No Benefit in Add-on Pulse Methylprednisolone for AAV Patients Needing Dialysis, Study Finds
Adding methylprednisolone pulse therapy to standard induction therapy does not appear to have any particular benefit for people with severe ANCA-associated vasculitis (AAV) who need dialysis, a study suggests.
The study, “The effect of pulse methylprednisolone induction therapy in Chinese patients with dialysis-dependent MPO-ANCA associated vasculitis,” was published in the journal International Immunopharmacology.
Many doctors apply pulses of methylprednisolone days before starting remission induction therapy with high doses of oral steroids and immunosuppressants in people with AAV who have kidney damage and need dialysis.
Methylprednisolone could help induce remission in AAV because it has anti-inflammatory effects and causes a reduction in the number of plasma cells, which produce anti-neutrophil cytoplasmic autoantibodies (ANCAs), the cause of AAV.
However, there isn’t any strong evidence regarding the benefits of using methylprednisolone in patients with severe AAV, and this medicine is associated with adverse events, such as infections.
Researchers in China performed a retrospective study to assess if methylprednisolone pulse therapy before remission induction therapy affected kidney recovery — deemed as no longer needing dialysis — and survival one year after treatment.
They evaluated 69 AAV patients who needed dialysis when they started treatment, 30 of whom received methylprednisolone for three days before starting induction therapy with oral prednisolone and cyclophosphamide. The remaining 39 participants only received induction therapy.
In total, 27 patients underwent kidney biopsies, 13 in the methylprednisolone group, and 14 in the non-methylprednisolone group. The biopsies of the participants who received methylprednisolone showed more inflammation but less damage to the kidney structures.
Results showed no significant differences in kidney recovery at one year (23.3% for methylprednisolone vs. 20.5% for controls), survival one year after treatment (26.7% vs. 23%), and adverse events between the groups.
The most common adverse events were severe infections and heart disease, with severe infections being the leading cause of death.
Looking at factors predicting kidney function recovery, the researchers found that participants with a higher disease activity — measured with the Birmingham Vasculitis Activity Score (BVAS) — had a lower chance of recovering kidney function and not needing dialysis in the future. They also had a higher risk of death from any cause.
Those with a lower estimated glomerular filtration rate — a test that measures kidney function — also had a higher risk of therapy-related death. On the other hand, patients who had been diagnosed for a shorter period of time had a higher chance of recovering kidney function.
The investigators found no biopsy parameters that could help predict patient outcome, even though there were differences in the biopsies of the two groups. This was probably because the low number of biopsies available did not allow for identifying any patterns.
“This retrospective study of MPO-AAV [AAV caused by ANCAs against myeloperoxidase] patients who required dialysis at presentation in a single Chinese center suggests that the addition of intravenous pulse [methylprednisolone] to standard induction of remission therapy with [cyclophsphamise] and high-dose oral steroids may not confer any benefit in terms of improving patient outcomes,” the researchers concluded.
This was a retrospective study that included a relatively small number of participants. Therefore, the investigators said that “a well-designed, randomized, controlled study with larger sample size is needed to further confirm these results.”