Table 1.

Baseline Clinical and Demographic Characteristics, Week 4 Remission, Week 12 CS-free Remission and Week 52 PUCAI Score Grouped by Week 52 Outcome

Week 52 F.valliable population (n=400a)	Week 52 CS-Free Remission (n=150)	Neither CS-Free Remission nor Additional Therapy (n=53)	Escalation to Immuno-modulator onlyb (n=74)	Escalation to Anti-TNFαc (n=123)	p-value
Age (years) (mean±SD)	12.3 ± 3.4	12.4 ± 3.8	12.9 ± 2.9	12.9 ± 3.0	0.30
Female (%)	69/150 (46%)	30/53 (57%)	36/74 (49%)	62/123 (50%)	0.60
Nonwhite race (%)	22/148 (15%)	9/53 (17%)	11/70 (16%)	20/121 (17%)	0.98
Clinical Characteristics:
Disease Extent:	N=150	N=53	N=74	N=123
Proctosigmoiditis	15 (10%)	5 (9%)	3 (4%)	4 (3%)	0.0041 *
Left-sided colitis	18 (12%)	8 (15%)	6 (8%)	6 (5%)
Extensive/Pancolitisd	117 (78%)	40 (75%)	65 (88%)	113 (92%)
PUCAI total score (range 0–85 by 5) (mean±SD)	45.6 ± 20.3	39.2 ± 16.3	51.6 ± 15.4	60.2 ± 18.1	<0.0001 **
% < 45	70/150 (47%)	34/53 (64%)	16/74 (22%)	23/123 (19%)	<0.0001 **
Percentage of Week 52 Outcomes by PUCAI total score category					<0.0001 **
10–30 (Mild) n=90	43/90 (48%)	23/90 (26%)	11/90 (12%)	13/90 (14%)
35–60 (Moderate) n=l 77	66/177 (37%)	25/177 (14%)	45/177 (25%)	41/177 (23%)
≥65 (Severe) n=133	41/133 (31%)	5/133 (4%)	18/133 (14%)	69/133 (52%)
Mayo total score (range 0–12) (mean±SD)	N=150 7.2 ± 2.5	N=53 6.5 ± 2.0	N=74 7.9 ± 2.0	N=123 9.1 ± 2.3	<0.0001 **
% ≥ 10	30 (20%)	6 (11%)	15 (20%)	64 (52%)	<0.0001 **
% ≥ 11	13 (9%)	1 (2%)	8 (11%)	47 (38%)	<0.0001 **
Mayo endoscopy score (range 0–3) (mean±SD)	N=150 2.1 ± 0.7	N=53 1.9 ± 0.6	N=74 2.2 ± 0.6	N=123 2.5 ± 0.6	<0.0001 **
Hemoglobin (g/dL)	N=139	N=49	N=68	N=120
Mean±SD	11.9 ± 2.0	12.0 ± 1.9	10.9 ± 2.3	10.8 ± 2.3	<0.0001 **
%<10g/dL	22 (16%)	7 (14%)	22 (32%)	45 (38%)	0.0001 **
ESR (mm/hr)	N=135	N=44	N=64	N=115
Median (P25, P75)	19 (11, 34)	17 (9, 35)	28 (12, 47)	30 (17, 46)	0.0005 **
CRPorhsCRP	N=113	N=37	N=51	N=100
>ULN	42 (37%)	12 (32%)	24 (47%)	59 (59%)	0.0044 *
Albumin (g/dL)	N=147	N=53	N=71	N=123
Mean±SD	3.8 ± 0.7	3.8 ± 0.8	3.6 ± 0.6	3.5 ± 0.7	0.0001 **
% <3.5 g/dL	40 (27%)	15 (28%)	22 (31%)	55 (45%)	0.0155 *
25 (OH) D (ng/mL)	N=136	N=50	N=68	N=113
Median (P25, P75)	29.5 (25.0, 36.9)	28.8 (24.2, 34.0)	28.7 (24.4, 35.1)	27.1 (22.2, 31.7)
< 20 ng/mL	12 (9%)	5 (10%)	3 (4%)	19 (17%)	0.055
20– < 30 ng/mL	61 (45%)	23 (46%)	34 (50%)	54 (48%)	0.11
≥ 30 ng/mL	63 (46%)	22 (44%)	31 (46%)	40 (35%)
Bioavailable 25 (OH) D (ng/mL)	N=136	N=51	N=66	N=112
Median (P25, P75)	1.5 (1.1, 2.1)	1.3 (0.8, 2.1)	1.2 (0.8, 1.8)	1.2 (0.8, 1.9)	0.0091 *
% ≥ 1.6 ng/mL	65 (48%)	20 (39%)	21 (32%)	36 (32%)	0.045 *
Rectal biopsy eosinophilic inflammation (count > 32/hpf)	75/126 (60%)	31/46 (67%)	43/63 (68%)	45/107 (42%)	0.0016 *
Week 4 Remissione	100/150 (67%)	27/53 (51%)	33/74 (45%)	38/123 (31%)	<0.0001 **
Week 4 fecal calprotectin (mcg/g) Median (P25, P75)	N=108 604.5 (144.8, 1519.3)	N=39 677.6 (233.2, 1597.7)	N=48 1014.3 (372.0, 2314.2)	N=78 1576.8 (564.6, 2975.5)	0.0008 **
Week 12 CS-free remissionf	79/150 (53%)	23/53 (43%)	15/74 (20%)	19/123 (15%)	<0.0001 **
Week 52 PUCAI total score category	N=149	N=51	N=69	N=105
<10 (Inactive)	149 (100%)	6 (12%)	40 (58%)	50 (48%)	<0.0001 **
10–30 (Mild)	0 (0%)	39 (76%)	24 (35%)	32 (30%)
35–60 (Moderate)	0 (0%)	5 (10%)	3 (4%)	17 (16%)
≥65 (Severe)	0 (0%)	1 (2%)	2 (3%)	6 (6%)

^*p<0.05,

^**p < 0.001. P-values comparing groups are from a chi-squared or Fisher’s exact test (noted by #) for categorical variables, a Mantel-Haenszel chi-squared test for ordinal variables, and ANOVA or Kruskal-Wallis test for continuous variables. P25, P75: 25^th and 75% percentile Additional characteristics are located in Table S3A

^aEvaluable population excludes participants who discontinued the study without additional therapy or colectomy

^b106 patients started on immunomodulators, 32 later escalated to anti-TNFα

^cIncludes one patient starting a calcineurin inhibitor and one patient who received colectomy without escalation to anti-TNFα

^dIncludes patients with fulminant disease with limited colonoscopy

^eweek 4 remission: PUCAI < 10 at week 4 with no prior treatment escalation or colectomy

^fweek 12 CS-free remission: PUCAI < 10 at week 12 and steroid-free for the prior 14 days with no prior treatment escalation or colectomy.