal, A.
AU - Proskorovsky, I.
AU - Kinter, E.
AU - Phillips, G.
AU - You, X.
AU - Sabatella, G.
N1 - Publisher Copyright:
©2015 Elsevier B.V.
PY - 2015/7/1
Y1 - 2015/7/1
N2 - Background The Phase III ADVANCE study has shown clinical benefits for peginterferon beta-1a 125 μg dosed every 2 weeks versus placebo at 1 year in patients with relapsing-remitting multiple sclerosis (MS). This study assessed the impact of peginterferon beta-1a and disease factors on health-related quality of life (HRQoL) using data from ADVANCE. Methods HRQoL was assessed at baseline and 12, 24, and 48 weeks using the 29-item Multiple Sclerosis Impact Scale (MSIS-29) and other generic HRQoL measures. Changes in scores from baseline within each group and differences in mean change from baseline between groups were evaluated. Post-hoc mixed-effects repeated measures analyses were performed to assess the impact of confirmed disability progression and relapses, and the interactions of treatment and these MS events on HRQoL. Predictors with p≥0.1 were excluded from the final models, unless they were clinically meaningful. Results Relapses and confirmed disability progression were major drivers of HRQoL. When comparing week 48 to baseline, in placebo-treated patients (n=500), confirmed disability progression was associated with a 6.0-point worsening (p<0.0001) of MSIS-29 physical scores, relative to a 1.9-point worsening (p=0.044) with peginterferon beta-1a every 2 weeks (n=512). Such findings were observed consistently with other generic HRQoL measures. Additionally, having a recent relapse (≤ days before the HRQoL assessment) was associated with a 10.0-point worsening (p<) of MSIS-29 psychological scores in placebo-treated patients, compared with a 3.5-point (p=0.031) worsening with peginterferon beta-1a every 2 weeks. Conclusion Treatment with peginterferon beta-1a could help to improve or maintain HRQoL in addition to clinical outcomes. Trial registration: ClinicalTrials.gov: NCT00906399.
AB - Background The Phase III ADVANCE study has shown clinical benefits for peginterferon beta-1a 125 μg dosed every 2 weeks versus placebo at 1 year in patients with relapsing-remitting multiple sclerosis (MS). This study assessed the impact of peginterferon beta-1a and disease factors on health-related quality of life (HRQoL) using data from ADVANCE. Methods HRQoL was assessed at baseline and 12, 24, and 48 weeks using the 29-item Multiple Sclerosis Impact Scale (MSIS-29) and other generic HRQoL measures. Changes in scores from baseline within each group and differences in mean change from baseline between groups were evaluated. Post-hoc mixed-effects repeated measures analyses were performed to assess the impact of confirmed disability progression and relapses, and the interactions of treatment and these MS events on HRQoL. Predictors with p≥0.1 were excluded from the final models, unless they were clinically meaningful. Results Relapses and confirmed disability progression were major drivers of HRQoL. When comparing week 48 to baseline, in placebo-treated patients (n=500), confirmed disability progression was associated with a 6.0-point worsening (p<0.0001) of MSIS-29 physical scores, relative to a 1.9-point worsening (p=0.044) with peginterferon beta-1a every 2 weeks (n=512). Such findings were observed consistently with other generic HRQoL measures. Additionally, having a recent relapse (≤ days before the HRQoL assessment) was associated with a 10.0-point worsening (p<) of MSIS-29 psychological scores in placebo-treated patients, compared with a 3.5-point (p=0.031) worsening with peginterferon beta-1a every 2 weeks. Conclusion Treatment with peginterferon beta-1a could help to improve or maintain HRQoL in addition to clinical outcomes. Trial registration: ClinicalTrials.gov: NCT00906399.
KW - Clinical trial
KW - Interferon
KW - Multiple sclerosis
KW - Peginterferon beta-1a
KW - Pegylation
KW - Quality of life
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U2 - 10.1016/j.msard.2015.06.004
DO - 10.1016/j.msard.2015.06.004
M3 - Article
C2 - 26195056
AN - SCOPUS:84937501650
SN - 2211-0348
VL - 4
SP - 350
EP - 357
JO - Multiple Sclerosis and Related Disorders
JF - Multiple Sclerosis and Related Disorders
IS - 4
ER -