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Extending natalizumab treatment up to eight weeks shown safe and effective in patients with multiple sclerosis: updated analysis from an ongoing multicenter study
Author(s): ,
L. Zhovtis Ryerson
Affiliations:
NYU Langone Medical Center, New York, NY
,
I. Kister
Affiliations:
NYU Langone Medical Center, New York, NY
,
J. Foley
Affiliations:
Rocky Mountain MS Clinic, Salt Lake City, UT
,
G. Remington
Affiliations:
Texas Southwestern Medical Center, Dallas, TX
,
B. Weinstock-Guttman
Affiliations:
University of Buffalo, Buffalo, NY
,
K. Pandey
Affiliations:
Barnabas Health System, Livingston, NJ
,
S. Pawate
Affiliations:
Vanderbilt University Medical Center, Nashville, TN
,
R. Bomprezzi
Affiliations:
University of Massachusetts School of Medicine, Wilcox, MA
,
D. Smith
Affiliations:
Multiple Sclerosis Center of Connecticut, Norwich, CT
,
D. Hojnacki
Affiliations:
University of Buffalo, Buffalo, NY
,
C. Kolb
Affiliations:
University of Buffalo, Buffalo, NY
,
D. Okuda
Affiliations:
University of Texas Southwestern Medical Center, Dallas, TX
,
T. Frohman
Affiliations:
University of Texas Southwestern Medical Center, Dallas, TX
,
J. Kalina
Affiliations:
NYU Langone Medical Center, New York, NY
,
T. Hoyt
Affiliations:
Rocky Mountain MS Clinic, Salt Lake City, UT
,
R. Green
Affiliations:
Barnabas Health System, Livingston, NJ
,
M. Fox
Affiliations:
NYU Langone Medical Center, New York, NY
,
S. Donnelly
Affiliations:
CUNY Graduate Center, New York, NY
,
E. Chamot
Affiliations:
University of Alabama at Birmingham, Birmingham, AL
,
E. Major
Affiliations:
National Institute of Neurological Disorders and Stroke, Bethesda, VA, United States
E. Frohman
Affiliations:
University of Texas Southwestern Medical Center, Dallas, TX
ECTRIMS Online Library. Zhovtis Ryerson L. Oct 7, 2015; 116756
Dr. Lana Zhovtis Ryerson
Dr. Lana Zhovtis Ryerson
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Abstract: 57

Type: YSI Session

Abstract Category: Risk management for disease modifying treatments

Background: NTZ is highly effective treatment for management of RRMS. However, its use is limited by susceptibility to PML in patients with prior immunosuppressive treatment or exposure to JC virus. In attempt to mitigate risk, we are exploring the effect of extended dose (ED) schedule for NTZ. We hypothesize that less frequent dosing may result in sub-maximal α4β1-integrin receptor saturation, adequate to exclude auto-reactive T cells from entry into CNS ('MS-protective'), but sufficiently permissive to enable normal CNS lymphocyte scavenging of JC-virus to occur ('PML-protective').

Objective: Investigate safety and efficacy of ED Natalizumab (NTZ) schedules.

Method: Recurrent planned retrospective chart review of NTZ-treated patients from 9 U.S. MS centers every six months is ongoing. Patients are stratified into 4 groups:

(1) standard dosing (SD)(n=674): q4wks;

(2) early extended dosing (EED) (n= 231): q4w3d-6w6d;

(3) late extended dosing (LED) (n=245): q7 - 8.5wks;

(4) variable extended dosing (VED) (n=208): patients alternating between EED and LED.

Adjusted annualized relapse rate (ARR), frequency of steroid usage, new T2 lesions, T1 enhancing lesions, and disease free rate (No Evidence of Disease Activity- NEDA) is calculated.

Results: ED groups show comparable efficacy across both clinical and radiological measures compared to SD group. ARR has remained low for both groups at 0.1 with 82% of ED patients having no evidence of radiological activity, compared to 85% in SD cohort. No cases of PML have yet been seen in the ED group, compared to 2 captured in SD. Although the trend is favorable with 1023 JCV - antibody positive person years collected thus far, we will need 1248 patient years to reach statistical significance.

Conclusion: ED of NTZ up to q8.5wks appears to maintain excellent efficacy profile of drug, with promising risk reduction of PML. Further efficacy and safety monitoring in this cohort is ongoing.

Disclosure: No grant or industry support was used for this study.

Lana Zhovtis Ryerson: Research support from Biogen Idec; speaker´s bureau and consulting work for Biogen Idec and Teva Pharmaceuticals

John Foley: has served as a consultants for and receives honoraria from Biogen, Genzyme, Teva, Novartis, and Avanir.

Bianca Weinstock-Guttman has participated in speaker´s bureaus and served as a consultant for Biogen Idec, Teva Neuroscience, EMD Serono, Novartis, Genzyme & Sanofi, Acorda Therapeutics, Inc. and Genentech. Dr. Weinstock-Guttman also has received grant/research support from the agencies listed in the previous sentence as well as Questcor Pharmaceuticals, Inc., and Shire. She serves in the editorial board for BMJ Neurology, Journal of International MS and CNS Drugs

Carlo Tornatore

Siddharama Pawate: nothing to disclose

Roberto Bomprezzi: nothing to disclose

Krupa Pandey: Consults and speaks for: Acorda, Biogen and TEVA

Derek Smith: Nothing to disclose

Ilya Kister served on scientific advisory board for Biogen Idec and

received research support from Guthy-Jackson Charitable Foundation,

National Multiple Sclerosis Society, Biogen-Idec, Serono, and

Navartis.

David Hojnacki: Nothing to disclose

Gina Remington: Nothing to disclose

Channa Kolb: Nothing to disclose

Teresa C. Frohman: Nothing to disclose

Darin Okuda: Nothing to disclose

Jennifer Kalina: Nothing to disclose

Tammy Hoyt: Nothing to disclose

Rivka Green: Nothing to disclose

Michael Fox: Nothing to disclose

Seamus Donnelly: Nothing to disclose

Eric Chamot: Nothing to disclose

Eugene Major: Nothing to disclose

Elliot Frohman: Nothing to disclose

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