Table 2.
Open in new tab

Proportions and IRs of TEAEs and events of interest reported in the ELEVATE UC clinical program stratified by age (Pivotal UC cohorta SAS with baseline MMS 4-9).

n (%) [IR per 100 PYb]; 95% CI per 100 PY
PY		Age (y)
<4040-59≥60
Placebo QD
(N = 146)		Etrasimod
2 mg QD
(N = 274)		Placebo QD
(N = 87)		Etrasimod
2 mg QD
(N = 189)		Placebo QD
(N = 27)		Etrasimod
2 mg QD
(N = 64)
Common TEAEsc
 Anemia17 (11.6) [29.7];
15.6, 43.9
57.2		26 (9.5) [20.7];
12.7, 28.6
125.7		4 (4.6) [10.4];
0.2, 20.6
38.4		12 (6.4) [11.5];
5.0, 18.0
104.5		1 (3.7) [9.4];
0.0, 27.9
10.6		0
NC
36.6
 Colitis ulcerative7 (4.8) [11.4];
2.9, 19.8
61.6		24 (8.8) [18.4];
11.0, 25.7
130.7		4 (4.6) [10.7];
0.2, 21.1
37.5		7 (3.7) [6.5];
1.7, 11.4
107.2		3 (11.1) [28.8];
0.0, 61.4
10.4		0
NC
36.6
 Headache7 (4.8) [11.5];
3.0, 19.9
61.2		18 (6.6) [14.1];
7.6, 20.6
127.7		2 (2.3) [5.3];
0.0, 12.7
37.7		13 (6.9) [12.8];
5.8, 19.7
102.0		0
NC
10.7		4 (6.3) [12.0];
0.2, 23.7
33.5
 Arthralgia4 (2.7) [6.6];
0.1, 13.1
60.7		3 (1.1) [2.2];
0.0, 4.8
134.3		1 (1.2) [2.6];
0.0, 7.7
38.7		10 (5.3) [9.5];
3.6, 15.4
105.1		1 (3.7) [9.7];
0.0, 28.7
10.3		4 (6.3) [11.5];
0.2, 22.8
34.7
 Fatigue1 (0.7) [1.6];
0.0, 4.8
62.2		2 (0.7) [1.5];
0.0, 3.6
134.4		1 (1.2) [2.6];
0.0, 7.8
37.9		2 (1.1) [1.9];
0.0, 4.5
107.0		0
NC
10.7		4 (6.3) [11.6];
0.2, 22.9
34.6
 Hypertension1 (0.7) [1.6];
0.0, 4.7
62.5		1 (0.4) [0.7];
0.0, 2.2
134.4		0
NC
38.9		6 (3.2) [5.6];
1.1, 10.2
106.3		1 (3.7) [9.5];
0.0, 28.2
10.5		4 (6.3) [11.3];
0.2, 22.4
35.3
 Pyrexia6 (4.1) [9.8];
2.0, 17.6
61.3		12 (4.4) [9.1];
3.9, 14.2
132.1		2 (2.3) [5.2];
0.0, 12.4
38.6		6 (3.2) [5.6];
1.1, 10.1
106.5		1 (3.7) [9.5];
0.0, 28.1
10.6		4 (6.3) [11.7];
0.2, 23.2
34.2
Serious infectionsd3 (2.1) [4.9];
0.0, 10.4
61.6		1 (0.4) [0.8];
0.0, 2.2
134.1		2 (2.3) [5.3];
0.0, 12.7
37.7		1 (0.5) [0.9];
0.0, 2.7
108.3		0
NC
10.7		1 (1.6) [2.7];
0.0, 8.1
36.5
Events of interest
 Macular edema1 (0.7) [1.6];
0.0, 4.7
62.6		0
NC
135.0		0
NC
38.9		2 (1.1) [1.8];
0.0, 4.4
108.6		0
NC
10.7		0
NC
36.6
 Cardiac events
  AV block first degree0
NC
62.6		1 (0.4) [0.7];
0.0, 2.2
134.9		0
NC
38.9		1 (0.5) [0.9];
0.0, 2.8
107.8		0
NC
10.7		0
NC
36.6
  AV block second degreee0
NC
62.6		0
NC
135.0		0
NC
38.9		1 (0.5) [0.9];
0.0, 2.7
108.8		0
NC
10.7		0
NC
36.6
  Bradycardia0
NC
62.6		2 (0.7) [1.5];
0.0, 3.5
134.6		0
NC
38.9		3 (1.6) [2.8];
0.0, 5.9
107.8		0
NC
10.7		0
NC
36.6
  Sinus bradycardia0
NC
62.6		2 (0.7) [1.5];
0.0, 3.6
134.1		0
NC
38.9		1 (0.5) [0.9];
0.0, 2.7
108.7		0
NC
10.7		1 (1.6) [2.7];
0.0, 8.1
36.6
 Infection events
  Cytomegalovirus infection0
NC
62.6		0
NC
135.0		0
NC
38.9		0
NC
108.8		0
NC
10.7		1 (1.6) [2.7];
0.0, 8.1
36.5
  Tuberculosis1 (0.7) [1.6];
0.0, 4.7
62.5		0
NC
135.0		0
NC
38.9		0
NC
108.8		0
NC
10.7		0
NC
36.6
  Herpes zoster1 (0.7) [1.6];
0.0, 4.7
62.5		0
