Safety summary
| Patients with event, n (%) | ||||||
|---|---|---|---|---|---|---|
| Up to month 3 | Cumulative period | |||||
| MTX inadequate responders* (n=71) | Anti-TNF inadequate responders† (n=52) | Overall (N=123) | MTX inadequate responders* (n=71) | Anti-TNF inadequate responders† (n=52) | Overall (N=123) | |
| AEs | 23 (32.4) | 26 (50.0) | 49 (39.8) | 49 (69.0) | 44 (84.6) | 93 (75.6) |
| SAEs‡ | 0 | 1 (1.9) | 1 (0.8) | 8 (11.3) | 5 (9.6) | 13 (10.6) |
| Discontinuation due to AEs | 0 | 1 (1.9) | 1 (0.8) | 1 (1.4) | 3 (5.8) | 4 (3.3) |
| SC injection site reactions | 0 | 2 (3.8) | 2 (1.6) | 0 | 2 (3.8) | 2 (1.6) |
| Infections | 10 (14.1) | 10 (19.2) | 20 (16.3) | 33 (46.5) | 23 (44.2) | 56 (45.5) |
| Malignancies | 0 | 0 | 0 | 0 | 2 (3.8) | 2 (1.6) |
| Autoimmune events | 0 | 0 | 0 | 1 (1.4) | 1 (1.9) | 2 (1.6) |
Data are based on all patients who received at least one dose of abatacept.
↵* Participated in AIM.
↵† Participated in ATTAIN.
↵‡ Subset of AEs.
AE, adverse event; AIM, Abatacept in Inadequate responders to Methotrexate; ATTAIN, Abatacept Trial in Treatment of Anti-TNF INadequate responders; MTX, methotrexate; SAE, serious adverse event; TNF, tumour necrosis factor.