Plasma exchange fails to reduce renal disease, mortality risk in ANCA-associated vasculitis
CHICAGO — Plasma exchange does not reduce the risk for end-stage renal disease or mortality among patients with ANCA-associated vasculitis, according to data presented by Peter A. Merkel, MD, MPH, of the University of Pennsylvania.
In addition, the same study found that lower-dose glucocorticoid regimens result in fewer serious infections and do not increase a patient’s risk for death or end-stage renal disease, compared with standard steroid dosing.
“There remains both controversy and unmet need in induction of remission,” Merkel said, addressing attendees at the ACR/ARHP 2018 Annual Meeting. “First, there is controversy around whether to add plasma exchange to standard treatment. It is used in a variety of autoimmune diseases to good effect, but its use in this disease is quite controversial, because there is a question surrounding whether it actually helps reduce end-stage renal disease and renal damage, and does it actually help save people’s lives. The second controversy is regarding how much prednisone to use.
To examine whether plasma exchange improves clinical outcomes among patients with severe ANCA-associated vasculitis, and if a lower-dose glucocorticoid regimen would reduce the risk for infection without also increasing the likelihood of end-stage renal disease or death, Merkel and colleagues conducted the PEXIVAS study, a two-by-two factorial, randomized controlled trial. The study included 704 participants recruited from 98 sites in 15 countries, and included 289 patients with PR3-ANCA- and 209 with MPO-ANCA-associated vasculitis. In addition, 691 of the participants demonstrated renal involvement, with 191 having alveolar hemorrhage.
The researchers randomly assigned participants to receive either seven plasma exchange procedures or no plasma exchange. Participants were also randomly chosen to receive either a standard or reduced regimen of glucocorticoids, in which the reduced regimen was defined as 60% of the standard by 6 months. All participants received immunosuppression in the form of either cyclophosphamide or rituximab (Rituxan, Genentech). Primary composite outcome was death from any cause or end-stage renal disease up to 7 years.
According to Merkel, any-cause death or end-stage renal disease occurred in 28% of patients who underwent plasma exchange, compared with 31% of those who received no plasma exchange. Regarding steroids, death or end-stage renal disease occurred in 28% of participants in the reduced-glucocorticoid group, compared with 26% of those treated with the standard regimen. In addition, participants who received the reduced regimen experienced serious infection less often in the first year of therapy compared to those in the standard group.
“The impact of this trial is that it gives providers important information to think about regarding the use of plasma exchange — what its role may or may not be in our patients,” Merkel said. “From the glucocorticoid arm, I think it will almost certainly change the way we approach their use and the dosing for ANCA-associated vasculitis.” – by Jason Laday
Merkel PA. Abstract 2788. Presented at ACR/ARHP Annual Meeting, Oct. 20-24, 2018; Chicago.
Disclosures: Merkel reports professional relationships with AbbVie, Boehringer-Ingelheim, Bristol-Myers Squibb, CaridianBCT, ChemoCentryx, Genentech, GlaxoSmithKline, InnfaRx, Insmed, Kypha and Kiniksa.