Table 1.
Adverse events in recent trials for induction treatment of severe ANCA-associated vasculitis
| Study (Reference) | End Points | Adverse Events | Infection | Hematologic Events | Hemorrhagic Cystitis | Cancer | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| de Groot et al. (50)a | Median time to remission (mo) | Remission rate (%) | Patients experiencing≥1 adverse event (%) | Adverse events (n) | Infections (n) | Leukopenia episodes (n) | Events (n) | Patients with cancer (%) | ||||
| Oral CYC (n=76) | 3 | 88 | 77 | 132 | 21 | 33 | 1 | 0 | ||||
| iv CYC (n=73) | 3 | 88 | 77 | 96 | 20 | 20 | 2 | 1 | ||||
| RAVE induction (5) | BVAS/WG score 0+successful steroid taper (%) | Patients experiencing≥1 selected adverse event (%) | Adverse events (n) | Severe infection (%) | Leukopenia (%) | Thrombocytopenia (%) | Patients with event (%) | Patients with cancer (%) | ||||
| RTX (n=99) | 64 | 22 | 1035 | 7 | 3 | 3 | 1 | 1 | ||||
| Oral CYC (n=98) | 53 | 33 | 1016 | 7 | 10 | 1 | 1 | 1 | ||||
| RAVE 18-mo follow-up (6) | Remission at 18 mo (%) | Patients experiencing≥ 1 adverse event (%) | Adverse events (n) | Severe infection (%) | Severe leukopenia (%) | Patients with event | Cancers (n) | |||||
| RTX (n=99) | 39 | 99 | 1399 | 12 | 5 | NN | 5 | |||||
| Oral CYC (n=98) | 33 | 100 | 1420 | 11 | 23 | NN | 2 | |||||
| RITUXVAS (7) | Sustained remission (%) | Patients experiencing severe adverse event (%) | Severe (%) | All (%) | Neutropenia (%) | Anemia (%) | Thrombocytopenia (%) | Patients with event | Cancers (n) | |||
| RTX (n=33) | 76 | 42 | 18 | 36 | 6 | 6 | 3 | NN | 2 | |||
| Control (n=11) | 82 | 36 | 18 | 27 | 9 | 18 | 0 | NN | 0 | |||
Gastrointestinal adverse effects not noted in any of the above trials. CYC, cyclophosphamide; iv, intravenous; RAVE, Rituximab in ANCA-Associated Vasculitis; BVAS/WG- Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis; RTX, rituximab; NN, adverse event not noted to have occurred, but not specifically mentioned in the manuscript; RITUXVAS, Rituximab Versus Cyclophosphamide in ANCA-associated Vasculitis.
a
In the de Groot et al. trial, two episodes of alopecia were recorded in the oral CYC group and amenorrhea was noted in 1% of the intravenous CYC group. Alopecia and reproductive abnormalities were not otherwise noted in the other trials.