ALEMTUZUMAB IMPROVES 3-YEAR QUALITY OF LIFE IN CARE-MS II

2015 ◽  
Vol 86 (11) ◽  
pp. e4.9-e4
Author(s):  
Alasdair Coles ◽  
Gavin Giovannoni ◽  
Thibault Moreau ◽  
Eva Havrdova ◽  
David Margolin ◽  
...  

In the 2-year, phase 3 CARE–MS II study (NCT00548405) of relapsing-remitting multiple sclerosis (RRMS) patients with inadequate efficacy response to prior therapy, alemtuzumab demonstrated superior efficacy and quality-of-life (QoL) improvements versus subcutaneous interferon beta-1a, with manageable safety. Here, QoL outcomes are examined in alemtuzumab-treated patients at Year 3 in an ongoing extension study (NCT00930553). 393 of 435 alemtuzumab 12 mg-treated patients entered the extension study; 80 received as-needed alemtuzumab retreatment during Year 3. Mean Functional Assessment of multiple sclerosis total score (scale 0–176) improved from baseline to year 3 (119.1 vs 124.8; P<0.0001), with 5 of 6 subscales significantly improved. Mean Short-Form 36–Item survey physical and mental component summary scores (scale 1–100) rose from baseline to Year 3 (42.7 vs 44.7; P<0.0001, and 44.9 vs 46.5; P=0.042, respectively), with 6 of 8 subscales improved, and 82% and 73% of patients, respectively, having a stable or improved score at Year 3. EuroQol 5–dimensional visual analogue scale score improved from baseline to Year 3 (70.1 vs 73.0; P=0.0045). Overall sustained improvement in physical, mental, and emotional aspects of QoL were observed through 3 years in this population of alemtuzumab-treated RRMS patients, even though most patients received only 2 alemtuzumab treatment courses.

2013 ◽  
Vol 20 (2) ◽  
pp. 253-257 ◽  
Author(s):  
Mariko Kita ◽  
Robert J Fox ◽  
J Theodore Phillips ◽  
Michael Hutchinson ◽  
Eva Havrdova ◽  
...  

Multiple sclerosis (MS) has a significant impact on health-related quality of life (HRQoL) with symptoms adversely affecting many aspects of everyday living. BG-12 (dimethyl fumarate) demonstrated significant efficacy in the phase III studies DEFINE and CONFIRM in patients with relapsing–remitting MS. In CONFIRM, HRQoL was worse in patients with greater disability at baseline, and who relapsed during the study, and improved with BG-12 treatment. Mean Short Form-36 Physical Component Summary scores for BG-12 increased over 2 years and scores for placebo decreased. Coupled with clinical and neuroradiological benefits, these HRQoL results further support BG-12 as an effective oral treatment for relapsing MS.


2020 ◽  
Author(s):  
Tjalf Ziemssen ◽  
Olaf Hoffmann ◽  
Luisa Klotz ◽  
Herbert Schreiber ◽  
Martin S Weber ◽  
...  

BACKGROUND A high proportion of patients with relapsing remitting multiple sclerosis convert to secondary progressive multiple sclerosis (SPMS) characterized by irreversibly progressing disability and cognitive decline. Siponimod (Mayzent), a selective sphingosine-1-phosphate receptor modulator, was recently approved by the European Medicines Agency for the treatment of adult SPMS patients with active disease, as evidenced by relapses or magnetic resonance imaging features of ongoing inflammatory activity. Approval by the Food and Drug Administration covers a broader range of indications, comprising clinically isolated syndrome, relapsing remitting multiple sclerosis, and active SPMS. However, treatment effects of siponimod have not been assessed in a structured setting in clinical routine so far. OBJECTIVE The objectives of AMASIA (imp<strong>A</strong>ct of <strong>M</strong>ayzent [siponimod] on second<strong>A</strong>ry progressive multiple <strong>S</strong>clerosis patients in a long-term non-<strong>I</strong>nterventional study in Germ<strong>A</strong>ny), a prospective noninterventional study, are to assess the long-term effectiveness and safety of siponimod in clinical routine and to evaluate the impact of disease burden on quality of life and socioeconomic conditions. Here, we report the study design of AMASIA. METHODS Treatment effects of siponimod will be evaluated in 1500 SPMS patients during a 3-year observational phase. According to the genetic polymorphism of CYP2C9, the initial dose will be titrated to the maintenance dose of 1 mg (CYP2C9*1*3 and *2*3) or 2 mg (all other polymorphisms of CYP2C9 except *3*3, which is contraindicated) taken orally once daily. Primary endpoint is the 6-month confirmed disability progression, as assessed by a functional composite endpoint comprising the Expanded Disability Status Scale and symbol digit modalities test to take appropriate account of cognitive changes and increase sensitivity. Further measures including multiple sclerosis activity data; assessments of functional domains; questionnaires addressing the patients’, physicians’, and relatives’ perspectives of disability progression; cognitive worsening; quality of life; and socioeconomic aspects will be documented using the multiple sclerosis documentation system MSDS3D. RESULTS AMASIA is being conducted between February 2020 and February 2025 in up to 250 neurological centers in Germany. CONCLUSIONS AMASIA will complement the pivotal phase III–derived efficacy and safety profile of siponimod with real-world data and will further evaluate several individual treatment aspects such as quality of life and socioeconomic conditions of patients and caregivers. It might help to establish siponimod as a promising option for the treatment of SPMS patients in clinical routine. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/19598


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