Table 2.
Placebo QD [N = 260] |
Etrasimod 2 mg QD [N = 527] |
|
---|---|---|
Minimum ALC at any time post-baseline; n [%] | 254 [97.69] | 519 [98.48] |
ALC < 0.2 × 109/L; n [%]a | 0 [0.0] | 18 [3.5] |
Serious/severe infections; n | 0 | 0 |
Opportunistic infections; n | 0 | 0 |
Herpes zoster; n | 0 | 0 |
Infections leading to discontinuation; n | 0 | 0 |
ALC < 0.5 × 109/L; n [%]a | 5 [2.0] | 206 [39.7] |
Serious/severe infections; n | 0 | 1 |
Opportunistic infections; n | 0 | 0 |
Herpes zoster; n | 0 | 1 |
Infections leading to discontinuation; n | 0 | 0 |
ALC ≥ 0.5 × 109/L; n [%]a | 249 [98.0] | 295 [56.8] |
Serious/severe infections; n | 5 | 2 |
Opportunistic infections; n | 1 | 1 |
Herpes zoster; n | 2 | 1 |
Infections leading to discontinuation; n | 1 | 2 |
ALC, absolute lymphocyte count; N, number of patients in the Pivotal UC cohort; n, number of patients with evaluable data; QD, once daily.
aPercentages are based on the number of patients with minimum ALC readings at any time post-baseline.