Table 3.
Adverse events in recent trials for maintenance treatment of lupus nephritis
| Study (Reference) | End Points | Infection | Hematologic Events | Cancer | GI Events | Alopecia | Reproductive Events | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Contreras et al. (15)a | Patient survival (%) | Renal survival (%) | Total | Severe | Leukopenia | Patients with cancer | Nausea | Vomiting | Diarrhea | Patients with event | Amenorrhea | ||
| MMF (n=20) | 95 | 95 | 32 | 2 | 2 | 0 | 14 | 10 | 12 | NN | 6 | ||
| AZA (n=19) | 100 | 80 | 29 | 2 | 6 | 0 | 7 | 4 | 9 | NN | 8 | ||
| iv CYC (n=20) | 80 | 74 | 77 | 25 | 10 | 0 | 65 | 55 | 12 | NN | 32 | ||
| MAINTAIN (16)b | Renal flare (%) | Benign infections (n) | Severe infections (n) | Leukopenia (n) | Anemia (n) | Patients with cancer (n) | Nausea/diarrhea (n) | Patients with event (n) | Transient amenorrhea (n) | ||||
| MMF (n=53) | 19 | 21 | 1 | 2 | 0 | 0 | 8 | 0 | 2 | ||||
| AZA (n=52) | 25 | 14 | 0 | 11 | 2 | 1 | 8 | 2 | 1 | ||||
| ALMS maintenance (17) | Treatment failure (%) | Total (%) | Severe (%) | Leukopenia (%) | Anemia (%) | Patients with cancer (%) | Nausea (%) | Vomiting (%) | Diarrhea (%) | Patients with event (%) | Patients with event | ||
| MMF (n=116) | 16.4 | 79 | 10 | 23 | 11 | 0 | 17 | 12 | 19 | 10 | NN | ||
| AZA (n=111) | 32.4 | 78 | 12 | 36 | 13 | 1 | 19 | 16 | 18 | 10 | NN | ||
GI, gastrointestinal; MMF, mycophenolate mofetil; NN, adverse event not noted to have occurred, but not specifically mentioned in the manuscript; AZA, azathioprine; iv CYC, intravenous cyclophosphamide; MAINTAIN, Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis; ALMS, Aspreva Lupus Management Study.
a
Adverse events in the trial by Contreras et al. are expressed as rate of event/patient-year.
b
Adverse events in the MAINTAIN trial are expressed as number of episodes of that event; in the MAINTAIN trial adverse events were not noted once the primary end point was met.