Arthritis Rheum 2001 Dec;44(12):2862-9
Mohan N, Edwards ET, Cupps TR, Oliverio
PJ, Sandberg G, Crayton H, Richert JR, Siegel JN.
Georgetown University Medical Center,
Washington, DC 20007, USA. nmohan@pol.net
OBJECTIVE:
To review the occurrence of neurologic
events suggestive of demyelination during anti-tumor necrosis factor alpha
(anti-TNFalpha) therapy for inflammatory arthritides.
METHODS:
The Adverse Events Reporting System
of the Food and Drug Administration (FDA) was queried following a report
of a patient with refractory rheumatoid arthritis who developed confusion
and difficulty with walking after receiving etanercept for 4 months.
RESULTS:
Nineteen patients with similar neurologic
events were identified from the FDA database, 17 following etanercept administration
and 2 following infliximab administration for inflammatory arthritis. All
neurologic events were temporally related to anti-TNFalpha therapy, with
partial or complete resolution on discontinuation. One patient exhibited
a positive rechallenge phenomenon.
CONCLUSION:
Further surveillance and studies
are required to better define risk factors for and frequency of adverse
events and their relationship to anti-TNFalpha therapies. Until more long-term
safety data are available, consideration should be given to avoiding anti-TNFalpha
therapy in patients with preexisting multiple sclerosis and to discontinuing
anti-TNFalpha therapy immediately when new neurologic signs and symptoms
occur, pending an appropriate evaluation.
PMID: 11762947 [PubMed - in process]