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9. High-Dose Immunosuppressive Therapy and Autologous Hematopoietic Cell Transplantation for Relapsing-Remitting Multiple Sclerosis (HALT-MS): A 3-Year Interim Report

Author

Nash, Richard A, Hutton, George J, Racke, Michael K, Popat, Uday, Devine, Steven M, Griffith, Linda M, Muraro, Paolo A, Openshaw, Harry, Sayre, Peter H, Stüve, Olaf, Arnold, Douglas L, Spychala, Meagan E, McConville, Kaitlyn C, Harris, Kristina M, Phippard, Deborah, Georges, George E, Wundes, Annette, Kraft, George H, and Bowen, James D

Subjects
Biomedical and Clinical Sciences, Immunology, Multiple Sclerosis, Transplantation, Clinical Research, Regenerative Medicine, Clinical Trials and Supportive Activities, Neurodegenerative, Brain Disorders, Autoimmune Disease, Neurosciences, Hematology, Stem Cell Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Adult, Combined Modality Therapy, Disease Progression, Disease-Free Survival, Female, Follow-Up Studies, Hematopoietic Stem Cell Transplantation, Humans, Immunosuppressive Agents, Magnetic Resonance Imaging, Male, Middle Aged, Multiple Sclerosis, Relapsing-Remitting, Transplantation, Autologous, Treatment Outcome
Abstract

ImportanceMost patients with relapsing-remitting (RR) multiple sclerosis (MS) who receive approved disease-modifying therapies experience breakthrough disease and accumulate neurologic disability. High-dose immunosuppressive therapy (HDIT) with autologous hematopoietic cell transplant (HCT) may, in contrast, induce sustained remissions in early MS.ObjectiveTo evaluate the safety, efficacy, and durability of MS disease stabilization through 3 years after HDIT/HCT.Design, setting, and participantsHematopoietic Cell Transplantation for Relapsing-Remitting Multiple Sclerosis (HALT-MS) is an ongoing, multicenter, single-arm, phase 2 clinical trial of HDIT/HCT for patients with RRMS who experienced relapses with loss of neurologic function while receiving disease-modifying therapies during the 18 months before enrolling. Participants are evaluated through 5 years after HCT. This report is a prespecified, 3-year interim analysis of the trial. Thirty-six patients with RRMS from referral centers were screened; 25 were enrolled.InterventionsAutologous peripheral blood stem cell grafts were CD34+ selected; the participants then received high-dose treatment with carmustine, etoposide, cytarabine, and melphalan as well as rabbit antithymocyte globulin before autologous HCT.Main outcomes and measuresThe primary end point of HALT-MS is event-free survival defined as survival without death or disease activity from any one of the following outcomes: (1) confirmed loss of neurologic function, (2) clinical relapse, or (3) new lesions observed on magnetic resonance imaging. Toxic effects are reported using National Cancer Institute Common Terminology Criteria for Adverse Events.ResultsGrafts were collected from 25 patients, and 24 of these individuals received HDIT/HCT. The median follow-up period was 186 weeks (interquartile range, 176-250) weeks). Overall event-free survival was 78.4% (90% CI, 60.1%-89.0%) at 3 years. Progression-free survival and clinical relapse-free survival were 90.9% (90% CI, 73.7%-97.1%) and 86.3% (90% CI, 68.1%-94.5%), respectively, at 3 years. Adverse events were consistent with expected toxic effects associated with HDIT/HCT, and no acute treatment-related neurologic adverse events were observed. Improvements were noted in neurologic disability, quality-of-life, and functional scores.Conclusions and relevanceAt 3 years, HDIT/HCT without maintenance therapy was effective for inducing sustained remission of active RRMS and was associated with improvements in neurologic function. Treatment was associated with few serious early complications or unexpected adverse events.

Published
2015

19. Brain volume change after high-dose immunosuppression and autologous hematopoietic cell transplantation for relapsing-remitting multiple sclerosis

Author

Lee, Hyunwoo, primary, Nakamura, Kunio, additional, Narayanan, Sridar, additional, Brown, Robert A, additional, Nash, Richard A, additional, Griffith, Linda M, additional, Steinmiller, Kaitlyn C, additional, Devine, Steven M, additional, Hutton, George J, additional, Popat, Uday, additional, Racke, Michael K, additional, Georges, George E, additional, Bowen, James D, additional, and Arnold, Douglas L, additional

Published
2021
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24. Comparative Adherence Trajectories of Oral Fingolimod and Injectable Disease Modifying Agents in Multiple Sclerosis

Author

Earla, Jagadeswara R, Hutton, George J, Thornton, J Douglas, Chen, Hua, Johnson, Michael L, and Aparasu, Rajender R

