S D Newsome1, S Guo2, A Altincatal3, I Proskorovsky4, E Kinter5, G Phillips6, X You7, G Sabatella8. 1. Department of Neurology, Johns Hopkins University, Baltimore, MD, USA. Electronic address: snewsom2@jhmi.edu. 2. Evidera, 430 Bedford Street, Suite 300, Lexington Office Park, Lexington, MA 02420, USA. Electronic address: shien.guo@evidera.com. 3. Evidera, 430 Bedford Street, Suite 300, Lexington Office Park, Lexington, MA 02420, USA. Electronic address: arman.altincatal@evidera.com. 4. Evidera, 7575 Trans-Canada Highway, Suite 500, St-Laurent, Quebec, Canada H4T 1V6. Electronic address: irina.proskorovsky@evidera.com. 5. Biogen, 225 Binney Street, Cambridge, MA 02142, USA. Electronic address: Elizabeth.Kinter@biogenidec.com. 6. Biogen, 225 Binney Street, Cambridge, MA 02142, USA. Electronic address: glenn.phillips@biogenidec.com. 7. Biogen, 225 Binney Street, Cambridge, MA 02142, USA. Electronic address: phil.you@biogenidec.com. 8. Biogen, 225 Binney Street, Cambridge, MA 02142, USA. Electronic address: guido.sabatella@biogenidec.com.
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.
RCT Entities:
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: Thomas F Scott; Bernd C Kieseier; Scott D Newsome; Douglas L Arnold; Xiaojun You; Serena Hung; Bjoern Sperling Journal: Mult Scler J Exp Transl Clin Date: 2016-11-15
Authors: Scott D Newsome; Thomas F Scott; Douglas L Arnold; Gereon Nelles; Serena Hung; Yue Cui; Shulian Shang; Maria L Naylor; Marcelo Kremenchutzky Journal: Ther Adv Neurol Disord Date: 2018-08-28 Impact factor: 6.570
Authors: Sophie Cleanthous; Stefan Cano; Elizabeth Kinter; Patrick Marquis; Jennifer Petrillo; Xiaojun You; Craig Wakeford; Guido Sabatella Journal: Mult Scler J Exp Transl Clin Date: 2017-08-15