Hope for stroke victims as perispinal etanercept treatment trial enters second phase

After her son received a “profoundly life-changing” medical treatment that eased symptoms of his brain injury, a Toowoomba scientist is working on the second phase of clinical trials into the drug, which is bringing hope to stroke victims.

Associate Professor Coralie Graham, who went into debt to get treatment for her son, has devoted her career to researching the drug — perispinal etanercept — and hopes the trials will lead to it being made available to others.

Her son Joel Shepherd suffered a traumatic brain injury when he was three, and 23 years later, in 2014, she took him to the United States to receive the treatment.

Dr Graham is the chief clinical investigator on the second phase of a world-first clinical trial at Queensland's Griffith University, which is looking at the effectiveness of perispinal etanercept on stroke patients.

Etanercept is normally used to treat arthritis, but the trial is testing the effectiveness of administering it above the spine.

Half of the 80 participants get a placebo while the others get the treatment, and researchers hope to have results later this year.

Scientists believe the drug could also be investigated for use in treating the effects of COVID-19, with many patients suffering loss of taste and smell, fatigue and stroke after being infected with the virus.

Dr Graham took her son to the US for treatment and is now working on Australian clinical trials.(ABC Southern Qld: Elly Bradfield)

Dr Graham said her son's treatment in the US had changed his life by improving his speech, mobility, memory and concentration, and lowering the frequency of his seizures.

“It is truly amazing to have a child who has such significant level of disability be able to regain some function, to be able to claim some of the life back,” she said.

“And that made him very aggressive because he couldn't concentrate. He couldn't speak and make his needs met.

“So his quality of life is dramatically better, as is mine, because I know now that he can go and enjoy things.”

Joel Shepherd enjoys spending time in Queen's Park in Toowoomba since his treatment.(ABC Southern Qld: Elly Bradfield )

'I'd do it all again'

Dr Graham, a registered nurse with 40 years' experience, completed a psychology degree and worked in the field to understand her son's condition.

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“So all in all, that trip [to the US] cost me about $45,000 that I would pay again in a heartbeat for the improvements that he's had,” she said.

Working on the clinical trial means being away from her family for extended periods of time, but she said it was worth it in the long run.

Since receiving the therapy in the US, Joel Shepherd's condition has improved dramatically.(ABC News: Elly Bradfield)

Associate Professor Stephen Ralph is working alongside Dr Graham on the Griffith University trial and said after positive results from phase one of the trial, the second stage had a broader approach.

“These are patients who, after their stroke, have been down the road of rehabilitation, don't show any real treatment improvement from that, so they get despondent,” Dr Ralph said.

Trial participant Kris Vanston is overwhelmed by dramatic improvements to his shoulder mobility, measured by Dr Stephen Ralph.(ABC News: Steve Keen)

Dr Ralph said a number of larger trials were needed before the treatment would be considered by Australia's Therapeutic Goods Administration.

If approved, it could then be placed on the Pharmaceutical Benefits Scheme.

“So, it's just a matter of time and money and effort.”

'Magic results'

Dr Ralph said the researchers were looking for participants to be part of the study.

Kris Vanston, who is undergoing treatment as part of the trial, has reported less pain and improved speech.

“It's just hope,” he said.

Kris Vanston lies inverted after the injection, supported by researcher Coralie Graham.(ABC News: Steve Keen)

Mr Vanston's life was turned upside down when he suffered a stroke last year and has been unable to work as a result.

“It is hard. It is difficult speaking,” he said. “The treatment is improving more.

There is also the possibility that the drug might help treat some patients who have suffered a loss of taste and smell, fatigue and stroke after being infected with COVID-19.

“Those patients do have a much higher degree of stroke,” Dr Graham said.

“Once you've had a stroke, you're going to have an area of neuroinflammation around that.


— Update: 25-12-2022 — We found an additional article Etanercept Injection for Stroke: Is This High-Cost, Experimential Treatment Worth It? from the website www.flintrehab.com for the keyword fda research on use of etanercept for stroke patients.

The Etanercept injection for stroke patients is causing controversy.

The success stories seem promising – but the non-randomized controlled clinical trials could be biased and the American Academy of Neurology has even issued a warning.

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If you’re considering this costly treatment, it’s important to know the facts before making a decision.

Here’s everything you need to know about Etanercept injections for stroke recovery.

What Is Etanercept?

