Background/Purpose: Tumor necrosis factor alpha inhibitors (TNFi) have successfully been used for the treatment of immune-mediated inflammatory disorders including rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) since 1998. However, several case reports and series have indicated that different neurological disorders including multiple sclerosis (MS), inflammatory neuropathies, demyelinating diseases and optic neuritis may be a serious, although rare, adverse event following TNFi treatment. A field of complexity as some studies show that RA is protective of MS and vice versa. We investigate the association between new-onset neurological events following TNFi-treatment in arthritis patients compared to non-TNFi-treated arthritis patients.

Methods: 41,026 patients registered in DANBIO between January 1, 2000 and January 20, 2017 were identified with a diagnosis of either RA, AS or PsA. Complete follow-up on mortality, emigration and newly diagnosed neurological diseases suspected to be associated with use of TNFi until May 10, 2017 was obtained by linkage to the Danish National Patient Registry and the Civil Registration System. A cox proportional hazard model was used to examine the association between use of TNFi and risk of a neurological event.

Results: The DANBIO arthritis cohort experienced 223,861 person-years of observation. 98 patients were diagnosed with demyelinating disease or inflammatory neuropathy during follow-up, with 49 contacts among ever TNFi-treated patients and 49 contacts among non-TNFi-treated patients corresponding to a Hazard Ratio (HR) of 1.52 (95% Confidence Interval (CI): 0.96-2.42) adjusted(adj) for age, gender and year of inclusion. TNFi treatment among RA patients was not associated with an increased risk of a neurological event (HR_adj=1.19, 95% CI: 0.65-2.18), whereas PsA and AS patients had an increased risk of having a neurological event following TNFi treatment (HR_adj=2.61, 95% CI: 1.11-6.13). In on-drug models the HR_adj for neurologic events in RA was 0.95 (95% CI: 0.49-1.83) and 2.43 (95% CI: 1.01-5.83) in PsA/AS.

Conclusion: The use of TNFi for the treatment of arthritis may be associated with increased risk of having a demyelinating disease or inflammatory neuropathy among patients with PsA or AS. Since these events are rare, larger multicenter studies are warranted to further characterize the risk.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/risk-of-neurological-adverse-events-during-tumour-necrosis-factor-inhibitor-treatment-for-arthritis-a-population-based-cohort-study-from-danbio-and-the-danish-national-patient-registry/