Renal Recovery for Patients with ANCA-Associated Vasculitis and Low eGFR in the ADVOCATE Trial of Avacopan

the ADVOCATE Study Group; Frank B. Cortazar; John L. Niles; David R.W. Jayne; Peter A. Merkel; Annette Bruchfeld; Huibin Yue; Thomas J. Schall; Pirow Bekker; C. Au Peh; A. Chakera; B. Cooper; J. Kurtkoti; D. Langguth; V. Levidiotis; G. Luxton; P. Mount; D. Mudge; E. Noble; R. Phoon; D. Ranganathan; A. Ritchie; J. Ryan; M. Suranyi; A. Rosenkranz; K. Lhotta; A. Kronbichler; N. Demoulin; C. Bovy; R. Hellemans; J. Hougardy; B. Sprangers; K. Wissing; C. Pagnoux; S. Barbour; S. Brachemi; S. Cournoyer; L. Girard; L. Laurin; P. Liang; D. Philibert; M. Walsh; V. Tesar; R. Becvar; P. Horak; I. Rychlik; W. Szpirt; H. Dieperink; J. Gregersen; P. Ivarsen; E. Krarup; C. Lyngsoe; C. Rigothier; J. Augusto; A. Belot; D. Chauveau; D. Cornec; N. Jourde-Chiche; M. Ficheux; A. Karras; A. Klein; F. Maurier; R. Mesbah; O. Moranne; A. Neel; T. Quemeneur; D. Saadoun; B. Terrier; P. Zaoui; M. Schaier; U. Benck; R. Bergner; M. Busch; J. Floege; F. Grundmann; H. Haller; M. Haubitz; B. Hellmich; J. Henes; B. Hohenstein; C. Hugo; C. Iking-Konert; F. Arndt; T. Kubacki; I. Kotter; P. Lamprecht; T. Lindner; J. Halbritter; H. Mehling; U. Schönermarck; N. Venhoff; V. Vielhauer; O. Witzke; I. Szombati; G. Szucs; G. Garibotto; F. Alberici; E. Brunetta; L. Dagna; S. De Vita; G. Emmi; A. Gabrielli; L. Manenti; F. Pieruzzi; D. Roccatello; C. Salvarani; H. Dobashi; T. Atsumi; S. Fujimoto; N. Hagino; A. Ihata; S. Kaname; Y. Kaneko; A. Katagiri; M. Katayama; Y. Kirino; K. Kitagawa; A. Komatsuda; H. Kono; T. Kurasawa; R. Matsumura; T. Mimura; A. Morinobu; Y. Murakawa; T. Naniwa; T. Nanki; N. Ogawa; H. Oshima; K. Sada; E. Sugiyama; T. Takeuchi; H. Taki; N. Tamura; T. Tsukamoto; K. Yamagata; M. Yamamura; P. van Daele; A. Rutgers; Y. Teng; R. Walker; I. Chua; M. Collins; K. Rabindranath; J. de Zoysa; M. Svensson; B. Grevbo; S. Kalstad; M. Little; M. Clarkson; E. Molloy; I. Agraz Pamplona; J. Anton; V. Barrio Lucia; S. Ciggaran; M. Cinta Cid; M. Diaz Encarnacion; X. Fulladosa Oliveras; M. Jose Soler; H. Marco Rusinol; M. Praga; L. Quintana Porras; A. Segarra; A. Bruchfeld; M. Segelmark; I. Soveri; E. Thomaidi; K. Westman; T. Neumann; M. Burnier; T. Daikeler; J. Dudler; T. Hauser; H. Seeger; B. Vogt; D. Jayne; J. Burton; R. Al Jayyousi; T. Amin; J. Andrews; L. Baines; P. Brogan; B. Dasgupta; T. Doulton; O. Flossmann; S. Griffin; J. Harper; L. Harper; D. Kidder; R. Klocke; P. Lanyon; R. Luqmani; J. McLaren; D. Makanjuola; L. McCann; A. Nandagudi; S. Selvan; E. O'Riordan; M. Patel; R. Patel; C. Pusey; D. Parks

doi:10.1016/j.ekir.2023.01.039

Renal Recovery for Patients with ANCA-Associated Vasculitis and Low eGFR in the ADVOCATE Trial of Avacopan

