Table 1.
Author (year) | Name of the study (Clinicaltrials.gov number) | Country | Study design | Intervention and comparison (number of patients)* | Patients | Outcomes |
Walsh et al (2020)24 | PEXIVAS (NCT00987389) | Multiple countries | Phase III, randomised, open label, 704 patients | Intervention: reduced-dose GC therapy (initial dose: 50–75 mg; maintenance dose continues at 5 mg/day from the end of week 23 until at least week 52; accumulative dose less than 60% of the standard) | 353 patients with severe AAV (mean age 63 years, 44% female) | Primary outcome: a composite of death from any cause or ESKD. Secondary outcomes: death from any cause, ESKD, sustained remission, serious adverse events, serious infections within 1 year and health-related quality of life. |
Comparison: standard-dose GC therapy (initial dose: 50–75 mg; maintenance dose continues at 5 mg/day from the end of week 23 until at least week 52) | 351 patients with severe AAV (mean age 63 years, 43% female) | |||||
Furuta et al (2021)18 | LoVAS (NCT02198248) | Japan, multicentric | Phase IV, randomised, open label, 140 patients | Intervention : low-dose GC treatment (initial dose : 0.5 mg/kg/day; discontinued at 5 months) | 70 patients with new diagnosis of AAV (median age: 73; 43% female) | Primary outcome: remission rate at 6 months. Secondary outcomes: time to remission, death, relapse, ESKD and the first serious adverse event, proportion of death, relapse and ESKD for efficacy at 6 months. |
Comparison : high-dose GC treatment (initial dose : 1 mg/kg/day; reduced to 10 mg/day by 5 months) | 70 patients with new diagnosis of AAV (median age: 74; 37% female) |
*Although these two trials are comparisons of different doses of GCs, the regimens are different, and the details are in the text.
AAV, antineutrophil cytoplasmic antibodies associated vasculitis; ESKD, end-stage kidney disease; GCs, glucocorticoids.