Plasma exchange does not improve survival or prevent serious kidney disease in people with ANCA vasculitis, a study found.
In addition, lower doses of glucocorticoids — steroid hormones that can ease inflammation — seem to be as effective as standard doses in terms of survival and kidney disease, with less risk of infection, the researchers said.
“This means we may not have to do plasma exchanges, which involve a catheter, can be uncomfortable, and are expensive,” Peter A. Merkel, MD, a professor at the University of Pennsylvania and study co-author, said in a press release.
“It’s also a big story when it comes to the glucocorticoids, because the ability to use less will reduce their toxicity and cut down on the chance for side effects,” Merkel said.
The study, “Plasma Exchange and Glucocorticoids in Severe ANCA-Associated Vasculitis,” was published in the New England Journal of Medicine.
Plasma exchange (plasmapheresis) involves replacing a person’s plasma — the non-cellular parts of blood. The process has been thought to help people with AAV by removing ANCAs from the blood.
The study details results of a Phase 3 clinical trial called PEXIVAS (NCT00987389), in which researchers aimed to assess the effectiveness of plasma exchange and glucocorticoid therapy, both common treatments for ANCA vasculitis. The trial enrolled 704 people with AAV with kidney involvement, who were recruited at 95 centers in 16 countries.
“[T]he international enrollment and broad eligibility criteria of the trial enhance the generalizability of the results,” the researchers said.
The participants were each randomized twice, to create a total of four treatment groups. Half were treated with plasma exchange, performed seven times over two weeks, as is standard. The other half did not receive plasma exchange.
Half the participants were treated with glucocorticoids at currently recommended doses; the other half received the same glucocorticoids, but at half the dosage. Participants were followed for a median of 2.9 years.
The trial’s primary endpoint was death or the development of end-stage kidney disease (ESKD). Because of the trial’s four-group design, the effects of both treatments could be analyzed in the same overall group of participants, and statistical analyses confirmed that the two treatments didn’t significantly affect each other.
One hundred (28.4%) of those who received plasma exchange died or reached ESKD, and 109 (31.0%) did not. There was no statistically significant difference, nor were there significant differences in any of the other outcomes analyzed, such as the development of serious adverse events. Additional subgroup and sensitivity analyses also failed to turn up significant differences.
Moreover, there were no significant differences in the rate of death/ESKD based on glucocortocoid dosage: those rates were 27.9% in the lower-dose group ,and 25.5% in the standard-dose group.
After one year after treatment, however, rates of serious infections were lower among people who received the lower glucocortocoid dosage, compared with the standard dose (27.2%, compared with 33.0%). Rates of other adverse events were generally comparable between the groups.
“[T]he current trial did not show that the addition of plasma exchange to standard therapy conferred benefits in patients with severe ANCA-associated vasculitis,” the researchers said, “but it did show that a reduced-dose regimen of oral glucocorticoids was noninferior to a standard-dose regimen.”
The findings should lead to major changes in the standard of care for people living with ANCA vasculitis, Merkel said.
“Adopting the changes in treatment we studied will greatly reduce our patients’ discomfort and their risk of developing several serious side effects from the current therapies,” he said.
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