NC
135.0		0
NC
38.9		2 (1.1) [1.85];
0.0, 4.4
108.4		1 (3.7) [9.4];
0.0, 27.7
10.7		0
NC
36.6
n (%) [IR per 100 PYb]; 95% CI per 100 PY
PY		Age (y)
<4040-59≥60
Placebo QD
(N = 146)		Etrasimod
2 mg QD
(N = 274)		Placebo QD
(N = 87)		Etrasimod
2 mg QD
(N = 189)		Placebo QD
(N = 27)		Etrasimod
2 mg QD
(N = 64)
Common TEAEsc
 Anemia17 (11.6) [29.7];
15.6, 43.9
57.2		26 (9.5) [20.7];
12.7, 28.6
125.7		4 (4.6) [10.4];
0.2, 20.6
38.4		12 (6.4) [11.5];
5.0, 18.0
104.5		1 (3.7) [9.4];
0.0, 27.9
10.6		0
NC
36.6
 Colitis ulcerative7 (4.8) [11.4];
2.9, 19.8
61.6		24 (8.8) [18.4];
11.0, 25.7
130.7		4 (4.6) [10.7];
0.2, 21.1
37.5		7 (3.7) [6.5];
1.7, 11.4
107.2		3 (11.1) [28.8];
0.0, 61.4
10.4		0
NC
36.6
 Headache7 (4.8) [11.5];
3.0, 19.9
61.2		18 (6.6) [14.1];
7.6, 20.6
127.7		2 (2.3) [5.3];
0.0, 12.7
37.7		13 (6.9) [12.8];
5.8, 19.7
102.0		0
NC
10.7		4 (6.3) [12.0];
0.2, 23.7
33.5
 Arthralgia4 (2.7) [6.6];
0.1, 13.1
60.7		3 (1.1) [2.2];
0.0, 4.8
134.3		1 (1.2) [2.6];
0.0, 7.7
38.7		10 (5.3) [9.5];
3.6, 15.4
105.1		1 (3.7) [9.7];
0.0, 28.7
10.3		4 (6.3) [11.5];
0.2, 22.8
34.7
 Fatigue1 (0.7) [1.6];
0.0, 4.8
62.2		2 (0.7) [1.5];
0.0, 3.6
134.4		1 (1.2) [2.6];
0.0, 7.8
37.9		2 (1.1) [1.9];
0.0, 4.5
107.0		0
NC
10.7		4 (6.3) [11.6];
0.2, 22.9
34.6
 Hypertension1 (0.7) [1.6];
0.0, 4.7
62.5		1 (0.4) [0.7];
0.0, 2.2
134.4		0
NC
38.9		6 (3.2) [5.6];
1.1, 10.2
106.3		1 (3.7) [9.5];
0.0, 28.2
10.5		4 (6.3) [11.3];
0.2, 22.4
35.3
 Pyrexia6 (4.1) [9.8];
2.0, 17.6
61.3		12 (4.4) [9.1];
3.9, 14.2
132.1		2 (2.3) [5.2];
0.0, 12.4
38.6		6 (3.2) [5.6];
1.1, 10.1
106.5		1 (3.7) [9.5];
0.0, 28.1
10.6		4 (6.3) [11.7];
0.2, 23.2
34.2
Serious infectionsd3 (2.1) [4.9];
0.0, 10.4
61.6		1 (0.4) [0.8];
0.0, 2.2
134.1		2 (2.3) [5.3];
0.0, 12.7
37.7		1 (0.5) [0.9];
0.0, 2.7
108.3		0
NC
10.7		1 (1.6) [2.7];
0.0, 8.1
36.5
Events of interest
 Macular edema1 (0.7) [1.6];
0.0, 4.7
62.6		0
NC
135.0		0
NC
38.9		2 (1.1) [1.8];
0.0, 4.4
108.6		0
NC
10.7		0
NC
36.6
 Cardiac events
  AV block first degree0
NC
62.6		1 (0.4) [0.7];
0.0, 2.2
134.9		0
NC
38.9		1 (0.5) [0.9];
0.0, 2.8
107.8		0
NC
10.7		0
NC
36.6
  AV block second degreee0
NC
62.6		0
NC
135.0		0
NC
38.9		1 (0.5) [0.9];
0.0, 2.7
108.8		0
NC
10.7		0
NC
36.6
  Bradycardia0
NC
62.6		2 (0.7) [1.5];
0.0, 3.5
134.6		0
NC
38.9		3 (1.6) [2.8];
0.0, 5.9
107.8		0
NC
10.7		0
NC
36.6
  Sinus bradycardia0
NC
62.6		2 (0.7) [1.5];
0.0, 3.6
134.1		0
NC
38.9		1 (0.5) [0.9];
0.0, 2.7
108.7		0
NC
10.7		1 (1.6) [2.7];
0.0, 8.1
36.6
 Infection events
  Cytomegalovirus infection0
NC
62.6		0
NC
135.0		0
NC
38.9		0
NC
108.8		0
NC
10.7		1 (1.6) [2.7];
0.0, 8.1
36.5
  Tuberculosis1 (0.7) [1.6];
0.0, 4.7
62.5		0
NC
135.0		0
NC
38.9		0
NC
108.8		0
NC
10.7		0
NC
36.6
  Herpes zoster1 (0.7) [1.6];
0.0, 4.7
62.5		0
NC
135.0		0
NC
38.9		2 (1.1) [1.85];
0.0, 4.4
108.4		1 (3.7) [9.4];
0.0, 27.7
10.7		0
NC
36.6