Subjects
Patient Preference and Adherence, disease modifying agent, adherence trajectory, DMA, fingolimod, injectable DMA, multiple sclerosis, group based trajectory modelling, GBTM, Original Research
Abstract

Jagadeswara R Earla,1 George J Hutton,2 J Douglas Thornton,1 Hua Chen,1 Michael L Johnson,1 Rajender R Aparasu1 1Pharmaceutical Health Outcomes and Policy, College of Pharmacy, University of Houston, Houston, TX, USA; 2Department of Neurology, Baylor College of Medicine, Houston, TX, USACorrespondence: Rajender R AparasuPharmaceutical Health Outcomes and Policy, College of Pharmacy, University of Houston, Texas Medical Center, 4849 Calhoun Road, Houston, TX 77204-5047, USATel +1 832-842-8374Email rraparasu@uh.eduBackground: Oral fingolimod is convenient to use than injectable disease modifying agents (DMAs) in patients with multiple sclerosis (MS). However, the existing literature regarding the comparative adherence trajectories between oral fingolimod and injectable DMAs is limited.Objective: To compare the adherence trajectories between oral DMA, fingolimod, and injectable DMAs in patients with MS.Methods: A retrospective longitudinal study was conducted using adults (≥ 18 years) with MS (ICD-9-CM: 340 and a DMA prescription) from the IBM MarketScan Commercial Claims and Encounters Database between 2010 and 2012. Patients were grouped into oral fingolimod or injectable DMA users based on the index DMA among patients with MS. The annual DMA adherence trajectories, based on the proportion of days covered (PDC), were examined using group-based trajectory modeling (GBTM) during the one-year follow-up period after treatment initiation. Multivariable multinomial logistic regression using stabilized inverse probability treatment weights (IPTW) was performed to assess the association between the DMA route of administration (Oral vs Injectable) and the adherence trajectory groups. The balance of covariates between oral and injectable DMAs before and after IPTW was checked against a standardized difference threshold of 0.25.Results: The study cohort consisted of 1,700 MS patients who were initiated with oral (15.8%) or injectable (84.2%) DMAs between 2010 and 2012. The adherence rates (PDC≥ 0.8) in oral fingolimod and injectable DMA users were found to be 64.7% and 50.8%, respectively. The GBTM grouped individuals in the study cohort into three adherence trajectories – rapid discontinuers (23.5%), complete adherers (49.9%), and slow decliners (26.6%). The multinomial logistic regression model with stabilized IPTW revealed that oral fingolimod users had higher odds to be a complete adherer (adjusted odds ratio [AOR]: 2.78, 95% CI: 1.85– 4.16) or a slow discontinuer (AOR: 2.62, 95% CI: 1.70– 4.05) than injectable DMA users.Conclusions: Oral DMA fingolimod was associated with better adherence than injectable DMAs across group-based trajectories. Further research is warranted to evaluate the adherence trajectories with newer oral DMAs introduced in the last decade for MS.Keywords: group based trajectory modelling, GBTM, adherence trajectory, multiple sclerosis, disease modifying agent, DMA, fingolimod, injectable DMA

Published
2020

25. Comparative Adherence Trajectories of Oral Fingolimod and Injectable Disease Modifying Agents in Multiple Sclerosis

Author

Earla,Jagadeswara R, Hutton,George J, Thornton,J Douglas, Chen,Hua, Johnson,Michael L, Aparasu,Rajender R, Earla,Jagadeswara R, Hutton,George J, Thornton,J Douglas, Chen,Hua, Johnson,Michael L, and Aparasu,Rajender R

Abstract

Jagadeswara R Earla,1 George J Hutton,2 J Douglas Thornton,1 Hua Chen,1 Michael L Johnson,1 Rajender R Aparasu1 1Pharmaceutical Health Outcomes and Policy, College of Pharmacy, University of Houston, Houston, TX, USA; 2Department of Neurology, Baylor College of Medicine, Houston, TX, USACorrespondence: Rajender R AparasuPharmaceutical Health Outcomes and Policy, College of Pharmacy, University of Houston, Texas Medical Center, 4849 Calhoun Road, Houston, TX 77204-5047, USATel +1 832-842-8374Email rraparasu@uh.eduBackground: Oral fingolimod is convenient to use than injectable disease modifying agents (DMAs) in patients with multiple sclerosis (MS). However, the existing literature regarding the comparative adherence trajectories between oral fingolimod and injectable DMAs is limited.Objective: To compare the adherence trajectories between oral DMA, fingolimod, and injectable DMAs in patients with MS.Methods: A retrospective longitudinal study was conducted using adults (≥ 18 years) with MS (ICD-9-CM: 340 and a DMA prescription) from the IBM MarketScan Commercial Claims and Encounters Database between 2010 and 2012. Patients were grouped into oral fingolimod or injectable DMA users based on the index DMA among patients with MS. The annual DMA adherence trajectories, based on the proportion of days covered (PDC), were examined using group-based trajectory modeling (GBTM) during the one-year follow-up period after treatment initiation. Multivariable multinomial logistic regression using stabilized inverse probability treatment weights (IPTW) was performed to assess the association between the DMA route of administration (Oral vs Injectable) and the adherence trajectory groups. The balance of covariates between oral and injectable DMAs before and after IPTW was checked against a standardized difference threshold of 0.25.Results: The study cohort consisted of 1,700 MS patients who were initiated with oral (15.8%) or injectable (84.2%) DMAs between 2010 and 2012. T

