Author Topic: (Abst.) High-dose immunosuppressive therapy and autologous HCT for RRMS  (Read 64 times)

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Offline agate

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It's only Class IV evidence, based on a small study, but worth noting, IMO.

From PubMed, February 4, 2017:

Quote
Neurology. 2017 Feb 1.

High-dose immunosuppressive therapy and autologous HCT for relapsing-remitting MS

Nash RA1, Hutton GJ2, Racke MK2, Popat U2, Devine SM2, Steinmiller KC2, Griffith LM2, Muraro PA2, Openshaw H2, Sayre PH2, Stuve O2, Arnold DL2, Wener MH2, Georges GE2, Wundes A2, Kraft GH2, Bowen JD2.

Author information

1From the Colorado Blood Cancer Institute (R.A.N.), Denver; Baylor College of Medicine (G.J.H.), Houston, TX; Ohio State University (M.K.R., S.M.D.), Columbus; MD Anderson Cancer Research Center (U.P.), Houston, TX; Rho, Inc. (K.C.S.), Chapel Hill, NC; National Institute of Allergy and Infectious Diseases (L.M.G.), National Institutes of Health, Bethesda, MD; Division of Brain Sciences (P.A.M.), Imperial College London, UK; City of Hope National Medical Center (H.O.), Duarte, CA; Immune Tolerance Network (P.H.S.), University of California San Francisco; University of Texas Southwestern (O.S.), Dallas; NeuroRx (D.L.A.), McGill University, Montreal, Canada; Fred Hutchinson Cancer Research Center (G.E.G.), University of Washington (M.H.W., A.W., G.H.K.); and Swedish Hospital Medical Center (J.D.B.), Seattle, WA. richard.nash@healthonecares.com.
2From the Colorado Blood Cancer Institute (R.A.N.), Denver; Baylor College of Medicine (G.J.H.), Houston, TX; Ohio State University (M.K.R., S.M.D.), Columbus; MD Anderson Cancer Research Center (U.P.), Houston, TX; Rho, Inc. (K.C.S.), Chapel Hill, NC; National Institute of Allergy and Infectious Diseases (L.M.G.), National Institutes of Health, Bethesda, MD; Division of Brain Sciences (P.A.M.), Imperial College London, UK; City of Hope National Medical Center (H.O.), Duarte, CA; Immune Tolerance Network (P.H.S.), University of California San Francisco; University of Texas Southwestern (O.S.), Dallas; NeuroRx (D.L.A.), McGill University, Montreal, Canada; Fred Hutchinson Cancer Research Center (G.E.G.), University of Washington (M.H.W., A.W., G.H.K.); and Swedish Hospital Medical Center (J.D.B.), Seattle, WA.


OBJECTIVE:

To evaluate the safety, efficacy, and durability of multiple sclerosis (MS) disease stabilization after high-dose immunosuppressive therapy (HDIT) and autologous hematopoietic cell transplantation (HCT).

METHODS:

High-Dose Immunosuppression and Autologous Transplantation for Multiple Sclerosis (HALT-MS) is a phase II clinical trial of HDIT/HCT for patients with relapsing-remitting (RR) MS who experienced relapses with disability progression (Expanded Disability Status Scale [EDSS] 3.0-5.5) while on MS disease-modifying therapy. The primary endpoint was event-free survival (EFS), defined as survival without death or disease activity from any one of: disability progression, relapse, or new lesions on MRI.

 Participants were evaluated through 5 years posttransplant. Toxicities were reported using the National Cancer Institute Common Terminology Criteria for Adverse Events (AE).

RESULTS:

Twenty-five participants were evaluated for transplant and 24 participants underwent HDIT/HCT. Median follow-up was 62 months (range 12-72). EFS was 69.2% (90% confidence interval [CI] 50.2-82.1). Progression-free survival, clinical relapse-free survival, and MRI activity-free survival were 91.3% (90% CI 74.7%-97.2%), 86.9% (90% CI 69.5%-94.7%), and 86.3% (90% CI 68.1%-94.5%), respectively.

AE due to HDIT/HCT were consistent with expected toxicities and there were no significant late neurologic adverse effects noted.

Improvements were noted in neurologic disability with a median change in EDSS of -0.5 (interquartile range -1.5 to 0.0; p = 0.001) among participants who survived and completed the study.

CONCLUSION:

HDIT/HCT without maintenance therapy was effective for inducing long-term sustained remissions of active RRMS at 5 years.

CLINICALTRIALSGOV IDENTIFIER:

NCT00288626.

CLASSIFICATION OF EVIDENCE:

This study provides Class IV evidence that participants with RRMS experienced sustained remissions with toxicities as expected from HDIT/HCT.

The abstract can be seen here.
MS Speaks--online for 13 years

SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010.

 

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