TABLE 11.
aSBIs and All Other Infections Occurring in >5% of PIDD Patients Treated With Privigen® for 12 Months
| Infections | ITT Population [N=80] No. (%) |
|---|---|
| aSBIs* | 6 (7.5) |
| Pneumonia | 3 (3.8) |
| Septic arthritis | 1 (1.3) |
| Osteomyelitis | 1 (1.3) |
| Visceral abscess | 1 (1.3) |
| All other infections | 66 (82.5) |
| Sinusitis | 25 (31.3) |
| Nasopharyngitis | 18 (22.5) |
| URTI | 15 (18.8) |
| Bronchitis | 11 (13.8) |
| Rhinitis | 11 (13.8) |
| Influenza | 10 (12.5) |
| Gastroenteritis | 7 (8.8) |
| Conjunctivitis | 6 (7.5) |
| Ear infection | 6 (7.5) |
| Urinary tract infection | 6 (7.5) |
Blood cultures were negative in 3 of the 6 patients with aSBIs and were not performed in 2 patients. In the patient with osteomyelitis, vancomycin-resistant enterococci and yeast-like fungi were found. aSBIs = acute serious bacterial infections; ITT = intention-to-treat; URTI = upper respiratory tract infection.
Source: Stein 2009. Reproduced with kind permission from Springer+Business Media: J Clin Immunol. Safety and efficacy of Privigen®, a 10% liquid immunoglobulin preparation for intravenous use, in patients with primary immunodeficiencies. 2009;29(1):137–144. Stein MR, Nelson RP, Church JA, et al. Table II.