Table 3.
Toxicity and immunosuppression.
| Characteristics | All Patients, N = 172 |
Non Responders (SD/PD), n = 90 | Responders (CR/PR), n = 79 | p-Value |
|---|---|---|---|---|
| Maximal severity of AE *, (%) | ||||
| None | 17 (10%) | 15 (17%) | 1 (1%) | - |
| Grade 1–2 | 45 (28%) | 22 (24%) | 23 (29%) | - |
| Grade 3–4 | 103 (60%) | 52 (58%) | 50 (66%) | 0.901 ¥ |
| Grade 5 | 4 (2%) | 1(1%) | 3 (4%) | - |
| Steroid treatment, (%) | 102 (59%) | 51 (57%) | 50 (63%) | 0.381 |
| Duration of steroid treatment, weeks—median (range) | 12 (1–153) | 12 (1–106) | 16 (1–153) | 0.039 |
| Maximal dose of steroids, mg/kg **—mean ± SD | 1.7 ± 2.3 | 2.1 ± 3.0 | 1.3 ± 1.2 | 0.060 |
| Advanced immune suppression † (%) | 11 (6%) | 5 (6%) | 6 (8%) | 0.592 |
AE adverse event. * According to the Common Terminology Criteria for Adverse Events (CTCAE) classification v5.0. ** Oral prednisolone equivalent dose. † Infliximab, mycophanolate mofetil, methotrexate, cyclosporine, intravenous immunoglobulin (IVIG) or plasma exchange. ¥ grades 3–4 vs. 1–2.