Abbreviations: AV, atrioventricular; CI, confidence interval; IR, incidence rate; MMS, modified Mayo score; n, number of unique patients with events; N, number of patients in the subgroup in the analysis set by treatment; NC, not calculated; PY, patient-years; QD, once daily; SAS, safety analysis set; TEAE, treatment-emergent adverse event; UC, ulcerative colitis.

For adverse events with 0 patients with event, % and IR are also 0, so not displayed.

In the randomized portion of the trials, no cases of malignancies, posterior reversible encephalopathy syndrome, or progressive multifocal leukoencephalopathy were observed.

aPivotal UC cohort comprised placebo-controlled phase 3 trials, ELEVATE UC 52 (NCT03945188) and ELEVATE UC 12 (NCT03996369).

bIRs were calculated as n/PY adjusted to per 100 PY, where PY is the sum of patients’ time from baseline to first adverse event episode or time in the study if the patient was event-free.

cCommon TEAEs were defined as occurring in >5% of patients in any subgroup.

dSerious infections were serious adverse events under the Medical Dictionary for Regulatory Activities System Organ Class of Infections and Infestations.

eMobitz type 1.

Table 2.
Open in new tab

Proportions and IRs of TEAEs and events of interest reported in the ELEVATE UC clinical program stratified by age (Pivotal UC cohorta SAS with baseline MMS 4-9).

