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Abstract
Background The PEXIVAS (Plasma exchange and glucocorticoids in severe antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis) trial showed that a reduced-dose glucocorticoid regimen (redGC) was non-inferior to a standard-dose regimen (standGC) with respect to death or end-stage kidney disease (ESKD) in patients with ANCA-associated vasculitis (AAV). However, the primary endpoint did not include disease progression or relapse, cyclophosphamide was the main induction therapy and rituximab (RTX)-treated patients tended to have a higher risk of death or ESKD with redGC. We aimed to evaluate the real-world use of redGC.
Methods We conducted a retrospective, multicentre study comparing PEXIVAS redGC with standGC in patients with AAV. The primary composite outcome was the occurrence of death, ESKD, AAV progression before remission or relapse within the 12 months following induction. Inverse probability of treatment weighting was used to correct for baseline imbalance between groups. Factors associated with the occurrence of the primary outcome were estimated.
Results A total of 234 patients were included. The primary composite outcome occurred in 42/126 (33%) patients with redGC versus 20/108 (19%) with standGC. In unweighted multivariable analysis and in weighted analysis, redGC was independently associated with the primary outcome but not with death or ESKD. Among redGC-treated patients, those with serum creatinine>300 µmol/L were more likely to achieve the primary outcome. RTX-treated patients who received redGC were more likely to experience death or ESKD and to achieve the primary outcome.
Conclusion In this study of patients with AAV primarily treated with RTX, redGC was associated with an increased risk of the primary outcome consisting of death, ESKD, AAV progression before remission or relapse.
- Granulomatosis with polyangiitis
- Glucocorticoids
- Cyclophosphamide
- Systemic vasculitis
- Rituximab
Data availability statement
Data are available upon reasonable request. Please send your request by email to benjamin.terrier@aphp.fr or sophie.nagle@aphp.fr.
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Data availability statement
Data are available upon reasonable request. Please send your request by email to benjamin.terrier@aphp.fr or sophie.nagle@aphp.fr.
Footnotes
Handling editor Josef S Smolen
Presented at This study was presented on plenary session, in ACR (American College of Rheumatology) Convergence meeting, in San Diego, California, in November 2023. The abstract of this study was published online on this occasion: abstract number: 0725; https://acrabstracts.org/abstract/real-life-use-of-the-pexivas-reduced-dose-glucocorticoidregimen-in-granulomatosis-with-polyangiitis-and-microscopic-polyangiitis/
Contributors Concept and design: BT, SN, XP. Acquisition, analysis or interpretation of data: all authors. Drafting of the manuscript: SN, BT. Statistical analysis: YN, MB. Critical revision of the manuscript: all authors. Supervision: BT. Guarantor: BT.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.
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