Abstract
BackgroundAnti-TNFα therapy has been associated with demyelination in clinical trials and small case series although the specific clinical features and outcomes have not been reported.MethodsAn expert panel assessed causality from report forms. Probable cases required a consistent history and examination conducted by a neurologist and radiological ±electrophysiological evidence of demyelination. Definite cases required a positive rechallenge.Results54 cases were recruited from 28 hospitals. 35 (24 female) were definite/probable. Adalimumab, Infliximab, Etanercept, and Certolizumab were implicated. Average age was 40 (95%CI 37–44) years and mean treatment duration 27 (95%CI 18–36) months. 22 cases (63%) presented with brain ±spinal lesions, 8 (23%) spine only, 5 (14%) peripheral demyelination. After drug withdrawal patients were followed for a mean 42 (95%CI 32–52) months. Of those with CNS lesions, 11/30 (37%) developed a relapsing demyelinating syndrome or Multiple Sclerosis (MS). Only 5/30 (17%) had complete symptom resolution after a mean 419 days (95% CI 36–802).ConclusionThis case series details the clinical features of demyelination following anti-TNFα therapy. Consistent with MS, young females are over-represented. Complete recovery is uncommon. Over one third develop a relapsing illness/MS. We aim to enlarge this cohort to explore genetic markers that identify at-risk patients.