Cumulative exposure adjusted event rates for the most frequent serious adverse events and serious infections*
| Adverse event | EAE rate on exposure to anakinra† (No of events per 100 patient-years) | |||
|---|---|---|---|---|
| Placebo‡ | 0 to 1 y | 0 to 2 y | 0 to 3 y | |
| (E = 120.9) | (E = 1041.8) | (E = 1754.8) | (E = 2273.0) | |
| *Most frequent serious adverse events or infections were those occurring at rates of ⩾1.0 event per 100 patient-year for the 0–3 year period. | ||||
| †Cumulative exposure adjusted event rates in the specified period for 1116 patients randomly assigned to anakinra (873 of whom continued treatment during the open label extension) and 230 patients randomly assigned to placebo who received at least one dose of anakinra during the open label extension. | ||||
| ‡Cumulative exposure adjusted event rates for patients who received placebo during the randomised, double blind phase. | ||||
| E, number of patient-years of exposure; EAE, exposure adjusted event; RA, rheumatoid arthritis; y, years. | ||||
| RA progression | 4.96 | 1.73 | 2.74 | 2.90 |
| Fractures | 0.83 | 0.86 | 1.08 | 1.19 |
| Pneumonia | 0.00 | 1.25 | 1.25 | 1.28 |