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Impact of peginterferon beta-1a and disease factors on quality of life in multiple sclerosis.
Mult Scler Relat Disord. 2015 Jul; 4(4):350-7.MS

Abstract

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 (≤29 days before the HRQoL assessment) was associated with a 10.0-point worsening (p<0.0001) 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.

Authors+Show Affiliations

Department of Neurology, Johns Hopkins University, Baltimore, MD, USA. Electronic address: snewsom2@jhmi.edu.Evidera, 430 Bedford Street, Suite 300, Lexington Office Park, Lexington, MA 02420, USA. Electronic address: shien.guo@evidera.com.Evidera, 430 Bedford Street, Suite 300, Lexington Office Park, Lexington, MA 02420, USA. Electronic address: arman.altincatal@evidera.com.Evidera, 7575 Trans-Canada Highway, Suite 500, St-Laurent, Quebec, Canada H4T 1V6. Electronic address: irina.proskorovsky@evidera.com.Biogen, 225 Binney Street, Cambridge, MA 02142, USA. Electronic address: Elizabeth.Kinter@biogenidec.com.Biogen, 225 Binney Street, Cambridge, MA 02142, USA. Electronic address: glenn.phillips@biogenidec.com.Biogen, 225 Binney Street, Cambridge, MA 02142, USA. Electronic address: phil.you@biogenidec.com.Biogen, 225 Binney Street, Cambridge, MA 02142, USA. Electronic address: guido.sabatella@biogenidec.com.

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26195056

Citation

Newsome, S D., et al. "Impact of Peginterferon Beta-1a and Disease Factors On Quality of Life in Multiple Sclerosis." Multiple Sclerosis and Related Disorders, vol. 4, no. 4, 2015, pp. 350-7.
Newsome SD, Guo S, Altincatal A, et al. Impact of peginterferon beta-1a and disease factors on quality of life in multiple sclerosis. Mult Scler Relat Disord. 2015;4(4):350-7.
Newsome, S. D., Guo, S., Altincatal, A., Proskorovsky, I., Kinter, E., Phillips, G., You, X., & Sabatella, G. (2015). Impact of peginterferon beta-1a and disease factors on quality of life in multiple sclerosis. Multiple Sclerosis and Related Disorders, 4(4), 350-7. https://doi.org/10.1016/j.msard.2015.06.004
Newsome SD, et al. Impact of Peginterferon Beta-1a and Disease Factors On Quality of Life in Multiple Sclerosis. Mult Scler Relat Disord. 2015;4(4):350-7. PubMed PMID: 26195056.
* Article titles in AMA citation format should be in sentence-case
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, Y1 - 2015/06/14/ PY - 2015/03/17/received PY - 2015/06/05/revised PY - 2015/06/10/accepted PY - 2015/7/22/entrez PY - 2015/7/22/pubmed PY - 2016/4/30/medline KW - Clinical trial KW - Interferon KW - Multiple sclerosis KW - Peginterferon beta-1a KW - Pegylation KW - Quality of life SP - 350 EP - 7 JF - Multiple sclerosis and related disorders JO - Mult Scler Relat Disord VL - 4 IS - 4 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 (≤29 days before the HRQoL assessment) was associated with a 10.0-point worsening (p<0.0001) 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. SN - 2211-0356 UR - https://www.unboundmedicine.com/medline/citation/26195056/Impact_of_peginterferon_beta_1a_and_disease_factors_on_quality_of_life_in_multiple_sclerosis_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S2211-0348(15)00075-9 DB - PRIME DP - Unbound Medicine ER -