Rapid improvement in severe long COVID following perispinal etanercept

References

• Soriano JB, Murthy S, Marshall JC, WHO Clinical Case Definition Working Group on Post-COVID-19 Condition, et al. A clinical case definition of post-COVID-19 condition by a Delphi consensus. Lancet Infect Dis. 2022;22(4):e102–e107.
   PubMed Web of Science ®Google Scholar
• Group P-CC Clinical characteristics with inflammation profiling of long COVID and association with 1-year recovery following hospitalisation in the UK: a prospective observational study. Lancet Respir Med. 2022. DOI:10.1016/S2213-2600(22)00127-8
   Web of Science ®Google Scholar
• Schwabenland M, Salie H, Tanevski J, et al. Deep spatial profiling of human COVID-19 brains reveals neuroinflammation with distinct microanatomical microglia-T-cell interactions. Immunity. 2021;54(7):1594–1610 e11.
   PubMed Web of Science ®Google Scholar
• García-Grimshaw M, Sankowski R, Valdés-Ferrer SI. Neurocognitive and psychiatric post-coronavirus disease 2019 conditions: pathogenic insights of brain dysfunction following severe acute respiratory syndrome coronavirus 2 infection. Curr Opin Neurol. 2022;35(3):375–383.
   PubMed Web of Science ®Google Scholar
• Ignatowski TA, Noble BK, Wright JR, et al. TNFalpha: a neuromodulator in the central nervous system. Adv Exp Med Biol. 1996;402:219–224.
   PubMedGoogle Scholar
• Benameur K, Agarwal A, Auld SC, et al. Encephalopathy and encephalitis associated with cerebrospinal fluid cytokine alterations and coronavirus disease, Atlanta, Georgia, USA, 2020. Emerg Infect Dis. 2020;26(9):2016–2021.
   PubMed Web of Science ®Google Scholar
• Heir R, Stellwagen D. TNF-Mediated homeostatic synaptic plasticity: from in vitro to in vivo models. Front Cell Neurosci. 2020;14:565841.
   PubMed Web of Science ®Google Scholar
• Pilotto A, Odolini S, Masciocchi S, et al. Steroid-responsive encephalitis in coronavirus disease 2019. Ann Neurol. 2020;88(2):423–427.
   PubMed Web of Science ®Google Scholar
• Lee MH, Perl DP, Nair G, et al. Microvascular injury in the brains of patients with covid-19. N Engl J Med. 2021;384(5):481–483.
   PubMed Web of Science ®Google Scholar
• Kuno R, Wang J, Kawanokuchi J, et al. Autocrine activation of microglia by tumor necrosis factor-alpha. J Neuroimmunol. 2005;162(1–2):89–96.
   PubMed Web of Science ®Google Scholar
• Spudich S, Nath A. Nervous system consequences of COVID-19. Science. 2022;375(6578):267–269.
   PubMed Web of Science ®Google Scholar
• Frankola KA, Greig NH, Luo W, et al. Targeting TNF-alpha to elucidate and ameliorate neuroinflammation in neurodegenerative diseases. CNS Neurol Disord Drug Targets. 2011;10(3):391–403.
   PubMed Web of Science ®Google Scholar
• Clark IA. Chronic cerebral aspects of long COVID, post-stroke syndromes and similar states share their pathogenesis and perispinal etanercept treatment logic. Pharmacol Res Perspect. 2022;10(2):e00926.
   PubMed Web of Science ®Google Scholar
• Marchand F, Tsantoulas C, Singh D, et al. Effects of etanercept and minocycline in a rat model of spinal cord injury. Eur J Pain. 2009;13(7):673–681.
   PubMed Web of Science ®Google Scholar
• Aden U, Favrais G, Plaisant F, et al. Systemic inflammation sensitizes the neonatal brain to excitotoxicity through a pro-/anti-inflammatory imbalance: key role of TNFalpha pathway and protection by etanercept. Brain Behav Immun. 2010;24(5):747–758.
   PubMed Web of Science ®Google Scholar
• Chio CC, Lin JW, Chang MW, et al. Therapeutic evaluation of etanercept in a model of traumatic brain injury. J Neurochem. 2010;115(4):921–929.
