Table 1.
Baseline characteristics of patients.
| Variable | Total (n = 41) |
|---|---|
| Gender, n (%) | |
| F | 18 (43.9) |
| M | 23 (56.1) |
| First-degree familiarity, n (%) | |
| No | 37 (90.2) |
| Yes | 4 (9.8) |
| Age at diagnosis (years), median [IQR] | 13.6 [11.3;15.8] |
| Age at diagnosis for CD (years), n (%) *,** | |
| A1a: <10 | 9 (25.7) |
| A1b: 10–17 | 22 (62.9) |
| A2: 17–40 | 4 (11.4) |
| Disease location for CD, n (%) ** | |
| L1: Distal 1/3 ileal + limited cecal disease | 8 (20.5) |
| L2: Colonic | 2 (5.1) |
| L3: Ileocolonic | 22 (56.4) |
| L4: Upper disease | 1 (2.6) |
| L3L4: Ileocolonic + upper disease | 5 (12.8) |
| L1L4: Distal 1/3 ileal + limited cecal disease + upper disease | 1 (2.6) |
| Disease behavior for CD, n (%) *,** | |
| Nonstricturing nonpenetrating | 18 (60) |
| Stricturing | 11 (36.7) |
| Penetrating | 1 (3.3) |
| Perianal disease for CD, n (%) ** | 4 (10.2) |
| Growth delay for CD, n (%) *,** | 6 (35.3) |
| Age at ADL-BioS start (years), median [IQR] | 16.0 [14.0;17.6] |
| Disease duration (years), median [IQR] | 0.62 [0.19;2.55] |
| Extraintestinal manifestation, n (%) | |
| No | 35 (85.4) |
| Yes | 6 (14.6) |
| Arthritis | 4 (9.7) |
| Erythema nodosum | 2 (4.8) |
| Previous surgery, n (%) | |
| No | 35 (85.4) |
| Yes | 6 (14.6) |
| Previous treatment, n (%) | |
| Steroids | 25 (61.0) |
| Azathioprine | 14 (34.1) |
| Mesalamine | 9 (22.0) |
| Metronidazole | 8 (19.5) |
| Infliximab | 4 (9.8) |
| Exclusive enteral nutrition | 1 (2.4) |
| Anti-TNF-α naïve, n (%) | |
| No | 4 (9.8) |
| Yes | 37 (90.2) |
| Switch from the originator, n (%) | |
| No | 32 (78.0) |
| Yes | 9 (22.0) |
| Scores and laboratory data (baseline), median [IQR] * | |
| PCDAI/PUCAI | 5.00 [5.00;20.0] |
| CRP (mg/dL) | 0.34 [0.11;1.27] |
| ESR (mm/h) | 13.0 [10.0;34.2] |
| Hb (gr/dL) | 12.4 [11.3;13.4] |
| Fecal calprotectin (µg/g) | 250 [150;462] |
| Concomitant drugs, n (%) *** | |
| Steroids | 11 (26.8) |
| Mesalamine | 5 (12.2) |
| Azathioprine | 3 (7.3) |
| Antibiotics (metronidazole, ciprofloxacin) | 2 (4.9) |
Abbreviations: ADL-BioS, adalimumab biosimilar; IQR, interquartile range; PCDAI, Pediatric Crohn’s Disease Activity Index; PUCAI, Pediatric Ulcerative Colitis Activity Index; CRP, C-reactive protein; ESR, erythrocyte sedimentation rate; Hb, hemoglobin. * Missing data. ** According to the Paris classification [11]. *** At induction.