Not being one to pass up an opportunity to comment on a topic like this, please allow me the opportunity to elucidate. Monoclonal antibodies are classified in pharmacological terms as biologics.
They represent a category of interventions for a variety of medical disorders and autoimmune diseases developed through the process of recombinant DNA or engineered gene splicing of chimeric and human antibodies.
For example, Infliximab (Remicade) is a chimeric monoclonal antibody biologic drug that works against tumour necrosis factor alpha (TNF-α) and is used to treat autoimmune diseases.
The term "Chimeric" means this monoclonal antibody was engineered from mouse genes... So... if you squeak a lot, your nose twitches and you have an uncontrollable urge to eat cheese... it could very well be the mouse genes in the Remicade.
Having been the recipient of a monoclonal antibody during a clinical trial at NIH as an intervention to prevent my retina from rejecting my body, I learned a lot about the "Mabs." During this clinical trial, I was subject to the full spectrum of adverse effects from a monoclonal antibody called daclizumab.
I'm reminded of the old saying "It's not nice to fool around with mother nature."
In this case, genetically modifying an antibody could have beneficial outcomes... then again, it could just as easily result in a condition best described in German slang as "Das ist Up-Gefoched" or in other words, "not good" as it could result in unforeseen disastrous consequences with some onerous adverse side effects. All of the "Mabs" insult the immune system leaving the patient open to infections and other maladies.
In my case, daclizumab effectively destroyed my immune system while I was taking it... The first adverse side effect was pancreatitis that started less than a month after the first infusion... it laid me low for weeks...
The second adverse side effect, that occurred a few months later, was squamous cell carcinoma. I still have a divot in my forehead from the Mohs surgical procedure where a surgeon excised a quarter sized chunk of hide out of my forehead to make sure he had "all" the cancerous lesion removed... and then some...
The final straw came with another dangerous infection... eosinophilic meningitis. It hit like a ton of bricks with a terrible bilateral headache that clearly wasn't a CH... so I had Joyce drive me to the National Eye Institute clinic at NIH, Bethesda, MD.
I walked into the clinic and told them I was suffering from a very terrible headache and it wasn't CH.
They sent me down to Radiology for a fluoroscopy-guided lumbar puncture. I felt the spinal fluid squirt out on my back and the headache pain stopped...
As I was walking back to the eye clinic, two of the physicians and a nurse from the eye clinic came running down the corridor, gang tackled me onto a gurney and rushed me back into Radiology for an MRI.
The microscopic examination of my spinal fluid revealed it was loaded with eosinophils... a special type of white blood cell indicating an infection. The MRI confirmed eosinophilic meningitis.
Sooo... If one of your neurologists suggests ALD403 (Alder BioPharmaceuticals Inc) or LY2951742 (Eli Lilly and Company) and taking part in a cluster headache trial of either one of these biologics... Take some time to think about it... Watch the next TV commercial for Humira (Adalimumab), listen carefully to the adverse effects... then think again.
ALD403 and LY2951742 are monoclonal antibodies with an appetite for calcitonin gene-related peptide (CGRP). CGRP has been found elevated during the pain phase of migraine and cluster headaches.
I suspect ALD403 and LY2951742 will be offered at a price consistent with the other popular biologics like Humira and Remicade which go for roughly $5,000 per infusion... and neither is a cure... so infusions will continue...
As an interesting side note, the 10,000 IU/day vitamin D3 in the anti-inflammatory regimen down-regulates/suppresses the production of CGRP... and 10,000 IU of vitamin D3 costs 12 cents... (~ 50 cents a day for the complete regimen). This regimen is effective for 82% of the CHers who start it.
Now let's take a look at the results from the RCTs of ALD403 and LY2951742...
"One of the agents, ALD403 (Alder BioPharmaceuticals Inc), is a genetically engineered humanized CGRP antibody delivered intravenously. A double-blind trial that randomly assigned patients to receive either the drug (n = 81) or placebo (n = 82) found that more participants receiving the drug had reduced migraine days compared with those receiving placebo.
At week 9 to 12, for example,
75.3% of the ALD 403 and 66.7% of the placebo groups had a 50% reduction in migraine days (P = .1603). The respective percentages for a 75% and 100% reduction in migraine days were 53.4% vs 30.8% (P = .0039) and 41.1% vs 16.7% (P = .0008), respectively.
"We regard a 50% reduction in headaches as a success, but in this study, there were a significant proportion of people who had a 75%, and even a 100% reduction in headaches, so it's very exciting," said Dr. Goadsby.
Another agent, LY2951742 (Eli Lilly and Company), a fully humanized monoclonal antibody to CGRP, also enjoyed positive phase 2 trial results. In this double-blind study, 106 participants received the treatment and 110 received a placebo, administered subcutaneously.
The mean change in migraine headache days at 3 months was −4.2 for the drug and −3.0 for the placebo group (P = .003).
As well, the drug was superior to placebo for all secondary endpoints, including headache days, migraine attacks, and 50% responder rate. Adverse events that were reported more frequently in the treatment group included upper respiratory tract infections, injection site pain, neck pain, abdominal pain, dizziness, injection site erythema, rash, hypertension, and pain in extremities."
My comment... I've seen some weasel worded RCT results... but these two RCTs take the cake... The average chronic migraineur experiences 15 or more migraine days a month. The average episodic migraineur experiences 3 to 14 migraine days a month. Accordingly, a reduction of 4.2 migraine days over a 3 month period is just so much noise...
In contrast, 82% of CHers who start the anti-inflammatory regimen experience a favorable response in the first month, some withing the first 24 hours as illustrated in the chart from the online survey of CHers taking this regimen to prevent their CH.
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By significant, we're talking a reduction from 3 CH/day to 3 CH/week or an 85% reduction in the frequency of CH attacks. 60% of CHers who start the anti-inflammatory regimen experience a lasting CH pain free response as long as they stay on this regimen.
It all comes down to the risk-reward ratio and bang for the buck when you consider different methods of controlling CH. You be the judge.
One final though comes to mind when discussing CH interventions... Medical science has yet to discover a medical disorder or disease caused by the lack of a man-made pharmaceutical agent, not already existing in human physiology...
Take care,
V/R, Batch
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The jab that could end the misery (Read 2533 times)
