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TAVNEOS was superior to prednisone in sustaining remission at Week 521,2

At Week 26, TAVNEOS was noninferior but not superior to prednisone in achieving remission2

Bar charts showing primary efficacy results
  • Remission is defined as achieving a Birmingham Vasculitis Activity Score (BVAS) of 0 and not taking glucocorticoids for treatment of ANCA-associated vasculitis within 4 weeks prior to Week 261
  • Sustained remission is defined as remission at Week 26 without relapse to Week 52 (BVAS of 0 and not taking glucocorticoids for treatment of ANCA-associated vasculitis within 4 weeks prior to Week 52)1

Reduction in the Risk of Relapse in Patients Treated With TAVNEOS2

Kaplan-Meier plot of time to relapse chart

Prespecified secondary endpoint not adjusted for multiplicity and subject to post-randomization variable dependence. Results should be interpreted with caution.

  • Relapse was defined as occurrence of 1 major item, at least 3 non-major items, or 1 or 2 non-major items for at least 2 consecutive visits on the BVAS after remission (BVAS of 0) had been achieved1
  • 10.1% of patients using TAVNEOS experienced relapse, compared with 21% of patients treated with prednisone2

TAVNEOS demonstrated
a 54% estimated reduction
in risk of relapse vs
prednisone-treated patients.3

Glucocorticoid load decreased for patients on TAVNEOS by approximately 2.5 g3†

Icon representing 86% Icon representing 86%
Reduction in median glucocorticoid load3†

Reduction in mean
glucocorticoid load3†

Icon representing 63% Icon representing 63%
  • Glucocorticoids were allowed as pre-medication for rituximab to reduce hypersensitivity reactions, taper after glucocorticoids given during the screening period, treatment of persistent vasculitis, worsening of vasculitis, or relapses, as well as for non-vasculitis reasons such as adrenal insufficiency1
    • The incidence of this additional glucocorticoid exposure was balanced between both groups2,3
  • Results are descriptive
†Prednisone equivalent.

Patients on TAVNEOS had lower glucocorticoid-related toxicity as measured by GTI3

  • GTI captures glucocorticoid toxicities, including4:
    • Infection, blood pressure changes, glucose tolerance, myopathy, and neuropsychiatric changes, and changes in weight, lipids, and skin
  • While GTI is a weighted and standardized tool to assess glucocorticoid-related toxicity across diseases, it is not specifically validated for ANCA-associated vasculitis or to evaluate the toxicity effects of other treatments. Certain rare but serious events associated with glucocorticoid use are omitted from the GTI score4,5
Bar charts of GTI-CWS/AIS scores

Lower scores indicate lower glucocorticoid toxicity for both AIS and CWS.2

  • The BMI, glucose tolerance, lipids, steroid myopathy, skin toxicity, and infection components of both scores were lower in TAVNEOS patients3
  • Differences of ≥10 points are clinically important5
  • GTI was not assessed beyond 26 weeks
Bar chart of GTI data: Cumulative Worsening Bar chart of GTI data: Aggregate Improvement

Effect on kidney function in patients taking TAVNEOS

Measured by the change in estimated glomerular filtration rate (eGFR) from baseline to Week 522,3

Bar charts showing eGFR at weeks 26 and 52

Prespecified secondary endpoint; analysis not adjusted for multiplicity and should be considered exploratory. Results should be interpreted with caution.

  • 81.2% of patients in the trial had renal involvement prior to treatment across the patient population2,3‡
  • Discontinuation of treatment with TAVNEOS at Week 52 resulted in the reduction of treatment-induced difference in eGFR3

Effect on eGFR in patients with stage 4 kidney disease

Results of a prespecified subgroup analysis in the 100 patients with stage 4 kidney disease at baseline3*

Chart showing change in eGFR over time

ADVOCATE was not powered to detect differences in subgroup analysis. Results from this exploratory subgroup analysis should be interpreted with caution.

*Stage 4 kidney disease defined as baseline eGFR of <30 mL/min/1.73 m2.3
eGFR, estimated glomerularfiltration rate; LSM, least squares mean; SEM, standard error of mean.

