Table 7 Adverse events (AE) occurring in ≥ 10 % of patients with systemic lupus erythematosus treated with blisibimod in the phase 1b study
Blisibimod | ||||||
|---|---|---|---|---|---|---|
Placebo | mg/kg SC | 6.0 mg/kg IV | All | |||
n (%) | (n = 13) | 0.3 (n = 12) | 1.0 (n = 13) | 3.0 (n = 12) | (n = 12) | (N = 49) |
Patients reporting an AE | 12 (92) | 12 (100) | 13 (100) | 11 (92) | 11 (92) | 47 (96) |
Nasopharyngitis | 1 (8) | 2 (17) | 5 (38) | 2 (17) | 2 (17) | 11 (22) |
Headache | 0 (0) | 0 (0) | 2 (15) | 2 (17) | 2 (17) | 11 (22) |
Injection site erythema | 0 (0) | 0 (0) | 2 (31) | 3 (25) | 0 (0) | 7 (17) |
Nausea | 1 (8) | 1 (8) | 1 (8) | 3 (25) | 2 (17) | 7 (14) |
Injection site prutitus | 0 (0) | 0 (0) | 3 (23) | 3 (25) | 0 (0) | 6 (12) |
Upper respiratory tract infection | 0 (0) | 3 (25) | 2 (15) | 0 (0) | 1 (8) | 6 (12) |
Urinary tract infection | 2 (15) | 0 (0) | 2 (15) | 3 (25) | 1 (8) | 6 (12) |
Arthralgia | 2 (15) | 1 (8) | 1 (8) | 2 (17) | 1 (8) | 5 (10) |
Back pain | 0 (0) | 1 (8) | 1 (8) | 2 (17) | 1 (8) | 5 (10) |
Diarrhea | 3 (23) | 1 (8) | 1 (8) | 3 (25) | 0 (0) | 5 (10) |
Gastroesophogeal reflux disease | 0 (0) | 1 (8) | 2 (15) | 2 (17) | 0 (0) | 5 (10) |
Systemic lupus | 2 (15) | 2 (17) | 1 (8) | 1 (8) | 1 (8) | 5 (10) |