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

Figure

Figure 1.
Figure 1. Flow chart showing the criteria for included patients.

Tables

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, N6697
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 white47 (71.2%)76 (78.4%)
  African American18 (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 level0.905
  Optimal18 (27.3%)16 (16.5%)
  Sub-optimal31 (47.0%)29 (29.9%)
  Missing data17 (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/SB12 (18.2%)19 (19.6%)
  Colonic/ilecolonic54 (81.8%)78 (80.4%)
  Isolated upper GI0 (0)0 (0)
Disease behavior, n (%)*0.0084
  Stricturing/penetrating47 (71.2%)49 (50.5%)
  Inflammatory19 (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
 
GroupTotal, NClinical response, N (%)Unadjusted OR (95% CI), P-valueAdjusted* OR (95% CI), P-value
*Adjusted for age, gender, race, duration of disease and vedolizumab experience.
Adalimumab9771 (73.2%)2.73 (1.41 - 5.28), 0.00282.40 (1.14 - 5.07), 0.0213
Ustekinumab6633 (50.0%)

 

Table 3. Proportions, Crude and Adjusted ORs for Clinical Remission in All Patients
 
GroupTotal, NClinical remission, N (%)Unadjusted OR (95% CI), P-valueAdjusted* 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.
Adalimumab9743 (44.3%)2.08 (1.06 - 4.08), 0.03362.35 (1.07 - 5.16), 0.0337
Ustekinumab6518 (27.7%)

 

Table 4. Proportions, Crude and Adjusted ORs for Clinical Response in TNF Naive Patients
 
GroupTotal, NClinical response, N (%)Unadjusted OR (95% CI), P-valueAdjusted* OR (95% CI), P-value
*Adjusted for age and gender. OR: odds ratio; TNF: tumor necrosis factor; CI: confidence interval.
Adalimumab8969 (77.5%)5.17 (1.33 - 20.15), 0.01784.26 (1.08 - 16.84), 0.0390
Ustekinumab104 (40.0%)

 

Table 5. Proportions, Crude and Adjusted ORs for Clinical Remission in TNF Naive Patients
 
GroupTotal, NClinical remission, N (%)Unadjusted OR (95% CI), P-valueAdjusted* OR (95% CI), P-value
*Adjusted for age and gender. OR: odds ratio; TNF: tumor necrosis factor; CI: confidence interval.
Adalimumab8941 (46.1%)1.71 (0.40 - 7.26), 0.46841.64 (0.39 - 6.97), 0.5033
Ustekinumab93 (33.3%)

 

Table 6. Proportions, Crude and Adjusted ORs for Clinical Response in TNF Experienced Patients
 
GroupTotal, NClinical response, N (%)Unadjusted OR (95% CI), P-valueAdjusted* OR (95% CI), P-value
*Adjusted for age and gender. OR: odds ratio; TNF: tumor necrosis factor; CI: confidence interval.
Adalimumab82 (25.0%)0.31 (0.06 - 1.67), 0.17320.38 (0.07 - 1.94), 0.2441
Ustekinumab5629 (51.8%)

 

Table 7. Proportions, Crude and Adjusted ORs for Clinical Remission in TNF Experienced Patients
 
GroupTotal, NClinical remission, N (%)Unadjusted OR (95% CI), P-valueAdjusted* OR (95% CI), P-value
*Adjusted for age and gender. OR: odds ratio; TNF: tumor necrosis factor; CI: confidence interval.
Adalimumab82 (25.0%)0.91 (0.17 - 5.02), 0.91481.22 (0.22 - 6.81), 0.8201
Ustekinumab5615 (26.8%)