Table 52.

Contingency table for initial clinical decision made (without level knowledge), 6 month clinical outcomes (post-levels), and ITLs and FCPLs with hypothetical decision prompts^%.

ITL	FCP	Initial clinical decision			6 month clinical outcome
		No action	Action – investigation∗	Action – dose De-escalation∗∗	No change (stable IFX and steroid free)	Dose escalation IFX∗∗∗  (no steroids)	Dose De-escalation∗∗	Investigation∗	Hospitalization or surgery	Dose escalation∗∗∗, steroids, and hospitalization or surgery
<3.0 μg/mL (Action – Dose Escalation)	<250 μg/g (No Action Required)	1/31 (3.2%)	0	0	0	0	0	0	0	1/31 (3.2%)
	≥250 μg/g (Action Required)	1/31 (3.2%)	0	0	1/31 (3.2%)	0	0	0	0	0
3.0–7.0 μg/mL (No Action)	<250 μg/g (No Action Required)	4/31 (12.9%)	0	0	4/31 (12.9%)	0	0	0	0	0
	≥250 μg/g (Action Required)	5/31 (16.1%)	1/31 (3.2%)	0	5/31 (16.1%)	0	0	1/31 (3.2%)	0	0
>7.0 μg/mL (Action – Dose De-escalation)	<250 μg/g (No Action Required)	12/31 (38.7%)	3/31 (9.7%)	0	10/31 (32.3%)	3/31 (9.7%)	1/31 (3.2%)	0	1/31 (3.2%)	0
	≥250 μg/g (Action Required)	3/31 (9.7%)	0	1/31 (3.2%)	4/31 (12.9%)	0	0	0	0	0

^%A FCPL of <250 μg/g should prompt “no action" while a FCPL of ≥250 μg/g should prompt “action" (e.g., investigation, dose escalation etc.); ITLs <3.0 μg/mL should prompt “action - dose escalation”, ITLs 3.0–7.0 μg/mL should prompt “no action”, and ITLs >7.0 μg/mL should prompt “action – dose de-escalation.”

^∗Investigation refers to endoscopy.

^∗∗Dose de-escalation refers to the dose of IFX being decreased and/or decreasing the frequency of IFX dosing.

^∗∗∗Dose escalation refers to the dose of IFX being increased and/or increasing the frequency of IFX dosing.