Determination of correlation of clearance with clinical outcomes for inflammatory bowel disease

Table 1 Characteristics of 10 patients treated with impact of Bayesian model-guided infliximab treatment at baseline and day 120

Patient number	1	3	4	5	6	7	8	9	11	12
Baseline
Sex	M	F	F	F	M	F	M	F	M	M
Age (years)	49	18	32	19	39	22	45	36	62	23
Body weight (kg)	44	55	58	50	99	53	95	63	84	63
Diagnosis	CD	UC	UC	UC	CD	CD	UC	UC	UC	UC
CD disease location	Ileocolonic	NA	NA	NA	Upper GI ileal	Ileocolonic	NA	NA	NA	NA
UC disease extent	NA	Extensive	Left-sided	Extensive	NA	NA	Left-sided	Extensive	Extensive	Left-sided
Disease duration (years)	31	1	11	1	5	11	2	11	3	8
CRP (mg/dL)	0.86	11.71	5.36	1.79	0.27	3.98	4.56	3.07	0.32	4.78
Albumin (g/L)	27.3	37.5	33.4	34.1	41.6	35.4	35.9	38.8	39.6	34.9
FCP (μg/g)	1560	3888	4360	3572	113	13024	1659	502	1597	12295
Concomitant steroids/immunosuppressants	PRED 20 mg/day; AZA 100 mg/day	AZA 100 mg/day	AZA 100 mg/day	PRED 20 mg/day	None	MTX 15 mg/week	PRED 10 mg/day	None	PRED 10 mg/day	PRED 15 mg/day; 6-MP 50 mg/day
Prior biologic exposure	Yes (IFX, ADL, UST)	No	No	No	No	Yes (UST, IFX, ADL, GOL, VDZ)	Yes	Yes (VDZ, IFX, ADL, GOL)	Yes (ADL, VDZ)	Yes (ADL, GOL)
First IFX dose (mg/kg)	4.5	5.4	10.3	10.0	6.1	5.7	10.4	9.5	9.5	9.5
Day 120
Observation period (months)	9	9	9	6	4	11	6	11	4	31
Body weight (kg)	67	58	60	53	98		104		82	77
CRP (mg/dL)	0.7	0.05	0.38	0.16	0.23		1.19		2.35	0.26
Albumin (g/L)	41.0	50.8	45.9	45.1	43.5		47.9		34.2	43.8
FCP (μg/g)	35	246	60	138	112		2690		467	176
Number of IFX doses received	7	7	5	8	5	2	6	3	6	4

Patient numbers are not consecutive as patient numbers 2 and 10 were not included in the compassionate use study. Patients 7 and 9 discontinued the compassionate use program early owing to antidrug antibody formation; patient 12 had 90 days of follow-up. 6-MP: Mercaptopurine; ADA: Antidrug antibody; ADL: Adalimumab; AZA: Azathioprine; CD: Crohn’s disease; CRP: C-reactive protein; F: Female; FCP: Fecal calprotectin; GI: Gastrointestinal; GOL: Golimumab; IFX: Infliximab; M: Male; MTX: Methotrexate; NA: Not applicable; PRED: Prednisone; UC: Ulcerative colitis; UST: Ustekizumab; VDZ: Vedolizumab.

Table 2 Initial infliximab clearance, probability of mucosal healing, probability of C-reactive protein normalization, and probability of antidrug antibody for patients who received Bayesian model-guided treatment

Patients	CL (L/day)	Probability of MHEAL	Probability of CRP normalization	Probability of ADA
1	0.6236	7.42	19.19	94.47
3	1.1102	0.73	3.95	100.00
4	0.3160	39.44	47.78	56.62
5	0.0168	73.32	70.22	18.14
6	0.2722	46.50	52.49	47.96
7	0.3937	28.18	39.42	71.38
8	0.6329	7.07	18.56	94.78
9	0.6095	7.94	20.15	93.99
11	0.4288	23.95	35.99	76.34
12	0.5125	14.82	28.13	86.66

ADA: Antidrug antibody; CL: Accelerated clearance; CRP: C-reactive protein; MHEAL: Mucosal healing.