   PubMed Web of Science ®Google Scholar
• Shen CH, Tsai RY, Shih MS, et al. Etanercept restores the antinociceptive effect of morphine and suppresses spinal neuroinflammation in morphine-tolerant rats. Anesth Analg. 2011;112(2):454–459.
   PubMed Web of Science ®Google Scholar
• Chastre A, Belanger M, Beauchesne E, et al. Inflammatory Cascades driven by tumor necrosis factor-alpha play a major role in the progression of acute liver failure and its neurological complications. PLOS One. 2012;7(11):e49670.
   PubMed Web of Science ®Google Scholar
• Roh M, Zhang Y, Murakami Y, et al. Etanercept, a widely used inhibitor of tumor necrosis factor-alpha (TNF-alpha), prevents retinal ganglion cell loss in a rat model of glaucoma. PLOS One. 2012;7(7):e40065.
   PubMed Web of Science ®Google Scholar
• Chio CC, Chang CH, Wang CC, et al. Etanercept attenuates traumatic brain injury in rats by reducing early microglial expression of tumor necrosis factor-alpha. BMC Neurosci. 2013;14:33.
   PubMed Web of Science ®Google Scholar
• Shi X, Zhou W, Huang H, et al. Inhibition of the inflammatory cytokine tumor necrosis factor-alpha with etanercept provides protection against lethal H1N1 influenza infection in mice. Crit Care. 2013;17(6):R301.
   PubMed Web of Science ®Google Scholar
• Ye J, Jiang R, Cui M, et al. Etanercept reduces neuroinflammation and lethality in mouse model of Japanese encephalitis. J Infect Dis. 2014;210(6):875–889.
   PubMed Web of Science ®Google Scholar
• Camara ML, Corrigan F, Jaehne EJ, et al. Effects of centrally administered etanercept on behavior, microglia, and astrocytes in mice following a peripheral immune challenge. Neuropsychopharmacol. 2015;40(2):502–512.
   PubMed Web of Science ®Google Scholar
• Bae HW, Lee N, Seong GJ, et al. Protective effect of etanercept, an inhibitor of tumor necrosis factor-alpha, in a rat model of retinal ischemia. BMC Ophthalmol. 2016;16:75.
   PubMed Web of Science ®Google Scholar
• Al Salihi MO, Kobayashi M, Tamari K, et al. Tumor necrosis factor-alpha antagonist suppresses local inflammatory reaction and facilitates olfactory nerve recovery following injury. Auris Nasus Larynx. 2017;44(1):70–78.
   PubMed Web of Science ®Google Scholar
• Hasturk AE, Gokce EC, Yilmaz ER, et al. Therapeutic evaluation of tumor necrosis factor-alpha antagonist etanercept against traumatic brain injury in rats: ultrastructural, pathological, and biochemical analyses. Asian J Neurosurg. 2018;13(4):1018–1025.
   PubMedGoogle Scholar
• Pinto A, Berdasco C, Arenas-Mosquera D, et al. Anti-inflammatory agents reduce microglial response, demyelinating process and neuronal toxin uptake in a model of encephalopathy produced by Shiga toxin 2. Int J Med Microbiol. 2018;308(8):1036–1042.
   PubMed Web of Science ®Google Scholar
• Li Y, Fan H, Ni M, et al. Etanercept reduces neuron injury and neuroinflammation via inactivating c-Jun N-terminal kinase and nuclear factor-kappaB pathways in Alzheimer's disease: an in vitro and in vivo investigation. Neuroscience. 2022;484:140–150.
   PubMed Web of Science ®Google Scholar
• Tobinick E. Perispinal etanercept advances as a neurotherapeutic. Expert Rev Neurother. 2018;18(6):453–455.
   PubMed Web of Science ®Google Scholar
• Tobinick E, Vega CP. The cerebrospinal venous system: anatomy, physiology, and clinical implications. MedGenMed. 2006;8(1):53.
   PubMedGoogle Scholar
• Tobinick EL. Perispinal delivery of CNS drugs. CNS Drugs. 2016;30(6):469–480.
   PubMed Web of Science ®Google Scholar
• Tobinick E. Rapid improvement of chronic stroke deficits after perispinal etanercept: three consecutive cases. CNS Drugs. 2011;25(2):145–155.
   PubMed Web of Science ®Google Scholar
• Tobinick E, Kim NM, Reyzin G, et al. Selective TNF inhibition for chronic stroke and traumatic brain injury: an observational study involving 629 consecutive patients treated with perispinal etanercept. CNS Drugs. 2012;26(12):1051–1070.
