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An unusual infection in MS patient treated with dimethyl fumarate: A case report of omphalitis
L Lorefice1, G Fenu1, F Cabras2
1Multiple Sclerosis Center, Department of Public Health and Clinical and Molecular Medicine, University of Cagliari, Italy.
Background:
Notoriously the treatment of multiple sclerosis (MS) is based on the use of several different drugs, characterized by a diverse mechanism of action, efficacy and safety. Recently, progress has been made towards developing new oral immunotherapies, and dimethyl fumarate is the third oral agent approved for the treatment of relapsing-remitting forms.
Case:
A 24-year-old patient, affected by relapsing remitting multiple sclerosis, started treatment in December 2014 with dimethyl fumarate. The common side effects (flushing and gastrointestinal events) of dimethyl fumarate occurred at the beginning of treatment, but resolved after 1 month. Six months later, the patient presented with serious recrudescence of the gastrointestinal event. In addition to this symptom, he had developed acute omphalitis-a very rare infection in adults.
Conclusion:
The pathogenic role of dimethyl fumarate to induce this rare infection was probably related to changes in immunological surveillance as well as to the irritant effect of this agent on the gastrointestinal epithelium. Therefore, post-marketing studies in clinical practice are still needed to provide the necessary long-term safety data.
Insights
Dimethyl fumarate, an oral treatment for multiple sclerosis (MS), may rarely cause severe gastrointestinal issues and acute omphalitis. Further post-marketing studies are needed to assess long-term safety.
Area of Science:
- Immunology
- Neurology
- Pharmacology
Background:
- Multiple sclerosis (MS) treatment involves various drugs with diverse efficacy and safety profiles.
- Dimethyl fumarate is an oral immunomodulatory drug approved for relapsing-remitting MS.
- Recent advancements include the development of new oral immunotherapies for MS management.
Observation:
- A 24-year-old patient with relapsing-remitting MS was treated with dimethyl fumarate.
- Initial common side effects (flushing, gastrointestinal events) resolved within a month.
- Six months later, the patient experienced severe gastrointestinal recurrence and acute omphalitis.
Findings:
- Dimethyl fumarate was associated with a rare case of acute omphalitis in an adult MS patient.
- The drug's irritant effect on the gastrointestinal epithelium may contribute to adverse events.
- Changes in immunological surveillance are hypothesized as a factor in the observed infection.
Implications:
- This case highlights a rare but serious potential adverse effect of dimethyl fumarate therapy.
- Post-marketing surveillance is crucial for identifying long-term safety data of new MS treatments.
- Further research is needed to understand the immunomodulatory and irritant mechanisms of dimethyl fumarate.

