Table 2 Incidence rates of OIs per 100 patient-years for OIs in controlled and cumulative periods
Controlled periods | Cumulative periods | |||||
|---|---|---|---|---|---|---|
Outcome | Abatacept: n = 2653; py = 2357 | Placebo: n = 1485; py = 1254 | Abatacept: n = 7044; py = 21,274 | |||
n (%) | IR/100 py (95% CI) | n (%) | IR/100 py (95% CI) | n (%) | IR/100 py (95% CI) | |
Opportunistic infections | 4 (0.2) | 0.17 (0.05–0.43) | 7 (0.5) | 0.56 (0.22–1.15) | 45 (0.6)* | 0.21 (0.15–0.28)* |
Esophageal candidiasis | 0 | 0 | 1 (0.1) | 0.08 (0.0–0.4) | 7 (0.1) | 0.03 (0.01–0.07) |
Pulmonary tuberculosis | 0 | 0 | 0 | 0 | 6 (0.1) | 0.03 (0.01–0.06) |
Eye infection, fungal | 1 (< 0.1) | 0.04 (0.0–0.2) | 0 | 0 | 3 (< 0.1) | 0.01 (0–0.04) |
Ophthalmic herpes simplex | 0 | 0 | 0 | 0 | 3 (< 0.1) | 0.01 (0–0.04) |
Aspergillus infection | 0 | 0 | 0 | 0 | 2 (< 0.1) | 0.01 (0–0.03) |
Blastocytosis infection | 0 | 0 | 0 | 0 | 2 (< 0.1) | 0.01 (0–0.03) |
Bronchopulmonary aspergillosis | 1 (< 0.1) | 0.04 (0.0–0.2) | 0 | 0 | 2 (< 0.1) | 0.01 (0–0.03) |
Lymph node tuberculosis | 0 | 0 | 0 | 0 | 2 (< 0.1) | 0.01 (0–0.03) |
Respiratory moniliasis | 0 | 0 | 1 (0.1) | 0.08 (0.0–0.4) | 2 (< 0.1) | 0.01 (0–0.03) |
Tuberculosis (unspecified) | 1 (< 0.1) | 0.04 (0–0.24) | 1 (0.1) | 0.08 (0–0.44) | 2 (< 0.1) | 0.01 (0–0.03) |
Blastomycosis | 0 | 0 | 0 | 0 | 1 (< 0.1) | 0.00 (0–0.03) |
Bone tuberculosis | 0 | 0 | 0 | 0 | 1 (< 0.1) | 0.00 (0–0.03) |
Candida pneumonia | 0 | 0 | 0 | 0 | 1 (< 0.1) | 0.00 (0–0.03) |
Cyclosporidium infection | 0 | 0 | 0 | 0 | 1 (< 0.1) | 0.00 (0–0.03) |
Fungal esophagitis | 0 | 0 | 1 (0.1) | 0.08 (0.0–0.4) | 1 (< 0.1) | 0.00 (0–0.03) |
Fungal pharyngitis | 0 | 0 | 0 | 0 | 1 (< 0.1) | 0.00 (0–0.03) |
Cryptococcal meningitis | 0 | 0 | 1 (0.1) | 0.08 (0.0–0.44) | 0 | 0 |
Gastrointestinal candidiasis | 0 | 0 | 1 (0.1) | 0.08 (0.0–0.44) | 0 | 0 |
Gastrointestinal fungal infection | 0 | 0 | 0 | 0 | 1 (< 0.1) | 0.00 (0–0.03) |
Histoplasmosis | 0 | 0 | 0 | 0 | 1 (< 0.1) | 0.00 (0–0.03) |
Peritoneal tuberculosis | 0 | 0 | 0 | 0 | 1 (< 0.1) | 0.00 (0–0.03) |
Pneumocystis jirovecii pneumonia | 0 | 0 | 1 (0.1) | 0.08 (0–0.4) | 1 (< 0.1) | 0.00 (0–0.03) |
Pneumonia pseudomonal | 1 (< 0.1) | 0.04 (0.0–0.2) | 0 | 0 | 1 (< 0.1) | 0.00 (0–0.03) |
Pseudomonas infection | 0 | 0 | 0 | 0 | 1 (< 0.1) | 0.00 (0–0.03) |
Fungal sinusitis | 0 | 0 | 0 | 0 | 1 (< 0.1) | 0.00 (0–0.03) |
Systemic candida | 0 | 0 | 0 | 0 | 1 (< 0.1) | 0.00 (0–0.03) |
Systemic mycosis | 0 | 0 | 0 | 0 | 1 (< 0.1) | 0.00 (0–0.03) |
Tuberculosis pleurisy | 0 | 0 | 0 | 0 | 1 (< 0.1) | 0.00 (0–0.03) |
Pseudomonal urinary tract infection | 0 | 0 | 0 | 0 | 1 (< 0.1) | 0.00 (0–0.03) |