Etanercept (Enbrel) is a drug that’s a tumor necrosis factor inhibitor that alters your body’s inflammation response.

Tumor necrosis factor (TNF) encourages inflammation in the body, which is needed to fight disease and infection. Etanercept interferes with TNF to discourage the body from producing this inflammatory response.

Etanercept is intended to fight inflammation in people with autoimmune diseases where inflammation is known to cause problems.

Right now, Etanercept is used to treat autoimmune diseases like rheumatoid arthritis and psoriasis.

Stroke is not mentioned in any of the literature on Etanercept. This shows that Etanercept is not conventionally used in stroke recovery.

So why are we starting now?

Using Etanercept with Stroke Patients

Fda research on use of etanercept for stroke patients

While stroke is not an autoimmune disease, researchers are exploring whether TNF inhibitors can help post-stroke disability by reducing inflammation in the brain.

This is interesting because it’s theorized that stroke may lead to a persistent neuroinflammatory response in the brain.

Researchers are questioning whether or not Etanercept can help reduce that inflammation – and if that will have any effect on post-stroke disability.

For the treatment of stroke, Etanercept is injected into the spine (perispinal etanercept) and the patient is tipped backwards to encourage the drug to enter the brain.

There have been eye-witness reports of a single dose of perispinal Etanercept producing an immediately improvement in expressive aphasia, speech apraxia, cognitive function, and left hemiparesis.

In a non-randomized study of 617 patients, more than 80% of participants saw a reduction in spasticity and more than 85% saw improved movement.

These results are overwhelmingly positive – and it could be biased.

Potential Bias of Etanercept in Stroke Rehabilitation

It was once reported that a patient paid $4,800 out-of-pocket for a single treatment of Etanercept and follow-up visit.

The only person currently offering – and therefore profiting – from Etanercept for stroke recovery is Dr. Edward Tobinik.

Tobinik was involved in the only clinical trials (one in 2011 and 2012) currently conducted on Etanercept for stroke.

Eventually, the American Academy of Neurology (AAN) caught wind of this and issued a warning.

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AAN Issues Advisory for Etanercept in Post-Stroke Disability

To further complicate the issue, the American Academy of Neurology (AAN) published a practice advisory in 2016 on the use of etanercept for stroke recovery.

The AAN states that there is insufficient evidence to determine the effectiveness of etanercept for post-stroke disability. It also cites that the treatment may be associated with adverse outcomes and high cost.

The AAN stated that the cost of a 25-mg vial of Etanercept is about $440 – which does not include the extra cost of pretreatment evaluation, administration, and follow up.

The AAN also states:

“Serious adverse events are described in studies of patients receiving etanercept for other conditions.

Such events include injection site reactions, reactivation of tuberculosis, reactivation of hepatitis B virus infection, congestive heart failure, demyelinating neurologic disorders, vasculitis, and hematologic disorders such as aplastic anemia and pancytopenia.”

Considering the Risk of Etanercept for Use in Stroke

While the side effects of etanercept can be serious, it’s not clear if these side effects are likely at the low dosage used for stroke patients.

In fact, the AAN’s practice advisory was criticized in an editorial by Ian Clark, who reprimands the AAN for overstating the potential side effects of Etanercept for stroke patients.

However, with perispinal Etanercept treatment in the early stages of development, it’s wise to by cautious and vigilant when deciding on treatment.

Further randomized, controlled clinical trials are needed to prove the efficacy of Etanercept for post-stroke disability.

What to Look for in Stroke Recovery Treatment

Fda research on use of etanercept for stroke patients

While the jury is still out on the efficacy of Etanercept for stroke recovery, neurologists can probably agree on one thing:

Neuroplasticity is at the core of reliable stroke recovery treatments.

Neuroplasticity is the mechanism that your brain uses to heal itself after stroke by forming new neural connections.

This rewiring happens with repetitive stimulus (or “massed practice”), which helps your brain understand what neural connections need building or strengthening.

Your brain likes to be efficient. Whatever you repeatedly practice is what your brain will attempt to get better at.

For example, high repetition of physical therapy exercises helps the brain rewire itself to improve movement.

It takes hard work – much more work than a single injection of Etanercept – but it’s has a proven track record of working.

Instead of getting seduced by expensive stroke treatments that promise overnight results, consider opting for the proven route.

References

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About the Author: Tung Chi