   PubMed Web of Science ®Google Scholar
• Shi K, Tian DC, Li ZG, et al. Global brain inflammation in stroke. Lancet Neurol. 2019;18(11):1058–1066.
   PubMed Web of Science ®Google Scholar
• Ralph SJ, Weissenberger A, Bonev V, et al. Phase I/II parallel double-blind randomized controlled clinical trial of perispinal etanercept for chronic stroke: improved mobility and pain alleviation. Expert Opin Investig Drugs. 2020;29(3):311–326.
   PubMed Web of Science ®Google Scholar
• Tobinick E. Immediate resolution of hemispatial neglect and central post-stroke pain after perispinal etanercept: case report. Clin Drug Investig. 2020;40(1):93–97.
   PubMed Web of Science ®Google Scholar
• Schaechter JD, Hightower BG, Kim M, et al. A pilot [(11)C]PBR28 PET/MRI study of neuroinflammation and neurodegeneration in chronic stroke patients. Brain Behav Immun Health. 2021;17:100336.
   PubMedGoogle Scholar
• Tobinick E. TNF-alpha inhibition for potential therapeutic modulation of SARS coronavirus infection. Curr Med Res Opin. 2004;20(1):39–40.
   PubMed Web of Science ®Google Scholar
• Feldmann M, Maini RN, Woody JN, et al. Trials of anti-tumour necrosis factor therapy for COVID-19 are urgently needed. Lancet. 2020;395(10234):1407–1409.
   PubMed Web of Science ®Google Scholar
• Robinson PC, Richards D, Tanner HL, et al. Accumulating evidence suggests anti-TNF therapy needs to be given trial priority in COVID-19 treatment. Lancet Rheumatol. 2020;2(11):e653–e655.
   PubMedGoogle Scholar
• Bohannon RW. Minimal clinically important difference for grip strength: a systematic review. J Phys Ther Sci. 2019;31(1):75–78.
   PubMedGoogle Scholar
• Hiroe T, Kojima M, Yamamoto I, et al. Gradations of clinical severity and sensitivity to change assessed with the beck depression Inventory-II in Japanese patients with depression. Psychiatry Res. 2005;135(3):229–235.
   PubMed Web of Science ®Google Scholar
• de Kleijn WP, De Vries J, Wijnen PA, et al. Minimal (clinically) important differences for the fatigue assessment scale in sarcoidosis. Respir Med. 2011;105(9):1388–1395.
   PubMed Web of Science ®Google Scholar
• Blum D, Meador K, Biton V, et al. Cognitive effects of lamotrigine compared with topiramate in patients with epilepsy. Neurology. 2006;67(3):400–406.
   PubMed Web of Science ®Google Scholar
• Wu CY, Hung SJ, Lin KC, et al. Responsiveness, minimal clinically important difference, and validity of the MoCA in stroke rehabilitation. Occup Ther Int. 2019;2019:2517658.
   PubMed Web of Science ®Google Scholar
• Burback D, Molnar FJ, St John P, et al. Key methodological features of randomized controlled trials of Alzheimer's disease therapy. Minimal clinically important difference, sample size and trial duration. Dement Geriatr Cogn Disord. 1999;10(6):534–540.
   PubMed Web of Science ®Google Scholar
• Meretta BM, Whitney SL, Marchetti GF, et al. The five times sit to stand test: responsiveness to change and concurrent validity in adults undergoing vestibular rehabilitation. VES. 2007;16(4–5):233–243.
   Google Scholar
• Nasreddine ZS, Phillips NA, Bedirian V, et al. The montreal cognitive assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005;53(4):695–699.
   PubMed Web of Science ®Google Scholar
• Aiello EN, Fiabane E, Manera MR, et al. Screening for cognitive sequelae of SARS-CoV-2 infection: a comparison between the Mini-Mental state examination (MMSE) and the Montreal Cognitive Assessment (MoCA). Neurol Sci. 2022;43(1):81–84.
   PubMed Web of Science ®Google Scholar
• McCrea M, Guskiewicz K, Doncevic S, et al. Day of injury cognitive performance on the military acute concussion evaluation (MACE) by U.S. military service members in OEF/OIF. Mil Med. 2014;179(9):990–997.
