Anti-TNF treatment for severe disc-related pain

From the INR, the leader* in the use of anatomically-targeted anti-TNF treatment

In the May 2009 issue of the journal Anesthesiology, Cohen and colleagues, from Walter Reed Army Medical Center and additional military and academic medical centers, evaluated the safety and efficacy of locally administered (epidural) etanercept in a randomized, double-blind, placebo-controlled, dose-response human study, and conducted a canine safety study of epidural etanercept [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]. The animal study revealed no behavioral, neurologic, or histologic evidence of drug-related toxicity, and there was also no evidence of acute human toxicity. Epidural etanercept was significantly more effective than placebo. This elegant and carefully designed study provides independent scientific support for the concept of localized, anatomically-targeted administration of etanercept for sciatica and other forms of disc-related pain. This concept, as well as the specific concept of epidural etanercept for sciatica, was invented by Edward Tobinick MD, Director of the INR®. Epidural administration is one of the forms of localized, anatomically-targeted delivery of etanercept that were detailed by Dr. Tobinick in his early patents which described the use of epidural and related perilesional methods of delivery of etanercept for sciatica (see U.S. patents 6,419,944* (filed April 5, 2001) and 6,537,549*), as well as in his later patents describing epidural and other forms of perispinal administration of etanercept for sciatica and related forms of intervertebral disc-related pain (see U.S. patents 6,982,089* and 7,214,658*).

Anatomically-targeted anti-TNF treatment (perispinal etanercept) is an innovative treatment modality which has been successfully used at the INR® for selected patients with severe disc-related pain (associated with single or multiple disc protrusions, disk bulge, disc herniation, or degenerative disc disease) , including severe back pain, neck pain, and sciatica, which had failed to adequately respond to all previous attempts at treatment, including fusion surgery, epidural steroid injections, and large doses of opioids[1, 2].

Perispinal etanercept for intractable sciatica and other forms of disc-related pain is an off-label patented treatment method invented and developed at the INR®[3]. For this reason patients with severe disc-related pain have flown to the INR from all over the U.S., Canada, Asia, and other parts of the world for this unique treatment.

No form of treatment for severe chronic pain is uniformly successful. Nevertheless, anatomically-targeted anti-TNF treatment, as utilized at the INR, is unique and may result in rapid pain improvement, within minutes after a single dose, even for patients with severe, chronic pain, in an office setting without the need for pre-operative medication nor anesthesia. Treatment is fast and gentle in the office, and patients may return to their usual daily activity immediately following the brief, in-office procedure.

Excess TNF has been increasingly recognized as a key factor in disc-related pain[4-12]. INR publications have been recognized and cited by an increasing number of scientific publications from leading academic centers around the world[13-32]. INR patents have been cited by patents and patent applications from leading biopharmaceutical and spine companies, including Amgen Fremont, Applied Molecular Evolution, DePuy Spine, General Hospital Corporation (Massachusetts General Hospital), GenMab, Johnson & Johnson, the Kennedy Institute of Rheumatology, Medarex, Medtronic, Pharmacia, Shering, Xencor and others.

In 2008 Edward Tobinick MD, Director of the INR, was named to the Editorial Board of the Journal of Neuroinflammation, and his scientific articles were cited by more than 40 scientific publications from academic researchers across the globe this year alone. In 2009 Dr. Tobinick has performed invited expert reviews for the journals Brain Research, Neuroscience, and Experimental Neurology, and, in addition to practicing medicine, continues to speak at international medical conferences and write and publish additional scientific articles, with a total of 20 published articles through March 2009.

Patients from Canada and overseas are advised to send their MRI reports to the INR for review by e-mail to nrimed@gmail.com, or by fax to (310) 824-6196. Further information is available by calling the INR at (310) 824-6199.

*Edward Tobinick MD, Director of the INR, invented the perispinal (and epidural) use of etanercept and other biologic anti-TNF therapeutics for the treatment of disc-related pain. The INR's treatment methods are protected by multiple issued U.S. patents, assigned to TACT IP LLC, including, but not limited to U.S. patents 6015557, 6177077, 6419934, 6419944, 6537549, 6982089 and 7214658.

2009 references:

1. Tobinick, E. Perispinal etanercept for neuroinflammatory disorders. Drug Discov Today. 2009 Feb;14(3-4):168-77. [Review].

2. Kato K., Kikuchi S., Shubayev VI, Myers RR. 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.

Additional references:

1. 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.
2. Tobinick, E.L. and S. Britschgi-Davoodifar, Perispinal TNF-alpha inhibition for discogenic pain. Swiss Med Wkly, 2003. 133(11-12): p. 170-7.
3. Tobinick, E., Tumor necrosis factor antagonists for the treatment of neurological disorders. US patent 6,015,557. Also, U.S. patents 6177077, 6419934, 6419944, 6537549, 6982089 and 7214658.
4. Peng, B., et al., Chemical radiculitis. Pain, 2007. 127(1-2): p. 11-6.
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23. Yan, L., G.M. Anderson, M. Dewitte, and M.T. Nakada, Therapeutic potential of cytokine and chemokine antagonists in cancer therapy. Eur J Cancer, 2006. 42(6): p. 793-802.
24. Furst, D.E., et al., Updated consensus statement on biological agents for the treatment of rheumatic diseases, 2006. Ann Rheum Dis, 2006. 65 Suppl 3: p. iii2-iii15.
25. Hildebrandt, A., et al., European guidelines for the management of chronic non-specific low back pain (Spanish version) (de la version espanola). On behalf of the COST B13 Working Group on Guidelines for Chronic Low Back Pain, 2005.
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