Page 91 - Binder2

Even patient advocacy groups, many of which rely on
funding from industry, often lacked the data—or the
freedom—to challenge the long-term effectiveness of the
very drugs seen as revolutionary breakthroughs.

And so the system settled into its rhythm.
Switching became standard.
Workarounds became guidelines.
The word “tolerization” disappeared from the
conversation—not because the problem went away, but
because the industry learned how to work around it without
disruption.

But make no mistake: the science was always there.
Studies showed anti-drug antibody formation in a
significant share of patients across multiple biologics. In a
study on Remicade 24% of patients using the drug were
found to have significant levels of ADAs. Another study on
Tysarbi revealed 16% of people had developed ADAs.
Rituxan was reported to have as high as 50% of patients
experiencing antibodies in lupus treatment.

Real-world evidence documented secondary loss of
response. Immunologists raised flags. But their warnings
never reached the decision-makers. Or if they did, they
were filed under “known but manageable risks.”

And that’s the heart of it: tolerization never felt like a
market failure.
It felt like background noise.
Something we could live with.

Until now.

Because the margins are tightening. The costs are rising.
And the cracks are starting to show.

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