Measurements of the Glucocorticoid Toxicity Index by treatment group and glucocorticoid use among study participants
| Prednisone taper+rituximab group (N=107) | Avacopan+rituximab group (N=107) | |
| Glucocorticoid Toxicity Index | ||
| Cumulative Worsening Score* | ||
| Week 13 | 35.6 (28.2 to 43.0) | 25.5 (18.1 to 33.0) |
| Difference | −10.0 (−20.5 to 0.5) | |
| Week 26 | 52.9 (45.5 to 60.4) | 38.0 (30.5 to 45.4) |
| Difference | −14.9 (−25.5 to –4.4) | |
| Aggregate Improvement Score* | ||
| Week 13 | 22.9 (15.5 to 30.3) | 11.9 (4.4 to 19.4) |
| Difference | −11.0 (−21.6 to –0.5) | |
| Week 26 | 20.2 (12.7 to 27.7) | 12.8 (5.3 to 20.3) |
| Difference | −7.3 (−18.0 to 3.3) | |
| Glucocorticoid use | ||
| Screening (week −2 to 0) | ||
| n (%) | 86 (80.4) | 83 (77.6) |
| Dose (mg prednisone equivalent)† | ||
| Mean | 823 | 863 |
| Median (range) | 290 (0–4465) | 392 (0–5805) |
| Weeks 0–26‡ | ||
| n (%) | 107 (100.0) | 103 (96.3) |
| Dose (mg prednisone equivalent)† | ||
| Mean | 3265 | 1417 |
| Median (range) | 3026 (1520–11 815) | 625 (0–19 492) |
| Weeks 26–52 | ||
| n (%) | 42 (39.3) | 28 (26.2) |
| Dose (mg prednisone equivalent)† | ||
| Mean | 443 | 330 |
| Median (range) | 0 (0–6333) | 0 (0–4565) |
| Weeks 0–52‡ | ||
| n (%) | 107 (100.0) | 103 (96.3) |
| Dose (mg prednisone equivalent)† | ||
| Mean | 3687 | 1731 |
| Median (range) | 3130 (1520–13 383) | 625 (0–21 680) |
*Data represent LS mean (95% CI). The Glucocorticoid Toxicity Index Cumulative Worsening Score ranges from 0 to 410, with higher scores indicating greater severity of toxic effects. The Glucocorticoid Toxicity Index Aggregate Improvement Score ranges from –317 to 410, with higher scores indicating greater severity of toxic effects.
†All doses were converted to prednisone equivalent (mg) and are calculated as total dose during a specified period. The prednisone-equivalent dose includes both intravenous and oral use of glucocorticoids. The n (%) data are the number of patients who used any glucocorticoids during the period and the mean and median (range) data are for all patients in the period.
‡All patients received rituximab; however, there were 7 patients in the prednisone taper group and 10 patients in the avacopan group with no recorded use of intravenous glucocorticoids during the initial 4-week study period.
LS mean, least squares mean.