Model for predicting patient response to non-surgical treatment for lower back pain

This technology is a prediction and treatment model evaluating a panel of circulating cytokines and patient demographic information to determine whether an individual will experience significant pain relief following epidural steroid injection (ESI).

Unmet Need: Method for predicting patients’ responsiveness to non-surgical treatment

Current treatments for lower back pain can be non-surgical or surgical. While generally considered low risk when compared to surgical options and a front line for pain management, spinal injection of epidural steroids (ESI) has received numerous FDA warnings due to rare but serious neurological events, including “loss of vision, stroke, paralysis, and death,” as well as an outbreak of fungal meningitis in 2012 that exposed 13,000 patients and resulted in 64 deaths. Additionally, studies have reported response rates as low as 30% from ESI, further highlighting the need for a screening method to determine which patients will optimally respond to ESI treatment.

The Technology: Cytokine profile to predict patient responsiveness to non-surgical treatment for pain relief

This technology presents a model that uses circulating levels of multiple cytokines from blood along with demographic information to predict an individual’s response to non-surgical treatment for lower back pain, such as ESI. Following a minimally invasive blood draw and evaluation of the biomarker panel, an algorithm assesses each of these independent positive and negative variables and demonstrates a highly predictive value. As a result, this technology can help physicians create individual, optimized treatment plans for patients with lower back pain by incorporating the predicted patient response.

The technology has been developed in clinical studies of lower back pain patients (N=55) versus healthy controls (N=57). Corroborating previous studies regarding the low response to ESI, only 23/55 LBP patients (42%) reported pain reduction following ESI treatment with this technology demonstrating a predictive value corresponding to an adjusted R2 of 0.87.

Applications:

• Blood test to predict response to epidural steroid injection treatment of back pain
• Personalized treatment plans for herniated disc and intervertebral disc degeneration
• Expanded to predict additional non-surgical treatment responses
• Expanded to predict response to other steroid injection therapies

Advantages:

• Minimally invasive, blood draw
• Can avoid dozens of potentially dangerous injections that would ultimately be ineffective
• For non-responders, can progress to alternative options more rapidly, speeding recovery time
• Enables patient-specific treatment planning
• Maximizes efficiency of treatment options available

Lead Inventor:

Nadeen Chahine, Ph.D.

Patent Information:

Patent Status

Related Publications:

• Weber KT, Alipui DO, Sison CP, Bloom O, Quraishi S, Overby MCC, Levine M, Chahine NO. “Serum levels of the proinflammatory cytokine interleukin-6 vary based on diagnoses in individuals with lumbar intervertebral disc diseases” Arthritis Res Ther. 2016 Jan; 18:3.

• Weber KT, Satoh S, Alipui DO, Virojanapa J, Levine M, Sison C, Quraishi S, Bloom O, Chahine NO. “Exploratory study for identifying systemic biomarkers that correlate with pain response in patients with intervertebral disc disorders” Immunol Res. 2015 Dec; 61(1-3): 170-180.

Tech Ventures Reference:

• IR CU18325

• Licensing Contact: Ron Katz