Table 3 Safety data
| Â | Placebo (N=19) | Recaticimab | ||||||
|---|---|---|---|---|---|---|---|---|
75 mg Q4W (N=10) | 150 mg Q4W (N=20) | 150 mg Q8W (N=10) | 300 mg Q8W (N=20) | 300 mg Q12W (N=10) | 450 mg Q12W (N=21) | All patients with recaticimab (N=91) | ||
Any TEAEs | 14 (73.7%) | 5 (50.0%) | 18 (90.0%) | 9 (90.0%) | 14 (70.0%) | 5 (50.0%) | 17 (81.0%) | 68 (74.7%) |
 Mild | 14 (73.7%) | 5 (50.0%) | 15 (75.0%) | 8 (80.0%) | 14 (70.0%) | 5 (50.0%) | 15 (71.4%) | 62 (68.1%) |
 Moderate | 0 | 0 | 2 (10.0%) | 1 (10.0%) | 0 | 0 | 2 (9.5%) | 5 (5.5%) |
 Severe | 0 | 0 | 1 (5.0%) | 0 | 0 | 0 | 0 | 1 (1.1%) |
TEAEs occurring in at least 5% of patients who received recaticimab or placebo | ||||||||
 Upper respiratory tract infection | 3 (15.8%) | 1 (10.0%) | 7 (35.0%) | 1 (10.0%) | 3 (15.0%) | 1 (10.0%) | 5 (23.8%) | 18 (19.8%) |
 Alanine aminotransferase increased | 2 (10.5%) | 0 | 2 (10.0%) | 2 (20.0%) | 2 (10.0%) | 2 (20.0%) | 1 (4.8%) | 9 (9.9%) |
 Blood glucose increased | 0 | 0 | 1 (5.0%) | 1 (10.0%) | 2 (10.0%) | 1 (10.0%) | 3 (14.3%) | 8 (8.8%) |
 Gamma-glutamyltransferase increased | 0 | 0 | 3 (15.0%) | 0 | 3 (15.0%) | 0 | 0 | 6 (6.6%) |
 White blood cell count increased | 1 (5.3%) | 0 | 1 (5.0%) | 0 | 2 (10.0%) | 0 | 2 (9.5%) | 5 (5.5%) |
 White blood cells urine positive | 1 (5.3%) | 0 | 0 | 0 | 3 (15.0%) | 0 | 2 (9.5%) | 5 (5.5%) |
 Injection-site reaction | 0 | 1 (10.0%) | 0 | 0 | 3 (15.0%) | 0 | 1 (4.8%) | 5 (5.5%) |
 Protein urine present | 0 | 0 | 2 (10.0%) | 0 | 0 | 0 | 3 (14.3%) | 5 (5.5%) |
 Aspartate aminotransferase increased | 1 (5.3%) | 0 | 2 (10.0%) | 1 (10.0%) | 0 | 2 (20.0%) | 0 | 5 (5.5%) |
 Blood bilirubin increased | 1 (5.3%) | 0 | 0 | 2 (20.0%) | 1 (5.0%) | 0 | 1 (4.8%) | 4 (4.4%) |
 Neutrophil count increased | 1 (5.3%) | 0 | 1 (5.0%) | 0 | 1 (5.0%) | 0 | 2 (9.5%) | 4 (4.4%) |
 Hyperuricaemia | 1 (5.3%) | 1 (10.0%) | 1 (5.0%) | 0 | 1 (5.0%) | 0 | 1 (4.8%) | 4 (4.4%) |
 Hypertension | 1 (5.3%) | 0 | 0 | 2 (20.0%) | 0 | 0 | 2 (9.5%) | 4 (4.4%) |
 Urinary tract infection | 1 (5.3%) | 0 | 0 | 0 | 0 | 0 | 3 (14.3%) | 3 (3.3%) |
 Pharyngitis | 2 (10.5%) | 0 | 1 (5.0%) | 0 | 0 | 0 | 1 (4.8%) | 2 (2.2%) |
 Urine leukocyte esterase positive | 1 (5.3%) | 0 | 1 (5.0%) | 0 | 1 (5.0%) | 0 | 0 | 2 (2.2%) |
 Red blood cells urine positive | 1 (5.3%) | 0 | 1 (5.0%) | 0 | 0 | 0 | 1 (4.8%) | 2 (2.2%) |
 Blood creatinine increased | 1 (5.3%) | 0 | 0 | 2 (20.0%) | 0 | 0 | 0 | 2 (2.2%) |
 Dizziness | 1 (5.3%) | 1 (10.0%) | 0 | 0 | 0 | 0 | 1 (4.8%) | 2 (2.2%) |
 Hematuria | 1 (5.3%) | 0 | 0 | 0 | 0 | 0 | 2 (9.5%) | 2 (2.2%) |
 Urinary sediment present | 1 (5.3%) | 0 | 1 (5.0%) | 0 | 0 | 0 | 0 | 1 (1.1%) |
 Blood creatine phosphokinase increased | 1 (5.3%) | 0 | 1 (5.0%) | 0 | 0 | 0 | 0 | 1 (1.1%) |
 Blood pressure increased | 1 (5.3%) | 0 | 0 | 0 | 0 | 1 (10.0%) | 0 | 1 (1.1%) |
 Type 2 diabetes mellitus | 1 (5.3%) | 0 | 0 | 0 | 0 | 0 | 1 (4.8%) | 1 (1.1%) |
 Muscle strain | 1 (5.3%) | 1 (10.0%) | 0 | 0 | 0 | 0 | 0 | 1 (1.1%) |
 Anemia | 1 (5.3%) | 0 | 1 (5.0%) | 0 | 0 | 0 | 0 | 1 (1.1%) |
 Urinary casts present | 1 (5.3%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
 Prothrombin time ratio increased | 1 (5.3%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
 Gastroenteritis | 1 (5.3%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
 Vaginal infection | 1 (5.3%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
 Pyrexia | 1 (5.3%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
 Arthralgia | 1 (5.3%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
 Supraventricular extrasystoles | 1 (5.3%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
 Leukocyturia | 1 (5.3%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
 Insomnia | 1 (5.3%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |