Rate of malignancy and standardised incidence ratio for malignancy in the rituximab All Exposure population and published data in adults with RA
| Any site* | Breast† | |
|---|---|---|
| Rate (per 100 pt-years) | ||
| All Exposure population (95% CI) | 0.69 (0.55 to 0.86) | 0.12 (0.06 to 0.20) |
| RA observational studies | ||
| Danish Cancer Registry‡ | 1.17 | 0.13 |
| National Databank for Rheumatic Diseases§ | 1.30 | 0.21 |
| Standardised incidence ratio | ||
| Malignancy incidence in All Exposure population¶ (95% CI) | 0.99 (0.79 to 1.23) | 0.66 (0.36 to 1.11) |
| Meta-analysis of malignancy incidence in adult RA patients** (95% CI) | 1.05 (1.01 to 1.09) | 0.84 (0.79 to 0.90) |
*Excluding non-melanoma skin cancer and non-malignant events.
†Only female patients.
‡Mellemkjaer et al.21
§Wolfe and Michaud.22
¶Surveillance Epidemiology and End Results database23 was used to obtain age- and sex-specific incidence ratio of malignancies for the US general population for standardised incidence ratio calculations (data were accessed in February 2011).
**Smitten et al.24
pt-year, patient year; RA, rheumatoid arthritis.