How has the disease course of pediatric ulcerative colitis changed throughout the biologics era? A comparison with the IBSEN study

Table 3 Clinical outcomes during the total follow-up period before (group A) and after (group B) infliximab approval

	Group A (n = 48)	Group B (n = 62)	P value
Number of relapsed patients	23 (47.9)	16 (25.8)	0.027b
Cumulative total relapses	40	22	0.006b
Number of relapses per person	1.74	1.38
Number of relapses per person per year	0.44	0.25
First relapse interval from diagnosis, yr	1.20 (0.60-2.50)	1.95 (1.35-3.93)	0.194b
Each relapse interval, yr	1.30 (0.60-3.55)	1.70 (1.00-4.20)	0.943b
Initial disease extent of relapsed patients			0.080c
E1 proctitis	7 (30.4)	0
E2 left colitis	2 (8.7)	0
E3 right colitis	3 (13.0)	2 (12.5)
E4 pancolitis	11 (47.8)	14 (87.5)
Number of hospitalizations per person	0.13	0.18	0.964b
Median PUCAIa during treatment period	10 (5-20)	5 (3.75-15)	< 0.001b
Median PUCAIa at the time of relapse	65 (52.5-75)	45 (45-55)	< 0.001b
Median cumulative corticosteroid free period	3.0 (2.6-3.7)	4.4 (3.1-6.0)	< 0.001b
Number of cumulative colectomies1	1	0

^aPediatric Ulcerative Colitis Activity Index (PUCAI) is a 6-item disease activity index intended for use in pediatric UC clinical trials with a score ranging from 0-85.

^bχ² test.

^cMann-Whitney test.

¹Statistical analysis was not performed as there was only one patient who underwent colectomy.

Values are n (percentage) or median (interquartile range); n: Number of patients; PUCAI: Pediatric Ulcerative Colitis Activity Index.