Patients with ANCA-associated vasculitis who are presented with pulmonary hemorrhage or renal dysfunction are at increased risk of death or developing end-stage renal disease. The primary reason for this may be delayed diagnosis, use of treatment strategy with incomplete efficacy, slow onset, and undesired and toxic effects. Thus, there is a requirement for more effective and safe treatment for this condition.
Explaining the scope of the study, the author wrote, “We conducted the PEXIVAS trial in patients with severe ANCA-associated vasculitis to compare the efficacy of plasma exchange with no plasma exchange with respect to death or ESKD.” The authors further added, “The trial also compared a reduced-dose regimen of glucocorticoids with a standard-dose regimen over the first 6 months of the treatment period to determine whether the reduced dose was non-inferior to the standard dose with respect to death or ESKD.”
The study was a randomized trial that evaluated the plasma exchange use and regimen of glucocorticoids in patients suffering from severe ANCA-associated vasculitis. Patients were divided to undergo plasma exchange or no plasma exchange. The random assignment was also done for standard therapy and reduced regimen of glucocorticoids. Follow-up was for 7 years.
Out of 352 patients, death or ESKD occurred in 100 patients in the group with plasma exchange while 109 out of 352 patients died in the group without plasma exchange. In the reduced dose group, 92 out of 330 patients either died or developed ESKD while in the standard-dose group, 83 out of 325 patients were either died or developed ESKD. The results meet the criterion of non-inferiority.