Remission

Primary endpoints

At Week 26, the TAVNEOS® arm was noninferior to the Active Control arm in achieving remission^2,*

At Week 52, the TAVNEOS® arm was superior to the Active Control arm in sustaining remission^1,2,†

Remission data of TAVNEOS® (avacopan) compared to Standard Therapy

At Week 26, the TAVNEOS® arm was noninferior to the Active Control arm in achieving remission^2,*

At Week 52, the TAVNEOS® arm was superior to the Active Control arm in sustaining remission^1,2,†

TAVNEOS arm = TAVNEOS + rituximab, or cyclophosphamide (followed by azathioprine or mycophenolate mofetil^‡).

Active Control arm = prednisone taper^¶ + rituximab, or cyclophosphamide (followed by azathioprine or mycophenolate mofetil^‡).

^*Remission was defined as achieving a Birmingham Vasculitis Activity Score (BVAS) of 0 and not taking glucocorticoids for treatment of GPA or MPA within 4 weeks prior to Week 26.²

^†Sustained remission was defined as remission at Week 26 and at Week 52 and not taking glucocorticoids for treatment of GPA or MPA within 4 weeks before Week 52, without relapse# between Week 26 and Week 52.^1,3

^‡If azathioprine not tolerated.

^¶Prednisone taper: 60 mg/day tapered to 0 over 20 weeks.

^#Relapse was defined as the occurrence of at least 1 major item, at least 3 non-major items, or 1 or 2 non-major items for at least 2 consecutive visits based on BVAS after a BVAS of 0 had been achieved.

Relapse Risk

The TAVNEOS® arm saw a reduced risk of relapse by half compared to the Active Control Arm²

10.1% of patients in the TAVNEOS® arm experienced a relapse, compared with 21% of patients in the Active Control arm²

Prespecified secondary endpoint not adjusted for multiplicity and subject to post-randomization variable dependence. Results should be interpreted with caution.²

Relapse is defined as the occurrence of one of the following after remission (BVAS of 0) had been achieved:^1,2

≥1 major item in the BVAS, or

≥3 minor items in the BVAS, or

1-2 minor items in the BVAS recorded at ≥2 consecutive visits

Prespecified secondary endpoint not adjusted for multiplicity and subject to post-randomization variable dependence. Results should be interpreted with caution.²

Relapse is defined as the occurrence of one of the following after remission (BVAS of 0) had been achieved:^1,2

≥1 major item in the BVAS, or

≥3 minor items in the BVAS, or

1-2 minor items in the BVAS recorded at ≥2 consecutive visits

Prespecified secondary endpoint not adjusted for multiplicity and subject to post-randomization variable dependence. Results should be interpreted with caution.²

^§ Adapted from Jayne DRW, et al. N Engl J Med. 2021;384:599-609.
CI = confidence interval.

Renal Function

The TAVNEOS® arm improved renal function, as measured by eGFR, from baseline compared to the Active Control Arm²

81.2% of patients in the trial had renal involvement based on BVAS prior to treatment²
Discontinuation of treatment with TAVNEOS® at Week 52 resulted in the reduction of treatment-induced difference in eGFR³

Prespecified secondary endpoint not adjusted for multiplicity and should be considered exploratory. Results should be interpreted with caution.²

^||Least-squares mean (LSM) change in eGFR from baseline to Weeks 26 and 52 in patients with renal involvement at baseline based on the BVAS.

BVAS = Birmingham Vasculitis Activity Score; eGFR = estimated glomerular filtration rate.

In a subgroup analysis, patients with stage 4 kidney disease at baseline experienced a least-squares mean change in eGFR improvement:^2,4

Results of a prespecified subgroup analysis in the 100 patients with eGFR <30 and ≥15 mL/min/1.73 m2 at baseline^2,4,5

Results of prespecified subgroup analysis in the 100 patients with eGFR <30 mL/min/1.73 m² and ≥15 mL/min/1.73 m² at baseline. Results from this exploratory subgroup analysis should be interpreted with caution.^2,3,5

improvement from baseline in the TAVNEOS® arm vs 38% in the Active Control arm^2,4

65%

Click here to see ADVOCATE data on patients with eGFR 15-20 mL/min/1.73 m2 at baseline chevron_right

uACR

Patients in the TAVNEOS® arm saw a decrease in albuminuria by Week 4^2,3,**

Change in Urinary Albumin-Creatinine Ratio (uACR) Over 52 Weeks (ITT Population)^2,3

