Adverse events (safety population)
| Placebo (N=108) | Sifalimumab | ||||
|---|---|---|---|---|---|
| 200 mg* (N=108) | 600 mg* (N=108) | 1200 mg* (N=107) | All dosages (N=323) | ||
| Patients with ≥1 event, n (%) | 94 (87.0) | 97 (89.8%) | 97 (89.8%) | 93 (86.9%) | 287 (88.9%) |
| Serious adverse events, n (%) | 19 (17.6) | 16 (14.8%) | 22 (20.4%) | 21 (19.6%) | 59 (18.3%) |
| Death, n (%) | 2 (1.9) | 0 (0.0%) | 2 (1.9%) | 2 (1.9%) | 4 (1.2%) |
| Adverse events leading to discontinuation, n (%) | 13 (12.0) | 10 (9.3%) | 12 (11.1%) | 14 (13.1%) | 36 (11.1%) |
| Grade 3 adverse events, n (%)† | 17 (15.7) | 16 (14.8%) | 11 (10.2%) | 18 (16.8%) | 45 (13.9%) |
| Grade 4 adverse events, n (%)‡ | 4 (3.7) | 3 (2.8%) | 3 (2.8%) | 4 (3.7%) | 10 (3.1%) |
| Adverse events of special interest, n (%)§ | 10 (9.3) | 14 (13.0%) | 10 (9.3%) | 18 (16.8%) | 42 (13.0%) |
| Most common adverse events, n (%)¶ | |||||
| SLE (worsening) | 37 (34.3) | 36 (33.3%) | 34 (31.5%) | 27 (25.2%) | 97 (30.0%) |
| Urinary tract infection | 15 (13.9) | 22 (20.4%) | 17 (15.7%) | 18 (16.8%) | 57 (17.6%) |
| Headache | 15 (13.9) | 16 (14.8%) | 15 (13.9%) | 12 (11.2%) | 43 (13.3%) |
| Upper respiratory tract infection | 10 (9.3) | 10 (9.3%) | 17 (15.7%) | 15 (14.0%) | 42 (13.0%) |
| Nasopharyngitis | 10 (9.3) | 12 (11.1%) | 13 (12.0%) | 9 (8.4%) | 34 (10.5%) |
| Bronchitis | 9 (8.3) | 12 (11.1%) | 4 (3.7%) | 15 (14.0%) | 31 (9.6%) |
| Diarrhoea | 8 (7.4) | 7 (6.5%) | 9 (8.3%) | 5 (4.7%) | 21 (6.5%) |
| Pharyngitis | 4 (3.7) | 3 (2.8%) | 6 (5.6%) | 12 (11.2%) | 21 (6.5%) |
| Infusion-related reaction | 6 (5.6) | 8 (7.4%) | 7 (6.5%) | 5 (4.7%) | 20 (6.2%) |
| Cough | 7 (6.5) | 7 (6.5%) | 5 (4.6%) | 6 (5.6%) | 18 (5.6%) |
| Herpes zoster | 1 (0.9) | 5 (4.6%) | 4 (3.7%) | 10 (9.3%)** | 19 (5.9%)** |
| Back pain | 3 (2.8) | 3 (2.8%) | 8 (7.4%) | 6 (5.6%) | 17 (5.3% ) |
*Days 1, 15 and 29, and then every 28 days thereafter.
†An event that requires intensive therapeutic intervention. The event interrupts usual activities of daily living or significantly affects the clinical status of the patient.
‡An event or its immediate sequelae that is associated with an imminent risk of death or with physical or mental disabilities that affect or limit ability of patient to perform activities of daily living.
§New or reactivated tuberculosis infection, Herpes zoster infection, malignancy, or reactions associated with infusion, hypersensitivity or anaphylaxis.
¶Adverse events reported by >5% of patients in the total (all dosages) sifalimumab group.
**Included one case of ophthalmic Herpes zoster, which began on day 1.
SLE, systemic lupus erythematosus.