Table 3.
Modified definition of SLE flaresa,b | ||||
---|---|---|---|---|
Moderate baseline SLE | Severe baseline SLE | |||
Patients initiating belimumab before IS use (N = 1909) |
Patients initiating belimumab after IS use (N = 3252) |
Patients initiating belimumab before IS use (N = 386) |
Patients initiating belimumab after IS use (N = 862) |
|
Rate of mild flares, PPYc, mean ± SEd | ||||
6 months | 4.63 ± 0.071 | 5.20 ± 0.058 | 4.91 ± 0.163 | 5.27 ± 0.114 |
12 months | 4.33 ± 0.050 | 4.87 ± 0.041 | 4.56 ± 0.115 | 5.09 ± 0.081 |
24 months | 4.27 ± 0.038 | 4.76 ± 0.031 | 4.40 ± 0.087 | 5.02 ± 0.063 |
Rate of moderate flares, PPYc, mean ± SEd | ||||
6 months | 2.12 ± 0.048 | 3.51 ± 0.047 | 2.74 ± 0.122 | 4.75 ± 0.108 |
12 months | 1.96 ± 0.033 | 2.87 ± 0.031 | 2.42 ± 0.084 | 3.85 ± 0.071 |
24 months | 1.84 ± 0.025 | 2.56 ± 0.023 | 2.29 ± 0.063 | 3.45 ± 0.052 |
Rate of severe flares, PPYc, mean ± SEd | ||||
6 months | 0.35 ± 0.019 | 0.50 ± 0.018 | 0.99 ± 0.073 | 2.07 ± 0.071 |
12 months | 0.32 ± 0.013 | 0.44 ± 0.012 | 0.89 ± 0.051 | 1.71 ± 0.047 |
24 months | 0.28 ± 0.010 | 0.40 ± 0.009 | 0.70 ± 0.035 | 1.48 ± 0.034 |
HCRU healthcare resource utilization, IS immunosuppressant, PPY per person-year, SE standard error, SLE systemic lupus erythematosus
aSLE flare episodes were identified and classified by severity on the basis of a previously published claims-based algorithm, which considers medications of interest and HCRU associated with an SLE diagnosis or SLE-related condition flare [26]
bThe modified definition categorized initiation of IS as filling a prescription for an immunosuppressant > 60 days after the days’ supply of the former prescription ended
cRate of PPY is calculated as the total number of visits across all patients divided by the total person-time of observation
dSE of the population incidence rate is calculated as √(total number of events)/(total follow-up time)