Real-world clinical outcomes in relapsing-remitting multiple sclerosis patients who switch from natalizumab to delayed-release dimethyl fumarate: a multicenter, retrospective, observational study (STRATEGY)
Author(s): ,
S. Cohan
Affiliations:
Providence Multiple Sclerosis Center, Portland, OR
,
H. Moses
Affiliations:
Department of Neurology, Neuroimmunology Division, Vanderbilt University Medical Center, Nashville, TN
,
J. Calkwood
Affiliations:
Schapiro Center for Multiple Sclerosis, Minneapolis Clinic of Neurology, Golden Valley, MN
,
C. Tornatore
Affiliations:
Department of Neurology, Medstar Georgetown University Hospital, Washington, DC
,
C. Laganke
Affiliations:
North Central Neurology Associates, Cullman, AL
,
K.E. Smoot
Affiliations:
Providence Multiple Sclerosis Center, Portland, OR
,
M. Mann
Affiliations:
Biogen, Inc., Cambridge, MA, United States
,
V. Meka
Affiliations:
Biogen, Inc., Cambridge, MA, United States
,
M. Okwuokenye
Affiliations:
Biogen, Inc., Cambridge, MA, United States
,
C. Hotermans
Affiliations:
Biogen, Inc., Cambridge, MA, United States
L. Meltzer
Affiliations:
Biogen, Inc., Cambridge, MA, United States
ECTRIMS Online Library. Cohan S. 10/08/15; 115559; 618
Stanley Cohan
Stanley Cohan
Contributions
Abstract
Abstract: P563

Type: Poster

Abstract Category: Immunomodulation / Immunosuppression

Background: Delayed-release dimethyl fumarate (DMF; also known as gastro-resistant DMF) may be a therapeutic option for patients with relapsing-remitting multiple sclerosis (RRMS) who are treated with natalizumab and require a change in therapy. However, there is limited information regarding standardized practices for transitioning patients from natalizumab to DMF. Clinical practices and switch protocols vary, and predictors of favourable treatment outcomes on DMF following natalizumab are not well understood.

Objectives: Present results of clinical practice outcomes (annualized relapse rate [ARR] and risk of relapse) in a Phase 4, retrospective, observational study of patients with RRMS who switched from natalizumab to DMF.

Methods: STRATEGY is performed through a single time point medical chart abstraction without required study visits or procedures. A total of 530 patients at 46 US sites have been enrolled. Key inclusion criteria include age ≥18 years, RRMS diagnosis (McDonald criteria), ≥12 months continuous treatment with natalizumab monotherapy prior to initiation of DMF, and initiation of DMF ≥12 months prior to enrolment. Patients are eligible to enrol regardless of current DMF use.

Results: Preliminary results (16 January 2015 database lock) are shown; final results will be presented. The preliminary analysis comprised 227 evaluable patients (mean age: 47 years). Overall risk of relapse

1 year after initiation of DMF was 25%. Overall ARR during DMF treatment (0.295) increased compared with the natalizumab treatment period (0.114) but was lower than 1 year prior to initiation of natalizumab (0.480). Risk of relapse 1 year after initiation of DMF was similar in patients with pre-natalizumab disease activity (≥1 relapse 1 year prior to natalizumab) compared with patients without pre-natalizumab disease activity (25.3% vs 24.8%). In patients with washout duration ≤90 days compared with patients with washout duration >90 days, risk of relapse 1 year after initiation of DMF was lower (16% vs 33%) and ARR 1 year after initiation of DMF was lower (0.181 vs 0.423).

Conclusions: Preliminary findings suggest that DMF may be a reasonable treatment option for patients who discontinue natalizumab in the real-world setting. Shorter natalizumab washout duration was associated with better clinical outcomes (lower risk of relapse and ARR) on DMF treatment. Final results will be presented.

Disclosure:

This study is supported by Biogen, Inc.

Stanley Cohan: research support from Biogen, Novartis, Genzyme, Roche, and Mallinckgrodt; advisory boards and steering committees for Biogen, Novartis, Genzyme, and Mallinckrodt; honoraria from Biogen, Novartis, Genzyme, and Acorda.

Jonathan Calkwood: advisory, consultancy, and speaker activities for Acorda, Bayer Healthcare, Biogen, EMD Serono, Genzyme, Mylan, Novartis, Questcor, and Teva; grant/research activities with Biogen, Genzyme, Novartis, Receptos, Roche, and Xenoport.

Christopher LaGanke: advisory, consultancy, and speaker activities for Acorda, Bayer Healthcare, Biogen, EMD Serono, Genzyme, Novartis, Pfizer, Questcor, Teva Neuroscience; research support from Bayer Healthcare, Biogen, Genzyme, GSK, Novartis, Pfizer, Teva Neuroscience, and Vaccinex.

Carlo Tornatore: consultant fees and research support from Biogen, Genzyme, and Novartis; Speaker Bureau for Biogen.

Harold Moses: consulting, speaker fees, and research support from Biogen, Teva, Bayer, EMDSerono, Genzyme, Novartis, and Avanir.

Kyle E. Smoot: advisory and speaker activities for Acorda, Biogen, EMD Serono, Genzyme, Novartis, and Teva.

Monica Mann: employee of and holds stock/stock options in Biogen.

Venkata Meka: employee of and holds stock/stock options in Biogen.

Macaulay Okwuokenye: employee of and holds stock/stock options in Biogen.

Christophe Hotermans: employee of and holds stock/stock options in Biogen.

Leslie Meltzer: employee of and holds stock/stock options in Biogen.

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