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Assessing the safety and effectiveness of rituximab in the treatment of multiple sclerosis
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
,
L. Weinkle
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. Oct 12, 2018; 229077
Brandi Vollmer
Brandi Vollmer
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Abstract: P1237

Type: Poster Sessions

Abstract Category: Therapy - Long-term treatment monitoring

Introduction: Rituximab (RTX), used in the off-label treatment of multiple sclerosis (MS), is a monoclonal antibody targeting CD20 and resulting in the depletion of B-cells.
Objective: To assess the safety and effectiveness of RTX for the treatment of MS in a clinical setting.
Methods: Patients with a diagnosis of MS and prescribed RTX at the Rocky Mountain MS Center at University of Colorado between January 2010 and October 2013 were identified. A random sample of 125 patients was included in this study. Patients were retrospectively followed from RTX start date until RTX end date, or December 2016. Data was collected from patient charts including lab data, relapse history, adverse events (AEs), MRI outcomes, disease history and patient characteristics. Descriptive statistics were used to describe the sample group.
Results: Patients had a mean age of 44.1 years at index date; were predominantly female (72%); and had a MS disease duration of 10.2 years. Of the 125 patients, 62.4%, 24.0%, and 13.6% were relapsing-remitting, secondary progressive, and primary progressive forms of MS, respectively. Patients had a mean time of follow-up of 40.6 months, a mean of 6.0 infusions (median: 7 infusions), and a mean cumulative dose of 4594 mg (median: 5000 mg). Infections while on RTX resulting in an emergency department visit or hospitalization occurred in 20 (16.0%) and 14 (11.2%) of patients, respectively. Of those with available lab data, 6 (7.9%) patients experienced IgG levels ≤500 mg/dL. Forty-two (55.3%) and 9 (11.8%) patients experienced IgM levels ≤40 and ≤20. Six (4.8%) patients experienced lymphopenia ≤500/mm3, and 3 (2.4%) experienced neutropenia ≤1000/mm3. During the first and second infusion, 45 (37.2%) and 15 (13.8%) patients experienced an infusion reaction resulting in interruption of RTX infusion. No patients experienced an infusion reaction that was life threating or resulted in hospitalization. Two (1.6%) patients were diagnosed with malignant cancer after RTX initiation. While being treated with RTX, 6 (4.8%), 2 (1.9%), and 24 (23.1%) experienced a clinical relapse, enhancing lesion or new T2 Lesion, respectively. After rebaselining on RTX, 5 (7.7%) patients with available MRI data experienced a new T2 lesion.
Conclusion: RTX appears safe and effective in the long-term treatment of MS. Further analysis of additional patients and CD20/CD19 absolute values to examine reconstitution will be conducted.
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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