Drug updated on 9/4/2024
Dosage Form | Capsule (oral; 10 mg) |
Drug Class | Complement 5a receptor antagonists |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids. TAVNEOS does not eliminate glucocorticoid use.
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Summary
- Tavneos (avacopan) is indicated as an adjunctive treatment for adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids. Tavneos does not eliminate glucocorticoid use.
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- Rituximab and Cyclophosphamide (CYC) combination therapy is as effective as glucocorticoids (GCs) in achieving remission, with potential superior effectiveness and a safer profile.
- Plasma exchange significantly reduces the risk of end-stage kidney disease (ESKD) at three months (RR 0.45, 95% CI 0.24 to 0.84) and 12 months (RR 0.47, 95% CI 0.24 to 0.86) in patients with renal vasculitis.
- Pulse Cyclophosphamide (CPA) increases remission rates (RR 1.17; 95% CI 1.02-1.35) compared to continuous CPA, with fewer relapses observed.
- Azathioprine (AZA) was associated with significantly less leukopenia during maintenance therapy compared to CPA.
- Plasma Exchange and Cotrimoxazole in Wegener's Granulomatosis: No specific safety concerns or adverse effects were mentioned for Plasma Exchange or Cotrimoxazole.
- Geriatric Population: Rituximab and CYC combination therapy, noted for its safer profile compared to GCs, may be particularly beneficial in geriatric patients with ANCA-associated vasculitis, a population more commonly affected by this condition. Adults with Renal Vasculitis: Plasma exchange significantly reduces the risk of end-stage kidney disease (ESKD), while Pulse CPA increases remission but with a higher risk of relapse. Azathioprine (AZA) is effective for maintenance therapy with fewer side effects, specifically less leukopenia, in this adult population.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Tavneos (avacopan) Prescribing Information. | 2021 | ChemoCentryx, Inc. One Amgen Center Drive Thousand Oaks, CA |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Recent advancements in the management of anti-neutrophil cytoplasmic antibody-associated vasculitis: a systematic review. | 2022 | Cureus |
Interventions for renal vasculitis in adults. | 2020 | The Cochrane Database of Systematic Reviews |