Gastroenterol Res

Gastroenterology Research, ISSN 1918-2805 print, 1918-2813 online, Open Access

Article copyright, the authors; Journal compilation copyright, Gastroenterol Res and Elmer Press Inc

Journal website http://www.gastrores.org

Original Article

Volume 12, Number 5, October 2019, pages 245-251

Comparative Effectiveness of Ustekinumab Versus Adalimumab in Induction of Clinical Response and Remission in Crohn’s Disease: Experience of a Real-World Cohort at a Tertiary Care Inflammatory Bowel Disease Referral Center

**Table 1.** Baseline Characteristics of Included Patients
	Ustekinumab (n = 66)	Adalimumab (n = 97)	P value
SD: standard deviation; TNF: tumor necrosis factor; BMI: body mass index; PPI: proton pump inhibitor; SB: small bowel; GI: gastrointestinal.
Eligible, N	66	97
Age (years), mean (SD)	42.5 (15.9)	40 (13.6)	0.287
Duration of disease (years), mean (SD)*	11.8 (11.5)	8.6 (9.4)	0.026
Race, %			0.509
Non-Hispanic white	47 (71.2%)	76 (78.4%)
African American	18 (27.3%)	19 (19.6%)
Female, n (%)	43 (65.2%)	62 (63.9%)	0.872
Nicotine use, n (%)	8 (12.3%)	22 (23.2%)	0.084
Steroid use, n (%)	17 (25.8%)	22 (22.7%)	0.651
Mesalamine use, n (%)	9 (13.6%)	11 (11.3%)	0.661
Thiopurine use, n (%)*	23 (34.8%)	19 (19.6%)	0.029
Methotrexate use, n (%)	7 (10.6%)	13 (13.4%)	0.593
TNF-experienced, n (%)*	56 (84.8%)	8 (8.2%)	< 0.00012
Vedolizumab-experienced, n (%)*	19 (28.8%)	1 (1.0%)	< 0.00012
Vitamin D level			0.905
Optimal	18 (27.3%)	16 (16.5%)
Sub-optimal	31 (47.0%)	29 (29.9%)
Missing data	17 (25.7%)	52 (53.6%)
PPI use, n (%)	30 (46.2%)	30 (31.3%)	0.055
BMI (kg/m²)			0.227
Underweight (< 18.5)	6 (9.1%)	9 (9.3%)
Normal weight (18.5 - 24.9)	26 (39.4%)	31 (32.0)
Overweight (25 - 29.9)	19 (28.8%)	26 (26.8)
Obese (≥ 30)	15 (22.7%)	31 (32.0)
Type 2 diabetes, n (%)*	8 (12.1%)	3 (3.1%)	0.024
Hypertension, n (%)	15 (22.7%)	11 (11.3%)	0.051
Disease location, n (%)			0.822
Ileal/SB	12 (18.2%)	19 (19.6%)
Colonic/ilecolonic	54 (81.8%)	78 (80.4%)
Isolated upper GI	0 (0)	0 (0)
Disease behavior, n (%)*			0.0084
Stricturing/penetrating	47 (71.2%)	49 (50.5%)
Inflammatory	19 (28.8%)	48 (49.5%)
Perianal disease, n (%)*	25 (37.9%)	17 (17.5%)	0.0035

Table 1. Baseline Characteristics of Included Patients

Ustekinumab (n = 66)

Adalimumab (n = 97)

P value

SD: standard deviation; TNF: tumor necrosis factor; BMI: body mass index; PPI: proton pump inhibitor; SB: small bowel; GI: gastrointestinal.

