Table 5

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‡1.170.13
 National Databank for Rheumatic Diseases§1.300.21
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.