Table 5.

Growth and Disease Characteristics at 12 and 24 Months among the 105 Participants that Completed the Open Label Extension

	12 months	24 months	p-value
Height Z-score*	−0.61 ± 0.97	−0.51 ± 0.98	< 0.001
BMI Z-score	−0.13 ± 1.06	−0.19 ± 1.00	0.27
Pediatric Crohn's Disease Activity Index	5 (3 - 15)	5 (0 - 13)	0.05
Inactive (≤ 10), n (%)	72 (69)	74 (72)	0.28
Mild (11-30), n (%)	26 (25)	29 (28)
Moderate/Severe (>30), n (%)	6 (6)	1 (1)
Laboratory Parameters
Serum 25(OH) vitamin D, ng/mL	34.2 ± 11.8	37.7 ± 15.6	0.01
Serum 25(OH) vitamin D < 20 ng/mL, n (%)	7 (7)	8 (8)	0.71
Serum albumin, g/dL	4.3 ± 0.5	4.3 ± 0.4	0.89
Hematocrit, %	37.9 ± 3.5	38.9 ± 3.8	< 0.001
Medications
Systemic steroids at the visit, n (%)	6 (6)	5 (5)	0.71
Systemic steroids anytime during interval, n (%)	14 (13)		--
Biologics at the visit, n (%)	45 (43)	48 (46)	0.32
Biologics anytime during the interval, n (%)	50 (48)		--

Data are presented as mean ± SD, n (%), or median (range)

^*Height Z-score data limited to those < 18 years of age at the 12 month visit.