Safety summary
| . | Sutimlimab (N = 22) . | Placebo (N = 20) . |
|---|---|---|
| TEAEs, n | 146 | 90 |
| Patients with ≥1 TEAE, n (%) | 21 (95.5) | 20 (100) |
| Patients with ≥1 related TEAE,* n (%) | 8 (36.4)† | 4 (20.0)‡ |
| Patients with ≥1 TEAE grade 3 or higher, n (%) | 5 (22.7) | 3 (15.0) |
| Patients with ≥1 TEAE infection grade 3 or higher, n (%) | 2 (9.1) | 1 (5.0) |
| TESAEs, n | 4 | 3 |
| Patients with ≥1 TESAE, n (%) | 3 (13.6) | 1 (5.0) |
| Patients with ≥1 related TESAE,* n (%) | 1 (4.5) | 0 |
| Patients with ≥1 TESAE infection, n (%) | 1 (4.5) | 1 (5.0) |
| Total number of TESAE thromboembolic events, n | 1 | 0 |
| Patients with ≥1 TESAE thromboembolic event, n (%) | 1 (4.5) | 0 |
| Patients who discontinued treatment and/or study owing to a TEAE, n (%) | 3 (13.6)§ | 0 |
| Deaths, n (%) | 0 | 0 |
| . | Sutimlimab (N = 22) . | Placebo (N = 20) . |
|---|---|---|
| TEAEs, n | 146 | 90 |
| Patients with ≥1 TEAE, n (%) | 21 (95.5) | 20 (100) |
| Patients with ≥1 related TEAE,* n (%) | 8 (36.4)† | 4 (20.0)‡ |
| Patients with ≥1 TEAE grade 3 or higher, n (%) | 5 (22.7) | 3 (15.0) |
| Patients with ≥1 TEAE infection grade 3 or higher, n (%) | 2 (9.1) | 1 (5.0) |
| TESAEs, n | 4 | 3 |
| Patients with ≥1 TESAE, n (%) | 3 (13.6) | 1 (5.0) |
| Patients with ≥1 related TESAE,* n (%) | 1 (4.5) | 0 |
| Patients with ≥1 TESAE infection, n (%) | 1 (4.5) | 1 (5.0) |
| Total number of TESAE thromboembolic events, n | 1 | 0 |
| Patients with ≥1 TESAE thromboembolic event, n (%) | 1 (4.5) | 0 |
| Patients who discontinued treatment and/or study owing to a TEAE, n (%) | 3 (13.6)§ | 0 |
| Deaths, n (%) | 0 | 0 |
AE, adverse event.
AEs with missing causality assessment were included in the related TEAEs/TESAEs; AEs with investigator causality assessment of “possible” or “probable” were considered related.
Patients experienced 28 events, including acrocyanosis, paresthesia oral, chest discomfort, infection site pruritis, seasonal allergy, herpes zoster, nasopharyngitis, upper respiratory tract infection, infusion-related reaction, cerebral venous thrombosis, headache, pruritis, skin lesion, hypertension, and hypotension.
Patients experienced 7 events, including diarrhea, dyspepsia, thirst, cold-stimulus headache, headache, rash erythematous, and toxic skin eruption.
Events comprised acrocyanosis and Raynaud phenomenon (in 1 patient), infusion-related reactions (in 1 patient), and increased blood IgM (in 1 patient).