Table 1.
Univariate Cox regression analysis studying the determinants associated with the description of the ADR in the SmPC of at least two TNF‐α inhibitors
| # of ADRs in second SmPC (%) | HR (95% CI) | |
|---|---|---|
| Nature of the ADR | ||
| Infections and infestations (n = 20) | 9 (45) | 2.1 (1.0–4.5) |
| Other (n = 115) | 25 (22) | Reference |
| Seriousness | ||
| Nonserious ADR (n = 61) | 6 (10) | Reference |
| Serious ADR (n = 74) | 28 (38) | 4.5 (1.8–10.8) |
| Regulatory importance | ||
| ADR not classified as important risk (n = 67) | 7 (10) | Reference |
| ADR classified as important risk (n = 68) | 27 (40) | 4.6 (2.0–10.5) |
| First‐in‐class | ||
| ADR first described in follow‐on drug (n = 97) | 17 (18) | Reference |
| ADR first described in first‐in‐class drug (n = 38) | 17 (45) | 2.8 (1.4–5.6) |
ADRs, adverse drug reactions; CI, confidence interval; HR, hazard ratio; SmPCs, summary of product characteristics.