Table 4.
Open in new tab

Summary of safety (most common TEAEsa) in the ELEVATE UC clinical program stratified according to baseline disease activity.

ELEVATE UC 52 + ELEVATE UC 12 (pooled)
Baseline MMS 5–7 (N = 525)		ELEVATE UC 52 + ELEVATE UC 12 (pooled)
Baseline MMS 8–9 (N = 218)
Patients, n (%)
[IR per 100 PY]		Etrasimod 2 mg QD
(N1 = 344)		Placebo QD
(N1 = 181)		Etrasimod 2 mg QD
(N1 = 152)		Placebo QD
(N1 = 66)
Any TEAE203 (59.0) [213.41]92 (50.8) [208.26]99 (65.1) [287.07]37 (56.1) [271.26]
Any serious TEAEb19 (5.5) [10.96]7 (3.9) [9.69]6 (3.9) [7.86]4 (6.1) [17.96]
Any TEAE leading to discontinuation20 (5.8) [11.24]6 (3.3) [8.16]5 (3.3) [6.56]2 (3.0) [8.63]
SOC
PT
Gastrointestinal disorders61 (17.7) [38.98]29 (16.0) [44.33]35 (23.0) [55.37]15 (22.7) [73.80]
 Colitis ulcerative17 (4.9) [9.65]8 (4.4) [11.04]10 (6.6) [13.24]6 (9.1) [26.93]
Infections and infestations59 (17.2) [37.36]33 (18.2) [53.90]34 (22.4) [52.20]10 (15.2) [49.88]
Investigations45 (13.1) [28.19]18 (9.9) [26.05]17 (11.2) [23.53]3 (4.5) [13.24]
Musculoskeletal and connective tissue
disorder		36 (10.5) [22.17]13 (7.2) [18.67]15 (9.9) [21.01]1 (1.5) [4.33]
Nervous system disorders36 (10.5) [21.86]10 (5.5) [14.12]22 (14.5) [33.57]8 (12.1) [36.42]
 Headache20 (5.8) [11.70]5 (2.8) [6.91]10 (6.6) [13.99]3 (4.5) [13.19]
 Dizziness9 (2.6) [5.12]08 (5.3) [10.92]1 (1.5) [4.26]
Blood and lymphatic system disorders30 (8.7) [17.42]17 (9.4) [24.59]19 (12.5) [28.06]7 (10.6) [31.47]
 Anemia21 (6.1) [12.00]15 (8.3) [21.65]17 (11.2) [24.91]6 (9.1) [26.89]
General disorders and administration-site conditions25 (7.3) [14.77]13 (7.2) [18.66]15 (9.9) [20.73]8 (12.1) [35.92]
Metabolism and nutrition disorders25 (7.3) [14.54]6 (3.3) [8.25]9 (5.9) [12.31]1 (1.5) [4.29]
Skin and subcutaneous tissue disorders16 (4.7) [9.13]9 (5.0) [12.81]11 (7.2) [15.38]7 (10.6) [33.44]
Eye disorders16 (4.7) [9.18]4 (2.2) [5.53]8 (5.3) [10.66]4 (6.1) [17.12]
Cardiac disorders12 (3.5) [6.78]4 (2.2) [5.46]9 (5.9) [12.16]0
ELEVATE UC 52 + ELEVATE UC 12 (pooled)
Baseline MMS 5–7 (N = 525)		ELEVATE UC 52 + ELEVATE UC 12 (pooled)
Baseline MMS 8–9 (N = 218)
Patients, n (%)
[IR per 100 PY]		Etrasimod 2 mg QD
(N1 = 344)		Placebo QD
(N1 = 181)		Etrasimod 2 mg QD
(N1 = 152)		Placebo QD
(N1 = 66)
Any TEAE203 (59.0) [213.41]92 (50.8) [208.26]99 (65.1) [287.07]37 (56.1) [271.26]
Any serious TEAEb19 (5.5) [10.96]7 (3.9) [9.69]6 (3.9) [7.86]4 (6.1) [17.96]
Any TEAE leading to discontinuation20 (5.8) [11.24]6 (3.3) [8.16]5 (3.3) [6.56]2 (3.0) [8.63]
SOC
PT
Gastrointestinal disorders61 (17.7) [38.98]29 (16.0) [44.33]35 (23.0) [55.37]15 (22.7) [73.80]
 Colitis ulcerative17 (4.9) [9.65]8 (4.4) [11.04]10 (6.6) [13.24]6 (9.1) [26.93]
Infections and infestations59 (17.2) [37.36]33 (18.2) [53.90]34 (22.4) [52.20]10 (15.2) [49.88]
Investigations45 (13.1) [28.19]18 (9.9) [26.05]17 (11.2) [23.53]3 (4.5) [13.24]
Musculoskeletal and connective tissue
disorder		36 (10.5) [22.17]13 (7.2) [18.67]15 (9.9) [21.01]1 (1.5) [4.33]
Nervous system disorders36 (10.5) [21.86]10 (5.5) [14.12]22 (14.5) [33.57]8 (12.1) [36.42]
 Headache20 (5.8) [11.70]5 (2.8) [6.91]10 (6.6) [13.99]3 (4.5) [13.19]
 Dizziness9 (2.6) [5.12]08 (5.3) [10.92]1 (1.5) [4.26]
Blood and lymphatic system disorders30 (8.7) [17.42]17 (9.4) [24.59]19 (12.5) [28.06]7 (10.6) [31.47]
 Anemia21 (6.1) [12.00]15 (8.3) [21.65]17 (11.2) [24.91]6 (9.1) [26.89]
General disorders and administration-site conditions25 (7.3) [14.77]13 (7.2) [18.66]15 (9.9) [20.73]8 (12.1) [35.92]
Metabolism and nutrition disorders25 (7.3) [14.54]6 (3.3) [8.25]9 (5.9) [12.31]1 (1.5) [4.29]
Skin and subcutaneous tissue disorders16 (4.7) [9.13]9 (5.0) [12.81]11 (7.2) [15.38]7 (10.6) [33.44]
Eye disorders16 (4.7) [9.18]4 (2.2) [5.53]8 (5.3) [10.66]4 (6.1) [17.12]
Cardiac disorders12 (3.5) [6.78]4 (2.2) [5.46]9 (5.9) [12.16]0

