Table 6.
Reported allergic reactions to biotechnological substances (Transplantation and Various)
| Biologics | ROA | Feature | Author | Year | HSR % |
IR % |
ISR % |
Urticaria % |
Anaphylaxis % |
|---|---|---|---|---|---|---|---|---|---|
| Transplantation | |||||||||
| Basiliximab | i.v. | Chimeric | FDA [142] | 2001 | 3.0–10.0 | – | – | – | – |
| Erickson et al. [143] | 2010 | – | – | 4.3 | – | – | |||
| Belatacept | i.v. | Human | FDA [146] | 2017 | 0 | 5.0 | – | – | 0 |
| EMA [147] | 2019 | – | 4.4–5.5 | – | – | ||||
| Muromonab | s.c.–i.v. | Mouse | Withdrawn | – | – | – | – | – | – |
| Daclizumab | s.c. | Humanized | Withdrawn | – | – | – | – | – | – |
| Various | |||||||||
| Abciximab |
i.v. s.c. |
Chimeric | Dery et al. [150] | 2004 | 0.3–0.6 | – | – | 0.1 | 0 |
| FDA [152] | 2019 | – | – | 0.1–3.6 | – | 0 | |||
| Eculizumab | i.v. | Humanized | FDA [153] | 2019 | – | – | – | – | – |
| EMA [154] | 2019 | 0.1–1.0 | 0.1–1.0 | 0.1–1.0 | 0.1–1.0 | ||||
| Lanadelumab | s.c. | Human | Banerji et al. [156] | 2018 | 1.2 | – | 52.4 | – | – |
| EMA [157] | 2018 | 1.2 | – | 53.0 | – | 0.0 | |||
| Natalizumab | i.v. | Humanized | Maggi et al. [65] | 2011 | – | 1.0–4.0 | – | – | – |
| EMA [158] | 2016 | <4.0 | 23.1 | – | <1.0 | ||||
| FDA [159] | 2019 | 1.0–1.5 | 11–24.0 | 1.0–2.0 | <1.0 | ||||
| Palivizumab | i.m. | Humanized | FDA [160] | 2009 | – | – | – | – | <0.001 |
| Chen et al. [161] | 2015 | 0.05 | – | – | – | – | |||
Side effects and reactions are given as described in the literature
ROA route of administration, s.c. Subcutaneous, i.v. intravenous, i.m. intramuscular, HSR hypersensitivity reaction, IR Infusion reactions, ISR Injection-site reaction, ADA anti-drug antibody