Background According to prospectus, cautious evaluation concerning potential risk of developing demyelinating diseases in patients treated with anti-TNF drugs should be considered before initiating therapy. There are several case reports of neurological complications in patients treated with anti-TNF drugs. The annual rate of this complications according with the Spanish Registry BIOBADASER in 2011, was 0.65/1000 patient-years (IC95 0.36-1.1) . Until now, there is no cause-effect relationship known.
Objectives To describe the demographic characteristics, underlying disease and anti-TNF drug used in patients who developed neurological complications in the period 2000 – 2014 in the Rheumatology Department of the Donostia University Hospital, Spain.
Methods We retrospectively identified patients who were administered anti-TNF drugs and subsequently developed neurological deficits. The analyzed variables were sex, age, underlying disease, anti-TNF drug, cumulative dose, complications, treatment and clinical outcome. The prevalence of these complications was measured.
Results We registered 388 patients treated with Infliximab (IFX), 39 with Adalimumab (ADA), 351 with Golimumab (GLM), 33 with Certolizumab (CZP) and 375 with Etanercept (ETN). A total of 7 cases (5 women and 2 men) were found with a median age of 48 years old, of whom 4 were diagnosed of rheumatoid arthritis (RA), 3 of spondyloarthritis (SA) and 1 of uveitis of unknown etiology. The anti-TNF drug found to be more associated with neurological complications was Infliximab (5 cases). The neurological complications included: posterior demyelinating optic neuritis (PDON), demyelinating motor polyneuropathy (DMPN) and “Stiff-man Syndrome” (SMS) with positive anti-glutamic acid decarboxylase (GAD) antibodies. The analized variables are shown in the table. The registered prevalence in our study was 0.6%.
Conclusions All neurological complications developed after the use of monoclonal antibodies, being IFX responsible for 71% of cases. The cumulative drug dosage with IFX was very variable amongst patients, therefore complications do not seem to be directly related to the dose.
C. Rodríguez Lozano. Seguridad de las terapias biolόgicas: nuevos datos de BIOBADASER. Reumatol Clin. 2011;6(S3):S1–S6.
Disclosure of Interest None declared