Table 1.

Demographics and baseline characteristicsa

CategoryPlacebo plus 60 mg Prednisone Control (n=23)Avacopan plus 20 mg Prednisone (n=22)Avacopan without Prednisone (n=22)
Age, y59.1±14.057.0±14.257.4±14.0
Men/women, no.17/614/816/6
White race, no.232222
Duration of vasculitis, months0 (0–162)0 (0–61)1 (0–108)
Body mass index, kg/m227.3±7.124.9±4.026.5±4.7
Disease history, no. (%)
 Newly diagnosed18 (78)15 (68)16 (73)
 Relapsed disease5 (22)7 (32)6 (27)
ANCA type, no. (%)
 Anti-myeloperoxidase–positive10 (43)12 (55)13 (59)
 Anti-proteinase 3 positive11 (48)10 (45)8 (36)
 Both anti-myeloperoxidase– and anti–proteinase 3–positive1 (4)00
 ANCA equivocal or negative1 (4)01 (5)
Disease type, no. (%)
 Granulomatosis with polyangiitis10 (44)11 (50)12 (55)
 Microscopic polyangiitis12 (52)11 (50)10 (45)
 Unknown1 (4)00
Disease assessment scores
 BVASb13.2±5.814.3±6.013.8±6.4
 Vasculitis damage index1.2±1.40.9±1.50.5±1.2
Organ involvement, no. (%)
 Renal involvement23 (100)21 (95)21 (95)
  Rise in serum creatinine2 (9)00
  High serum creatinine15 (65)11 (50)6 (27)c
  Hematuria22 (96)20 (91)21 (95)
  Proteinuria18 (78)20 (91)16 (73)
  Hypertension3 (13)5 (23)2 (9)
 Pulmonary involvement9 (39)8 (36)7 (32)
 Constitutional signs or symptomsd19 (83)17 (77)16 (73)
 Cutaneous involvement4 (17)1 (5)4 (18)
 Mucous membranes and eyes1 (4)1 (5)4 (18)
 Ear, nose, and throat9 (39)5 (23)8 (36)
 Cardiovascular involvement01 (5)2 (9)
 Neurologic involvement3 (13)5 (23)2 (9)
eGFR, ml/min per 1.73 m2e47.6±15.152.5±26.754.7±19.6
UACR, mg/gf354 (28–5962)279 (24–2459)283 (25–3051)
Prior medications of interest
 Systemic glucocorticoids, no. (%)11 (48)14 (64)11 (50)
  Prednisone-equivalent daily dose  per patient, mg534944
  IV glucocorticoids, no. (%)5 (25)9 (41)5 (23)
 Immunosuppressants including azathioprine, methotrexate, or mycophenolate mofetil, no. (%)2 (9)4 (18)3 (14)
 Cyclophosphamide or rituximab, no.000
  • a Plus-minus values are mean±SD.

  • b The BVAS version 3 was used to capture vasculitis disease activity. The score ranges from 0 to 63, with higher scores denoting more severe disease activity.

  • c P<0.05 for comparison of avacopan versus control; Fisher exact test.

  • d Constitutional signs and symptoms included weight loss, fever, arthralgia, and myalgia.

  • e eGFR on the basis of the Modified Diet in Renal Disease equation derived from serum creatinine (see Supplemental Material).

  • f UACR values are geometric means and ranges.