Table 1.
Ontamalimab 75 mg [n = 164] | Ontamalimab 225 mg [n = 166] | Ontamalimab overall [n = 330] | |
---|---|---|---|
Mean [SD] age, years | 40.5 [12.75] | 41.1 [13.68] | 40.8 [13.21] |
Sex, n [%] male | 102 [62.2] | 96 [57.8] | 198 [60.0] |
Ethnicity, n [%] Hispanic or Latino | 4 [2.4] | 6 [3.6] | 10 [3.0] |
Race, n [%] | |||
White | 148 [90.2] | 143 [86.1] | 291 [88.2] |
Black | 3 [1.8] | 2 [1.2] | 5 [1.5] |
Asian | 11 [6.7] | 15 [9.0] | 26 [7.9] |
Other | 2 [1.2] | 6 [3.6] | 8 [2.4] |
Mean [SD] BMI, kg/m2 | 25.25 [5.69] | 25.24 [4.59] | 25.24 [5.16] |
Anti-TNF naïve, n [%] | 68 [41.5] | 76 [45.8] | 144 [43.6] |
Mean [SD] time since UC diagnosis, yearsa | 8.69 [7.04] | 7.56 [7.36] | 8.12 [7.21] |
Mean [SD] total Mayo score | 6.0 [2.87] | 5.9 [2.84] | 6.0 [2.85] |
Mean [SD] Mayo endoscopic subscore | 2.2 [0.07] | 2.2 [0.06] | 2.2 [0.05] |
Mean [SD] concentration of hsCRP [mg/dL]b | n = 160 | n = 162 | n = 322 |
0.94 [1.266] | 0.73 [0.89] | 0.83 [1.10] | |
Mean [SD] concentration of FC [µg/g]c | n = 142 | n = 155 | n = 329 |
2468.3 [3819.3] | 1924.7 [2541.8] | 2184.6 [3222.4] | |
Receiving systemic glucocorticoids for UC, n [%] | 59 [36.0] | 71 [42.8] | 130 [39.4] |
Smoking classification, n [%]c | |||
Never smoked | 107 [65.2] | 102 [61.4] | 209 [63.3] |
Smoker | 8 [4.9] | 9 [5.4] | 17 [5.2] |
Ex-smoker | 49 [29.9] | 55 [33.1] | 104 [31.5] |
Clinical responder at baseline, n [%]d | 79 [48.2] | 75 [45.2] | 154 [46.7] |
Mucosal healing at baseline, n [%] | 34 [20.7] | 33 [19.9] | 67 [20.3] |
Treatment groups based on initial randomisation assignment.
BMI, body mass index; FC, faecal calprotectin; hsCRP, high-sensitivity C-reactive protein; SD, standard deviation; TNF, tumour necrosis factor; UC, ulcerative colitis.
aCalculated as: [[date of visit 1 in TURANDOT II − date of diagnosis from TURANDOT] + 1] / 365.25.
bCalculated for patients included in the pharmacodynamic analyses only.
cAt screening in TURANDOT.
dThose who achieved clinical response based on total Mayo score at Week 12 in TURANDOT.