Incidence rate of hospitalised infection per 100 person-years (95% CI)*† | ||||||
Analysis | Fostamatinib trials | CORRONA | SRR | NOAR | CORRONA International | IORRA |
Main analysis: main cohort defined from 1 January 2000 | 2.92 (2.44 to 3.46) | 1.30 (1.18 to 1.42) | 1.62 (1.52 to 1.72) | 1.56 (1.30 to 1.88) | 1.50 (1.09 to 2.05) | 1.14 (1.05 to 1.25) |
Sensitivity analysis 1: Subcohort; active RA (patients with seropositive/erosive RA and with ≥4+4 tender/swollen joints) | 2.92 (2.44 to 3.46) | 1.82 (1.52 to 2.17) | 1.80 (1.65 to 1.97) | 1.91 (1.29 to 2.78) | 3.09 (1.98 to 4.71) | 1.59 (1.37 to 1.84) |
Sensitivity analysis 2: sub-cohort; treatment switch/addition in biologicals-naïve patients (MTX/DMARD-IR) | 2.74 (2.24 to 3.33) | 2.35 (1.71 to 3.18) | 2.02 (1.83 to 2.22) | 2.09 (1.45 to 2.99) | NC | 1.37 (1.22 to 1.54) |
Sensitivity analysis 3: subcohort; treatment switch/addition in patients previously treated with biologicals (BLX-IR) | 4.23 (2.79 to 6.16) | 1.86 (1.48 to 2.32) | 3.40 (2.92 to 3.95) | NA | NA | NA |
Sensitivity analysis 4: subcohort; MTX/DMARD-IR patients with RA trial programme exclusion criteria also applied | 2.74 (2.24 to 3.33) | 2.29 (1.62 to 3.18) | 1.85 (1.66 to 2.05) | 2.07 (1.42 to 3.01) | NC | 1.33 (1.18 to 1.51) |
Sensitivity analysis 5: subcohort; BLX-IR patients with RA trial programme exclusion criteria also applied | 4.23 (2.79 to 6.16) | 1.65 (1.26 to 2.14) | 3.17 (2.67 to 3.74) | NA | NA | NA |
Sensitivity analysis 6: main cohort; main cohort defined from 1 January 2005 | 2.92 (2.44 to 3.46) | 1.30 (1.19 to 1.43) | 1.77 (1.65 to 1.90) | 1.38 (1.11 to 1.71) | 1.50 (1.09 to 2.05) | 1.10 (0.99 to 1.23) |
Sensitivity analysis 7: subcohort; MTX/DMARD-IR patients with 18 months truncated follow-up | 2.74 (2.24 to 3.33) | 2.84 (1.95 to 4.05) | 2.10 (1.78 to 2.48) | 2.68 (1.35 to 4.91) | NC | 0.99 (0.77 to 1.27) |
Sensitivity analysis 8: subcohort; BLX-IR patients with 18 months truncated follow-up | 4.23 (2.79 to 6.16) | 1.75 (1.30 to 2.32) | 3.67 (2.91 to 4.61) | NA | NA | NA |
Sensitivity analysis 9: main cohort standardised for HAQ score in addition to sex and age‡ | 2.92 (2.44 to 3.46) | 1.92 (1.67 to 2.24) | 2.05 (1.87 to 2.26) | 1.88 (1.53 to 2.31) | 2.18 (1.47 to 3.16) | 1.86 (1.62 to 2.16) |
*Approximate CIs based on the gamma distribution for registry data and exact Poisson CIs for fostamatinib data.
†Incidence rates for the registry data were standardised according to the age and sex distribution in the appropriate corresponding cohort (overall, MTX-IR or BLX-IR) of the fostamatinib dataset; for fostamatinib, crude incidence is presented. (Except in sensitivity analysis 9, see footnote ‡.)
‡Incidence rates for the registry data were standardised according to the age, sex and HAQ distribution in the overall cohort of the fostamatinib dataset; for fostamatinib, crude incidence is presented.
BLX-IR, inadequate responders to biologicals; CORRONA, Consortium of Rheumatology Researchers of North America; DMARDs, disease-modifying antirheumatic drugs; HAQ, Health Assessment Questionnaire; IORRA, Institute of Rheumatology Rheumatoid Arthritis; MTX-IR, inadequate responders to methotrexate; MTX/DMARD-IR, inadequate responders to methotrexate/DMARDs; NA, not available; NC, not calculated due to too few events (rates were only produced if at least five events were observed); NOAR, Norfolk Arthritis Register; RA, rheumatoid arthritis; SRR, Swedish Rheumatology Registry.