Table 2 Infusion reactions meeting criteria of anaphylaxis
Patient | Sex | Race | Weight (kg) | Tophi present | Regimen | Responder status | SUA at time of IR (mg/dL) | Dose of pegloticase when IR occurred | Time from infusion initiation to IR (min) | Severity of the adverse event | Signs and symptoms | Action taken | Disposition |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | Male | White | 108.9 | No | 8 mg Q2w | Nonresponder | 9.1 | 5 | 13 | Moderate | Dyspnea, tongue edema | Stop infusion | Exit trial |
2 | Male | White | 107.9 | Yes | 8 mg Q2w | Nonresponder | 6.9 | 3 | 135 | Mild | Urticaria, wheezing | Stop infusion | Continue |
3 | Male | Native Hawaiian or Pacific islander | 98.0 | Yes | 8 mg Q2w | Nonresponder | 9.2 | 1 | 18 | Mild | Flushing, hypotension, tachycardia, urticaria | Stop infusion | Exit trial |
4 | Male | Black or African American | 103.3 | Yes | 8 mg Q4w | Nonresponder | 9.2 | 3 | 33 | Moderate | Dyspnea, hypoxia, tachycardia, urticaria | Stop infusion; treatment with diphenhydramine and salbutamol | Exit trial |
5 | Male | White | 111.1 | No | 8 mg Q4w | Nonresponder | 9.8 | 2 | 15 | Moderate | Cough, dyspnea, flushing | Stop infusion | Continue complete trial |
6 | Male | White | 53.1 | Yes | 8 mg Q4w | Nonresponder | NA | 2 | 5 | Moderate | Dyspnea, erythema, pruritus | Interrupted infusion, but completed; treatment with diphenhydramine | Continue |