Table 2.
Differences in Baseline Characteristics Between Patients Who Did and Did Not Achieve Steroid-Free Remission at Week 14 (Infliximab or Vedolizumab) or Week 16 (Ustekinumab) of Therapy
| Characteristic | SFDR at week 14 (n = 48) | No SFDR at week 14 (n = 93) | P value |
|---|---|---|---|
|
| |||
| Female gender, n (%) | 28 (58.3) | 51 (54.8) | .69 |
| Age, y, mean (SD) | 34.94 (12.4) | 42.90 (18.3) | .007a |
| Hispanic ethnicity, n (%) | 2 (4.2) | 4 (4.3) | .97 |
| Race, n (%) | .56 | ||
| White | 45 (93.8) | 84 (90.3) | |
| African American | 2 (4.2) | 8 (8.6) | |
| Asian | 1 (2.1) | 1 (1.1) | |
| Other | 0 (0) | 0 (0) | |
| Disease type, n (%) | .69 | ||
| CD | 28 (58.3) | 51 (54.8) | |
| UC | 20 (41.7) | 42 (45.2) | |
| Active smoker at baseline, n (%) | 5 (10.4) | 9 (9.7) | .89 |
| Years with IBD, median (IQR) | 5 (1–14) | 6 (2–13) | .63 |
| History of bowel resection,b n (%) | 5 (10.4) | 15 (16.1) | .36 |
| Phenotype of CDb | |||
| Location, n (%) | .32 | ||
| L1: Ileal | 4 (14.3) | 15 (29.4) | |
| L2: Colonic | 6 (21.4) | 8 (15.7) | |
| L3: Ileocolonic | 18 (64.3) | 28 (54.9) | |
| L4: Upper gastrointestinal tract involvement, n (%) | 2 (7.1) | 4 (7.8) | 1.00 |
| B1: Not stricturing, nonpenetrating, n (%) | 14 (50.0) | 20 (39.2) | .35 |
| B2: Stricturing, n (%) | 7 (25.0) | 23 (45.1) | .08 |
| B3: Penetrating, n (%) | 5 (17.9) | 12 (23.5) | .56 |
| Phenotype of UCc | |||
| UC extension, n (%) | .51 | ||
| Proctitis | 1 (5.0) | 1 (2.38) | |
| Left-sided colitis | 7 (35.0) | 11 (26.19) | |
| Pan-colitis | 12 (60.0) | 30 (71.43) | |
| Body composition parameters at baseline | |||
| Total mass, kg, mean (SD) | 72.6 (16.3) | 86.3 (21.5) | <.001a |
| Body mass index, kg/m2, mean (SD) | 25.1 (4.2) | 29.9 (7.4) | <.001a |
| Percentage of body fat, mean (SD) | 30.7 (9.5) | 37.2 (10.3) | <.001a |
| Total IA-VATc mass, kg, mean (SD) | 0.7 (0.5) | 1.5 (1.2) | <.001a |
| Total fat mass, kg, mean (SD) | 22.7 (10.0) | 33.2 (15.1) | <.001a |
| IA-VATd percentage of total body mass, mean (SD) | 0.8 (0.5) | 1.6 (1.1) | <.001a |
| Total lean mass, kg, mean (SD) | 46.8 (11.0) | 49.4 (10.7) | .17 |
| Medications at baseline and previous exposure | |||
| Previous use of biologic, n (%) | 20 (41.7) | 67 (72.0) | <.01a |
| Biologic started, n (%) | .65 | ||
| Infliximab | 17 (35.4) | 35 (37.6) | |
| Ustekinumab | 13 (27.1) | 30 (32.3) | |
| Vedolizumab | 18 (37.5) | 28 (30.1) | |
| Receiving steroids at baseline, n (%) | 27 (56.3) | 67 (72.0) | .06 |
| Use of mesalamine, n (%) | 6 (12.5) | 7 (7.53) | .33 |
| Receiving combination therapy with immunomodulator, n (%) | 19 (39.6) | 44 (47.3) | .38 |
| Receiving a thiopurine for combination therapy, n (%) | 16 (33.3) | 35 (37.6) | .61 |
| Receiving a methotrexate for combination therapy, n (%) | 5 (10.4) | 10 (10.8) | .95 |
| Baseline disease activity | |||
| Simple Endoscopic Score for CD,b median (IQR) | 11 (7.3–16) | 8 (7–14) | .46 |
| Harvey Bradshaw Index,b median (IQR) | 5 (2–7) | 6 (3–8) | .14 |
| Partial Mayo Score,c median (IQR) | 6 (4–7) | 5 (4–6) | .27 |
| Endoscopic Mayo Score,c n (%) | .32 | ||
| 2 | 10 (50) | 10 (50) | |
| 3 | 10 (50) | 10 (50) | |
| Baseline C-reactive protein, mg/dL, median (IQR) | 0.3 (0.1–0.6) | 0.7 (0.3–1.6) | .006a |
| Baseline albumin, mg/dL, mean (SD) | 4.28 (0.4) | 4.11 (0.5) | .043a |
| Baseline fecal calprotectin,e μg/mg, median (IQR) | 553.5 (274–980) | 851 (291 –2208) | .146 |
| Drug level at weeks 14–16 in the higher 2 quartilesf n (%) | 33 (73.3) | 31 (35.6) | <.0001 |
| Infliximab pharmacokineticsg | |||
| Infliximab drug levels week 14, mg/dL, median (IQR) | 11.4 (9.1–18.9) | 3.7 (0.5–13.0) | .03a |
| Detectable anti-infliximab antibodies, n (%) | 5 (15.2) | 1 (5.9) | .31 |
| Vedolizumab pharmacokineticsg | |||
| Vedolizumab drug levels week 14, mg/dL, median (IQR) | 14.3 (11.3–23.6) | 9.0 (5.6–14.0) | .01a |
| Detectable anti-vedolizumab antibodies, n (%) | 1 (3.9) | 0 (0) | .40 |
| Ustekinumab pharmacokineticsg | |||
| Ustekinumab drug levels week 16, mg/dL, median (IQR) | 7.8 (6.5–10.3) | 3.6 (2.3–5.2) | .003a |
| Detectable anti-ustekinumab antibodies, n (%) | 0 (0) | 0 (0) | NA |
| Dose escalated before weeks 14–16, n (%) | 2 (2.2)g | 0 (0) | .31 |
IQR, interquartile range; NA, not applicable.
a
Statistically significant.
b
Applies to patients with CD.
c
Applies to patients with UC.
d
70 patients in the cohort had baseline fecal calprotectin performed.
e
Stratified by each biologic and done at week 14 (infliximab or vedolizumab) or week 16 (ustekinumab)
f
As applies based on the drug the patient was taking.
g
Both patients who received dose escalation were on infliximab.