Eligible, N

Age (years), mean (SD)

42.5 (15.9)

40 (13.6)

0.287

Duration of disease (years), mean (SD)*

11.8 (11.5)

8.6 (9.4)

0.026

Race, %

0.509

Non-Hispanic white

47 (71.2%)

76 (78.4%)

African American

18 (27.3%)

19 (19.6%)

Female, n (%)

43 (65.2%)

62 (63.9%)

0.872

Nicotine use, n (%)

8 (12.3%)

22 (23.2%)

0.084

Steroid use, n (%)

17 (25.8%)

22 (22.7%)

0.651

Mesalamine use, n (%)

9 (13.6%)

11 (11.3%)

0.661

Thiopurine use, n (%)*

23 (34.8%)

19 (19.6%)

0.029

Methotrexate use, n (%)

7 (10.6%)

13 (13.4%)

0.593

TNF-experienced, n (%)*

56 (84.8%)

8 (8.2%)

< 0.00012

Vedolizumab-experienced, n (%)*

19 (28.8%)

1 (1.0%)

< 0.00012

Vitamin D level

0.905

Optimal

18 (27.3%)

16 (16.5%)

Sub-optimal

31 (47.0%)

29 (29.9%)

Missing data

17 (25.7%)

52 (53.6%)

PPI use, n (%)

30 (46.2%)

30 (31.3%)

0.055

BMI (kg/m²)

0.227

Underweight (< 18.5)

6 (9.1%)

9 (9.3%)

Normal weight (18.5 - 24.9)

26 (39.4%)

31 (32.0)

Overweight (25 - 29.9)

19 (28.8%)

26 (26.8)

Obese (≥ 30)

15 (22.7%)

31 (32.0)

Type 2 diabetes, n (%)*

8 (12.1%)

3 (3.1%)

0.024

Hypertension, n (%)

15 (22.7%)

11 (11.3%)

0.051

Disease location, n (%)

0.822

Ileal/SB

12 (18.2%)

19 (19.6%)

Colonic/ilecolonic

54 (81.8%)

78 (80.4%)

Isolated upper GI

0 (0)

Disease behavior, n (%)*

0.0084

Stricturing/penetrating

47 (71.2%)

49 (50.5%)

Inflammatory

19 (28.8%)

48 (49.5%)

Perianal disease, n (%)*

25 (37.9%)

17 (17.5%)

0.0035

**Table 2.** Proportions, Crude and Adjusted Odds Ratios for Clinical Response in All Patients
Group	Total, N	Clinical response, N (%)	Unadjusted OR (95% CI), P-value	Adjusted* OR (95% CI), P-value
*Adjusted for age, gender, race, duration of disease and vedolizumab experience.
Adalimumab	97	71 (73.2%)	2.73 (1.41 - 5.28), 0.0028	2.40 (1.14 - 5.07), 0.0213
Ustekinumab	66	33 (50.0%)

Table 2. Proportions, Crude and Adjusted Odds Ratios for Clinical Response in All Patients

Group

Total, N

Clinical response, N (%)

Unadjusted OR (95% CI), P-value

Adjusted* OR (95% CI), P-value

*Adjusted for age, gender, race, duration of disease and vedolizumab experience.

Adalimumab

71 (73.2%)

2.73 (1.41 - 5.28), 0.0028

2.40 (1.14 - 5.07), 0.0213

Ustekinumab

33 (50.0%)

**Table 3.** Proportions, Crude and Adjusted ORs for Clinical Remission in All Patients
Group	Total, N	Clinical remission, N (%)	Unadjusted OR (95% CI), P-value	Adjusted* OR (95% CI), P-value
*Adjusted for age, gender, race, duration of disease and vedolizumab experience. OR: odds ratio; TNF: tumor necrosis factor; CI: confidence interval.
Adalimumab	97	43 (44.3%)	2.08 (1.06 - 4.08), 0.0336	2.35 (1.07 - 5.16), 0.0337
Ustekinumab	65	18 (27.7%)

Table 3. Proportions, Crude and Adjusted ORs for Clinical Remission in All Patients

Group

Total, N

Clinical remission, N (%)

Unadjusted OR (95% CI), P-value

Adjusted* OR (95% CI), P-value

*Adjusted for age, gender, race, duration of disease and vedolizumab experience. OR: odds ratio; TNF: tumor necrosis factor; CI: confidence interval.

