TABLE 3.
Infection and malignancy findings from long-term biologic therapy clinical trials
| Drug and study | Population (exposure duration) | Helminth infections | Opportunistic infections | Malignancy |
| Benralizumab | ||||
| BORA [82] | Asthma (2 years) | None | Incidence similar in years 1 and 2 (no percentage cited) | Incidence <1% |
| SIROCCO/CALIMA/BORA [48, 93] | Asthma (2 years) | None | No overall incidence cited (0.6% herpes zoster) | Incidence <1% |
| ZONDA/BORA [94] | Asthma (1.6 years) | None | No overall incidence cited | None |
| MELTEMI [85] | Asthma (up to 5 years) | None | Infection incidence did not increase with longer drug exposure | Incidence <1% |
| Mepolizumab | ||||
| COSMOS [95] | Asthma (1.5 years) | None | No overall incidence cited | None |
| COLUMBA [96] | Asthma (3.5 years) | None | Incidence 7% (2% herpes zoster; one serious event) | Incidence 2%, consistent with age- and sex-adjusted SEER data |
| COSMEX [97] | Asthma (up to 4.8 years) | None | Incidence 4% (0.9% herpes zoster) | Incidence 2% |
| MHE100901 [98] | HES (4.8 years) | None | Incidence 1% | Greater incidence versus SEER may reflect risk in HES |
| Reslizumab | ||||
| Long-term extension [99] | Asthma (up to 2 years) | None | None | Incidence 1%, consistent with population expectations |
SEER: Surveillance, Epidemiology, and End Results; HES: hypereosinophilic syndrome.