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Background: TNFi are effective treatments for multiple immune-mediated inflammatory diseases. There are five TNFi’s approved for clinical use. Despite their acceptable safety/efficacy profile, serious side effects have been reported, including central and peripheral nervous system demyelinating diseases (DD).ͥ Causation remains controversial and there is a paucity of data on the long-term outcomes in these patients.
Objectives: To assess long term outcomes in patients with DD related to TNFi use.
Methods: We conducted a database search and then retrospective chart review to identify patients with potential TNFi related neurologic events at a university medical center between 2006 and 2016. 15 total patients (13 living, 2 deceased) were ultimately identified. Six were able to be contacted by phone to assess their current status. Four of these patients were able to attend a one time-visit to complete a neurologic assessment and musculoskeletal examination. Interviews over the phone or in person were used to complete multiple assessments for disability.
Results: 15 patients with DD were identified from among 4600 patients on TNFi’s for various indications (0.3%). Mean duration of follow-up was 6.8 years. Neurologic symptoms occurred >12 months after starting a TNFi in 8/15 (53%) patients. 47% of patients had been exposed to two or more TNFi’s. 40% received some form of treatment for their DD, including MS disease modifying therapies, IVIG and immunosuppression. No patients experienced worsening DD after stopping their TNFi except for one patient with MS who experienced a repeat flare. Two of three patients diagnosed with MS after TNFi had a first degree relative with MS. 3/15 (20%) experienced complete resolution of their symptoms. Two patients were deceased; cause of death was thought not directly related to DD on chart review.
Conclusion: Prevalence of DD after TNFi exposure was low at our center, consistent with previously published data. Presentations included both central and peripheral demyelinating events. With the exception of one patient who developed MS, withdrawal of TNFi’s appeared to halt further progression or development of new neurologic symptoms. It is unclear if treatment for DD is beneficial after diagnosis and TNFi withdrawal.
Patient Data:
Baseline characteristics and 6-month outcome of patients who have switched from originator to ABP 501
| Age | Sex | Indication | TNFi at time of event | Neurologic Presentation/Diagnosis | Duration of follow-up, years | DD status at last follow-up |
|---|---|---|---|---|---|---|
| 32 | F | JIA | E | Ataxia, paresthesias, dysarthria, nystagmus, tetraparesis | 11 | Persistent despite tx |
| 58 | M | PsA | G | Paresthesias | 9 | Improved no tx |
| 38 | F | AS | A | Numbness and weakness | 5 | Resolved, no tx |
| 54 | M | PsA | E | Paresthesias, cognitive impairment | 10 | Persistent, no tx |
| 51 | F | AS | A | Incontinence, paresthesias | 10 | Persistent, no tx |
| 26 | F | Crohn’s | A | Optic neuritis | 11 | Resolved, no tx |
| 49 | M | PsA | A | Multifocal motor neuropathy | 3 | Resolved after tx |
| 37 | M | PsA | A | Weakness, spasticity, paresthesias, optic neuritis | 9 | Persistent, on tx |
| 33 | F | PsA | A | Optic neuritis, transverse myelitis (MS) | 5 | Flared, no tx |
| 59 | F | PsA | E | Transverse myelitis (MS) | 9 | Deceased |
| 45 | F | AS | I | Transverse myelitis | 7 | Deceased |
| 70 | M | RA | A | CIDP | 1 | Received treatment but lost to follow-up |
| 34 | F | Crohn’s | A | Small fiber neuropathy | 11 | Persistent, no tx |
| 62 | F | RA | E | Optic neuritis | <1 | Lost to follow-up after initial visit |
| 42 | M | Uveitis, retinal vasculitis | A | Paresthesias (MS) | 1 | Persistent, on tx |
Juvenile idiopathic arthritis (JIA), Psoriatic arthritis (PsA), Ankylosing spondylitis (AS), Rheumatoid Arthritis (RA)
Adalimumab (A), Etanercept (E), Golimumab (G), Infliximab (I)
Treatment (tx)
REFERENCES:
[1]ͥKemanetzoglou E, Andreadou E. CNS Demyelination with TNF-α Blockers. Curr Neurol Neurosci Rep . 2017;17(4):36. doi:10.1007/s11910-017-0742-1
Disclosure of Interests: Nicholas Stienstra: None declared, Michael Lane: None declared, Joel Horton: None declared, Anand Kumthekar: None declared, Nishad Sathe: None declared, Christy Sunny: None declared, Vijayshree Yadav Consultant of: Alexion (one time consulting fee), Atul Deodhar Grant/research support from: AbbVie, Eli Lilly, GSK, Novartis, Pfizer, UCB, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB