Safety summary
| Adverse event, n (%) | Pooled placebo (n=79) | Otilimab 90 mg once weekly (n=156) | Otilimab 150 mg once weekly (n=158) | Sarilumab 200 mg once every 2 weeks (n=156) |
| Weeks 0–12 | ||||
| Any AE | 37 (47) | 65 (42) | 63 (40) | 72 (46) |
| Any SAE | 2 (3) | 4 (3) | 1 (<1) | 5 (3) |
| Any AESI | 0 (0) | 11 (7) | 7 (4) | 24 (15) |
| Serious infection* | 0 (0) | 1 (<1) | 0 (0) | 1 (<1) |
| Serious infection, excluding COVID-19* | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Latent TB* | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| TB reactivation* | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| PAP* | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| COVID-19 diagnosis† | 4 (5) | 4 (3) | 3 (2) | 6 (4) |
| Any adjudicated CV event | 1 (1) | 0 (0) | 0 (0) | 0 (0) |
| Adjudicated MACE | 1 (1) | 0 (0) | 0 (0) | 0 (0) |
| VTE (DVT and/or PE) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| DVT only | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| PE only | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Any malignancy | 0 (0) | 1 (<1) | 0 (0) | 1 (<1) |
| Any malignancy, excluding NMSC | 0 (0) | 0 (0) | 0 (0) | 1 (<1) |
| Fatal SAE | 0 (0) | 1 (<1) | 0 (0) | 0 (0) |
| Weeks 0–24‡ | ||||
| Any AE | 92 (59) | 99 (63) | 98 (63) | |
| Any SAE | 8 (5) | 1 (<1) | 12 (8) | |
| Any AESI | 16 (10) | 15 (9) | 33 (21) | |
| Serious infection | 4 (3) | 0 (0) | 2 (1) | |
| Serious infection, excluding COVID-19 | 2 (1) | 0 (0) | 0 (0) | |
| Latent TB | 0 (0) | 4 (3) | 2 (1) | |
| TB reactivation | 0 (0) | 0 (0) | 0 (0) | |
| PAP | 0 (0) | 0 (0) | 0 (0) | |
| COVID-19 diagnosis† | 8 (5) | 7 (4) | 8 (5) | |
| Any adjudicated CV event | 0 (0) | 0 (0) | 0 (0) | |
| Adjudicated MACE | 0 | 0 | 0 | |
| VTE (DVT and/or PE) | 0 (0) | 0 (0) | 0 (0) | |
| DVT only | 0 (0) | 0 (0) | 0 (0) | |
| PE only | 0 (0) | 0 (0) | 0 (0) | |
| Any malignancy | 1 (<1) | 0 (0) | 1 (<1) | |
| Any malignancy, excluding NMSC | 0 (0) | 0 (0) | 1 (<1) | |
| Fatal SAE | 1 (<1) | 0 (0) | 1 (<1) | |
*Only select AESIs with relevance to the MoA of otilimab or sarilumab are reported. See online supplemental table 9 for all AESIs.
†Total cases (either AEs or SAEs).
‡Data reported for patients who were randomised to active treatments from baseline. See online supplemental table 6 for the safety summary for patients who switched from placebo to active treatment at week 12.
AE, adverse event; AESI, adverse event of special interest; CV, cardiovascular; DVT, deep vein thrombosis; MACE, major adverse cardiovascular event; MoA, mechanism of action; NMSC, non-melanoma skin cancer; PAP, pulmonary alveolar proteinosis; PE, pulmonary embolism; SAE, serious adverse event; TB, tuberculosis; VAS, Visual Analogue Scale; VTE, venous thromboembolism.