   PubMed Web of Science ®Google Scholar
• Fawns-Ritchie C, Deary IJ. Reliability and validity of the UK biobank cognitive tests. PLOS One. 2020;15(4):e0231627.
   PubMed Web of Science ®Google Scholar
• Henry JD, Crawford JR. A meta-analytic review of verbal fluency performance following focal cortical lesions. Neuropsychology. 2004;18(2):284–295.
   PubMed Web of Science ®Google Scholar
• Hendriks C, Drent M, Elfferich M, et al. The fatigue assessment scale: quality and availability in sarcoidosis and other diseases. Curr Opin Pulm Med. 2018;24(5):495–503.
   PubMed Web of Science ®Google Scholar
• Master H, Coleman G, Dobson F, et al. A narrative review on measurement properties of fixed-distance walk tests up to 40 meters for adults with knee osteoarthritis. J Rheumatol. 2021;48(5):638–647.
   PubMed Web of Science ®Google Scholar
• Gagnon C, Mathieu J, Desrosiers J. Standardized finger-nose test validity for coordination assessment in an ataxic disorder. Can j Neurol Sci. 2004;31(4):484–489.
   PubMed Web of Science ®Google Scholar
• Tobinick EL. Targeted etanercept for treatment-refractory pain due to bone metastasis: two case reports. Clin Ther. 2003;25(8):2279–2288.
   PubMed Web of Science ®Google Scholar
• Tobinick EL. Targeted etanercept for discogenic neck pain: uncontrolled, open-label results in two adults. Clin Ther. 2003;25(4):1211–1218.
   PubMed Web of Science ®Google Scholar
• Tobinick EL, Britschgi-Davoodifar S. Perispinal TNF-alpha inhibition for discogenic pain. Swiss Med Wkly. 2003;133(11–12):170–177.
   PubMed Web of Science ®Google Scholar
• Tobinick E, Davoodifar S. Efficacy of etanercept delivered by perispinal administration for chronic back and/or neck disc-related pain: a study of clinical observations in 143 patients. Curr Med Res Opin. 2004;20(7):1075–1085.
   PubMed Web of Science ®Google Scholar
• Tobinick E, Gross H, Weinberger A, et al. TNF-alpha modulation for treatment of Alzheimer's disease: a 6-month pilot study. MedGenMed. 2006;8(2):25.
   PubMedGoogle Scholar
• Tobinick E. Perispinal etanercept for treatment of Alzheimer's disease. Curr Alzheimer Res. 2007;4(5):550–552.
   PubMed Web of Science ®Google Scholar
• Tobinick EL, Gross H. Rapid improvement in verbal fluency and aphasia following perispinal etanercept in Alzheimer's disease. BMC Neurol. 2008;8(1):27.
   PubMed Web of Science ®Google Scholar
• Tobinick EL, Gross H. Rapid cognitive improvement in Alzheimer's disease following perispinal etanercept administration. J Neuroinflammation. 2008;5:2.
   PubMed Web of Science ®Google Scholar
• Tobinick E. Deciphering the physiology underlying the rapid clinical effects of perispinal etanercept in alzheimer's disease. Curr Alzheimer Res. 2012;9(1):99–109.
   PubMed Web of Science ®Google Scholar
• Tobinick E, Rodriguez-Romanacce H, Levine A, et al. Immediate neurological recovery following perispinal etanercept years after brain injury. Clin Drug Investig. 2014;34(5):361–366.
   PubMed Web of Science ®Google Scholar
• Tobinick E, Rodriguez-Romanacce H, Kinssies R, et al. Perispinal etanercept for traumatic brain injury. In: Heidenreich KA, editor. Chapter 7, new therapeutics for traumatic brain injury. New York: Academic Press/Elsevier; 2017.
   Google Scholar
• Gerhard A, Schwarz J, Myers R, et al. Evolution of microglial activation in patients after ischemic stroke: a [11C](R)-PK11195 PET study. Neuroimage. 2005;24(2):591–595.
   PubMed Web of Science ®Google Scholar
• Pappata S, Levasseur M, Gunn RN, et al. Thalamic microglial activation in ischemic stroke detected in vivo by PET and [11C]PK1195. Neurology. 2000;55(7):1052–1054.
