Table 1.
Demographics and disease characteristics of HD IFX patients.
| n = 86 | n | % | n | % | |
|---|---|---|---|---|---|
| Age at diagnosis, [median years ±SD] | 16 | ±10.8 kg/m2 | Medical hospitalizations | ||
| Age at HD IFX start, [median years ±SD] | 28.6 | ±12.0 kg/m2 | No prior hospitalizations | 46 | 53.5% |
| BMI, [median kg/m2 ±SD] | 20.39 | ±5.22 kg/m2 | 1 prior hospitalization | 16 | 18.6% |
| Female | 45 | 52.3% | 2 prior hospitalizations | 13 | 15.1% |
| 3+ prior hospitalizations | 11 | 12.8% | |||
| Smokinga | Surgical hospitalizations | ||||
| Never | 57 | 66.3% | No prior hospitalizations | 47 | 54.7% |
| Former | 12 | 14.0% | 1 prior hospitalization | 17 | 19.8% |
| Current | 3 | 3.5% | 2 prior hospitalizations | 6 | 7.0% |
| Locationa | 3+ prior hospitalizations | 16 | 18.6% | ||
| Small bowel only | 13 | 15.1% | Prior medication usage | ||
| Large bowel only | 21 | 24.4% | Any immunomodulator | 74 | 86.1% |
| Small and large bowel | 51 | 59.3% | 6MP or azathioprine | 70 | 81.4% |
| Any upper involvement | 11 | 12.8% | Methotrexate | 21 | 24.4% |
| Any perianal involvement | 41 | 47.7% | Other immunomodulatore | 2 | 2.3% |
| Phenotype | |||||
| Inflammatory | 33 | 38.4% | Any non-IFX biologic agent | 25 | 29.1% |
| Penetrating | 36 | 41.9% | Adalimumab | 19 | 22.1% |
| Fibrostenotic | 6 | 7.0% | Certolizumab pegol | 8 | 9.3% |
| Penetrating, fibrostenotic | 11 | 12.8% | Other non-IFX biologic agentf | 4 | 4.7% |
| Disease severitya | |||||
| Asymptomatic | 1 | 1.2% | Prior IFX treatment with Hiatus > 24 weeks |
42 | 48.8% |
| Steroid-dependent | 4 | 4.7% | Concomitant medication usage | ||
| Mild-moderateb | 0 | 0.0% | 6MP or azathrioprine | 38 | 44.2% |
| Moderate-severec | 77 | 89.5% | Methotrexate | 4 | 4.7% |
| Severe-fulminantd | 0 | 0.0% | Other immunomodulatord | 0 | 0% |
HD IFX, high-dose infliximab; SD, standard deviation; 6MP, 6-mercaptopurine.
aItems for which not all patients’ data were available.
bMild-moderate: ambulatory, tolerates oral alimentation, without manifestations of dehydration, toxicity, abdominal tenderness, painful mass, obstruction, or >10% weight loss.
cModerate-severe: failed to respond to treatment for mild-moderate disease, with fevers, significant weight loss, abdominal pain or tenderness, intermittent nausea or vomiting, or significant anemia.
dSevere-fulminant: persisting symptoms despite the introduction of steroids as outpatients or with high fever, persistent vomiting, evidence of intestinal obstruction, rebound tenderness, cachexia, or evidence of an abscess.
eOther immunomodulators included cyclosporine, tacrolimus.
fOther non-IFX biologics included abatacept, natalizumab, vedolizumab.