n (%) [IR per 100 PYb]; 95% CI per 100 PY
PY		Age (y)
<4040-59≥60
Placebo QD
(N = 146)		Etrasimod
2 mg QD
(N = 274)		Placebo QD
(N = 87)		Etrasimod
2 mg QD
(N = 189)		Placebo QD
(N = 27)		Etrasimod
2 mg QD
(N = 64)
Common TEAEsc
 Anemia17 (11.6) [29.7];
15.6, 43.9
57.2		26 (9.5) [20.7];
12.7, 28.6
125.7		4 (4.6) [10.4];
0.2, 20.6
38.4		12 (6.4) [11.5];
5.0, 18.0
104.5		1 (3.7) [9.4];
0.0, 27.9
10.6		0
NC
36.6
 Colitis ulcerative7 (4.8) [11.4];
2.9, 19.8
61.6		24 (8.8) [18.4];
11.0, 25.7
130.7		4 (4.6) [10.7];
0.2, 21.1
37.5		7 (3.7) [6.5];
1.7, 11.4
107.2		3 (11.1) [28.8];
0.0, 61.4
10.4		0
NC
36.6
 Headache7 (4.8) [11.5];
3.0, 19.9
61.2		18 (6.6) [14.1];
7.6, 20.6
127.7		2 (2.3) [5.3];
0.0, 12.7
37.7		13 (6.9) [12.8];
5.8, 19.7
102.0		0
NC
10.7		4 (6.3) [12.0];
0.2, 23.7
33.5
 Arthralgia4 (2.7) [6.6];
0.1, 13.1
60.7		3 (1.1) [2.2];
0.0, 4.8
134.3		1 (1.2) [2.6];
0.0, 7.7
38.7		10 (5.3) [9.5];
3.6, 15.4
105.1		1 (3.7) [9.7];
0.0, 28.7
10.3		4 (6.3) [11.5];
0.2, 22.8
34.7
 Fatigue1 (0.7) [1.6];
0.0, 4.8
62.2		2 (0.7) [1.5];
0.0, 3.6
134.4		1 (1.2) [2.6];
0.0, 7.8
37.9		2 (1.1) [1.9];
0.0, 4.5
107.0		0
NC
10.7		4 (6.3) [11.6];
0.2, 22.9
34.6
 Hypertension1 (0.7) [1.6];
0.0, 4.7
62.5		1 (0.4) [0.7];
0.0, 2.2
134.4		0
NC
38.9		6 (3.2) [5.6];
1.1, 10.2
106.3		1 (3.7) [9.5];
0.0, 28.2
10.5		4 (6.3) [11.3];
0.2, 22.4
35.3
 Pyrexia6 (4.1) [9.8];
2.0, 17.6
61.3		12 (4.4) [9.1];
3.9, 14.2
132.1		2 (2.3) [5.2];
0.0, 12.4
38.6		6 (3.2) [5.6];
1.1, 10.1
106.5		1 (3.7) [9.5];
0.0, 28.1
10.6		4 (6.3) [11.7];
0.2, 23.2
34.2
Serious infectionsd3 (2.1) [4.9];
0.0, 10.4
61.6		1 (0.4) [0.8];
0.0, 2.2
134.1		2 (2.3) [5.3];
0.0, 12.7
37.7		1 (0.5) [0.9];
0.0, 2.7
108.3		0
NC
10.7		1 (1.6) [2.7];
0.0, 8.1
36.5
Events of interest
 Macular edema1 (0.7) [1.6];
0.0, 4.7
62.6		0
NC
135.0		0
NC
38.9		2 (1.1) [1.8];
0.0, 4.4
108.6		0
NC
10.7		0
NC
36.6
 Cardiac events
  AV block first degree0
NC
62.6		1 (0.4) [0.7];
0.0, 2.2
134.9		0
NC
38.9		1 (0.5) [0.9];
0.0, 2.8
107.8		0
NC
10.7		0
NC
36.6
  AV block second degreee0
NC
62.6		0
NC
135.0		0
NC
38.9		1 (0.5) [0.9];
0.0, 2.7
108.8		0
NC
10.7		0
NC
36.6
  Bradycardia0
NC
62.6		2 (0.7) [1.5];
0.0, 3.5
134.6		0
NC
38.9		3 (1.6) [2.8];
0.0, 5.9
107.8		0
NC
10.7		0
NC
36.6
  Sinus bradycardia0