Published
2020

28. Pregnancy outcomes and postpartum relapse rates in women with RRMS treated with alemtuzumab in the phase 2 and 3 clinical development program over 16 years

Author

Oh, Jiwon, primary, Achiron, Anat, additional, Celius, Elisabeth G., additional, Chambers, Christina, additional, Derwenskus, Joy, additional, Devonshire, Virginia, additional, Hellwig, Kerstin, additional, Hutton, George J., additional, McCombe, Pamela, additional, Moore, Marie, additional, Rog, David, additional, Schneider, Jean-Raphael, additional, Simm, Renata Faria, additional, Sousa, Livia, additional, Vincent, Stephen G., additional, Chung, Luke, additional, Daizadeh, Nadia, additional, Mitchell, Colin, additional, and Compston, D. Alastair S., additional

Published
2020
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30. Postpartum Relapse After First On-Study Pregnancy in RRMS Patients Treated With Alemtuzumab in the Phase 2 and 3 Clinical Development Program Over 8 Years (169)

Author

Celius, Elisabeth G., primary, Oh, Jiwon, additional, Achiron, Anat, additional, Compston, D Alastair S., additional, Devonshire, Virginia, additional, Hellwig, Kerstin, additional, Hutton, George J., additional, McCombe, Pamela, additional, Moore, Marie, additional, Simm, Renata Faria, additional, Sousa, Livia, additional, Vincent, Stephen G., additional, Chung, Luke, additional, Daizadeh, Nadia, additional, Mitchell, Colin, additional, and Rog, David, additional

Published
2020
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37. Evaluation of Dalfampridine Extended Release 5 and 10 mg in Multiple Sclerosis: A Randomized Controlled Trial

Author

Yapundich, Robert, Applebee, Angela, Bethoux, Francois, Goldman, Myla D., Hutton, George J., Mass, Michele, Pardo, Gabriel, Klingler, Michael, Henney, Herbert R., Blight, Andrew R., and Carrazana, Enrique J.

Subjects
Articles
Abstract

Dalfampridine extended-release (ER) tablets, 10 mg twice daily, have been shown to improve walking in people with multiple sclerosis. We evaluated the safety and efficacy of dalfampridine-ER 5 mg compared with 10 mg.Patients were randomized to double-blind treatment with twice-daily dalfampridine-ER tablets, 5 mg (n = 144) or 10 mg (n = 143), or placebo (n = 143) for 4 weeks. Primary efficacy endpoint was change from baseline walking speed by the Timed 25-Foot Walk 3 to 4 hours after the last dose. At 40% of sites, 2-week change from baseline walking distance was measured by the 6-Minute Walk test.At 4 weeks, walking speed changes from baseline were 0.363, 0.423, and 0.478 ft/s (placebo, dalfampridine-ER 5 mg, and dalfampridine-ER 10 mg, respectively [P = NS]). Post hoc analysis of average changes between pretreatment and on-treatment showed that relative to placebo, only dalfampridine-ER 10 mg demonstrated a significant increase in walking speed (mean ± SE): 0.443 ± 0.042 ft/s versus 0.303 ± 0.038 ft/s (P = .014). Improvement in 6-Minute Walk distance was significantly greater with dalfampridine-ER 10 mg (128.6 ft, P = .014) but not with 5 mg (76.8 ft, P = .308) relative to placebo (41.7 ft). Adverse events were consistent with previous studies. No seizures were reported.Dalfampridine-ER 5 and 10 mg twice daily did not demonstrate efficacy on the planned endpoint. Post hoc analyses demonstrated significant increases in walking speed relative to placebo with dalfampridine-ER 10 mg. No new safety signals were observed.

Published
2015

39. Best Practices in the Management of Multiple Sclerosis: Advanced Strategies for Improved Patient Outcomes.

Author

Hutton, George J.

