Table 3.
Overall TEAEs
| MS | RA | SLE | Total | |||||||||||||
| Placebo (n=54) |
Evobrutinib (n=208) |
Placebo (n=97) |
Evobrutinib (n=293) |
Placebo (n=120) |
Evobrutinib (n=360) |
Placebo (n=271) |
Evobrutinib (n=861) |
|||||||||
| n (%) | EAIR | n (%) | EAIR | n (%) | EAIR | n (%) | EAIR | n (%) | EAIR | n (%) | EAIR | n (%) | EAIR | n (%) | EAIR | |
| Any TEAE | 26 (48.1) | 148.3 | 115 (55.3) | 119.7 | 44 (45.4) | 306.8 | 146 (49.8) | 331.8 | 99 (82.5) | 302.1 | 309 (85.8) | 343.0 | 169 (62.4) | 261.4 | 570 (66.2) | 247.6 |
| Any Grade ≥3 TEAE | 5 (9.3) | 20.9 | 16 (7.7) | 10.6 | 2 (2.1) | 9.7 | 8 (2.7) | 12.3 | 25 (20.8) | 27.3 | 78 (21.7) | 28.6 | 32 (11.8) | 23.5 | 102 (11.8) | 20.9 |
| Any treatment-related Grade ≥3 TEAE | 2 (3.7) | 8.3 | 10 (4.8) | 6.6 | 1 (1.0) | 4.9 | 3 (1.0) | 4.6 | 10 (8.3) | 10.2 | 33 (9.2) | 11.4 | 13 (4.8) | 9.1 | 46 (5.3) | 9.1 |
| Any Grade ≥4 TEAE | 1 (1.9) | 4.2 | 1 (0.5) | 0.7 | 0 (0.0) | – | 1 (0.3) | 1.5 | 1 (0.8) | 1.0 | 5 (1.4) | 1.7 | 2 (0.7) | 1.4 | 7 (0.8) | 1.3 |
| Any treatment-related Grade ≥4 TEAE | 0 (0.0) | – | 0 (0.0) | – | 0 (0.0) | – | 0 (0.0) | – | 0 (0.0) | – | 3 (0.8) | 1.0 | 0 (0.0) | – | 3 (0.3) | 0.6 |
| Any serious TEAE | 2 (3.7) | 8.4 | 8 (3.8) | 5.3 | 2 (2.1) | 9.7 | 5 (1.7) | 7.7 | 10 (8.3) | 10.1 | 35 (9.7) | 12.1 | 14 (5.2) | 9.8 | 48 (5.6) | 9.5 |
| TEAEs leading to treatment withdrawal | 5 (9.3) | 20.8 | 17 (8.2) | 11.1 | 6 (6.2) | 28.9 | 11 (3.8) | 16.8 | 15 (12.5) | 15.1 | 47 (13.1) | 15.7 | 26 (9.6) | 18.0 | 75 (8.7) | 14.5 |
| Any TEAE leading to death | 0 (0.0) | – | 0 (0.0) | – | 0 (0.0) | – | 0 (0.0) | – | 0 (0.0) | – | 2 (0.6)* | 0.7 | 0 (0.0) | – | 2 (0.2)* | 0.4 |
EAIR presented as events/100 patient-years.
*Both patients were in the high disease activity subpopulation. One patient was in the evobrutinib 25 mg QD group. Fatal TEAEs of acute kidney injury, hepatitis and pancreatitis were reported, none of which were considered to be related to evobrutinib. The other patient was in the evobrutinib 75 mg QD group and died from infection-related complications due to bone marrow failure with a history of and concomitant leflunomide treatment. This fatal event was considered to be treatment related by the Investigator.
EAIR, exposure-adjusted incidence rates; MS, multiple sclerosis; QD, once daily; RA, rheumatoid arthritis; SLE, systemic lupus erythematosus; TEAEs, treatment-emergent adverse events.