Table 3.
Summary of safety in ELEVATE UC 52 and ELEVATE UC 12, stratified by prior bio/JAKi exposure [baseline MMS 4–9; pooled].
| Patients, n [%] [IR, per 100 PY] | ELEVATE UC 52 + ELEVATE UC 12 | |||
|---|---|---|---|---|
| Bio/JAKi-naïve | Bio/JAKi-experienced | |||
| Placebo QD [N = 176] |
Etrasimod 2 mg QD [N = 364] |
Placebo QD [N = 84] |
Etrasimod 2 mg QD [N = 163] |
|
| Any TEAEs | 86 [48.9] | 218 [59.9] | 49 [58.3] | 100 [61.3] |
| Any SAEs | 9 [5.1] [12.31] | 16 [4.4] [8.23] | 2 [2.4] [6.58] | 10 [6.1] [13.36] |
| Any AEs leading to discontinuation | 3 [1.7] [3.97] | 17 [4.7] [8.56] | 5 [6.0] [16.56] | 8 [4.9] [10.53] |
| AEs leading to death | 0 | 0 | 0 | 0 |
| Most common TEAEsa | ||||
| Headache | 6 [3.4] [8.12] | 23 [6.3] [12.26] | 3 [3.6] [9.98] | 12 [7.4] [16.56] |
| Colitis ulcerativeb | 9 [5.1] [12.12] | 18 [4.9] [9.15] | 5 [6.0] [16.95] | 13 [8.0] [17.48] |
| Pyrexia | 3 [1.7] [4.00] | 16 [4.4] [8.24] | 6 [7.1] [20.28] | 6 [3.7] [7.97] |
| Nausea | 2 [1.1] [2.67] | 15 [4.1] [7.70] | 2 [2.4] [6.61] | 4 [2.5] [5.32] |
| Dizziness | 0 | 12 [3.3] [6.19] | 1 [1.2] [3.27] | 6 [3.7] [8.07] |
| Alanine aminotransferase increased | 1 [0.6] [1.32] | 10 [2.7] [5.09] | 1 [1.2] [3.28] | 1 [0.6] [1.30] |
| Arthralgia | 5 [2.8] [6.79] | 9 [2.5] [4.58] | 1 [1.2] [3.31] | 8 [4.9] [10.74] |
| Infections [all] | 32 [18.2] [51.43] | 63 [17.3] [36.08] | 14 [16.7] [52.27] | 36 [22.1] [54.40] |
| Serious infections | 4 [2.3] [5.42] | 3 [0.8] [1.51] | 1 [1.2] [3.28] | 0 |
| Herpes zoster | 1 [0.6] [1.32] | 1 [0.3] [0.50] | 1 [1.2] [3.28] | 1 [0.6] [1.30] |
| Opportunistic infectionsc | 0 | 1 [0.3] [0.50] | 1 [1.2] [3.28] | 0 |
| AESId | ||||
| Bradycardiae | 0 | 2 [0.5] [1.00] | 0 | 0 |
| Sinus bradycardiae | 0 | 2 [0.5] [1.00] | 0 | 0 |
| AV block, 1st degree | 0 | 2 [0.5] [1.01] | 0 | 0 |
| AV block, 2nd degree [Mobitz I] | 0 | 1 [0.3] [0.50] | 0 | 0 |
| Hypertensionf | 2 [1.1] [2.65] | 9 [2.5] [4.56] | 0 | 4 [2.5] [5.33] |
| Macular oedema | 0 | 0 | 0 | 1 [0.6] [1.30] |
For AEs with 0 patients with events, percentage values, and IRs are also 0 and so are not displayed.
AE, adverse event; AESI, adverse events of special interest; AV, atrioventricular; bio/JAKi, biologic/Janus kinase inhibitor; IR, incidence rate; MedDRA, Medical Dictionary for Regulatory Activities; N, total number of patients; n, number of patients with evaluable data within each category; PY, patient-years; QD, once daily; SAE, serious adverse event; TEAE, treatment-emergent adverse event; UC, ulcerative colitis.
aThe most common TEAEs included above are the five most frequently occurring TEAEs among patients who received etrasimod, per subgroup. Common TEAEs were defined as those reported > 1% patients [etrasimod treatment group] and with a higher IR in the etrasimod treatment group than in the placebo group, in the overall population.
b‘Colitis ulcerative’ includes UC worsening/UC flares.
cBased on MedDRA Standardised Query for Opportunistic infections [narrow definition], MedDRA version 24.1. Included ‘Cytomegalovirus infection’ for the etrasimod group and ‘Tuberculosis’ for the placebo group.
dAESIs are sponsor-designated events of interest, defined as a subset of TEAEs that met the criteria of the sponsor’s medical review.
eFive additional cases of ‘Bradycardia’/‘Sinus bradycardia’ were reported by study investigators; however, these did not meet the AESI review criteria.
fIncluded ‘Hypertension’, ‘Essential hypertension’, ‘Hypertensive crisis’, and ‘Blood pressure increased’.