Prespecified secondary endpoint of patients with renal involvement and albuminuria at baseline; analysis not adjusted for multiplicity and should be considered exploratory. Results should be interpreted with caution.²

Elevated albuminuria may reflect underlying impairment of kidney function^6,7
Percent changes from baseline are based on ratios of geometric means of visit over baseline²
The uACR analysis was only performed in patients who met BVAS criteria for renal involvement at baseline and who also had a uACR ≥10 mg albumin/g creatinine²

^**Based on percentage change from baseline in uACR in patients with baseline renal involvement and baseline uACR >10 mg/g (52-week study period).^2,3

BVAS = Birmingham Vasculitis Activity Score; ITT = intent to treat; LSM = least squares mean; SEM = standard error of the mean.

Click here to see ADVOCATE data on patients with ENT and/or respiratory involvement at baseline arrow_right

Quality of Life

Patients in the TAVNEOS® arm experienced improved quality of life³

Patients in the TAVNEOS® arm reported greater improvement across physical and mental health-related quality-of-life metrics at Weeks 26 and 52 compared to patients in the Active Control arm^3,††

Greater Improvement Seen in the Physical Component Score of the SF-36 (V2) in Patients in the TAVNEOS® Arm^8,‡‡

Greater Improvement Seen in the Mental Component Score of the SF-36 (V2) in Patients in the TAVNEOS® Arm^8,‡‡

Prespecified secondary endpoint not adjusted for multiplicity and should be considered exploratory. Results should be interpreted with caution. The SF-36 was not specifically validated for GPA and MPA.²

^††As assessed by the 36-Item Short Form Health Survey (SF-36), version 2. SF-36 scores range from 0 (worst) to 100 (best).²

^‡‡Scores reflect change from baseline (least squares mean ± standard error of the mean).³

^¶¶Role-Physical is one of the eight SF-36 domains. It assesses the limitations in routine activities because of physical health capabilities.⁹

^##Role-Emotional is one of the eight SF-36 domains. It assesses the limitations on routine activities because of emotional factors.⁹

GPA = granulomatosis with polyangiitis; MPA = microscopic polyangiitis.

Glucocorticoid Exposure

Patients in the TAVNEOS® arm experienced a reduction in glucocorticoid exposure

Total glucocorticoid dose decreased for patients in the TAVNEOS® arm by ^10,§§

TAVNEOS® arm = 600 mg;
Active Control arm = 3097.5 mg

TAVNEOS® arm = 1675.5 mg;
Active Control arm = 3846.9 mg

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 non-study-supplied glucocorticoid exposure was balanced between both arms⁴
Results are descriptive

^§§Prednisone equivalent dose per patient.

^§§ Prednisone equivalent dose per patient.

EULAR = European Alliance of Associations for Rheumatology; RTX = rituximab; CYC = cyclophosphamide.

Primary endpoints

At Week 26, the TAVNEOS® arm was noninferior to the Active Control arm in achieving remission^2,*

At Week 52, the TAVNEOS® arm was superior to the Active Control arm in sustaining remission^1,2,†

At Week 26, the TAVNEOS® arm was noninferior to the Active Control arm in achieving remission^2,*

At Week 52, the TAVNEOS® arm was superior to the Active Control arm in sustaining remission^1,2,†

91%

of patients in the TAVNEOS® arm who achieved remission at Week 26 remained in remission at Week 52 vs 78% of patients in the Active Control arm²

The TAVNEOS® arm saw a reduced risk of relapse by half compared to the Active Control Arm²

10.1% of patients in the TAVNEOS® arm experienced a relapse, compared with 21% of patients in the Active Control arm²

The TAVNEOS® arm improved renal function, as measured by eGFR, from baseline compared to the Active Control Arm²

In a subgroup analysis, patients with stage 4 kidney disease at baseline experienced a least-squares mean change in eGFR improvement:^2,4

Patients in the TAVNEOS® arm saw a decrease in albuminuria by Week 4^2,3,**

Prespecified secondary endpoint of patients with renal involvement and albuminuria at baseline; analysis not adjusted for multiplicity and should be considered exploratory. Results should be interpreted with caution.²

Patients in the TAVNEOS® arm experienced improved quality of life³

Patients in the TAVNEOS® arm reported greater improvement across physical and mental health-related quality-of-life metrics at Weeks 26 and 52 compared to patients in the Active Control arm^3,††

