Overall adverse events and discontinuations due to adverse events at 1 year and after 2 years of long-term extension
| AE | DB phase | LTE | |
|---|---|---|---|
| Abatacept 2 mg/kg+etanercept (n = 85) | Placebo+etanercept (n = 36) | Abatacept 10 mg/kg+etanercept (n = 80) | |
| AE, adverse event; DB, double blind; LTE, long-term extension; SAE, serious adverse event; URTI, upper respiratory tract infection. | |||
| Values are number (%). | |||
| *Occurring in ⩾10% of patients in the abatacept treatment group. | |||
| †Related events include those considered by the investigator to be certain, probable or possibly related to the study drug. | |||
| Deaths | 0 | 0 | 1 (1.3) |
| Total AEs | 79 (92.9) | 32 (88.9) | 78 (97.5) |
| Most common AEs* | |||
| Rheumatoid arthritis | 37 (43.5) | 13 (36.1) | 24 (30) |
| URTI | 20 (23.5) | 5 (13.9) | 23 (28.8) |
| Headache | 20 (23.5) | 5 (13.9) | 10 (12.5) |
| Fatigue | 14 (16.5) | 6 (16.7) | 14 (17.5) |
| Sinusitis | 14 (16.5) | 3 (8.3) | 18 (22.5) |
| Nausea | 13 (15.3) | 1 (2.8) | 12 (15) |
| Arthralgia | 13 (15.3) | 3 (8.3) | 5 (6.3) |
| Dizziness | 13 (15.3) | 2 (5.6) | 8 (10) |
| Diarrhoea | 12 (14.1) | 2 (5.6) | 13 (16.3) |
| Cough | 11 (12.9) | 3 (8.3) | 11 (13.8) |
| Rash | 11 (12.9) | 3 (8.3) | 10 (12.5) |
| Discontinuations due to AEs | 10 (11.8) | 1 (2.8) | 8 (10) |
| Related AEs† | 53 (62.4) | 17 (47.2) | 52 (65) |
| SAEs | 14 (16.5) | 1 (2.8) | 26 (32.5) |
| Musculoskeletal and connective tissue disorders | 1 (1.2) | 0 | 9 (11.3) |
| Vascular disorders | 0 | 1 (1.2) | 6 (7.5) |
| Malignancies | — | — | 3 (3.8) |
| Gastrointestinal disorders | — | — | 3 (3.8) |
| Infections and infestations | 3 (3.5) | 0 | 1 (1.3) |
| Nervous system disorders | 2 (2.4) | 0 | 1 (1.3) |
| Respiratory, thoracic and mediastinal disorders | 30 (35.3) | 7 (9.4) | 32 (40) |
| Related SAEs† | 5 (5.9) | 0 | 3 (3.8) |
| Serious infections | 3 (3.5) | 0 | 1 (1.3) |