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DewDiligence

05/15/11 6:48 PM

#120051 RE: biomaven0 #120046

...over time and multiple switches you might develop neutralizing antibodies that might reduce efficacy. So it's less of a concern with say Lovenox than it would be with say the RA biologics that patients are going to be on for years.

Whether antibodies to such drugs as the TNF-a class are problematic in a practical sense is controversial—see, for instance, #msg-61989536.
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jq1234

05/15/11 6:59 PM

#120053 RE: biomaven0 #120046

rather that over time and multiple switches you might develop neutralizing antibodies that might reduce efficacy.



Neutralizing antibodies could be developed over time even without switches. Is there any evidence patients who switched among several currently approved anti-TNF biologics are more likely to develop neutralizing antibody? I am not aware that at all.

For ERT Cerezyme, relatively high percentage (mid teens) of patients developed antibodies, and these patients had higher risk for hypersensitivity. That was one concern about switching among ERTs. So far no evidence of this at all.