Tuesday


AMPYRA IMPROVES WALKING SPEED, WALKING ENDURANCE & COMMUNITY PARTICIPATION IN VETRANS WITH MULTIPLE SCLEROSIS (a longitudinal cohort study)


Mult Scler. 2013 Oct 7.

Source:

Oregon Health and Science University and Portland VA Medical Center, USA.
Abstract

BACKGROUND:

In short-term trials, dalfampridine extended release (ER) improves walking in people with multiple sclerosis (MS). The tolerability and effects of dalfampridine-ER in clinical practice have not been reported.

OBJECTIVES:

The objective of this paper is to determine the clinical tolerability and effects of dalfampridine on walking and community participation.

METHODS:

All patients at the Portland VA Medical Center prescribed dalfampridine-ER over one year completed the Timed 25-Foot Walk (T25FW), Multiple Sclerosis Walking Scale-12 (MSWS-12), Two-Minute Timed Walk (2MTW), and Community Integration Questionnaire (CIQ) at baseline and follow-up clinic visits. Ongoing use and measures over one year were analyzed.

CONCLUSIONS: Dalfampridine-ER was associated with short-term improvements in walking speed and community participation, and sustained improvements in walking endurance and self-perceived impact of MS on walking for one year. Our study supports the utility of this medication in late MS.

Saturday

Treatment with dalfampridine (AMPYRA) resulted in clinically relevant improvements in walking speed and endurance in MS patients with limited ambulation and helped improve their motor function


RESULTS: Treatment with dalfampridine resulted in significant improvement in walking speed and endurance (p < 0.05). Walking speed increased by 33% and walking endurance by 31 %, representing clinically meaningful improvement. This change was
not influenced by change in muscle tone. This improvement in mobility was associated with a clinically significant change in motor function.

ECTRIMS UPDATE #2: BIOGEN HAS 3 NEW MS TREATMENTS THEY ARE WORKING ON THAT ARE BEING PRESENTED AT ECTRIMS: THE WORLDWIDE MEETING OF NEUROLOGISTS:



Data at The ECTRIMS Meetings will be presented from across Biogen Idec’s portfolio, including:

Investigational medicines:

PLEGRIDY(pegylated interferon beta-1a): a potential new molecular entity for relapsing forms of MS in which interferon beta-1a is pegylated to extend its half-life and prolong its exposure in the body. Pegylation offers a less-frequent dosing schedule.

DACLIZUMAB HIGH-YIELD PROCESS (DAC HYP): is being developed as a once-monthly subcutaneous injection. DAC HYP is believed to target the activated immune cells that can play a key role in MS without causing general immune cell depletion. DAC HYP is being developed under a collaboration agreement with AbbVie, Inc.

Anti-LINGO-1 (BIIB033): is the first candidate being investigated for its potential to repair neurons damaged by MS.

Approved medicines:

TYSABRI® (natalizumab): offers established efficacy that has been proven to reduce relapses and slow disability progression.

TECFIDERA® (dimethyl fumarate): an oral treatment for relapsing forms of MS, including relapsing-remitting MS (RRMS), which has been clinically proven to significantly reduce important measures of disease activity with a favorable safety/tolerability profile. TECFIDERA is currently approved in the United States, Canada and Australia.

FAMPYRA® (prolonged-release fampridine tablets): the first approved treatment to address the unmet medical need of walking improvement in MS patients, demonstrating efficacy in patients with all MS types. Approved in the European Union.

The titles of key Biogen Idec abstracts are as follows:

TYSABRI:

October 3

Poster #519: Effects of natalizumab treatment on freedom from disease activity by baseline characteristics in AFFIRM
Poster #524: Natalizumab reduces the disabling amplitude of multiple sclerosis relapses and improves post-relapse residual disability
October 4

Poster #1050: Disease activity and disability progression decrease beyond two years on natalizumab in relapsing multiple sclerosis patients in the TYSABRI® (natalizumab) Observational Programme
TECFIDERA:

October 3

Poster #538: 4-year follow-up of oral BG-12 (dimethyl fumarate) treatment in relapsing remitting multiple sclerosis (RRMS): integrated clinical efficacy data from the DEFINE, CONFIRM, and ENDORSE studies
October 4

