Page 130 - Binder2

Why It Key
Concept Definition
Matters Indicators/Outcomes
Captures
Measures tolerization;
Time to duration often Duration of therapeutic
Secondary from initial
Loss of efficacy to overlooked effect before failure;
yet drives
onset of resistance or
Response when the most neutralization
(SLOR) drug stops
working treatment
changes
Reflects real-
Tracks how
long world
durability;
patients Therapy continuation
Drug Survival stay on a integrates duration; dropout trends
Curves dropout due
therapy to inefficacy over time
before or side
stopping it
effects
Clinical
remission
Sustained maintained Long-term remission
Clinical without Indicates true under consistent
tolerance and
Remission dose immune therapy; absence of
with Persistent change, escalation or ADA
Exposure switching, compatibility formation
or immune
suppression
Lack of
immune Provides a Low/no ADAs; stable
activity biological,
Immunological against the not just pharmacokinetics; IL-10
high, IL-17 low,
Quiescence biologic symptomatic, Treg/Th17 balance,
despite measure of
ongoing stability inactive memory B cells
use

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