aThe most common TEAEs were defined as those that occurred in >5% of patients who received etrasimod or placebo across disease activity subgroups.

bSerious adverse events were defined as any events that resulted in death, were life threatening, required patient hospitalization or prolongation of existing hospitalization, resulted in a persistent or significant disability or incapacity, resulted in a congenital anomaly or birth defect, or were deemed medically significant.

Abbreviations: IR, incidence rate; MMS, modified Mayo score; N, number of patients in each disease activity subgroup; N1, number of patients in each treatment group; n, number of patients experiencing each adverse event; PT, Preferred Term; PY, patient-year; QD, once daily; SOC, System Organ Class; TEAE, treatment-emergent adverse event; UC, ulcerative colitis.

Table 4.
Open in new tab

Summary of safety (most common TEAEsa) in the ELEVATE UC clinical program stratified according to baseline disease activity.

ELEVATE UC 52 + ELEVATE UC 12 (pooled)
Baseline MMS 5–7 (N = 525)		ELEVATE UC 52 + ELEVATE UC 12 (pooled)
Baseline MMS 8–9 (N = 218)
Patients, n (%)
[IR per 100 PY]		Etrasimod 2 mg QD
(N1 = 344)		Placebo QD
(N1 = 181)		Etrasimod 2 mg QD
(N1 = 152)		Placebo QD
(N1 = 66)
Any TEAE203 (59.0) [213.41]92 (50.8) [208.26]99 (65.1) [287.07]37 (56.1) [271.26]
Any serious TEAEb19 (5.5) [10.96]7 (3.9) [9.69]6 (3.9) [7.86]4 (6.1) [17.96]
Any TEAE leading to discontinuation20 (5.8) [11.24]6 (3.3) [8.16]5 (3.3) [6.56]2 (3.0) [8.63]
SOC
PT
Gastrointestinal disorders61 (17.7) [38.98]29 (16.0) [44.33]35 (23.0) [55.37]15 (22.7) [73.80]
 Colitis ulcerative17 (4.9) [9.65]8 (4.4) [11.04]10 (6.6) [13.24]6 (9.1) [26.93]
Infections and infestations59 (17.2) [37.36]33 (18.2) [53.90]34 (22.4) [52.20]10 (15.2) [49.88]
Investigations45 (13.1) [28.19]18 (9.9) [26.05]17 (11.2) [23.53]3 (4.5) [13.24]
Musculoskeletal and connective tissue
disorder		36 (10.5) [22.17]13 (7.2) [18.67]15 (9.9) [21.01]1 (1.5) [4.33]
Nervous system disorders36 (10.5) [21.86]10 (5.5) [14.12]22 (14.5) [33.57]8 (12.1) [36.42]
 Headache20 (5.8) [11.70]5 (2.8) [6.91]10 (6.6) [13.99]3 (4.5) [13.19]
 Dizziness9 (2.6) [5.12]08 (5.3) [10.92]1 (1.5) [4.26]
Blood and lymphatic system disorders30 (8.7) [17.42]17 (9.4) [24.59]19 (12.5) [28.06]7 (10.6) [31.47]
 Anemia21 (6.1) [12.00]15 (8.3) [21.65]17 (11.2) [24.91]6 (9.1) [26.89]
General disorders and administration-site conditions25 (7.3) [14.77]13 (7.2) [18.66]15 (9.9) [20.73]8 (12.1) [35.92]
Metabolism and nutrition disorders25 (7.3) [14.54]6 (3.3) [8.25]9 (5.9) [12.31]1 (1.5) [4.29]
Skin and subcutaneous tissue disorders16 (4.7) [9.13]9 (5.0) [12.81]11 (7.2) [15.38]7 (10.6) [33.44]
Eye disorders16 (4.7) [9.18]4 (2.2) [5.53]8 (5.3) [10.66]4 (6.1) [17.12]