Adalimumab

43 (44.3%)

2.08 (1.06 - 4.08), 0.0336

2.35 (1.07 - 5.16), 0.0337

Ustekinumab

18 (27.7%)

**Table 4.** Proportions, Crude and Adjusted ORs for Clinical Response in TNF Naive Patients
Group	Total, N	Clinical response, N (%)	Unadjusted OR (95% CI), P-value	Adjusted* OR (95% CI), P-value
*Adjusted for age and gender. OR: odds ratio; TNF: tumor necrosis factor; CI: confidence interval.
Adalimumab	89	69 (77.5%)	5.17 (1.33 - 20.15), 0.0178	4.26 (1.08 - 16.84), 0.0390
Ustekinumab	10	4 (40.0%)

Table 4. Proportions, Crude and Adjusted ORs for Clinical Response in TNF Naive Patients

Group

Total, N

Clinical response, N (%)

Unadjusted OR (95% CI), P-value

Adjusted* OR (95% CI), P-value

*Adjusted for age and gender. OR: odds ratio; TNF: tumor necrosis factor; CI: confidence interval.

Adalimumab

69 (77.5%)

5.17 (1.33 - 20.15), 0.0178

4.26 (1.08 - 16.84), 0.0390

Ustekinumab

4 (40.0%)

**Table 5.** Proportions, Crude and Adjusted ORs for Clinical Remission in TNF Naive Patients
Group	Total, N	Clinical remission, N (%)	Unadjusted OR (95% CI), P-value	Adjusted* OR (95% CI), P-value
*Adjusted for age and gender. OR: odds ratio; TNF: tumor necrosis factor; CI: confidence interval.
Adalimumab	89	41 (46.1%)	1.71 (0.40 - 7.26), 0.4684	1.64 (0.39 - 6.97), 0.5033
Ustekinumab	9	3 (33.3%)

Table 5. Proportions, Crude and Adjusted ORs for Clinical Remission in TNF Naive Patients

Group

Total, N

Clinical remission, N (%)

Unadjusted OR (95% CI), P-value

Adjusted* OR (95% CI), P-value

*Adjusted for age and gender. OR: odds ratio; TNF: tumor necrosis factor; CI: confidence interval.

Adalimumab

41 (46.1%)

1.71 (0.40 - 7.26), 0.4684

1.64 (0.39 - 6.97), 0.5033

Ustekinumab

3 (33.3%)

**Table 6.** Proportions, Crude and Adjusted ORs for Clinical Response in TNF Experienced Patients
Group	Total, N	Clinical response, N (%)	Unadjusted OR (95% CI), P-value	Adjusted* OR (95% CI), P-value
*Adjusted for age and gender. OR: odds ratio; TNF: tumor necrosis factor; CI: confidence interval.
Adalimumab	8	2 (25.0%)	0.31 (0.06 - 1.67), 0.1732	0.38 (0.07 - 1.94), 0.2441
Ustekinumab	56	29 (51.8%)

Table 6. Proportions, Crude and Adjusted ORs for Clinical Response in TNF Experienced Patients

Group

Total, N

Clinical response, N (%)

Unadjusted OR (95% CI), P-value

Adjusted* OR (95% CI), P-value

*Adjusted for age and gender. OR: odds ratio; TNF: tumor necrosis factor; CI: confidence interval.

Adalimumab

2 (25.0%)

0.31 (0.06 - 1.67), 0.1732

0.38 (0.07 - 1.94), 0.2441

Ustekinumab

29 (51.8%)

**Table 7.** Proportions, Crude and Adjusted ORs for Clinical Remission in TNF Experienced Patients
Group	Total, N	Clinical remission, N (%)	Unadjusted OR (95% CI), P-value	Adjusted* OR (95% CI), P-value
*Adjusted for age and gender. OR: odds ratio; TNF: tumor necrosis factor; CI: confidence interval.
Adalimumab	8	2 (25.0%)	0.91 (0.17 - 5.02), 0.9148	1.22 (0.22 - 6.81), 0.8201
Ustekinumab	56	15 (26.8%)

Table 7. Proportions, Crude and Adjusted ORs for Clinical Remission in TNF Experienced Patients

Group

Total, N

Clinical remission, N (%)

Unadjusted OR (95% CI), P-value

Adjusted* OR (95% CI), P-value

*Adjusted for age and gender. OR: odds ratio; TNF: tumor necrosis factor; CI: confidence interval.

Adalimumab

2 (25.0%)

0.91 (0.17 - 5.02), 0.9148

1.22 (0.22 - 6.81), 0.8201

Ustekinumab

15 (26.8%)