Treatment details and outcomes of 16 patients with lupus nephritis (LN) who received sirolimus during active nephritis or disease quiescence.
| Patients who received sirolimus during active disease | ||||||||
|---|---|---|---|---|---|---|---|---|
| Patient | Tx for LN Before Sirolimus | Response to Previous Tx | Indication of Sirolimus | Duration of Sirolimus | Dose of Concomitant PSL | Mean Achieved Sirolimus Dosage | Mean 12-h Trough Sirolimus Level, μg/l | Key Outcomes |
| 1* | – | – | History of malignancy | 8 weeks | 35 mg/day | 1 mg/day | 2.9 ± 0.1 | Tx discontinuation because of rash; switched to PSL + FK after stopping sirolimus. One episode of hematological flare. No recurrence of malignancy. |
| 2 | PSL + MMF | PR | MMF intolerance | 84 mos | 40 mg/day | 1 mg/day | 6.1 ± 3.2 | Achieved CR; no clinical relapse. |
| 3* | – | – | History of malignancy | 82 mos | 50 mg/day | 2 mg/day | 6.0 ± 2.5 | Achieved CR; no clinical relapse or recurrence of malignancy. |
| 4 | PSL + MMF | PR | MMF intolerance | 10 weeks | 40 mg/day | 1 mg/day | 7.7 ± 0.6 | Tx discontinuation because of cholecystitis Switched to PSL + AZA after stopping sirolimus. ESRF after 27 mos. |
| 5 | PRED + FK | PR | FK intolerance | 84 mos | 40 mg/day | 3 mg/day | 5.9 ± 1.3 | Achieved CR; no clinical relapse. |
| Patients who received sirolimus during disease quiescence | ||||||
|---|---|---|---|---|---|---|
| Patient | Indication of Tx | Duration of Tx | Dose of Concomitant PSL | Mean Achieved Sirolimus Dosage | Mean 12-h Trough Sirolimus Level, μg/l | Key Outcomes |
| 6 | MMF intolerance | 110 mos | 5 mg/day | 1 mg/day | 3.9 ± 0.4 | No clinical relapse. |
| 7 | MMF intolerance | 11 weeks | 5 mg/day | 1 mg/day | 3.7 ± 0.1 | Tx discontinuation because of headache. |
| 8 | History of malignancy | 65 mos | 4 mg/day | 1 mg/day | 3.5 ± 0.6 | No clinical relapse or recurrence of malignancy. |
| 9 | FK intolerance | 11 weeks | 5 mg/day | 1 mg/day | < 2.0 | Tx discontinuation because of rash. |
| 10 | History of malignancy | 48 mos | 5 mg/day | 2 mg/day | 3.8 ± 0.8 | No clinical relapse or recurrence of malignancy. |
| 11 | MMF intolerance | 56 mos | 7.5 mg/day | 1 mg/day | 3.7 ± 2.0 | No clinical relapse. |
| 12 | FK intolerance | 48 mos | 6 mg/day | 1 mg/day | 3.3 ± 0.4 | No clinical relapse. |
| 13 | History of malignancy | 48 mos | 2.5 mg/day | 1 mg/day | 3.9 ± 0.3 | No clinical relapse or recurrence of malignancy. |
| 14 | History of malignancy | 48 mos | 5 mg/day | 2 mg/day | 4.8 ± 0.8 | No clinical relapse or recurrence of malignancy. |
| 15 | History of malignancy | 48 mos | 5 mg/day | 1 mg/day | 6.4 ± 1.1 | No clinical relapse or recurrence of malignancy. |
| 16 | MMF intolerance | 36 mos | 9 mg/day | 1 mg/day | 2.6 ± 0.8 | One episode of renal relapse; Tx discontinuation because of leukopenia. |
↵* Patients 1 and 3 received sirolimus as their first treatment for LN because of their history of malignancy. AZA: azathioprine; CR: complete remission; ESRF: endstage renal failure; FK: tacrolimus; MMF: mycophenolate mofetil; PR: partial remission; PSL: prednisolone.