Cardiac disorders12 (3.5) [6.78]4 (2.2) [5.46]9 (5.9) [12.16]0
ELEVATE UC 52 + ELEVATE UC 12 (pooled)
Baseline MMS 5–7 (N = 525)		ELEVATE UC 52 + ELEVATE UC 12 (pooled)
Baseline MMS 8–9 (N = 218)
Patients, n (%)
[IR per 100 PY]		Etrasimod 2 mg QD
(N1 = 344)		Placebo QD
(N1 = 181)		Etrasimod 2 mg QD
(N1 = 152)		Placebo QD
(N1 = 66)
Any TEAE203 (59.0) [213.41]92 (50.8) [208.26]99 (65.1) [287.07]37 (56.1) [271.26]
Any serious TEAEb19 (5.5) [10.96]7 (3.9) [9.69]6 (3.9) [7.86]4 (6.1) [17.96]
Any TEAE leading to discontinuation20 (5.8) [11.24]6 (3.3) [8.16]5 (3.3) [6.56]2 (3.0) [8.63]
SOC
PT
Gastrointestinal disorders61 (17.7) [38.98]29 (16.0) [44.33]35 (23.0) [55.37]15 (22.7) [73.80]
 Colitis ulcerative17 (4.9) [9.65]8 (4.4) [11.04]10 (6.6) [13.24]6 (9.1) [26.93]
Infections and infestations59 (17.2) [37.36]33 (18.2) [53.90]34 (22.4) [52.20]10 (15.2) [49.88]
Investigations45 (13.1) [28.19]18 (9.9) [26.05]17 (11.2) [23.53]3 (4.5) [13.24]
Musculoskeletal and connective tissue
disorder		36 (10.5) [22.17]13 (7.2) [18.67]15 (9.9) [21.01]1 (1.5) [4.33]
Nervous system disorders36 (10.5) [21.86]10 (5.5) [14.12]22 (14.5) [33.57]8 (12.1) [36.42]
 Headache20 (5.8) [11.70]5 (2.8) [6.91]10 (6.6) [13.99]3 (4.5) [13.19]
 Dizziness9 (2.6) [5.12]08 (5.3) [10.92]1 (1.5) [4.26]
Blood and lymphatic system disorders30 (8.7) [17.42]17 (9.4) [24.59]19 (12.5) [28.06]7 (10.6) [31.47]
 Anemia21 (6.1) [12.00]15 (8.3) [21.65]17 (11.2) [24.91]6 (9.1) [26.89]
General disorders and administration-site conditions25 (7.3) [14.77]13 (7.2) [18.66]15 (9.9) [20.73]8 (12.1) [35.92]
Metabolism and nutrition disorders25 (7.3) [14.54]6 (3.3) [8.25]9 (5.9) [12.31]1 (1.5) [4.29]
Skin and subcutaneous tissue disorders16 (4.7) [9.13]9 (5.0) [12.81]11 (7.2) [15.38]7 (10.6) [33.44]
Eye disorders16 (4.7) [9.18]4 (2.2) [5.53]8 (5.3) [10.66]4 (6.1) [17.12]
Cardiac disorders12 (3.5) [6.78]4 (2.2) [5.46]9 (5.9) [12.16]0

aThe most common TEAEs were defined as those that occurred in >5% of patients who received etrasimod or placebo across disease activity subgroups.

bSerious adverse events were defined as any events that resulted in death, were life threatening, required patient hospitalization or prolongation of existing hospitalization, resulted in a persistent or significant disability or incapacity, resulted in a congenital anomaly or birth defect, or were deemed medically significant.

Abbreviations: IR, incidence rate; MMS, modified Mayo score; N, number of patients in each disease activity subgroup; N1, number of patients in each treatment group; n, number of patients experiencing each adverse event; PT, Preferred Term; PY, patient-year; QD, once daily; SOC, System Organ Class; TEAE, treatment-emergent adverse event; UC, ulcerative colitis.

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