Table 3.
Reported allergic reactions to biotechnological substances (Dermatology)
| Biologics | ROA | Feature | Authors | Year | HSR % |
IR % |
ISR % |
Urticaria % |
Anaphylaxis % |
|---|---|---|---|---|---|---|---|---|---|
| Alefacept | i.m., i.v. | Human | FDA [31] | 2012 | 0.2 | – | 16.0 | <1.0 | – |
| Efalizumab | s.c. | Humanized | Gordon et al. [32] | 2003 | – | – | – | – | 0 |
| FDA [33] | 2009 | 8.0 | – | 1.0 | – | ||||
| Brunasso et al. [34] | 2011 | – | 4.0 | – | – | ||||
| Ixekizumab | s.c. | Humanized | FDA [35] | 2017 | ≤0.1 | – | 17.0 | <0.1 | – |
| Strober et al. [36] | 2017 | 0.1 | 6.8 | <0.1 | 0 | ||||
| Secukinumab | s.c. | Human | EMA [37] | 2015 | 6.5–11.2 | – | 5.6 | <0.1 | 0 |
| Schwensen et al. [38] | 2017 | – | 3.0 | – | 2.0 | ||||
| FDA [39] | 2018 | – | – | 0.6–1.2 | – | ||||
| Deodhar et al. [40] | 2019 | 2.4 | 0.8–1.3 | – | – | ||||
| Ustekinumab |
i.v. s.c. |
Human | EMA [41] | 2017 | – | – | 3.0 | – | 0 |
| FDA [42] | 2018 | 0.08 | 0.1 | 1.0–2.0 | <0.1 | <0.1 | |||
| Ghosh et al. [43] | 2019 | <1.0 | 0 | – | <1.0 | 0 | |||
| Dupilumab | s.c. | Human | FDA [44] | 2017 | <0.1 | – | 10.0 | <1.0 | – |
| Ou et al. [45] | 2018 | – | 13.2 | – | – | ||||
| EMA [46] | 2019 | 3.0–4.3 | 16.0–20.1 | 0.5–1.3 | 0.2 | ||||
| Ligelizumab | s.c | Humanized | Maurer et al. [47] | 2019 | – | – | 4.0–7.0 | – | 0 |
| Quilizumab | s.c. | Humanized | Harris et al. [48] | 2016 | – | – | 6.9 | – | – |
ROA route of administration, HSR hypersensitivity reaction, IR infusion reaction, ISR Injection-site reaction, i.m. intramuscular, s.c. subcutaneous, i.v. intravenous, FDA Food and Drug Administration, EMA European Medicines Agency