Table 4.
Characteristics of the study cohort treated with B-cell depletion
| Number | LN class | Baseline treatment | Rituximab | Protein:creatinine ratioa(mg/mmol) | SLEDAI | BILAG/renal | End point (months) | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Responders | Regimen | Cycleb | Baseline | +12 months | Baseline | +12 months | Baseline | +12 months | |||
| 10 | V + III (A) | MMF, HCQ | RTX + i.v. MP×2 | 1 | 2010 | 387 | 7 | 4 | 34/A | 12/B | 12 |
| 11 | IV-S (A/C) | MMF, HCQ, Pred | RTX | 1 | 161 | <20 | 13 | 3 | 31/B | 2/D | 12 |
| 12 | III (A/C) | MMF, HCQ, Pred, i.v. MP×3 | RTX + i.v. MP×2 | 1 | 83 | <20 | 17 | 4 | 15/C | 3/D | 12 |
| 14 | IV-G (A) | MTX, HCQ, Pred, imMPx1 | RTX + i.v. MP×2 | 2 | 211 | 90 | 13 | 6 | 30/B | 3/C | 12 |
| 13 | V + IV-S (A/C) | AZA, Pred | RTX + i.v. MP×2 | 2 | 1236 | 189 | 10 | 3 | 13/A | 2/C | 12 |
| Non-responders | Regimen | Cycleb | Baseline | At flare | Baseline | At flare | Baseline | At flare | Time of flare (months) | ||
| 1 | III (A/C) | MMF, HCQ | RTX + i.v. MP×2 | 1 | 290 | 275 | 8 | 8 | 13/A | 22/A | 3 |
| 2 | IV-S (A) | MMF, HCQ, Pred | RTX | 1 | 223 | 198 | 19 | 14 | 45/A | 22/A | 1 |
| 3 | III (A) | HCQ | RTX + i.v. MP×2 | 1 | 289 | 243 | 12 | 6 | 23/A | 14/A | 3 |
| 4 | V + III (A) | MMF, HCQ, Pred | Ofatumumab | 2 | 604 | 382 | 18 | 22 | 26/A | 19/A | 1 |
| 19 | III (A) | MMF, HCQ | RTX + i.v. MP×2 | 2 | 229 | 485 | 8 | 9 | 13/A | 13/A | 3 |
| 7 | V + III (C) | MMF, HCQ | RTX + i.v. MP×2 | 3 | 732 | 1469 | 6 | 7 | 8/B | 9/B | 3 |
All patients received two infusions of 1000 mg of RTX or the fully humanized CD20 monoclonal ofatumumab with hydrocortisone to prevent infusion reactions. Patients defined as non-responders were treated with CYC at the time of flare.
a
The protein:creatinine ratio normal range is <20 mg/nmol.
b
Cycle number indicates total number of cycles received, including the one during this study. MP: methylprednisolone; Pred: prednisolone; RTX: rituximab.