Table 1.
Infection events evaluated in the pooled phase 3 ELEVATE UC 52 and ELEVATE UC 12 trials.
| Placebo QD [N = 260] |
Etrasimod 2 mg QD [N = 527] |
|||
|---|---|---|---|---|
| n [%]a | IR [95% CI] per 100 PYb | n [%]a | IR [95% CI] per 100 PYb | |
| Infections and infestationsc | 46 [17.7] | 48.97 [34.80, 63.13] | 99 [18.8] | 41.14 [32.98, 49.30] |
| Most frequent infections occurring in ≥1% of patients | ||||
| COVID-19c | 12 [4.6] | 11.85 [5.15, 18.56] | 23 [4.4] | 8.55 [5.05, 12.04] |
| Urinary tract infectionc | 3 [1.2] | 2.87 [0.00, 6.11] | 10 [1.9] | 3.68 [1.40, 5.95] |
| Nasopharyngitisc | 6 [2.3] | 5.76 [1.15, 10.37] | 6 [1.1] | 2.18 [0.44, 3.93] |
| Respiratory tract infection viralc | 2 [0.8] | 1.90 [0.00, 4.54] | 6 [1.1] | 2.19 [0.44, 3.95] |
| Serious infections | 5 [1.9] | 4.67 [0.42, 8.92] | 3 [0.6] | 1.02 [0.00, 2.31] |
| Infection AESId | ||||
| Severe infections | 5 [1.9] | 4.67 [0.42, 8.92] | 3 [0.6] | 1.02 [0.00, 2.31] |
| Herpes zoster | 2 [0.8] | 1.66 [0.00, 4.29] | 2 [0.4] | 0.68 [0.00, 1.78] |
| Herpes simplexc | 0 | N/Ae | 1 [0.2] | 0.36 [0.00, 1.07] |
| Oral herpesc | 1 [0.4] | 0.94 [0.00, 2.79] | 3 [0.6] | 1.09 [0.00, 2.32] |
| Opportunistic infectionsf | 1 [0.4] | 0.92 [0.00, 3.03] | 1 [0.2] | 0.42 [0.00, 1.38] |
| Infections leading to study treatment discontinuationg | 1 [0.4] | 0.92 [0.00, 3.03] | 2 [0.4] | 0.68 [0.00, 1.78] |
AESI, adverse event of special interest; CI, confidence interval; CMH, Cochran–Mantel–Haenszel; CMV, cytomegalovirus infection; CTCAE, Common Terminology Criteria for Adverse Events; IR, incidence rate; PY, patient-years; QD, once daily; TB, tuberculosis.
aMedDRA version 24.1 System Organ Class and Preferred Terms. Opportunistic infections were identified using Standardized MedDRA Query ‘Opportunistic Infection’ [narrow scope].
bIR [95% CI] was calculated adjusted to the study stratification using CMH weighting method at each level of a categorical baseline risk factor; 95% CI per 100 PY was estimated using normal approximation to Poisson model, adjusted per 100 PY. If n > 0 but the lower 95% CI limit <0, it was set to 0.
cIR [95% CI] was not study-adjusted.
dInfections were considered AESI if they were severe [CTCAE Grade ≥ 3], opportunistic infections, or herpes infections.
eIR per 100 PY and 95% CI were not calculated due to 0 patients with event.
fOne event of CMV was reported in the etrasimod 2 mg QD group; this was determined to be mild in severity and was detected by stool testing as a result of increased bowel movement frequency. One case of TB was reported in the placebo group.
gA total of three patients discontinued the study treatment due to infections; one patient each discontinued due to Clostridioides difficile infection and COVID-19 in the etrasimod group, and one patient in the placebo group discontinued due to TB. The patient who discontinued due to C. difficile infection had a positive stool pathogen test for C. difficile toxin at screening and was erroneously randomised in the study due to an oversight, which was considered a protocol deviation.