Prospective Evaluation of De-Escalation From antiCD-20 Therapies to Dimethyl Fumarate (Tecfidera) or Diroximel Fumarate (Vumerity)

Ten patients >18 years of age with a minimum of 2 years of MS disease stability (no relapse or new magnetic resonance imaging lesions) and at least one year of experience on an anti-CD20 agent prior to initiating de-escalation with diroximel fumarate (Vumerity®) or dimethyl fumarate (Tecfidera®) will be followed for 24 months post de-escalation. To account for screen failures and withdrawals, up to 15 may be enrolled.

Inclusion criteria

• Diagnosed with relapsing forms of MS
• > 18 years of age at the time of initiation of de-escalation
• No evidence of new inflammatory disease activity (no new T2/contrast enhancing lesions, absence of relapses) for at least two years prior to de-escalation
• Have had multiple sclerosis related symptoms at least 3 years prior to baseline visit.
• Taking an anti-CD20 therapy most recently as a DMT continuously for at least one year (have received at least 2 courses) prior to de-escalation.
• Are 6-12 months from their last anti-CD20 infusion
• Willing to follow the protocol
• Able to undergo a brain MRI without anesthesia

Exclusion criteria

• Any progression of neurological symptoms in the year prior to the screening visit that would be consistent with progressive MS.
• Use of any non-FDA-approved DMT or systemic corticosteroids in the last 2 years. (Note: Use of inhaled or topical steroids are not an exclusion criteria. Also, use of oral steroids for no greater than 14 days given for a non-MS condition is not exclusionary).
• IgG levels <300 mg/dL
• lymphocytes <800 cells/mm3
• EDSS >6.5
• Is considering pregnancy at the screening visit
• Prior use of alemtuzumab, mitoxantrone, cyclophosphamide, methotrexate, cyclosporine or any experimental MS treatment in the last 5 years.
• Prior allergy to Vumerity
• Other significant medical or psychiatric illness, if uncontrolled. Examples: uncontrolled hypertension, uncontrolled diabetes, uncontrolled asthma, uncontrolled depression
• Cancers other than basal cell skin cancers within the last 5 years
• Unable to give informed consent or follow the protocol.
• Unable to undergo brain MRI.
• History of other chronic neurological illnesses that might mimic MS with chronic or intermittent symptoms (i.e. ALS, myasthenia gravis, chronic neuropathy, etc.)