Summary of other important treatment-emergent AE incidence
| Number of patients (%) | Otilimab 90 mg (N=1456) | Otilimab 150 mg (N=1459) |
| Adjudicated GI perforation | 3 (<1) | 4 (<1) |
| Adjudicated CV events | 12 (<1) | 15 (<1) |
| CV death | 2 (<1) | 5 (<1) |
| Non-fatal MI | 4 (<1) | 4 (<1) |
| Hospitalisation for unstable angina | 0 | 0 |
| Non-fatal stroke | 1 (<1) | 3 (<1) |
| Hospitalisation for heart failure | 1 (<1) | 0 |
| Deep vein thrombosis | 4 (<1) | 2 (<1) |
| Pulmonary embolism | 2 (<1) | 3 (<1) |
| Any malignancy | 12 (<1) | 11 (<1) |
| Solid, excluding non-melanoma skin cancer | 11 (<1) | 7 (<1) |
| Breast | 2 (<1) | 2 (<1) |
| Lungs | 3 (<1) | 0 |
| Other | 6 (<1) | 5 (<1) |
| Non-melanoma skin cancer | 1 (<1) | 3 (<1) |
| Haematologic | 0 | 1 (<1) |
| Lymphoma | 0 | 0 |
| Any malignancy, excluding non-melanoma skin cancer | 11 (<1) | 8 (<1) |
| Any herpes infection | 30 (2) | 25 (2) |
| Herpes zoster | 19 (1) | 17 (1) |
| Herpes simplex | 11 (<1) | 8 (<1) |
| Non-specific herpes infection | 0 | 0 |
| All-cause mortality | 10 (<1) | 9 (<1)* |
| Pneumonia (serious and non-serious)† | 23 (2) | 24 (2) |
| Pneumonia (serious and non-serious), excluding COVID-19 infections‡ | 13 (<1) | 12 (<1) |
| Hepatitis B and hepatitis B reactivation | 1 (<1) | 0 |
| Thromboembolic events§ | 13 (<1) | 20 (1) |
*One additional death (due to septic shock) that occurred in the otilimab 150 mg group after the safety follow-up visit (starting 64 days and resulting in death 65 days after the last dose) was not considered treatment emergent and is not reported in this table.
†Derived from infective pneumonia (narrow SMQ).
‡Derived from infective pneumonia (narrow SMQ) excluding the following PTs: suspected COVID-19, COVID-19, COVID-19 pneumonia or asymptomatic COVID-19.
§Thromboembolic events were reported using SMQs and captured broader AE terms of thrombosis including the adjudicated thrombotic events, DVT and PE and other thrombotic events such as peripheral arterial occlusion and cerebral infarction.
AE, adverse event; CV, cardiovascular; DVT, deep vein thrombosis; GI, gastrointestinal; MedDRA, Medical Dictionary for Regulatory Activities; MI, myocardial infarction; PE, pulmonary embolism; PT, preferred term; SMQ, standardised MedDRA queries.