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   DIR Return to: TECFIDERA (dimethyl fumarate, BG-12, Fumaderm)
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       #Post#: 303--------------------------------------------------
       (AAN) Transient neurologic worsening after starting Tecfidera in
        progressive MS
       By: agate Date: May 9, 2014, 3:36 pm
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       Presented as a poster session at the AAN annual conference in
       Philadelphia, April 29, 2014:
       [quote][P2.228] Transient Neurologic Worsening after Initiation
       of Dimethyl Fumarate Therapy in Progressive Multiple Sclerosis
       Patients
       James Stark, Sydney Chirls, Saud Sadiq
       New York, NY, USA
       OBJECTIVE:
       To describe a syndrome of neurologic worsening after initiation
       of dimethyl fumarate in patients with progressive forms of MS.
       BACKGROUND:
       Dimethyl fumarate (DMF) was recently approved for the treatment
       of relapsing forms of multiple sclerosis. Given its novel
       mechanism of action, there has been considerable interest in the
       study of DMF in patients with progressive forms of MS, as
       treatment options are limited. We used DMF for progressive MS as
       an off label agent.
       DESIGN/METHODS:
       This is a retrospective chart review at a single MS center of
       patients who initiated treatment with DMF. All patients gave an
       informed consent and the study is IRB approved.
       RESULTS:
       All progressive disease MS patients at our center who were not
       on other disease modifying therapy and consented to take DMF
       were included in the analysis. We identified 14 of 259
       (5%)patients who following initiation of DMF treatment developed
       acute neurologic worsening. Ten of the 14 patients had secondary
       progressive MS and 4 had primary progressive. Eleven of the 14
       patients (78%) were female with a mean age of 52 years (range
       41-61), and patients had a mean disease duration of 19.7 years
       (range 10-30). The EDSS ranged from 3.5 to 8.5 (mean 6.3). The
       duration of DMF treatment before the onset of worsening
       neurologic symptoms was variable (1-42 days). The most common
       neurologic complaint was increased motor weakness.
       All patients returned to baseline neurologic status after
       discontinuation of DMF, generally within a few days.
       CONCLUSIONS:
       Patients with progressive forms of MS may experience a transient
       worsening of neurologic function following initiation of therapy
       with DMF. This effect appears independent of the subtype of
       progressive disease and not related to the well described
       adverse effects associated with DMF therapy. It is likely that
       this worsening is caused by a conduction block as it reverses
       with cessation of treatment.
       Study Supported by:
       None.
       Category - MS and CNS Inflammatory Disease: Clinical Science
       P2: Poster Session II: MS and CNS Inflammatory Disease:
       Treatment Safety
       [/quote]
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