ADVOCATE was not powered to detect differences in subgroup analysis. Results from this exploratory subgroup analysis should be interpreted with caution.

  • A 5.5 mL/min/1.73 m2 difference between the TAVNEOS and prednisone groups (95% CI, 1.7 to 9.5)2,3

Patients on TAVNEOS had greater improvements
in physical health-related
quality-of-life scores vs
the prednisone group2,3

  • Prespecified secondary endpoint, analysis not adjusted for multiplicity and should be considered exploratory.
    Results should be interpreted with caution
  • SF-36 is not specifically validated for ANCA-associated vasculitis
Health-related quality of life bar chart
Safety & Dosing

INDICATION

TAVNEOS (avacopan) is 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.

Important Safety Information

CONTRAINDICATIONs

Serious hypersensitivity to avacopan or to any of the excipients.

WARNINGS AND PRECAUTIONS

Hepatotoxicity: Serious cases of hepatic injury have been observed in patients taking TAVNEOS, including life-threatening events. Obtain liver test panel before initiating TAVNEOS, every 4 weeks after start of therapy for 6 months and as clinically indicated thereafter. Monitor patients closely for hepatic adverse reactions, and consider pausing or discontinuing treatment as clinically indicated (refer to section 5.1 of the Prescribing Information). TAVNEOS is not recommended for patients with active, untreated, and/or uncontrolled chronic liver disease (e.g., chronic active hepatitis B, untreated hepatitis C, uncontrolled autoimmune hepatitis) and cirrhosis. Consider the risks and benefits before administering this drug to a patient with liver disease.

Serious Hypersensitivity Reactions:Cases of angioedema occurred in a clinical trial, including 1 serious event requiring hospitalization. Discontinue immediately if angioedema occurs and manage accordingly. TAVNEOS must not be readministered unless another cause has been established.

Hepatitis B Virus (HBV) Reactivation:Hepatitis B reactivation, including life-threatening hepatitis B, was observed in the clinical program. Screen patients for HBV. For patients with evidence of prior infection, consult with physicians with expertise in HBV and monitor during TAVNEOS therapy and for 6 months following. If patients develop HBV reactivation, immediately discontinue TAVNEOS and concomitant therapies associated with HBV reactivation, and consult with experts before resuming.

Serious Infections:Serious infections, including fatal infections, have been reported in patients receiving TAVNEOS. The most common serious infections reported in the TAVNEOS group were pneumonia and urinary tract infections. Avoid use of TAVNEOS in patients with active, serious infection, including localized infections. Consider the risks and benefits before initiating TAVNEOS in patients with chronic infection, at increased risk of infection, or who have been to places where certain infections are common.

ADVERSE REACTIONS

The most common adverse reactions (≥5% of patients and higher in the TAVNEOS group vs. prednisone group) were nausea, headache, hypertension, diarrhea, vomiting, rash, fatigue, upper abdominal pain, dizziness, blood creatinine increased, and paresthesia.

DRUG INTERACTIONS

Avoid coadministration of TAVNEOS with strong and moderate CYP3A4 enzyme inducers. Reduce TAVNEOS dose when coadministered with strong CYP3A4 enzyme inhibitors to 30 mg once daily. Monitor for adverse reactions and consider dose reduction of certain sensitive CYP3A4 substrates.

TAVNEOS is available as a 10 mg capsule.

Please see Full Prescribing Information and Medication Guide for TAVNEOS.

To report a suspected adverse event, call 1-833-828-6367. You may report to the FDA directly by visiting www.fda.gov/medwatch or calling 1-800-332-1088.

