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Showing content with the highest reputation on 12/07/2017 in all areas

  1. There are 4 RCTs registered in cinicaltrials.gov using mAbs (monoclonal antibodies - 3 for Fremanezumab and one for Galcanezumab) as the intervention for CH and more are likely to follow. Three of the mAbs tested with migraine had an appetite for calcitonin gene-related peptide (CGRP) and a fourth that plugs the CGRP receptor. IMHO... the use of mAbs is still focused on the treatment of symptoms (neurogenic inflammation and the pain caused by CGRP) and not on one of the underlying causes. If you follow the basic antibody antigen mechanism of action where an antibody attaches to an antigen (in this case CGRP), marking it for destruction by killer cells and larger white blood cells, the cow (CGRP in this case) is already out of the barn... To my way of thinking, this means that monoclonal antibodies that attack CGRP or block its receptors will never be fully effective as they're playing a catch-up game from the get go... Using an objective statistical measure of efficacy called the Number Needed to Treat (NNT) to prevent one migraineur from having a sever (not complete cessation) migraine headache attack, the mAb Erenumab has an NNT of 6. That means you need to treat 6 episodic migraineurs to prevent one episodic migraineur from having a sever attack. In other words... Erenumab was ineffective for 5 out of 6 episodic migraineurs (83%) treated. In reality, any NNT of 10 or less is considered "good." See the following link for more details: http://journals.sagepub.com/doi/abs/10.1177/0333102417732504?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%3dpubmed In comparison, Torpiramate and Propranolo each had NNTs of 5 in preventing one episodic migraineur from having a severe attack. Erenumab was equally effective for chronic migraineurs with an NNT of 6. In comparison, BOTOX had an NNT of 9 and two RCTs for Torpiramate had NNTs of 13 and 4. We won't know the efficacy of mAbs in prevneting CH until some time in 2018 or longer. FDA approval following phase 3 studies will still be needed so two years to market as a CH prophylactic is an optimistic guess at this point. Moreover, as these are man-made, genetically engineered foreign antibodies with no physiological means of production from within the human genome, they will need to be replaced periodically (like monthly) in order to maintain a therapeutic serum concentration... The cost of these mAbs is still unknown at this point... However, I strongly suspect it will be in the same price range per month as Humira (Adalimumab)... $100 to $185 out of pocket copay ($5 if AbbVie covers the injection) to $6.600 without assistance. For reference, vitamin D3 plus Omega-3 fish oil and the vitamin D3 cofactors has a mechanism of action that downregulates/suppresses the expression of CGRP at the genetic layer... In other words, vitamin D3 bars the barn doors to prevent the cows (CGRP) from escaping the genetic layer. Using the above statistical method of expressing efficacy, the anti-inflammatory regimen has a raw NNT of 3 or 2 in preventing one CHer from having a CH... Numbers count... Take care, V/R, Batch .
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