Table 2.
Univariable and multivariable logistic regression analysis of associations between patient demographics and baseline characteristics and HEMI at Week 12 of LUCENT-1 [NRI] in patients randomised to mirikizumab 300 mg IV in LUCENT-1
| Parameter | Category | Univariable analysis | Multivariable analysis | ||
|---|---|---|---|---|---|
| OR [95% CI] | p-value | OR [95% CI] | p-value | ||
| Age | <40 vs > 40 years | 1.44 [1.07-1.95] | 0.0169 | ||
| Sex | Female vs male | 1.60 [1.18-2.17] | 0.0024 | 1.60 [1.11-2.30] | 0.0108 |
| Ethnicitya | Hispanic/Latino vs non-Hispanic/non-Latino | 0.64 [NA-NA] | 0.2611 | ||
| Not reported vs non-Hispanic/non-Latino | 8.05 [0.41 to > 999] | ||||
| Race | American Indian/Alaska Native vs White | 0.83 [NA-NA] | 0.8652 | ||
| Asian vs White | 1.25 [NA-NA] | ||||
| Black vs White | 0.83 [NA-NA] | ||||
| Native Hawaiian/Pacific Islander vs White | 0.90 [NA-NA] | ||||
| Multiple vs White | 0.90 [NA-NA] | ||||
| Geographical region | Europe vs North America | 1.10 [0.70-1.76] | 0.4164 | ||
| Other vs North America | 1.29 [0.84-2.04] | ||||
| Weight | <100 vs ≥ 100 kg | 0.89 [0.51-1.59] | 0.6805 | ||
| BMI | Underweight [<18.5 kg/m2] vs normal [≥18.5 and < 25 kg/m2] | 1.02 [0.54-1.84] | 0.2863 | ||
| Overweight [≥25 and < 30 kg/m2] vs normal [≥18.5 and 25 kg/m2] | 0.71 [0.49-1.02] | ||||
| Obese [≥30 and < 40 kg/m2] vs normal [≥18.5 and < 25 kg/m2] | 0.88 [0.55-1.38] | ||||
| Extreme obese [≥40 kg/m2] vs normal [≥18.5 and < 25 kg/m2] | 1.79 [0.55-5.45] | ||||
| Tobacco use | Current vs never | 1.02 [0.50-1.97] | 0.6381 | ||
| Former vs never | 0.85 [0.60-1.19] | ||||
| Baseline corticosteroid use | No vs yes | 1.34 [0.99-1.83] | 0.0613 | ||
| Baseline immunomodulator use | No vs yes | 1.39 [0.97-2.02] | 0.0715 | 1.67 [1.08-2.57] | 0.0199 |
| Duration of UC | <3 vs ≥ 7 years | 1.23 [0.87-1.75] | 0.4986 | ||
| ≥3 to < 7 vs ≥ 7 years | 1.09 [0.74-1.58] | ||||
| Baseline disease locationb | Left-sided colitis vs pancolitis | 1.40 [1.02-1.93] | 0.0377 | ||
| Baseline faecal calprotectin | ≤250 vs > 250 μg/g | 2.46 [1.49-4.04] | 0.0005 | ||
| Baseline CRP | ≤6 vs 6 mg/L | 2.35 [1.69-3.31] | <0.0001 | 1.95 [1.31-2.91] | 0.0011 |
| Baseline MMS | Moderate [4–6] vs severe [7–9] | 2.05 [1.51-2.78] | <0.0001 | ||
| Baseline ES | 2 vs 3 | 3.11 [2.28-4.25] | <0.0001 | 2.04 [1.41-2.94] | 0.0002 |
| Baseline SF subscore | <3 vs 3 | 2.37 [1.75-3.23] | <0.0001 | 2.28 [1.59-3.28] | <0.0001 |
| Baseline RB subscore | <2 vs ≥ 2 | 0.95 [0.70-1.28] | 0.7250 | ||
| Prior biologic or tofacitinib failure | Not failed vs failed | 2.95 [2.12-4.17] | <0.0001 | 2.63 [1.77-3.91] | <0.0001 |
BMI, body mass index; CI, confidence interval; CRP, C-reactive protein; ES, endoscopic score; HEMI, histological-endoscopic mucosal improvement; IV, intravenous; MMS, modified Mayo score; NA, not applicable; NRI, non-responder imputation; OR, odds ratio; RB, rectal bleeding; SF, stool frequency; UC, ulcerative colitis.
aOnly includes responses from US sites.
bEight patients with proctitis were combined with left-sided colitis when examining disease location.