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Ann: PARADIGM RECEIVES FEEDBACK FROM US FDA ON IND SUBMISSION, page-145

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  1. 4,437 Posts.
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    Good in that it seems to be efficacious, at least a bit more than methotrexate and appears to have some DMARD effects in some patients.

    Bad in that it does cause side effects, some are serious AND the FDA has slapped a boxed warning on it. It can tend to weaken some patient's immune systems. Some 0.2% in clinical studies developed TB. (Known to increase chances of TB when immune systems are compromised for example). 0.2% may not sound like much but multiply it out by the numbers that may one day use this drug.



    Just my views

    Last edited by Mozzarc: 02/10/21
 
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