NC
62.6		2 (0.7) [1.5];
0.0, 3.6
134.1		0
NC
38.9		1 (0.5) [0.9];
0.0, 2.7
108.7		0
NC
10.7		1 (1.6) [2.7];
0.0, 8.1
36.6
 Infection events
  Cytomegalovirus infection0
NC
62.6		0
NC
135.0		0
NC
38.9		0
NC
108.8		0
NC
10.7		1 (1.6) [2.7];
0.0, 8.1
36.5
  Tuberculosis1 (0.7) [1.6];
0.0, 4.7
62.5		0
NC
135.0		0
NC
38.9		0
NC
108.8		0
NC
10.7		0
NC
36.6
  Herpes zoster1 (0.7) [1.6];
0.0, 4.7
62.5		0
NC
135.0		0
NC
38.9		2 (1.1) [1.85];
0.0, 4.4
108.4		1 (3.7) [9.4];
0.0, 27.7
10.7		0
NC
36.6
n (%) [IR per 100 PYb]; 95% CI per 100 PY
PY		Age (y)
<4040-59≥60
Placebo QD
(N = 146)		Etrasimod
2 mg QD
(N = 274)		Placebo QD
(N = 87)		Etrasimod
2 mg QD
(N = 189)		Placebo QD
(N = 27)		Etrasimod
2 mg QD
(N = 64)
Common TEAEsc
 Anemia17 (11.6) [29.7];
15.6, 43.9
57.2		26 (9.5) [20.7];
12.7, 28.6
125.7		4 (4.6) [10.4];
0.2, 20.6
38.4		12 (6.4) [11.5];
5.0, 18.0
104.5		1 (3.7) [9.4];
0.0, 27.9
10.6		0
NC
36.6
 Colitis ulcerative7 (4.8) [11.4];
2.9, 19.8
61.6		24 (8.8) [18.4];
11.0, 25.7
130.7		4 (4.6) [10.7];
0.2, 21.1
37.5		7 (3.7) [6.5];
1.7, 11.4
107.2		3 (11.1) [28.8];
0.0, 61.4
10.4		0
NC
36.6
 Headache7 (4.8) [11.5];
3.0, 19.9
61.2		18 (6.6) [14.1];
7.6, 20.6
127.7		2 (2.3) [5.3];
0.0, 12.7
37.7		13 (6.9) [12.8];
5.8, 19.7
102.0		0
NC
10.7		4 (6.3) [12.0];
0.2, 23.7
33.5
 Arthralgia4 (2.7) [6.6];
0.1, 13.1
60.7		3 (1.1) [2.2];
0.0, 4.8
134.3		1 (1.2) [2.6];
0.0, 7.7
38.7		10 (5.3) [9.5];
3.6, 15.4
105.1		1 (3.7) [9.7];
0.0, 28.7
10.3		4 (6.3) [11.5];
0.2, 22.8
34.7
 Fatigue1 (0.7) [1.6];
0.0, 4.8
62.2		2 (0.7) [1.5];
0.0, 3.6
134.4		1 (1.2) [2.6];
0.0, 7.8
37.9		2 (1.1) [1.9];
0.0, 4.5
107.0		0
NC
10.7		4 (6.3) [11.6];
0.2, 22.9
34.6
 Hypertension1 (0.7) [1.6];
0.0, 4.7
62.5		1 (0.4) [0.7];
0.0, 2.2
134.4		0
NC
38.9		6 (3.2) [5.6];
1.1, 10.2
106.3		1 (3.7) [9.5];
0.0, 28.2
10.5		4 (6.3) [11.3];
0.2, 22.4
35.3
 Pyrexia6 (4.1) [9.8];
2.0, 17.6
61.3		12 (4.4) [9.1];
3.9, 14.2
132.1		2 (2.3) [5.2];
0.0, 12.4
38.6		6 (3.2) [5.6];
1.1, 10.1
106.5		1 (3.7) [9.5];
0.0, 28.1
10.6		4 (6.3) [11.7];
0.2, 23.2
34.2
Serious infectionsd3 (2.1) [4.9];
0.0, 10.4
61.6		1 (0.4) [0.8];
0.0, 2.2
134.1		2 (2.3) [5.3];
0.0, 12.7
37.7		1 (0.5) [0.9];
0.0, 2.7
108.3		0
NC
10.7		1 (1.6) [2.7];
0.0, 8.1
36.5
Events of interest
