Baseline characteristics, concomitant medications and medical history in patients with cardiovascular-related TEAEs in the etrasimod UC clinical programme (Placebo-controlled UC and All UC cohorts)
| Bradycardia and sinus bradycardia | AV block | Hypertension | |||||||
| Placebo-controlled UC cohort | All UC cohort | Placebo-controlled UC cohort | All UC cohort | Placebo-controlled UC cohort | All UC cohort | ||||
| Etrasimod 2 mg QD (N=11) | Placebo QD (N=0) | Etrasimod 2 mg QD (N=14) | Etrasimod 2 mg QD (N=4) | Placebo QD (N=0) | Etrasimod 2 mg QD (N=7) | Etrasimod 2 mg QD (N=15) | Placebo QD (N=4) | Etrasimod 2 mg QD (N=24) | |
| Age, n (%) | |||||||||
| <50 years | 7 (63.6) | 0 | 8 (57.1) | 3 (75.0) | 0 | 5 (71.4) | 4 (26.7) | 2 (50.0) | 9 (37.5) |
| ≥50 years | 4 (36.4) | 0 | 6 (42.9) | 1 (25.0) | 0 | 2 (28.6) | 11 (73.3) | 2 (50.0) | 15 (62.5) |
| Sex, n (%) | |||||||||
| Male | 4 (36.4) | 0 | 7 (50.0) | 1 (25.0) | 0 | 3 (42.9) | 7 (46.7) | 4 (100.0) | 13 (54.2) |
| Female | 7 (63.6) | 0 | 7 (50.0) | 3 (75.0) | 0 | 4 (57.1) | 8 (53.3) | 0 | 11 (45.8) |
| BMI, n (%) | |||||||||
| <25 kg/m2 | 5 (45.5) | 0 | 6 (42.9) | 3 (75.0) | 0 | 5 (71.4) | 6 (40.0) | 3 (75.0) | 10 (41.7) |
| ≥25 to <30 kg/m2 | 4 (36.4) | 0 | 4 (28.6) | 1 (25.0) | 0 | 2 (28.6) | 5 (33.3) | 0 | 8 (33.3) |
| ≥30 kg/m2 | 2 (18.2) | 0 | 4 (28.6) | 0 | 0 | 0 | 4 (26.7) | 1 (25.0) | 6 (25.0) |
| Pre-dose heart rate, n (%) | |||||||||
| <50 bpm | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| ≥50 to <60 bpm | 1 (9.1) | 0 | 1 (7.1) | 1 (25.0) | 0 | 1 (14.3) | 4 (26.7) | 1 (25.0) | 4 (16.7) |
| ≥60 to ≤100 bpm | 10 (90.9) | 0 | 13 (92.9) | 3 (75.0) | 0 | 6 (85.7) | 11 (73.3) | 3 (75.0) | 20 (83.3) |
| >100 bpm | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| SBP, n (%) | |||||||||
| <90 mm Hg | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| ≥90 to ≤120 mm Hg | 7 (63.6) | 0 | 9 (64.3) | 2 (50.0) | 0 | 3 (42.9) | 2 (13.3) | 0 | 2 (8.3) |
| >120 mm Hg | 4 (36.4) | 0 | 5 (35.7) | 2 (50.0) | 0 | 4 (57.1) | 13 (86.7) | 4 (100.0) | 22 (91.7) |
| DBP, n (%) | |||||||||
| <60 mm Hg | 1 (9.1) | 0 | 1 (7.1) | 0 | 0 | 0 | 0 | 0 | 0 |
| ≥60 to ≤80 mm Hg | 7 (63.6) | 0 | 8 (57.1) | 3 (75.0) | 0 | 5 (71.4) | 3 (20.0) | 1 (25.0) | 6 (25.0) |
| >80 mm Hg | 3 (27.3) | 0 | 5 (35.7) | 1 (25.0) | 0 | 2 (28.6) | 12 (80.0) | 3 (75.0) | 18 (75.0) |
| Relevant cardiovascular concomitant medications, n (%) | |||||||||
| Use of beta-blocking agents | 2 (18.2) | 0 | 2 (14.3) | 0 | 0 | 0 | 0 | 1 (25.0) | 1 (4.2) |
| Use of calcium channel-blocking agents | 0 | 0 | 0 | 0 | 0 | 0 | 2 (13.3) | 0 | 2 (8.3) |
| Use of agents acting on the renin–angiotensin system | 1 (9.1) | 0 | 1 (7.1) | 1 (25.0) | 0 | 1 (14.3) | 4 (26.7) | 1 (25.0) | 5 (20.8) |
| Use of diuretics | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (25.0) | 0 |
| Relevant cardiovascular medical history, n (%) | |||||||||
| Hypercholesterolaemia related | NC | NC | NC | NC | NC | NC | 1 (6.7) | 0 | 2 (8.3) |
| Hypertension* | 2 (18.2) | 0 | 3 (21.4) | 1 (25.0) | 0 | 1 (14.3) | 6 (40.0) | 2 (50.0) | 8 (33.3) |
| Diabetes related | NC | NC | NC | NC | NC | NC | 2 (13.3) | 0 | 3 (12.5) |
MedDRA V.24.1 coding dictionary applied.
*Includes patients with a medical history of hypertension, which may have been identified using any of the following customised search terms: hypertension or essential hypertension or BP ambulatory increased or BP increased or BP diastolic increased or BP diastolic abnormal or BP systolic increased or BP systolic abnormal or BP abnormal or mean arterial pressure increased or labile hypertension or diastolic hypertension or systolic hypertension or secondary hypertension or accelerated hypertension or hypertensive crisis or malignant hypertension or hypertensive emergency or hypertensive urgency or BP inadequately controlled.
AV, atrioventricular; BMI, body mass index; BP, blood pressure; DBP, diastolic BP; MedDRA, Medical Dictionary for Regulatory Activities; N, total number of patients included in the analysis; n, number of patients with events within the specified group; NC, not calculated; QD, once daily; SBP, systolic BP; TEAE, treatment-emergent adverse event; UC, ulcerative colitis.