Table 2.
Characteristics of patients with Crohn’s disease undergoing ustekinumab dose escalation
| Study | Age, median (IQR) | Sex (male, %) | Disease Duration, years (IQR) | Disease Location (I/C/IC/U, %) | Disease Complications (B2/B3/P, %) | Prior IBD Surgery (%) | Prior TNFα antagonist(%) | Prior VDZ (%) | Concurrent IMM (%) | Concurrent steroids (%) |
|---|---|---|---|---|---|---|---|---|---|---|
| Biemanns* 7 | 38 (29–52) | 40 | 12.3 (7.5–19.3) |
31/34/34/5 | 29/18/17 | 62 | 99 | 21 | 20 | 16 |
| Fumery* 11 | 35 (28–49) | 48 | 11.6 (7.3–20.2) |
NR | 28/37/47 | 49 | 99 | 55 | 27 | 29 |
| Hudson15 | -- | -- | -- | 0/0/100/0 | 0/50/0 | -- | -- | -- | -- | -- |
| Kopylov17 | 35 (26–49) | 55 | 10 (5–17) | 18/22/61/0 | 37/27/23 | 57 | 56** | 40** | 17 | 24 |
| Ollech18 | 36 (27–51) | 47 | 14.4 (7.1–23) | 13/15/70/4 | 41/29/10 | -- | 93† | 46† | -- | 41 |
| Sedano20 | 52 (33–66) | 33 | -- | 0/13/73/13 | 20/33/20 | 53 | 40 | 13 | -- | 53 |
| Dalal10 | 42 (NR) | 44 | 12.7–15.5 (NR) |
13/22/62/2 | 18/55/42 | 64 | 100 | 48 | -- | 24 |
| Haider13 | 39 (21–27) | 73 | 11.4 (2–24) | 27/7/67/20 | 33/20/20 | 47 | 100 | 53 | 67 | 13 |
| Johnson* 16 | 38 (NR) | 48 | -- | -- | -- | -- | 90 | -- | -- | -- |
| Ramaswamy19 | 55 (NR) | 45 | -- | -- | -- | -- | -- | -- | 65 | 39 |
| Bundschuh8 | 40 (24–61) | 56 | -- | -- | --/--/73 | 82 | 96 | -- | -- | 55 |
| Cohen9 | 39 (NR) | 44 | -- | --/--/52/-- | 57/--/-- | 54 | 95 | 47 | -- | -- |
| Glass12 | 38 (33–49) | 50 | 18 (10.2) | 13/23/62/2 | 20/23/63 | 65 | 92 | 74 | 31 | 25 |
| Heron14 | 35.5 | 54 | -- | -- | -- | -- | -- | -- | -- | -- |
| Young21 | -- | -- | -- | -- | 33/48/-- | -- | -- | -- | -- | -- |
[Abbreviations: IQR=interquartile range, SD= standard deviation, NR=not reported, I=ileal, C=colonic, IC=ileocolonic, U=upper gut, B2=stricturing, B3=penetrating, P=perianal, IBD=Inflammatory Bowel Disease, TNF=tumor necrosis factor, VDZ=vedolizumab, IMM=immunomodulator]
Percentages of baseline characteristics from larger total cohort than just those who received ustekinumab dose escalation
Kopylov et al reported prior biologics as: 33 patients with 1 prior biologic, 56 patients with 2 prior biologics, 46 patients with 3 prior biologics, 2 patients with 4 prior biologics, and 57 patients received both prior TNFα antagonists and vedolizumab. Though biologic type is not clearly reported, the synthesized results reported in the table are made under the reasonable assumption that most patients receive TNFα antagonist as first line therapy for moderate to severe Crohn’s Disease.
Ollech et al reported prior biologics as: 6 patients with one or no prior biologic, 6 patients with >1 prior biologic, 2 patients with prior vedolizumab exposure, and 3 biologic naïve patients. Though biologic type is not clearly reported, the synthesized results reported in the table are made under the reasonable assumption that most patients receive TNFα antagonist as first line therapy for moderate to severe Crohn’s Disease.