Subjects
MAGNETIC resonance imaging, MULTIPLE sclerosis, DISEASE management, TREATMENT effectiveness
Abstract

There are several strategies to improve patient outcomes in multiple sclerosis (MS). The first is to prescribe disease-modifying therapy and ensure the patient is adherent with the therapy. Disease-modifying therapy comes in various dosage forms which can be chosen to enhance adherence. Appropriate monitoring with MRI is another way to enhance outcomes. [ABSTRACT FROM AUTHOR]

Published
2018

42. Functional brain network changes associated with maintenance of cognitive function in multiple sclerosis

Author

Helekar, Santosh A., Shin, Jae C., Mattson, Brandi J., Bartley, Krystle, Stosic, Milena, Saldana-King, Toni, Montague, P. Read, Hutton, George J., Helekar, Santosh A., Shin, Jae C., Mattson, Brandi J., Bartley, Krystle, Stosic, Milena, Saldana-King, Toni, Montague, P. Read, and Hutton, George J.

Abstract

In multiple sclerosis (MS) functional changes in connectivity due to cortical reorganization could lead to cognitive impairment (CI), or reflect a re-adjustment to reduce the clinical effects of widespread tissue damage. Such alterations in connectivity could result in changes in neural activation as assayed by executive function tasks. We examined cognitive function in MS patients with mild to moderate CI and age-matched controls. We evaluated brain activity using functional magnetic resonance imaging (fMRI) during the successful performance of the Wisconsin card sorting (WCS) task by MS patients, showing compensatory maintenance of normal function, as measured by response latency and error rate. To assess changes in functional connectivity throughout the brain, we performed a global functional brain network analysis by computing voxel-by-voxel correlations on the fMRI time series data and carrying out a hierarchical cluster analysis. We found that during the WCS task there is a significant reduction in the number of smaller size brain functional networks, and a change in the brain areas representing the nodes of these networks in MS patients compared to age-matched controls. There is also a concomitant increase in the strength of functional connections between brain loci separated at intermediate-scale distances in these patients. These functional alterations might reflect compensatory neuroplastic reorganization underlying maintenance of relatively normal cognitive function in the face of white matter lesions and cortical atrophy produced by MS.

Published
2010
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43. Treatment of Severe Relapsing-Remitting Multiple Sclerosis with High-Dose Immunosuppressive Therapy and Autologous Hematopoietic Cell Transplantation: 2-Year Follow-up Results of the HALT MS Clinical Trial (Immune Tolerance Network: ITN033AI)

Author

Nash, Richard, primary, Hutton, George J., additional, Racke, Michael, additional, Popat, Uday, additional, Devine, Steven M., additional, Georges, George, additional, Griffith, Linda, additional, Muraro, Paolo A., additional, Openshaw, Harry, additional, Sayre, Peter, additional, Stuve, Olaf, additional, Arnold, Douglas, additional, Spychala, Meagan, additional, Lim, Noha, additional, Malhotra, Sachin, additional, Phippard, Deborah, additional, Wundes, Annette, additional, Kraft, George H., additional, and Bowen, James D., additional

Published
2013
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44. Treatment of Severe Relapsing-Remitting Multiple Sclerosis with High-Dose Immunosuppressive Therapy and Autologous Hematopoietic Cell Transplantation: 2-Year Follow-up Results of the HALT MS Clinical Trial (Immune Tolerance Network: ITN033AI)

Author

Nash, Richard A., primary, Hutton, George J., additional, Racke, Michael K, additional, Popat, Uday R., additional, Devine, Steven M., additional, Georges, George E., additional, Griffith, Linda M., additional, Muraro, Paolo A, additional, Openshaw, Harry, additional, Sayre, Peter H., additional, Stuve, Olaf, additional, Arnold, Douglas L, additional, Spychala, Meagan, additional, Lim, Noha, additional, Malhotra, Sachin, additional, Phippard, Deborah, additional, Wundes, Annette, additional, Kraft, George H, additional, and Bowen, James D, additional

Published
2012
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45. Treatment of Severe Relapsing-Remitting Multiple Sclerosis with High-Dose Immunosuppressive Therapy and Autologous Hematopoietic Cell Transplantation: Early Results of the HALT MS Clinical Trial (Immune Tolerance Network: ITN033AI)

Author

Nash, Richard A., primary, Hutton, George J, additional, Racke, Michael K, additional, Popat, Uday R, additional, Devine, Steven M., additional, Griffith, Linda M., additional, Muraro, Paolo A, additional, Openshaw, Harry, additional, Sayre, Peter H., additional, Stuve, Olaf, additional, Arnold, Douglas L, additional, Wruck, Lisa, additional, Wundes, Annette, additional, Kraft, George H, additional, and Bowen, James D, additional

Published
2011
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