Summary of adverse events and malignancy type for all patients who received one dose of abatacept during 3 years of the study
| Event, IR/100 patient-years | Double-blind period abatacept+MTX (n=433) | Cumulative period* abatacept+MTX (n=594) |
|---|---|---|
| Total AEs | 303.4 | 249.8 |
| Total SAEs | 17.7 | 15.1 |
| Infections | 90.5 | 70.8 |
| Serious infections | 4.2 | 3.2 |
| Malignancies | 1.7 | 1.5 |
| Autoimmune events | 2.5 | 2.2 |
| Malignancy type, n | ||
| Total patients with malignancies | 7 | 24 |
| Non-melanoma skin cancer | 5 | 15 |
| Basal cell carcinoma | 4 | 12 |
| Squamous cell carcinoma | 1 | 3 |
| Solid organ | 0 | 6 |
| Lung | 0 | 3 |
| Prostate | 0 | 1 |
| Endometrial | 0 | 1 |
| Melanoma | 0 | 1 |
| Haematological | 2 | 3 |
| Lymphoma | 1 | 2 |
| Myelodysplastic syndrome | 1 | 1 |
* Data are presented for all patients who participated in the long-term extension regardless of randomised double-blind treatment group.
AE, adverse event; IR, incidence rate; MTX, methotrexate; SAE, serious adverse event.