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inconsistently reported in regulatory filings, and often
omitted from product labels.
If we’re going to solve tolerization, we can’t keep ignoring
its earliest—and clearest—signal.
We must start listening to what the immune system is
telling us.
And that begins by measuring, tracking, and sharing ADA
data with the rigor it demands.
Because immune durability isn’t a mystery.
It’s a measurable outcome—we just have to choose to
measure it.
2. Response Must Be Redefined as Resilience
Currently, most biologic trials define success as initial
response—a reduction in disease activity, biomarker
improvement, or symptom relief over a short window. But
this approach treats efficacy as a moment in time, not a
trajectory.
We need to reframe success as durability—not just if a
biologic works, but how long it continues to work in the
presence of an immune system that is constantly watching,
adapting, and responding.
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