Table 3.
Examples of ISP variability across biologic agent disease area when administered subcutaneously
| Biologic agent | Type of agent | Indication | Study duration (weeks) | ISP, % (n/N) or reporting rate (n/N) | References |
|---|---|---|---|---|---|
| Studies | |||||
| Adalimumab | Anti-TNF | Psoriasis | 12 | 6.7 (3/45) | Gordon et al. [100] |
| Adalimumab | Anti-TNF | RA | 24 | 11.3 (36/318) | Furst et al. [101] |
| Adalimumab | Anti-TNF | CD | 56 | 1.9 (5/261) | Colombel et al. [102] |
| Galcanezumab | Humanised mAb (CGRP) | Chronic headache | 12 | 11.1 (13/117) | Dodick et al. [103] |
| Glatiramer acetate | Immunomodulator | RRMS | 16 | 56.5 (61/108)b | Wolinsky et al. [104] |
| Insulin | Hormone | Diabetes | 0.14 (1 day) | 16.5 (13/79) | Zijlstra et al. [34] |
| Mepolizumab | Humanised mAb (IL-5) | Asthma | 8 | 64 (36/56) | Bel et al. [105] |
| Spontaneous reports | |||||
| Adalimumaba | Anti-TNF | Psoriasis | ns | 3650/15637 | Grace et al. [106] |
| Etanercepta | Anti-TNF | Psoriasis | ns | 23/141 | Grace et al. [106] |
| Ixekizumaba | Humanised mAb (IL-17) | Psoriasis | ns | 350/1771 | Grace et al. [106] |
| Secukinumaba | Humanised mAb (IL-17) | Psoriasis | ns | 166/654 | Grace et al. [106] |
| Ustekinumaba | Humanised mAb (IL-12/IL-23) | Psoriasis | ns | 6/8 | Grace et al. [106] |
CD Crohn’s disease, CGRP calcitonin gene-related peptide, IL interleukin, mAb monoclonal antibody, ns not specified, RA rheumatoid arthritis, RRMS relapsing–remitting multiple sclerosis, TNF tumour necrosis factor
aSpontaneous reporting of ISP in post-marketing databases
bISP reported as part of injection-site reaction (annualised event rate of 55.3% reported for ISP)