Page 466 - Binder2
P. 466

In wealthy health systems, when a biologic fails, patients
               often have options: new lines of therapy, rapid drug
               switching, advanced diagnostics, and specialist
               consultations. Failure, while disruptive, is buffered by
               access.


               But in many parts of the world, failure is final.

               In lower-income and under-resourced settings, a failed
               biologic isn’t just a clinical setback—it’s a catastrophic
               event. There may be no second-line therapy. No
               opportunity to retry. No infrastructure to pivot.


               This is the tolerization divide: a systemic inequity where
               immunogenicity hits hardest in the very places that can
               least absorb its consequences.




               When Switching Isn’t an Option


               The current biologic paradigm assumes failure is
               manageable:


                   •  That a patient can be monitored regularly for signs
                       of ADA formation.
                   •  That SLOR can be caught early, and the therapy
                       escalated or changed.
                   •  That cold-chain logistics, infusion centers, and
                       prescription formularies will absorb the churn.


               But what happens in a clinic that:

                   •  Can only afford a single biologic per condition?
                   •  Can’t store or transport drugs that require
                       refrigeration?

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