Save
Efficacy analysis of opicinumab in relapsing multiple sclerosis: the Phase 2b SYNERGY trial
Author(s): ,
D Cadavid
Affiliations:
Biogen, Cambridge, MA
,
K.R Edwards
Affiliations:
MS Center of Northeastern New York, Latham, NY, United States
,
R Hupperts
Affiliations:
Maastricht University Medical Center, Sittard, The Netherlands
,
J Drulović
Affiliations:
Clinic of Neurology, Clinical Centre of Serbia, Faculty of Medicine, University of Belgrade, Belgrade, Serbia
,
X Montalban
Affiliations:
Vall d'Hebron University Hospital, Barcelona, Spain
,
H.-P Hartung
Affiliations:
Department of Neurology, Heinrich-Heine University, Dusseldorf, Germany
,
B Brochet
Affiliations:
Bordeaux Hospital University Centre and University of Bordeaux, Bordeaux, France
,
P.A Calabresi
Affiliations:
The Johns Hopkins Multiple Sclerosis Center, Baltimore, MD, United States
,
R Rudick
Affiliations:
Biogen, Cambridge, MA
,
A Ibrahim
Affiliations:
Biogen, Maidenhead, United Kingdom
,
Y Zhang
Affiliations:
Biogen, Cambridge, MA
,
L Xu
Affiliations:
Biogen, Cambridge, MA
on behalf of the SYNERGY investigators
on behalf of the SYNERGY investigators
Affiliations:
ECTRIMS Online Library. Cadavid D. Sep 16, 2016; 147038; 192
Dr. Diego Cadavid
Dr. Diego Cadavid
Login now to access Regular content available to all registered users.

You may also access this content "anytime, anywhere" with the Free MULTILEARNING App for iOS and Android
Abstract
Discussion Forum (0)
Rate & Comment (0)

Abstract: 192

Type: Oral

Abstract Category: Therapy - disease modifying - Neurorepair

Background: Opicinumab (BIIB033), a human monoclonal antibody, was genetically engineered to have low effector function, and blocks LINGO-1, a CNS-specific negative regulator of myelination and axonal regeneration. Opicinumab was effective and well tolerated in preclinical models of remyelination/Phase 1 studies, respectively, and in the Phase 2a proof of biology RENEW study resulted in evidence of enhanced remyelination in participants with a first episode of acute optic neuritis.

Goals: Evaluate the efficacy of opicinumab vs placebo in disabled participants with relapsing MS active over the previous year when used chronically and concurrently with intramuscular (IM) interferon (IFN) beta-1a.

Methods: SYNERGY (NCT01864148) is a recently completed randomised, double-blind, placebo-controlled, dose-ranging proof-of-concept study. Participants (18-58 y) with active RRMS or SPMS over the previous year were randomised to intravenous 3, 10, 30 or 100 mg/kg opicinumab or placebo every 4 weeks for 19 doses with IM IFN beta-1a 30 mcg once weekly for 72-84 weeks to treat the inflammatory component, and assessed for 84 weeks. The primary endpoint is the percentage of participants experiencing confirmed improvement of neurophysical and/or cognitive function over 72 weeks measured by a composite comprising the Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), 9-Hole Peg Test (9HPT) and 3-Second Paced Auditory Serial Addition Test (PASAT-3); improvement is defined as a ≥1.0 point decrease in EDSS (from baseline ≤6.0) and/or ≥15% improvement from baseline in T25FW, 9HPT or PASAT-3, all confirmed for ≥3 months. Secondary efficacy endpoints include percentage with 3 month confirmed worsening of neurophysical and/or cognitive function and/or disability over 72 weeks, based on EDSS, T25FW, 9HPT and PASAT-3. Other clinical efficacy endpoints include MS-COG, 6-Minute Walk Test, Scripps Neurological Rating Scale and patient-reported outcomes.

Results: 418 participants, 330 with RRMS and 88 with SPMS, were randomised; 330 completed the study. Details of the primary, secondary, and other clinical efficacy outcomes will be presented for the first time.

Conclusions: SYNERGY results will determine the potential efficacy of opicinumab for improving pre-existing disability and/or preventing further disease worsening in disabled participants with relapsing MS via enhancing CNS repair when used concurrently with IM IFN beta-1a to control the inflammatory component.

Disclosure: This study was supported by Biogen (Cambridge, MA, USA).

Diego Cadavid, Richard Rudick, Adama Ibrahim, Yiwei Zhang and Lei Xu: employees of and stockholders in Biogen.

Keith Edwards: consulting fees and speaker bureaus for Biogen and Genzyme; research support from Actelion, Biogen, Eisai, Eli Lilly, Forum Pharmaceuticals, Genentech, Genzyme/Sanofi, Hoffman-La Roche, Merz Pharmaceuticals, Novartis, Pfizer and Vaccinex.

Raymond Hupperts: advisor/speaker/consultant for Biogen, Merck Serono, Novartis, and Sanofi-Aventis, research support from Biogen and Merck Serono.

Jelena Drulović: advisor/speaker for Bayer HealthCare, Genzyme, Medis, Merck, Novartis, and Sanofi-Aventis, research support from the Ministry of Education and Science, Republic of Serbia (project no. 175031).

Xavier Montalban: speaker fees/travel expense reimbursement from and steering committees/advisory boards for Actelion, Almirall, Bayer HealthCare, Biogen, Genzyme, Merck, NeuroTec, Novartis, Octapharma, Receptos, Roche, Sanofi-Aventis, Teva and Trophos.

Hans-Peter Hartung: speaker fees/travel expense reimbursement from and steering committees/advisory boards for Biogen, Geneuro, Genzyme, Merck, Medimmune, Novartis, Octapharma, Receptos, Roche, Sanofi-Aventis and Teva.

Bruno Brochet: advisory boards for and he/his institution has received honoraria from Bayer HealthCare, Genzyme, Novartis, Roche, and Teva, research support for his institution from Bayer HealthCare, Biogen, Genzyme, MedDay, Novartis and Roche.

Peter Calabresi: compensation for consulting from Vertex; research support to Johns Hopkins from Biogen, MedImmune and Novartis.

Biogen provided funding for medical writing support in the development of this abstract. Becky Gardner PhD (Excel Scientific Solutions, Horsham, UK) wrote the first draft of the abstract based on input from authors. Biogen reviewed and provided feedback on the abstract. The authors had full editorial control of the abstract, and provided their final approval of all content.

Code of conduct/disclaimer available in General Terms & Conditions
Anonymous User Privacy Preferences

Strictly Necessary Cookies (Always Active)

MULTILEARNING platforms and tools hereinafter referred as “MLG SOFTWARE” are provided to you as pure educational platforms/services requiring cookies to operate. In the case of the MLG SOFTWARE, cookies are essential for the Platform to function properly for the provision of education. If these cookies are disabled, a large subset of the functionality provided by the Platform will either be unavailable or cease to work as expected. The MLG SOFTWARE do not capture non-essential activities such as menu items and listings you click on or pages viewed.


Performance Cookies

Performance cookies are used to analyse how visitors use a website in order to provide a better user experience.



Google Analytics is used for user behavior tracking/reporting. Google Analytics works in parallel and independently from MLG’s features. Google Analytics relies on cookies and these cookies can be used by Google to track users across different platforms/services.


Save Settings