Treatment of inflammatory disorders
Inventors
Levine, Jacob A. • Chernoff, David • Simhambhatla, Murthy V.
Assignees
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Publication Number
US-12582819-B2
Publication Date
2026-03-24
Expiration Date
Abstract
Methods and apparatuses for treating inflammatory diseases by neurostimulation in patients who have failed to adequately respond or have become intolerant to a drug therapy (such as a TNF inhibitor and/or a JAK inhibitor).
Core Innovation
The invention describes neurostimulation methods and devices for reducing inflammation in patients who are intolerant of or have not responded adequately to TNF or JAK inhibitors. It applies energy to activate a neuroimmune anti-inflammatory pathway, with the stated aim of reducing inflammation and restoring responsiveness to a previously ineffective drug. The background problem described in the provided content is inadequate response or intolerance to these inhibitor therapies.
The treatment regimen may be used with drug therapy, including administration of the drug concurrently with or following restoration of its efficacy. The document describes nerve targets and implantable and transcutaneous devices, and reports clinical examples involving refractory rheumatoid arthritis and Crohn’s disease. It also describes potential effects including potentiation of co-therapy or permitting dose reduction, and reports improved disease-activity measures in the clinical examples.
Claims Coverage
The claim coverage encompasses three inventive features across claims 1, 18, and 19 for reducing inflammation in patients who are intolerant of or have failed to respond to TNF-inhibitor therapy using energy application to activate a neuroimmune anti-inflammatory pathway and restore drug efficacy.
Neuroimmune pathway activation with TNF-inhibitor treatment
Claim 1 identifies a patient who has failed to respond to TNF-inhibitor therapy, applies electrical energy to activate a neuroimmune anti-inflammatory pathway and restore the drug’s efficacy, and treats the patient with the TNF-inhibiting drug concurrently with or following restoration.
Electrical energy applied to selected nerves
Claim 18 covers activating a neuroimmune anti-inflammatory pathway by applying electrical energy to a selected nerve to restore the efficacy of a TNF-inhibiting drug, followed by or concurrent with treatment using that drug.
Energy application followed by TNF-inhibitor treatment
Claim 19 covers applying energy to a selected nerve to activate a neuroimmune anti-inflammatory pathway and restore the efficacy of a TNF-inhibiting drug, followed by or concurrent with administration of the same drug or a drug of the same class.
The claim coverage centers on reducing inflammation and restoring the efficacy of TNF-inhibitor therapy through activation of a neuroimmune anti-inflammatory pathway, varying by energy application mode, nerve selection, and subsequent or concurrent drug administration.
Stated Advantages
The treatment is intended to reduce inflammation in patients who are intolerant of or have failed to respond to TNF-inhibitor therapy.
The treatment is intended to restore the efficacy of a TNF-inhibiting drug that the patient has not responded to.
The document states that neurostimulation may potentiate co-therapy or permit dose reduction.
Documented Applications
Treatment of inflammatory disease in patients intolerant of or inadequately responsive to TNF or JAK inhibitors.
The document reports clinical examples involving refractory rheumatoid arthritis and Crohn’s disease, including vagus nerve stimulation.
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