 Macular edema1 (0.7) [1.6];
0.0, 4.7
62.6		0
NC
135.0		0
NC
38.9		2 (1.1) [1.8];
0.0, 4.4
108.6		0
NC
10.7		0
NC
36.6
 Cardiac events
  AV block first degree0
NC
62.6		1 (0.4) [0.7];
0.0, 2.2
134.9		0
NC
38.9		1 (0.5) [0.9];
0.0, 2.8
107.8		0
NC
10.7		0
NC
36.6
  AV block second degreee0
NC
62.6		0
NC
135.0		0
NC
38.9		1 (0.5) [0.9];
0.0, 2.7
108.8		0
NC
10.7		0
NC
36.6
  Bradycardia0
NC
62.6		2 (0.7) [1.5];
0.0, 3.5
134.6		0
NC
38.9		3 (1.6) [2.8];
0.0, 5.9
107.8		0
NC
10.7		0
NC
36.6
  Sinus bradycardia0
NC
62.6		2 (0.7) [1.5];
0.0, 3.6
134.1		0
NC
38.9		1 (0.5) [0.9];
0.0, 2.7
108.7		0
NC
10.7		1 (1.6) [2.7];
0.0, 8.1
36.6
 Infection events
  Cytomegalovirus infection0
NC
62.6		0
NC
135.0		0
NC
38.9		0
NC
108.8		0
NC
10.7		1 (1.6) [2.7];
0.0, 8.1
36.5
  Tuberculosis1 (0.7) [1.6];
0.0, 4.7
62.5		0
NC
135.0		0
NC
38.9		0
NC
108.8		0
NC
10.7		0
NC
36.6
  Herpes zoster1 (0.7) [1.6];
0.0, 4.7
62.5		0
NC
135.0		0
NC
38.9		2 (1.1) [1.85];
0.0, 4.4
108.4		1 (3.7) [9.4];
0.0, 27.7
10.7		0
NC
36.6

Abbreviations: AV, atrioventricular; CI, confidence interval; IR, incidence rate; MMS, modified Mayo score; n, number of unique patients with events; N, number of patients in the subgroup in the analysis set by treatment; NC, not calculated; PY, patient-years; QD, once daily; SAS, safety analysis set; TEAE, treatment-emergent adverse event; UC, ulcerative colitis.

For adverse events with 0 patients with event, % and IR are also 0, so not displayed.

In the randomized portion of the trials, no cases of malignancies, posterior reversible encephalopathy syndrome, or progressive multifocal leukoencephalopathy were observed.

aPivotal UC cohort comprised placebo-controlled phase 3 trials, ELEVATE UC 52 (NCT03945188) and ELEVATE UC 12 (NCT03996369).

bIRs were calculated as n/PY adjusted to per 100 PY, where PY is the sum of patients’ time from baseline to first adverse event episode or time in the study if the patient was event-free.

cCommon TEAEs were defined as occurring in >5% of patients in any subgroup.

dSerious infections were serious adverse events under the Medical Dictionary for Regulatory Activities System Organ Class of Infections and Infestations.

eMobitz type 1.

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