   PubMed Web of Science ®Google Scholar
• Beattie EC, Stellwagen D, Morishita W, et al. Control of synaptic strength by glial TNFalpha. Science. 2002;295(5563):2282–2285.
   PubMed Web of Science ®Google Scholar
• Halassa MM, Fellin T, Haydon PG. The tripartite synapse: roles for gliotransmission in health and disease. Trends Mol Med. 2007;13(2):54–63.
   PubMed Web of Science ®Google Scholar
• Santello M, Volterra A. TNFalpha in synaptic function: switching gears. Trends Neurosci. 2012;35(10):638–647.
   PubMed Web of Science ®Google Scholar
• Bains JS, Oliet SH. Glia: they make your memories stick!. Trends Neurosci. 2007;30(8):417–424.
   PubMed Web of Science ®Google Scholar
• Spriggs DR, Sherman ML, Michie H, et al. Recombinant human tumor necrosis factor administered as a 24-hour intravenous infusion. A phase I and pharmacologic study. J Natl Cancer Inst. 1988;80(13):1039–1044.
   PubMedGoogle Scholar
• Schwartz JE, Scuderi P, Wiggins C, et al. A phase I trial of recombinant tumor necrosis factor (rTNF) administered by continuous intravenous infusion in patients with disseminated malignancy. Biotherapy. 1989;1(3):207–214.
   PubMedGoogle Scholar
• Qin L, Wu X, Block ML, et al. Systemic LPS causes chronic neuroinflammation and progressive neurodegeneration. Glia. 2007;55(5):453–462.
   PubMed Web of Science ®Google Scholar
• Riazi K, Galic MA, Kuzmiski JB, et al. Microglial activation and TNFalpha production mediate altered CNS excitability following peripheral inflammation. Proc Natl Acad Sci USA. 2008;105(44):17151–17156.
   PubMed Web of Science ®Google Scholar
• Zaremba J, Skrobanski P, Losy J. Tumour necrosis factor-alpha is increased in the cerebrospinal fluid and serum of ischaemic stroke patients and correlates with the volume of evolving brain infarct. Biomed Pharmacother. 2001;55(5):258–263.
   PubMed Web of Science ®Google Scholar
• Tarkowski E, Andreasen N, Tarkowski A, et al. Intrathecal inflammation precedes development of alzheimer's disease. J Neurol Neurosurg Psychiatry. 2003;74(9):1200–1205.
   PubMed Web of Science ®Google Scholar
• Bonizzato S, Ghiggia A, Ferraro F, et al. Cognitive, behavioral, and psychological manifestations of COVID-19 in post-acute rehabilitation setting: preliminary data of an observational study. Neurol Sci. 2022;43(1):51–58.
   PubMed Web of Science ®Google Scholar
• Hosp JA, Dressing A, Blazhenets G, et al. Cognitive impairment and altered cerebral glucose metabolism in the subacute stage of COVID-19. Brain. 2021;144(4):1263–1276.
   PubMed Web of Science ®Google Scholar
• Matos AMB, Dahy FE, de Moura JVL, NeuroCovBR Study Group, et al. Subacute cognitive impairment in individuals with mild and moderate COVID-19: a case series. Front Neurol. 2021;12:678924.
   PubMed Web of Science ®Google Scholar
• Shanley JE, Valenciano AF, Timmons G, et al. Longitudinal evaluation of neurologic-post acute sequelae SARS-CoV-2 infection symptoms. Ann Clin Transl Neurol. 2022. DOI:10.1002/acn3.51578
   PubMed Web of Science ®Google Scholar
• Di Pietro DA, Comini L, Gazzi L, et al. Neuropsychological pattern in a series of Post-Acute COVID-19 patients in a rehabilitation unit: Retrospective analysis and correlation with functional outcomes. Int J Environ Res Public Health. 2021;18(11):5917.
   Web of Science ®Google Scholar
• Douaud G, Lee S, Alfaro-Almagro F, et al. SARS-CoV-2 is associated with changes in brain structure in UK biobank. Nature. 2022;604(7907):697–707.
   PubMed Web of Science ®Google Scholar
• Enrichment strategies for clinical trials to support determination of effectiveness of human drugs and biological products, guidance for industry. Silver Spring, MD: U.S. Food and Drug Administration, Center for Biologics Evaluation and Research; 2019. Available from: https://www.regulations.gov/document/FDA-2012-D-1145-0040
   Google Scholar