Poster #1004: 4-year follow-up of oral BG-12 (dimethyl fumarate) treatment in relapsing remitting multiple sclerosis (RRMS): integrated magnetic resonance imaging (MRI) outcomes from DEFINE, CONFIRM, and ENDORSE
Poster #1127: Interim analysis of quality of life in patients with relapsing remitting multiple sclerosis treated with BG-12 (dimethyl fumarate) in the ENDORSE study
Poster #996: Safety profile of BG-12 (dimethyl fumarate) in relapsing remitting multiple sclerosis: long-term interim results from the ENDORSE extension study
Poster #990: Effect of BG-12 (dimethyl fumarate) in newly diagnosed relapsing remitting multiple sclerosis (RRMS) patients from the DEFINE and CONFIRM studies
Poster #1100: Dimethyl fumarate and monomethyl fumarate are distinguished by non-overlapping pharmacodynamic effects in vivo
FAMPYRA:

October 3

Poster #665: Long-term prolonged-release fampridine treatment and health-related quality of life outcomes: nine-month interim analysis of the ENABLE study
Poster #658: Health-related quality of life outcomes following long-term treatment with prolonged-release fampridine: impact on psychological outcomes in the ENABLE study
October 4

Poster #1128: Changes in physical functioning and activity following long-term treatment with prolonged-release fampridine in the ENABLE study
PLEGRIDY:

October 3

Poster #514: Peginterferon beta-1a provides improvements in clinical and radiological disease activity in relapsing-remitting multiple sclerosis: year 1 findings from the phase 3 ADVANCE study
October 4

Poster #989: Magnetic resonance imaging results from the first year of the ADVANCE study, a pivotal phase 3 trial of peginterferon beta-1a in patients with relapsing-remitting multiple sclerosis
Anti-LINGO-1:

October 3

Poster #545: The use of magnetic resonance imaging to monitor the safety of anti-LINGO-1: findings from phase I studies in healthy volunteers and subjects with multiple sclerosis
Poster #378: Blocking LINGO1 promotes axonal regeneration in the rat optic nerve crush model
DACLIZUMAB HYP:

October 4

Poster #977: Reduction in brain atrophy with extended daclizumab HYP treatment: results of SELECT and the SELECT extension study
Poster #864: Evaluation of immunogenicity in multiple sclerosis patients continuously treated with daclizumab-HYP during the SELECT and SELECTION clinical trials.

VIDEO: Acorda Therapeutics (AMPYRA) CEO Ron Cohen on how the partial government shutdown affects the pharmaceutical industry




STUDY: AMPYRA (Dalfampridine) improves walking speed, walking endurance, and community participation in veterans with multiple sclerosis: a longitudinal cohort study

Conclusions: AMPYRA (Dalfampridine-ER) was associated with short-term improvements in walking speed and community participation, and sustained improvements in walking endurance and self-perceived impact of MS on walking for one year. Our study supports the utility of Ampyra in late MS. 
Objectives: The objective of this paper is to determine the clinical tolerability and effects of dalfampridine on walking and community participation.
Methods: All patients at the Portland VA Medical Center prescribed dalfampridine-ER over one year completed the Timed 25-Foot Walk, Multiple Sclerosis Walking Scale-12, Two-Minute Timed Walk, and Community Integration Questionnaire (CIQ) at baseline and follow-up clinic visits.

Multiple Sclerosis Journal. published 7 October 2013,10.1177/1352458513507356
Michelle H. Cameron, Oregon Health and Science University and Portland VA Medical Center, 3181 SW Sam Jackson Park Road, L226, Portland, OR 97219, USA. Email: cameromi@ohsu.edu
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Tecfidera & Ampyra Show Potential for Quality of Life Improvement in Patients With MS


New MS drugs ishow potential for improving quality of life  of patients with multiple sclerosis.




A SERVICE DEVELOPMENT AUDIT OF FAMPRIDINE (AMPYRA) USE IN MS.
The 2MWT and accelerometry are good objective measures of walking disability in addition to the T25FW. Accelerometry provides additional real-life data regarding activity during the day, and offers information regarding the impact of fatigue on a patient. The MSWS-12 subjectively measures impact of walking disability and the ABC score predicts falls. The use of an assistive device identifies walking disability and predicts risk of falls. Given the uncertainty regarding falls risk in patients using fampridine, physicians should consider using these tools to monitor patients under consideration for the drug.