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therapies within 12–24 months due to declining
response.
• In Crohn’s disease, loss of response to infliximab
is observed in 20–40% of patients over time.

This isn’t the rare exception. It’s the rule we don’t talk
about.

Not Just Rare—Predictable

Tolerization is not an anomaly. It is expected in certain
drug classes and patient populations:

Biologic/Drug
Disease Area ADA Impact
Classes
Anti-TNF
IBD (Remicade, 30% lose response
within first year
Humira)
High ADA risk in
Anti-CD20
MS younger/naïve
(Rituxan, Ocrevus)
patients
Enzyme
Fabry/Pompe Replacement Immune rejection
(Rare) limits long-term care
Therapies
Refractory Krystexxa 90% ADA rate; 50–
Gout 60% discontinue

Some of the world’s highest-grossing drugs—Humira,
Remicade, Keytruda, Stelara—all carry real-world rates
of loss-of-response that are vastly underreported in clinical
trials, which are too short, too controlled, or too selective to
capture the immunologic fallout.

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