Prespecified secondary endpoint not adjusted for multiplicity and should be considered exploratory. Results should be interpreted with caution. The SF-36 was not specifically validated for GPA and MPA.²

Patients in the TAVNEOS® arm experienced a reduction in glucocorticoid exposure

Explore safety and tolerability data

Important safety information

Contraindications

Warnings and Precautions

Adverse Reactions

Drug Interactions

INDICATION

The TAVNEOS® (avacopan) arm was superior compared to the Active Control arm in sustaining remission at 1 year1,2

Primary endpoints

At Week 26, the TAVNEOS® arm was noninferior to the Active Control arm in achieving remission2,*

At Week 52, the TAVNEOS® arm was superior to the Active Control arm in sustaining remission1,2,†

At Week 26, the TAVNEOS® arm was noninferior to the Active Control arm in achieving remission2,*

At Week 52, the TAVNEOS® arm was superior to the Active Control arm in sustaining remission1,2,†

91%

of patients in the TAVNEOS® arm who achieved remission at Week 26 remained in remission at Week 52 vs 78% of patients in the Active Control arm2

The TAVNEOS® arm saw a reduced risk of relapse by half compared to the Active Control Arm2

10.1% of patients in the TAVNEOS® arm experienced a relapse, compared with 21% of patients in the Active Control arm2

The TAVNEOS® arm improved renal function, as measured by eGFR, from baseline compared to the Active Control Arm2

In a subgroup analysis, patients with stage 4 kidney disease at baseline experienced a least-squares mean change in eGFR improvement:2,4

Patients in the TAVNEOS® arm saw a decrease in albuminuria by Week 42,3,**

Prespecified secondary endpoint of patients with renal involvement and albuminuria at baseline; analysis not adjusted for multiplicity and should be considered exploratory. Results should be interpreted with caution.2

Patients in the TAVNEOS® arm experienced improved quality of life3

Patients in the TAVNEOS® arm reported greater improvement across physical and mental health-related quality-of-life metrics at Weeks 26 and 52 compared to patients in the Active Control arm3,††

Prespecified secondary endpoint not adjusted for multiplicity and should be considered exploratory. Results should be interpreted with caution. The SF-36 was not specifically validated for GPA and MPA.2

Patients in the TAVNEOS® arm experienced a reduction in glucocorticoid exposure

Explore safety and tolerability data

Important safety information

Contraindications

Warnings and Precautions

Adverse Reactions

Drug Interactions

INDICATION

The TAVNEOS® (avacopan) arm was superior compared to the Active Control arm in sustaining remission at 1 year^1,2

At Week 26, the TAVNEOS® arm was noninferior to the Active Control arm in achieving remission^2,*

At Week 52, the TAVNEOS® arm was superior to the Active Control arm in sustaining remission^1,2,†

At Week 26, the TAVNEOS® arm was noninferior to the Active Control arm in achieving remission^2,*

At Week 52, the TAVNEOS® arm was superior to the Active Control arm in sustaining remission^1,2,†

of patients in the TAVNEOS® arm who achieved remission at Week 26 remained in remission at Week 52 vs 78% of patients in the Active Control arm²

The TAVNEOS® arm saw a reduced risk of relapse by half compared to the Active Control Arm²

10.1% of patients in the TAVNEOS® arm experienced a relapse, compared with 21% of patients in the Active Control arm²

The TAVNEOS® arm improved renal function, as measured by eGFR, from baseline compared to the Active Control Arm²

In a subgroup analysis, patients with stage 4 kidney disease at baseline experienced a least-squares mean change in eGFR improvement:^2,4

Patients in the TAVNEOS® arm saw a decrease in albuminuria by Week 4^2,3,**

Prespecified secondary endpoint of patients with renal involvement and albuminuria at baseline; analysis not adjusted for multiplicity and should be considered exploratory. Results should be interpreted with caution.²

Patients in the TAVNEOS® arm experienced improved quality of life³

Patients in the TAVNEOS® arm reported greater improvement across physical and mental health-related quality-of-life metrics at Weeks 26 and 52 compared to patients in the Active Control arm^3,††

Prespecified secondary endpoint not adjusted for multiplicity and should be considered exploratory. Results should be interpreted with caution. The SF-36 was not specifically validated for GPA and MPA.²