the ADVOCATE Study Group, Frank B. Cortazar, John L. Niles, David R.W. Jayne, Peter A. Merkel, Annette Bruchfeld, Huibin Yue, Thomas J. Schall, Pirow Bekker, C. Au Peh, A. Chakera, B. Cooper, J. Kurtkoti, D. Langguth, V. Levidiotis, G. Luxton, P. Mount, D. Mudge, E. Noble, R. PhoonD. Ranganathan, A. Ritchie, J. Ryan, M. Suranyi, A. Rosenkranz, K. Lhotta, A. Kronbichler, N. Demoulin, C. Bovy, R. Hellemans, J. Hougardy, B. Sprangers, K. Wissing, C. Pagnoux, S. Barbour, S. Brachemi, S. Cournoyer, L. Girard, L. Laurin, P. Liang, D. Philibert, M. Walsh, V. Tesar, R. Becvar, P. Horak, I. Rychlik, W. Szpirt, H. Dieperink, J. Gregersen, P. Ivarsen, E. Krarup, C. Lyngsoe, C. Rigothier, J. Augusto, A. Belot, D. Chauveau, D. Cornec, N. Jourde-Chiche, M. Ficheux, A. Karras, A. Klein, F. Maurier, R. Mesbah, O. Moranne, A. Neel, T. Quemeneur, D. Saadoun, B. Terrier, P. Zaoui, M. Schaier, U. Benck, R. Bergner, M. Busch, J. Floege, F. Grundmann, H. Haller, M. Haubitz, B. Hellmich, J. Henes, B. Hohenstein, C. Hugo, C. Iking-Konert, F. Arndt, T. Kubacki, I. Kotter, P. Lamprecht, T. Lindner, J. Halbritter, H. Mehling, U. Schönermarck, N. Venhoff, V. Vielhauer, O. Witzke, I. Szombati, G. Szucs, G. Garibotto, F. Alberici, E. Brunetta, L. Dagna, S. De Vita, G. Emmi, A. Gabrielli, L. Manenti, F. Pieruzzi, D. Roccatello, C. Salvarani, H. Dobashi, T. Atsumi, S. Fujimoto, N. Hagino, A. Ihata, S. Kaname, Y. Kaneko, A. Katagiri, M. Katayama, Y. Kirino, K. Kitagawa, A. Komatsuda, H. Kono, T. Kurasawa, R. Matsumura, T. Mimura, A. Morinobu, Y. Murakawa, T. Naniwa, T. Nanki, N. Ogawa, H. Oshima, K. Sada, E. Sugiyama, T. Takeuchi, H. Taki, N. Tamura, T. Tsukamoto, K. Yamagata, M. Yamamura, P. van Daele, A. Rutgers, Y. Teng, R. Walker, I. Chua, M. Collins, K. Rabindranath, J. de Zoysa, M. Svensson, B. Grevbo, S. Kalstad, M. Little, M. Clarkson, E. Molloy, I. Agraz Pamplona, J. Anton, V. Barrio Lucia, S. Ciggaran, M. Cinta Cid, M. Diaz Encarnacion, X. Fulladosa Oliveras, M. Jose Soler, H. Marco Rusinol, M. Praga, L. Quintana Porras, A. Segarra, A. Bruchfeld, M. Segelmark, I. Soveri, E. Thomaidi, K. Westman, T. Neumann, M. Burnier, T. Daikeler, J. Dudler, T. Hauser, H. Seeger, B. Vogt, D. Jayne, J. Burton, R. Al Jayyousi, T. Amin, J. Andrews, L. Baines, P. Brogan, B. Dasgupta, T. Doulton, O. Flossmann, S. Griffin, J. Harper, L. Harper, D. Kidder, R. Klocke, P. Lanyon, R. Luqmani, J. McLaren, D. Makanjuola, L. McCann, A. Nandagudi, S. Selvan, E. O'Riordan, M. Patel, R. Patel, C. Pusey, D. Parks