References: 1. Jayne DRW, Merkel PA, Schall TJ, Bekker P; ADVOCATE Study Group. Avacopan for the treatment of ANCA-associated vasculitis. N Engl J Med. 2021;384(7):599 609. doi:10.1056/NEJMoa2023386 2. Jayne DRW, Merkel PA, Schall TJ, Bekker P; ADVOCATE Study Group. Avacopan for the treatment of ANCA-associated vasculitis. N Engl J Med. 2021;384(7)(suppl):1 41. 3. Warrington KJ. Avacopan - time to replace glucocorticoids? N Engl J Med. 2021;384(7):664 665. doi:10.1056/NEJMe2033621 4. TAVNEOS® (avacopan) Prescribing Information. ChemoCentryx, Inc. 5. Data on File, ChemoCentryx, Inc.
References: 1. King C, Harper L, Little M. The complications of vasculitis and its treatment. Best Pract Res Clin Rheumatol. 2018;32(1):125-136. doi:10.1016/j.berh.2018.07.009 2. Jennette JC, Nachman PH. ANCA glomerulonephritis and vasculitis. Clin J Am Soc Nephrol. 2017;12(10):1680-1691. doi:10.2215/CJN.02500317 3. Guillevin L, Pagnoux C, Karras A, et al. Rituximab versus azathioprine for maintenance in ANCA-associated vasculitis. N Engl J Med. 2014;371(19):1771-1780. doi:10.1056/NEJMoa1404231 4. Stone JH, Merkel PA, Spiera R, et al. Rituximab versus cyclophosphamide for ANCA-associated vasculitis. N Engl J Med. 2010;363(3):221-232. doi:10.1056/NEJMoa0909905 5. Specks U, Merkel PA, Seo P, et al. Efficacy of remission-induction regimens for ANCA-associated vasculitis. N Engl J Med. 2013;369(5):417-427. doi:10.1056/NEJMoa1213277 6. Yasir M, Goyal A, Bansal P, et al. Corticosteroid adverse effects. StatPearls [Internet]. Accessed May 5, 2021. https://www.ncbi.nlm.nih.gov/books/NBK531462 7. Little MA, Nightingale P, Verburgh CA, et al. Early mortality in systemic vasculitis: relative contribution of adverse events and active vasculitis. Ann Rheum Dis. 2010;69(6):1036-1043. doi:10.1136/ard.2009.109389
References: 1. TAVNEOS® (avacopan) Prescribing Information. ChemoCentryx, Inc. 2. Jayne DRW, Merkel PA, Schall TJ, Bekker P; ADVOCATE Study Group. Avacopan for the treatment of ANCA-associated vasculitis. N Engl J Med. 2021;384(7):599-609. doi:10.1056/NEJMoa2023386 3. Al-Hussain T, Hussein MH, Conca W, Al Mana H, Akhtar M. Pathophysiology of ANCA-associated vasculitis. Adv Anat Pathol. 2017;24(4):226-234. doi:10.1097/PAP.0000000000000154 4. Anders HJ, Nakazawa D. Being an ADVOCATE for people with ANCA vasculitis. Clin J Am Soc Nephrol. 2021;16(10):1581-1583. doi:10.2215/CJN.03670321 5. Chen M, Jayne DRW, Zhao MH. Complement in ANCA-associated vasculitis: mechanisms and implications for management. Nat Rev Nephrol. 2017;13(6):359-367. doi:10.1038/nrneph.2017.37 6. Jennette JC, Nachman PH. ANCA glomerulonephritis and vasculitis. Clin J Am Soc Nephrol. 2017;12(10):1680-1691. doi:10.2215/CJN.02500317 7. Moiseev S, Lee JM, Zykova A, et al. The alternative complement pathway in ANCA-associated vasculitis: further evidence and a meta-analysis. Clin Exp Immunol. 2020;202(3):394-402. doi:10.1111/cei.13498
References: 1. TAVNEOS® (avacopan) Prescribing Information. ChemoCentryx, Inc. 2. Jayne DRW, Merkel PA, Schall TJ, Bekker P, for the ADVOCATE Study Group. Avacopan for the treatment of ANCA-associated vasculitis. N Engl J Med. 2021;384(7):599-609. doi:10.1056/NEJMoa2023386 3. Data on File, ChemoCentryx, Inc.
References: 1. TAVNEOS® (avacopan) Prescribing Information. ChemoCentryx, Inc. 2. Jayne DRW, Merkel PA, Schall TJ, Bekker P, for the ADVOCATE Study Group. Avacopan for the treatment of ANCA-associated vasculitis. N Engl J Med. 2021;384(7):599-609. doi:10.1056/NEJMoa2023386 3. Data on File, ChemoCentryx, Inc. 4. Miloslavsky EM, Naden RP, Bijlsma JW, et al. Development of a glucocorticoid toxicity index (GTI) using multicriteria decision analysis. Ann Rheum Dis. 2017;76(3):543-546. doi:10.1136/annrheumdis-2016-210002 5. McDowell PJ, Stone JH, Zhang Y, et al. Quantification of glucocorticoid-associated morbidity in severe asthma using the glucocorticoid toxicity index. J Allergy Clin Immunol Pract. 2021;9(1):365-372.e5. doi:10.1016/j.jaip.2020.08.032
References: 1. TAVNEOS® (avacopan) Prescribing Information. ChemoCentryx, Inc. 2. Data on File, ChemoCentryx, Inc. 3. Jayne DRW, Merkel PA, Schall TJ, Bekker P, for the ADVOCATE Study Group. Avacopan for the treatment of ANCA-associated vasculitis. N Engl J Med. 2021;384(7):599-609. doi:10.1056/NEJMoa2023386

