Incidence of AEa among ADA initiators.
| Variables | All ADA Initiators | ||
|---|---|---|---|
| Patients with ≥ 1 Event, n | Followup Time, PY | Rate, Events/100 PY (95% CI) | |
| Serious infections b | 83 | 4452 | 1.86 (1.50–2.31) |
| Tuberculosis | 0 | 4751 | 0 (N/A) |
| CHF requiring hospitalization | 7 | 4728 | 0.15 (0.07–0.31) |
| Drug-induced SLE | 2 | 4750 | 0.04 (0.01–0.17) |
| Any AE listed above leading to discontinuation of ADAc | 33 | 4494 | 0.73 (0.52–1.03) |
| Malignancyd | 56e | 8691 | 0.64 (0.50–0.84) |
| Mortality | 31 | 9268 | 0.33 (0.24–0.48) |
↵a Among patients without a history of and who were not experiencing the particular event at the time of ADA initiation.
↵b Serious infections included those that led to hospitalization or intravenous antibiotics, including joint/bursa infections, cellulitis, sinusitis, diverticulitis, sepsis, pneumonia, bronchitis, gastroenteritis, meningitis, urinary tract infection, upper respiratory infection, or other specified infections. Among those with serious infections, the number of opportunistic infections was calculated, including histoplasmosis, coccidioidomycosis, pneumocystosis, listeria, herpes zoster/varicella zoster virus, and active tuberculosis. Not specifically collected were aspergillosis, blastomycosis, legionella, and candidiasis information.
↵c Excludes malignancy because all person-time was used to assess rate of malignancy, regardless of ADA continuation or discontinuation during followup.
↵d Excluding nonmelanoma skin cancer.
↵e Includes solid tumors (n = 40), melanoma (n = 8), lymphoma (n = 6), and other blood cancers (n = 2). ADA: adalimumab; AE: adverse event; CHF: congestive heart failure; N/A: not applicable; PY: person-years; SLE: systemic lupus erythematosus.