The new Spine study now joins three previous randomized controlled trials (RCTs) as the fourth RCT supporting the efficacy of etanercept for treating disc-related pain
Los Angeles, California (PRWEB) November 07, 2013
A new randomized clinical trial (RCT) published in the November 1, 2013 issue of the journal Spine (1) provides new evidence for the efficacy of etanercept used off-label for relief of persistent sciatica associated with lumbar disc herniation, a common health problem with significant unmet medical need. Etanercept belongs to the class of potent anti-inflammatory drugs known as TNF inhibitors.
The new etanercept study follows a 2012 comparative effectiveness trial of epidural etanercept versus an epidural steroid injection that found etanercept to be superior to the epidural steroid(cortisone) injection(2).
The new Spine study joins three previous RCTs as the fourth RCT supporting the efficacy of etanercept for treating disc-related pain(1-4). The clinical evidence of the effectiveness of etanercept for this indication has been accumulating for more than a decade(1-9). Increasing basic science and clinical evidence supports the scientific rationale of TNF inhibition for neuroinflammation(10-19).
The first account of the favorable clinical effect of etanercept for sciatica, and the invention of epidural administration of etanercept for this indication, was published in 2001, authored by Edward Tobinick, M.D., the founder of the Institute of Neurological Recovery(INR)(20). Dr. Tobinick and his colleagues have written multiple peer-reviewed articles documenting the clinical effects of perispinal etanercept used at the INR off-label for sciatica, cervical radiculopathy, intractable low back pain and related symptoms associated with lumbar disc herniation(5-9, 21). Perispinal administration of etanercept is a patented invention of Dr. Tobinick(21). Please note that results can vary, not all patients respond, etanercept may have adverse effects and is off-label for neurological indications.
Etanercept holds great promise for the large patient population with intractable spinal pain for which existing medical treatment options have not provided adequate pain relief.
1. Freeman, B.J., et al., Randomized, Double-blind, Placebo-Controlled, Trial of Transforaminal Epidural Etanercept for the Treatment of Symptomatic Lumbar Disc Herniation. Spine (Phila Pa 1976), 2013. 38(23): p. 1986-94.
2. Ohtori, S., et al., Epidural administration of spinal nerves with the tumor necrosis factor-alpha inhibitor, etanercept, compared with dexamethasone for treatment of sciatica in patients with lumbar spinal stenosis: a prospective randomized study. Spine (Phila Pa 1976), 2012. 37(6): p. 439-44.
3. Sainoh, T., et al., Intradiscal Administration of Tumor Necrosis Factor-Alpha Inhibitor, Etanercept, Clinically Improves Intractable Discogenic Low Back Pain: A Prospective Randomized Study, in International Society for the Study of the Lumbar Spine 40th Annual Meeting. 2013: Scottsdale, Arizona.
4. Cohen, S.P., et al., Randomized, double-blind, placebo-controlled, dose-response, and preclinical safety study of transforaminal epidural etanercept for the treatment of sciatica. Anesthesiology, 2009. 110(5): p. 1116-26.
5. Tobinick, E.L., Targeted etanercept for discogenic neck pain: uncontrolled, open-label results in two adults. Clinical Therapeutics, 2003. 25(4): p. 1211-8.
6. Tobinick, E.L. and S. Britschgi-Davoodifar, Perispinal TNF-alpha inhibition for discogenic pain. Swiss Med Wkly, 2003. 133(11-12): p. 170-7.
7. Tobinick, E. and S. Davoodifar, 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): p. 1075-85.
8. Tobinick, E., Perispinal etanercept for neuroinflammatory disorders. Drug Discov Today, 2009. 14(3-4): p. 168-77.
9. Tobinick, E., Perispinal etanercept: a new therapeutic paradigm in neurology. Expert Review of Neurotherapeutics, 2010. 10(6): p. 985-1002.
10. Kato, K., et al., Distribution and tumor necrosis factor-alpha isoform binding specificity of locally administered etanercept into injured and uninjured rat sciatic nerve. Neuroscience, 2009. 160(2): p. 492-500.
11. Chio, C.C., et al., Therapeutic evaluation of etanercept in a model of traumatic brain injury. J Neurochem, 2010. 115(4): p. 921-9.
12. Clark, I.A., L.M. Alleva, and B. Vissel, The roles of TNF in brain dysfunction and disease. Pharmacol Ther, 2010. 128(3): p. 519-48.
13. Watanabe, K., et al., Etanercept attenuates pain-related behavior following compression of the dorsal root ganglion in the rat. Eur Spine J, 2011. 20(11): p. 1877-84.
14. Shen, C.H., et al., Etanercept restores the antinociceptive effect of morphine and suppresses spinal neuroinflammation in morphine-tolerant rats. Anesth Analg, 2011. 112(2): p. 454-9.
15. Tobinick, E., 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): p. 1051-70.
16. Lei, B., et al., Tumor necrosis factor alpha antagonism improves neurological recovery in murine intracerebral hemorrhage. J Neuroinflammation, 2013. 10(1): p. 103.
17. King, M.D., C.H. Alleyne, Jr., and K.M. Dhandapani, TNF-alpha receptor antagonist, R-7050, improves neurological outcomes following intracerebral hemorrhage in mice. Neurosci Lett, 2013. 542: p. 92-6.
18. Iwatsuki, K., et al., Targeting anti-inflammatory treatment can ameliorate injury-induced neuropathic pain. PLoS One, 2013. 8(2): p. e57721.
19. Boivin, N., et al., The combination of valacyclovir with an anti-TNF alpha antibody [etanercept] increases survival rate compared to antiviral therapy alone in a murine model of herpes simplex virus encephalitis. Antiviral Research, 2013. in press, http://dx.doi.org/10.1016/j.antiviral.2013.10.007.
20. U.S. patent 6,419,944, and additional applicable U.S. patents, Edward Tobinick M.D., inventor, assigned to TACT IP, LLC.
21. Applicable patents, all assigned to TACT IP LLC and licensed to the INR include 6,419,944; 6,982,089 and other issued and pending U.S. patents.