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Serious hypersensitivity to avacopan or to any of the excipients.

WARNINGS AND PRECAUTIONS

INDICATION

TAVNEOS (avacopan) is 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.

INDICATION

TAVNEOS (avacopan) is 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.

INDICATION

TAVNEOS (avacopan) is 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.

Important Safety Information

CONTRAINDICATIONs

Serious hypersensitivity to avacopan or to any of the excipients.

WARNINGS AND PRECAUTIONS

Hepatotoxicity: Serious cases of hepatic injury have been observed in patients taking TAVNEOS, including life-threatening events. Obtain liver test panel before initiating TAVNEOS, every 4 weeks after start of therapy for 6 months and as clinically indicated thereafter. Monitor patients closely for hepatic adverse reactions, and consider pausing or discontinuing treatment as clinically indicated (refer to section 5.1 of the Prescribing Information). TAVNEOS is not recommended for patients with active, untreated, and/or uncontrolled chronic liver disease (e.g., chronic active hepatitis B, untreated hepatitis C, uncontrolled autoimmune hepatitis) and cirrhosis. Consider the risks and benefits before administering this drug to a patient with liver disease.

Serious Hypersensitivity Reactions:Cases of angioedema occurred in a clinical trial, including 1 serious event requiring hospitalization. Discontinue immediately if angioedema occurs and manage accordingly. TAVNEOS must not be readministered unless another cause has been established.

Hepatitis B Virus (HBV) Reactivation:Hepatitis B reactivation, including life-threatening hepatitis B, was observed in the clinical program. Screen patients for HBV. For patients with evidence of prior infection, consult with physicians with expertise in HBV and monitor during TAVNEOS therapy and for 6 months following. If patients develop HBV reactivation, immediately discontinue TAVNEOS and concomitant therapies associated with HBV reactivation, and consult with experts before resuming.

Serious Infections:Serious infections, including fatal infections, have been reported in patients receiving TAVNEOS. The most common serious infections reported in the TAVNEOS group were pneumonia and urinary tract infections. Avoid use of TAVNEOS in patients with active, serious infection, including localized infections. Consider the risks and benefits before initiating TAVNEOS in patients with chronic infection, at increased risk of infection, or who have been to places where certain infections are common.

ADVERSE REACTIONS

The most common adverse reactions (≥5% of patients and higher in the TAVNEOS group vs. prednisone group) were nausea, headache, hypertension, diarrhea, vomiting, rash, fatigue, upper abdominal pain, dizziness, blood creatinine increased, and paresthesia.

DRUG INTERACTIONS

Avoid coadministration of TAVNEOS with strong and moderate CYP3A4 enzyme inducers. Reduce TAVNEOS dose when coadministered with strong CYP3A4 enzyme inhibitors to 30 mg once daily. Monitor for adverse reactions and consider dose reduction of certain sensitive CYP3A4 substrates.

TAVNEOS is available as a 10 mg capsule.

Please see Full Prescribing Information and Medication Guide for TAVNEOS.

To report a suspected adverse event, call 1-833-828-6367. You may report to the FDA directly by visiting www.fda.gov/medwatch or calling 1-800-332-1088.