Ocrelizumab Effects on the Metabolome in MS

Ocrelizumab Effects on the Metabolome in MS

Publication date: Mar 13, 2019

In this observational study, the investigators aim to recruit 50 patients over an 10-12 month period. The investigators will recruit patients with relapsing-remitting MS (based on 2017 McDonald Criteria) beginning treatment with ocrelizumab and fulfilling study inclusion and exclusion criteria. Participants recruited in this study will be participants in the Johns Hopkins MS Precision Medicine Center of Excellence bio-banking protocol which requires collection of serum and plasma at 6-monthly intervals and hence will have blood collection performed prior to Ocrevus start and then at 6, 12, 18 and 24 months following ocrelizumab initiation as part of the bio-banking protocol. All recruited participants will provide written informed consent. The investigators will collect demographic and clinical characteristics at baseline and update these at follow-up visits. These will include disease duration, co-morbidities, relapses, treatment status and history. The investigators will also collect physiological variables – height and weight at each visit. All recruited patients will return for follow up visits at 6,12, 18 and 24 months post-ocrelizumab initiation. At each visit patients will undergo the following evaluations – EDSS, MSFC, SDMT, fatigue scale (MFIS), quality of life measure (MS-QOL), depression scale (Beck depression inventory, 2nd version) and Block Food Frequency Questionnaire. The investigators will then utilize plasma collected at the various time points to perform global metabolomics analysis. This will yield measures of various metabolites in the circulation, including amino acids and metabolites of the amino acids. The investigators will utilize this data to determine the change in the circulating metabolome produced by treatment with ocrelizumab. Following this the investigators will assess changes in the various clinical measures collected – disability (EDSS, MSFC), cognition (SDMT), mood (BDI-II), fatigue (MFIS) and quality of life (MS-QOL) with Ocrelizumab treatment and correlate these with the changes noted in the metabolome. This approach will allow us to determine whether the metabolic changes are associated with/ could underlie the changes noted in clinical measures.

Concepts Keywords
Amino Acids Multiple sclerosis
Beck Depression Inventory Chemotherapy
Blood Metabolomics
Chemotherapy Metabolomics
Cognition Metabolome
Comorbidity Monoclonal antibodies
Demographic Breakthrough therapy
Depression Ocrelizumab
Diabetes Drugs
Disability Systems biology
Fatigue Metabolism
Hypothyroidism Branches of biology
Informed Consent Genentech
Metabolome Chemotherapy
Metabolomics Uncontrolled hypothyroidism diabetes
MFIS
Multiple Sclerosis
Neurodegenerative Disorder
Observational Study
Physician
Plasma
Protocol
Rituximab
Serum

Semantics

Type Source Name
disease MESH Sclerosis
gene UNIPROT ALG3
gene UNIPROT NR4A2
drug DRUGBANK Rituximab
disease DOID hypothyroidism
disease MESH hypothyroidism
disease MESH comorbidity
gene UNIPROT EHD1
disease MESH neurodegenerative disorder
disease MESH relapsing remitting multiple sclerosis
disease MESH Diagnosis
drug DRUGBANK Amino acids
disease MESH depression
gene UNIPROT SLC35G1
disease MESH relapses
disease DOID relapsing-remitting MS
gene UNIPROT DNMT1
gene UNIPROT CD69
gene UNIPROT CD5L
drug DRUGBANK Ocrelizumab

Original Article

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