ArticleACR open rheumatology2025
Safety of Avacopan for the Treatment of Antineutrophil Cytoplasmic Antibody-Associated Vasculitis: Combined Data From Three Clinical Trials.
Article in ACR open rheumatology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 13 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX168 in Subjects With Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis on Background of Cyclophosphamide or Rituximab Treatment
A Randomized, Double-Blind, Placebo-Controlled, Dose Assessment Phase 2 Study to Evaluate the Safety and Efficacy of CCX168 in Subjects With Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis
A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis Treated Concomitantly With Rituximab or Cyclophosphamide/Azathioprine
Who cites it
13 citing papers in PubMed.
- Multi-database pharmacovigilance identifies disproportionate reporting of hepatobiliary events with avacopan: an integrative study with network pharmacology and interpretable machine learning.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- The evolving landscape of complement therapeutics in rheumatology.Annals of the rheumatic diseases · 2026Review
- Avacopan-Associated Hepatotoxicity: Clinical Signal, Liver Injury Patterns, and Plausible Mechanisms.Cureus · 2026Review
- Plasma Macrophage Migration Inhibitory Factor as a Biomarker of Thromboinflammatory Dysregulation in Anti-Neutrophil Cytoplasmic Antibody- Associated Vasculitis.Archives of rheumatology · 2026Article
- Systematic Review of Efficacy and Safety of Avacopan in Real-World Clinical Practice.Kidney international reports · 2026Article
- Real-world safety assessment of avacopan in patients with antineutrophil cytoplasmic antibody-associated vasculitis.RMD open · 2026Article
- Evaluation of the Long-Term Safety of Avacopan in Antineutrophil Cytoplasmic Antibody-Associated Vasculitis in the Real World (AvacoStar): Protocol for a Noninterventional Prospective Cohort Study.JMIR research protocols · 2026Article
- Evolving Therapeutic Strategies in ANCA-Associated Vasculitis: Current Standards and Emerging Targets for GPA and MPA.Clinical reviews in allergy & immunology · 2026Review
- Making use of avacopan in clinical practice.Clinical kidney journal · 2026Review
- Targeting the complement system in ANCA-associated vasculitis management.Rheumatology (Oxford, England) · 2026Review
- ANCA-associated vasculitis: a phase-oriented therapeutic framework from immunopathology to precision treatment.Frontiers in medicine · 2026Review
- Renal Involvement in Mixed Cryoglobulinemic Vasculitis: Current Perspectives.Journal of clinical medicine · 2025Review
- Antineutrophil cytoplasmic antibody-associated vasculitis: insights into relapse risk and future management directions.Frontiers in immunology · 2025Review
Corrections and comments
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Authors and funding
7 authors.
Funding
Abstract
objectiveThis study aimed to report the safety of avacopan, an oral selective complement C5a receptor antagonist, using pooled data from clinical trials in patients with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] or microscopic polyangiitis [MPA]).
methodsData were included from two phase 2 (CLEAR [NCT01363388] and CLASSIC [NCT02222155]) and one phase 3 (ADVOCATE [NCT02994927]) double-blind randomized controlled trials comparing the safety and efficacy of avacopan with active non-avacopan control regimens to induce remission in patients with GPA or MPA. In CLEAR and ADVOCATE, avacopan-treated patients received either no or lower doses of study-supplied prednisone than the control groups; in CLASSIC, all groups received the same dose of study-supplied prednisone. Assessments included rates of exposure-adjusted adverse events (AEs), serious AEs (SAEs), and AEs of special interest.
resultsOverall, 439 patients with GPA or MPA (avacopan: n = 239; non-avacopan: n = 200) were included. The exposure-adjusted rates of AEs, SAEs, white blood cell (WBC) count reductions, and infections were lower with avacopan versus control (between-group differences in rate per 100 patient-years -151.9 [95% confidence interval (CI) -218.6 to -85.3], -20.8 [95% CI -38.3 to -3.3], -11.6 [95% CI -22.2 to -1.2], and -24.3 [95% CI -48.5 to -0.1], respectively). SAEs associated with hepatic function abnormalities occurred in 4.4% of the avacopan group and 2.8% of the control group.
conclusionIn clinical trials of GPA or MPA, use of avacopan was associated with fewer AEs, SAEs, and WBC count reductions and fewer infections than non-avacopan treatment. Safety data support the use of avacopan in patients with GPA or MPA.
Identifiers
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.