AE of special interest reported during the 5-year study period.
| AE | DB 24-week Period SC ABA + MTX, n = 744 | DB 24-week Period IV ABA + MTX, n = 731 | LTE 174-week Period SC ABA + MTX, n = 1372 | LTE 5-year Period SC ABA + MTX, n = 1373* | ||||
|---|---|---|---|---|---|---|---|---|
| n (%) | IR (95% CI) | n (%) | IR (95% CI) | n (%) | IR (95% CI) | n (%) | IR (95% CI) | |
| Infections | 237 (31.9) | 84.54 (74.12–96.01) | 227 (31.1) | 82.92 (72.48–94.44) | 803 (58.5) | 44.80 (41.76–48.01) | 962 (70.1) | 38.60 (36.24–41.12) |
| Serious infections | 5 (0.7) | 1.48 (0.62–3.56) | 10 (1.4) | 3.05 (1.64–5.67) | 50 (3.6) | 1.72 (1.30–2.27) | 85 (6.2)† | 1.68 (1.35–2.07) |
| Autoimmune disorders | 6 (0.8) | 1.78 (0.80–3.96) | 6 (0.8) | 1.83 (0.82–4.07) | 38 (2.8) | 1.31 (0.95–1.79) | 67 (4.9)‡ | 1.33 (1.05–1.69) |
| Malignancies | 2 (0.3) | 0.59 (0.15–2.36) | 5 (0.7) | 1.52 (0.63–3.65) | 35 (2.6) | 1.19 (0.86–1.66) | 56 (4.1)§ | 1.09 (0.84–1.42) |
↵* At entry into the LTE period, 99.1% of patients were taking MTX and < 1% were taking a concomitant non-MTX DMARD.
↵† Including pneumonia (n = 16), urinary tract infection (n = 6), and appendicitis (n = 5).
↵‡ Including psoriasis (n = 13), chronic gastritis (n = 11), Sjögren syndrome (n = 10), and vasculitis (n = 6).
↵§ Including basal cell carcinoma (n = 15); breast cancer, squamous cell carcinoma, squamous cell carcinoma of skin (n = 4 each); thyroid neoplasm (n = 3); and cervical carcinoma Stage 0, invasive ductal breast carcinoma, non–small cell lung cancer, prostate cancer (n = 2 each). DB: double blind; DMARD: disease-modifying antirheumatic drug; IR: incidence rate (events per 100 patient-yrs); IV: intravenous; LTE: longterm extension; MTX: methotrexate; SAE: serious adverse event; SC: subcutaneous; ABA: abatacept.