Research output: Contribution to journal › Article › peer-review

28 Scopus citations

Abstract

Introduction: In the 330-patient ADVOCATE trial of avacopan for the treatment of antineutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis, in which 81% of patients had renal involvement, estimated glomerular filtration rate (eGFR) increased on average 7.3 ml/min per 1.73 m² in the avacopan group and 4.1 ml/min per 1.73 m² in the prednisone group (P = 0.029) at week 52. This new analysis examines the results in the patient subgroup with severe renal insufficiency at enrollment into the trial, i.e., eGFR ≤20 ml/min per 1.73 m². Methods: eGFR was determined at baseline and over the course of the trial. Changes in eGFR were compared between the 2 treatment groups. Results: In ADVOCATE, 27 of 166 patients (16%) in the avacopan group and 23 of 164 patients (14%) in the prednisone group had a baseline eGFR ≤20 ml/min per 1.73 m². At week 52, eGFR increased on average 16.1 and 7.7 ml/min per 1.73 m² in the avacopan and prednisone groups, respectively (P = 0.003). The last eGFR value measured during the 52-week treatment period was ≥2-fold higher than baseline in 41% of patients in the avacopan group compared to 13% in the prednisone group (P = 0.030). More patients in the avacopan group versus prednisone group had increases in eGFR above 20, 30, and 45 ml/min per 1.73 m², respectively. Serious adverse events occurred in 13 of 27 patients (48%) in the avacopan group and 16 of 23 patients (70%) in the prednisone group. Conclusion: Among patients with baseline eGFR ≤20 ml/min per 1.73 m² in the ADVOCATE trial, eGFR improved more in the avacopan group than in the prednisone group.

Original language	English
Pages (from-to)	860-870
Number of pages	11
Journal	Kidney International Reports
Volume	8
Issue number	4
DOIs	https://doi.org/10.1016/j.ekir.2023.01.039
State	Published - Apr 2023

Keywords

ANCA-associated vasculitis
avacopan
complement
complement 5a receptor
low eGFR
renal recovery

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10.1016/j.ekir.2023.01.039

Cite this

the ADVOCATE Study Group, Cortazar, F. B., Niles, J. L., Jayne, D. R. W., Merkel, P. A., Bruchfeld, A., Yue, H., Schall, T. J., Bekker, P., Peh, C. A., Chakera, A., Cooper, B., Kurtkoti, J., Langguth, D., Levidiotis, V., Luxton, G., Mount, P., Mudge, D., Noble, E., ... Parks, D. (2023). Renal Recovery for Patients with ANCA-Associated Vasculitis and Low eGFR in the ADVOCATE Trial of Avacopan. Kidney International Reports, 8(4), 860-870. https://doi.org/10.1016/j.ekir.2023.01.039

@article{f24aeefbd32a48b7926f2bfe01e2bbd0,

title = "Renal Recovery for Patients with ANCA-Associated Vasculitis and Low eGFR in the ADVOCATE Trial of Avacopan",

abstract = "Introduction: In the 330-patient ADVOCATE trial of avacopan for the treatment of antineutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis, in which 81% of patients had renal involvement, estimated glomerular filtration rate (eGFR) increased on average 7.3 ml/min per 1.73 m2 in the avacopan group and 4.1 ml/min per 1.73 m2 in the prednisone group (P = 0.029) at week 52. This new analysis examines the results in the patient subgroup with severe renal insufficiency at enrollment into the trial, i.e., eGFR ≤20 ml/min per 1.73 m2. Methods: eGFR was determined at baseline and over the course of the trial. Changes in eGFR were compared between the 2 treatment groups. Results: In ADVOCATE, 27 of 166 patients (16%) in the avacopan group and 23 of 164 patients (14%) in the prednisone group had a baseline eGFR ≤20 ml/min per 1.73 m2. At week 52, eGFR increased on average 16.1 and 7.7 ml/min per 1.73 m2 in the avacopan and prednisone groups, respectively (P = 0.003). The last eGFR value measured during the 52-week treatment period was ≥2-fold higher than baseline in 41% of patients in the avacopan group compared to 13% in the prednisone group (P = 0.030). More patients in the avacopan group versus prednisone group had increases in eGFR above 20, 30, and 45 ml/min per 1.73 m2, respectively. Serious adverse events occurred in 13 of 27 patients (48%) in the avacopan group and 16 of 23 patients (70%) in the prednisone group. Conclusion: Among patients with baseline eGFR ≤20 ml/min per 1.73 m2 in the ADVOCATE trial, eGFR improved more in the avacopan group than in the prednisone group.",

keywords = "ANCA-associated vasculitis, avacopan, complement, complement 5a receptor, low eGFR, renal recovery",

