Safety summary
| Period I (Introduction phase) | Period II (Withdrawal phase) | Period III (Reintroduction phase) | ||||
|---|---|---|---|---|---|---|
| Period II SC placebo | ||||||
| Patients with event (n (%)) | SC abatacept (with intravenous abatacept load) (n=167) | SC abatacept (n=40) | SC placebo (n=80) | Period II SC abatacept (with intravenous placebo load) (n=40) | Intravenous abatacept load (n=35) | Intravenous placebo load (n=44) |
| AEs | 82 (49.1) | 13 (32.5) | 29 (36.3) | 15 (37.5) | 17 (48.6) | 16 (36.4) |
| Most common AEs* | ||||||
| URTI | 12 (7.2) | 1 (2.5) | 0 | 2 (5.0) | 1 (2.9) | 1 (2.3) |
| Vaginal infection | 0 | 2 (5.0) | 0 | 0 | 0 | 0 |
| Nausea | 2 (1.2) | 2 (5.0) | 0 | 0 | 0 | 0 |
| Flu | 5 (3.0) | 0 | 1 (1.3) | 0 | 2 (5.7) | 2 (4.5) |
| UTI | 3 (1.8) | 1 (2.5) | 1 (1.3) | 3 (7.5) | 0 | 1 (2.3) |
| Laryngitis | 1 (0.6) | 0 | 0 | 0 | 3 (8.6) | 0 |
| Discontinuations due to AEs | 1 (0.6) | 0 | 0 | 0 | 0 | 0 |
| SAEs | 3 (1.8) | 0 | 2 (2.5) | 0 | 0 | 1 (2.3) |
| Deaths | 1 (0.6) | 0 | 0 | 0 | 0 | 0 |
| Infections and infestations | 42 (25.1) | 5 (12.5) | 7 (8.8) | 7 (17.5) | 8 (22.9) | 7 (15.9) |
| Serious infections† | 1 (0.6) | 0 | 0 | 0 | 0 | 0 |
| Malignancies | 0 | 0 | 0 | 0 | 0 | 0 |
| Autoimmune events | 0 | 0 | 0 | 0 | 0 | 0 |
| SC injection site reaction | 2 (1.2) | 0 | 0 | 0 | 0 | 0 |
| Acute infusional events | 1 (0.6)‡ | 0 | 0 | 0 | 0 | 0 |
↵* AEs reported in ≥5% of patients in any group during any treatment period.
↵† Serious infections is a subset of SAEs.
↵‡ Mild non-serious headache, considered probably related to study drug, was reported following intravenous abatacept loading in period I.
AE, adverse event; SAE, serious adverse event; SC, subcutaneous; URTI, upper respiratory tract infection; UTI, urinary tract infection.