Summary of treatment-emergent AEs and AESI incidence
| Otilimab 90 mg (N=1456) | Otilimab 150 mg (N=1459) | |
| Any AE, n (%) | 902 (62) | 931 (64) |
| AE PTs occurring in ≥5% of patients in either treatment arm, n (%) | ||
| COVID-19 | 145 (10) | 142 (10) |
| Rheumatoid arthritis* | 124 (9) | 133 (9) |
| Upper respiratory tract infection | 65 (4) | 88 (6) |
| Any AESI, n (%) | 120 (8) | 95 (7) |
| Serious infections | 36 (2) | 28 (2) |
| Serious infections, excluding COVID-19 | 24 (2) | 18 (1) |
| Opportunistic infections | 5 (<1) | 1 (<1) |
| Active TB | 0 | 0 |
| Latent TB | 43 (3) | 27 (2) |
| TB reactivation | 0 | 0 |
| Neutropaenia | 8 (<1) | 8 (<1) |
| Persistent cough† | 3 (<1) | 3 (<1) |
| Persistent dyspnoea‡ | 0 | 2 (<1) |
| PAP | 0 | 0 |
| Serious hypersensitivity reactions | 0 | 0 |
| Injection site reactions | 29 (2) | 31 (2) |
*Refers to an RA flare or worsening of RA.
†Persistent cough is defined as a cough (CTCAE grade ≥2) for three consecutive weeks (≥21 days).
‡Persistent dyspnoea is defined as a dyspnoea (dyspnoea scale grade ≥2) for three consecutive weeks (≥21 days).
AE, adverse event; AESI, adverse event of special interest; CTCAE, Common Terminology Criteria for Adverse Events; PAP, pulmonary alveolar proteinosis; PT, preferred term; RA, rheumatoid arthritis; TB, tuberculosis.