author = "{the ADVOCATE Study Group} and Cortazar, {Frank B.} and Niles, {John L.} and Jayne, {David R.W.} and Merkel, {Peter A.} and Annette Bruchfeld and Huibin Yue and Schall, {Thomas J.} and Pirow Bekker and Peh, {C. Au} and A. Chakera and B. Cooper and J. Kurtkoti and D. Langguth and V. Levidiotis and G. Luxton and P. Mount and D. Mudge and E. Noble and R. Phoon and D. Ranganathan and A. Ritchie and J. Ryan and M. Suranyi and A. Rosenkranz and K. Lhotta and A. Kronbichler and N. Demoulin and C. Bovy and R. Hellemans and J. Hougardy and B. Sprangers and K. Wissing and C. Pagnoux and S. Barbour and S. Brachemi and S. Cournoyer and L. Girard and L. Laurin and P. Liang and D. Philibert and M. Walsh and V. Tesar and R. Becvar and P. Horak and I. Rychlik and W. Szpirt and H. Dieperink and J. Gregersen and P. Ivarsen and E. Krarup and C. Lyngsoe and C. Rigothier and J. Augusto and A. Belot and D. Chauveau and D. Cornec and N. Jourde-Chiche and M. Ficheux and A. Karras and A. Klein and F. Maurier and R. Mesbah and O. Moranne and A. Neel and T. Quemeneur and D. Saadoun and B. Terrier and P. Zaoui and M. Schaier and U. Benck and R. Bergner and M. Busch and J. Floege and F. Grundmann and H. Haller and M. Haubitz and B. Hellmich and J. Henes and B. Hohenstein and C. Hugo and C. Iking-Konert and F. Arndt and T. Kubacki and I. Kotter and P. Lamprecht and T. Lindner and J. Halbritter and H. Mehling and U. Sch{\"o}nermarck and N. Venhoff and V. Vielhauer and O. Witzke and I. Szombati and G. Szucs and G. Garibotto and F. Alberici and E. Brunetta and L. Dagna and {De Vita}, S. and G. Emmi and A. Gabrielli and L. Manenti and F. Pieruzzi and D. Roccatello and C. Salvarani and H. Dobashi and T. Atsumi and S. Fujimoto and N. Hagino and A. Ihata and S. Kaname and Y. Kaneko and A. Katagiri and M. Katayama and Y. Kirino and K. Kitagawa and A. Komatsuda and H. Kono and T. Kurasawa and R. Matsumura and T. Mimura and A. Morinobu and Y. Murakawa and T. Naniwa and T. Nanki and N. Ogawa and H. Oshima and K. Sada and E. Sugiyama and T. Takeuchi and H. Taki and N. Tamura and T. Tsukamoto and K. Yamagata and M. Yamamura and {van Daele}, P. and A. Rutgers and Y. Teng and R. Walker and I. Chua and M. Collins and K. Rabindranath and {de Zoysa}, J. and M. Svensson and B. Grevbo and S. Kalstad and M. Little and M. Clarkson and E. Molloy and Pamplona, {I. Agraz} and J. Anton and Lucia, {V. Barrio} and S. Ciggaran and Cid, {M. Cinta} and Encarnacion, {M. Diaz} and Oliveras, {X. Fulladosa} and Soler, {M. Jose} and Rusinol, {H. Marco} and M. Praga and Porras, {L. Quintana} and A. Segarra and A. Bruchfeld and M. Segelmark and I. Soveri and E. Thomaidi and K. Westman and T. Neumann and M. Burnier and T. Daikeler and J. Dudler and T. Hauser and H. Seeger and B. Vogt and D. Jayne and J. Burton and {Al Jayyousi}, R. and T. Amin and J. Andrews and L. Baines and P. Brogan and B. Dasgupta and T. Doulton and O. Flossmann and S. Griffin and J. Harper and L. Harper and D. Kidder and R. Klocke and P. Lanyon and R. Luqmani and J. McLaren and D. Makanjuola and L. McCann and A. Nandagudi and S. Selvan and E. O'Riordan and M. Patel and R. Patel and C. Pusey and D. Parks",

note = "Publisher Copyright: {\textcopyright} 2023 International Society of Nephrology",

year = "2023",

month = apr,

doi = "10.1016/j.ekir.2023.01.039",

language = "English",

volume = "8",

pages = "860--870",

journal = "Kidney International Reports",

issn = "2468-0249",

number = "4",

}

the ADVOCATE Study Group, Cortazar, FB, Niles, JL, Jayne, DRW, Merkel, PA, Bruchfeld, A, Yue, H, Schall, TJ, