Comparison of rituximab vs fingolimod, dimethyl fumarate and natalizumab in the treatment of multiple sclerosis: two year experience
Author(s): ,
B. Vollmer
Affiliations:
Department of Neurology, Rocky Mountain Multiple Sclerosis Center at the University of Colorado
,
K. Nair
Affiliations:
Skagg`s School of Pharmacy and Pharmaceutical Sciences, University of Colorado, Aurora, CO, United States
,
S. Sillau
Affiliations:
Department of Neurology, Rocky Mountain Multiple Sclerosis Center at the University of Colorado
,
J. Corboy
Affiliations:
Department of Neurology, Rocky Mountain Multiple Sclerosis Center at the University of Colorado
,
T. Vollmer
Affiliations:
Department of Neurology, Rocky Mountain Multiple Sclerosis Center at the University of Colorado
E. Alvarez
Affiliations:
Department of Neurology, Rocky Mountain Multiple Sclerosis Center at the University of Colorado
ECTRIMS Online Library. Vollmer B. 10/10/18; 228406; P562
Brandi Vollmer
Brandi Vollmer
Contributions
Abstract

Abstract: P562

Type: Poster Sessions

Abstract Category: Therapy - Immunomodulation/Immunosuppression

Introduction: Rituximab (RTX) has been used for the off-label treatment of multiple sclerosis (MS). Limited comparative effectiveness data exists comparing RTX to other highly effective therapies. Objective: Compare discontinuation rates and efficacy of rituximab (RTX) to fingolimod (FTY), dimethyl fumarate (DMF), natalizumab (NTZ) over two years in MS patients.
Methods: Patients prescribed FTY, DMF, NTZ or RTX at the Rocky Mountain MS Center at the University of Colorado between January, 2010 and October, 2013 were identified. Clinician-reported data including relapse history, adverse events, MRI outcomes, disease history and patient characteristics were retrospectively collected. Primary outcome was the probability of discontinuing drug by the end of year two. Simple and adjusted logistic regression were used for pairwise data analysis controlling for age, disease duration, type of MS, gender, and enhancing lesion at baseline.
Results: A total of 182, 271, 342, and 451 patients initiated RTX, FTY, DMF and NTZ and were included in this study. Patients had a mean age of 43.9(RTX), 42.5(FTY), 45.8(DMF) and 39.8(NTZ) years at the index date; were predominantly female (65.9% RTX; 72.0% FTY; 69.6% DMF; 76.7% NTZ); and were largely relapsing-remitting MS (62.1% RTX; 90.0% FTY; 77.5% DMF; 84.7% NTZ). At ≤24 months, 46(25.3%), 93(34.3%), 161(47.1%) and 147(32.6%) discontinued RTX, FTY, DMF, and NTZ, respectively. FTY versus RTX had an adjusted odds ratio(aOR) of 1.96 (95%CI:1.23-3.13,p=0.005) for discontinuation at ≤24 months. DMF versus RTX had an aOR of 3.32 (95%CI:2.15-5.13,p< 0.001). NTZ versus RTX had an aOR of 1.50 (95%CI:0.99-2.28,p=0.109). The leading cause of discontinuation RTX and NTZ were issues with insurance (9.9%) and being JCV positive (12.6%), respectively. Adverse events were the leading cause for discontinuation for FTY (17%) and DMF (24.0%). Fewer RTX patients (14.8%) experienced disease activity including a contrast enhancing lesion, a new T2 lesion and/or a clinical relapse during follow up compared to FTY (34.7%, p=< 0.001), DMF (33.6%, p=< 0.001) and NTZ (22.2%, p=0.037).
Conclusions: The odds of discontinuing ≤24 months was lower for RTX versus FTY and DMF. RTX demonstrated the lowest unadjusted disease activity outcomes. Given the differences in baseline characteristics, additional methods of adjustment will be presented.
Disclosure: Brandi Vollmer has nothing to disclose. Kavita V Nair has consulted and/or received research support from Astellas, Genentech, Novartis, and Biogen; consulting for Astellas and Genentech. Stefan H Sillau has nothing to disclose. John Corboy has received grant support from Biogen Idec, Novartis, Med Day, NMSS, and PCORI, has received honorarium for speaking from the Rocky Mountain MS Center and PRIME CME, and has received compensation as editor of Neurology: Clinical Practice. Timothy Vollmer has received compensation for activities such as advisory boards, lectures and consultancy with Academic CME; Alcimed; Anthem Blue Cross; Genentech/Roche; Biogen IDEC; Novartis; CellGene; Epigene; Rocky Mountain MS Center;GLG Consulting; Ohio Health; TG Therapeutics; Topaz Therapeutics; Deleara Lawyers; Teva Neuroscience He received research support from Teva Neuroscience; NIH/NINDS; Rocky Mountain MS Center; Actelion; Roche/Genentech; UT Southwestern and TG Therapeutics, Inc. Enrique Alvarez: has consulted for Biogen, Genzyme, Genentech, Teva, and Novartis; and received research funding from Rocky Mountain MS Center, Biogen, Novartis, Acorda, and Alkermes.

Abstract: P562

Type: Poster Sessions

Abstract Category: Therapy - Immunomodulation/Immunosuppression

Introduction: Rituximab (RTX) has been used for the off-label treatment of multiple sclerosis (MS). Limited comparative effectiveness data exists comparing RTX to other highly effective therapies. Objective: Compare discontinuation rates and efficacy of rituximab (RTX) to fingolimod (FTY), dimethyl fumarate (DMF), natalizumab (NTZ) over two years in MS patients.
Methods: Patients prescribed FTY, DMF, NTZ or RTX at the Rocky Mountain MS Center at the University of Colorado between January, 2010 and October, 2013 were identified. Clinician-reported data including relapse history, adverse events, MRI outcomes, disease history and patient characteristics were retrospectively collected. Primary outcome was the probability of discontinuing drug by the end of year two. Simple and adjusted logistic regression were used for pairwise data analysis controlling for age, disease duration, type of MS, gender, and enhancing lesion at baseline.
Results: A total of 182, 271, 342, and 451 patients initiated RTX, FTY, DMF and NTZ and were included in this study. Patients had a mean age of 43.9(RTX), 42.5(FTY), 45.8(DMF) and 39.8(NTZ) years at the index date; were predominantly female (65.9% RTX; 72.0% FTY; 69.6% DMF; 76.7% NTZ); and were largely relapsing-remitting MS (62.1% RTX; 90.0% FTY; 77.5% DMF; 84.7% NTZ). At ≤24 months, 46(25.3%), 93(34.3%), 161(47.1%) and 147(32.6%) discontinued RTX, FTY, DMF, and NTZ, respectively. FTY versus RTX had an adjusted odds ratio(aOR) of 1.96 (95%CI:1.23-3.13,p=0.005) for discontinuation at ≤24 months. DMF versus RTX had an aOR of 3.32 (95%CI:2.15-5.13,p< 0.001). NTZ versus RTX had an aOR of 1.50 (95%CI:0.99-2.28,p=0.109). The leading cause of discontinuation RTX and NTZ were issues with insurance (9.9%) and being JCV positive (12.6%), respectively. Adverse events were the leading cause for discontinuation for FTY (17%) and DMF (24.0%). Fewer RTX patients (14.8%) experienced disease activity including a contrast enhancing lesion, a new T2 lesion and/or a clinical relapse during follow up compared to FTY (34.7%, p=< 0.001), DMF (33.6%, p=< 0.001) and NTZ (22.2%, p=0.037).
Conclusions: The odds of discontinuing ≤24 months was lower for RTX versus FTY and DMF. RTX demonstrated the lowest unadjusted disease activity outcomes. Given the differences in baseline characteristics, additional methods of adjustment will be presented.
Disclosure: Brandi Vollmer has nothing to disclose. Kavita V Nair has consulted and/or received research support from Astellas, Genentech, Novartis, and Biogen; consulting for Astellas and Genentech. Stefan H Sillau has nothing to disclose. John Corboy has received grant support from Biogen Idec, Novartis, Med Day, NMSS, and PCORI, has received honorarium for speaking from the Rocky Mountain MS Center and PRIME CME, and has received compensation as editor of Neurology: Clinical Practice. Timothy Vollmer has received compensation for activities such as advisory boards, lectures and consultancy with Academic CME; Alcimed; Anthem Blue Cross; Genentech/Roche; Biogen IDEC; Novartis; CellGene; Epigene; Rocky Mountain MS Center;GLG Consulting; Ohio Health; TG Therapeutics; Topaz Therapeutics; Deleara Lawyers; Teva Neuroscience He received research support from Teva Neuroscience; NIH/NINDS; Rocky Mountain MS Center; Actelion; Roche/Genentech; UT Southwestern and TG Therapeutics, Inc. Enrique Alvarez: has consulted for Biogen, Genzyme, Genentech, Teva, and Novartis; and received research funding from Rocky Mountain MS Center, Biogen, Novartis, Acorda, and Alkermes.

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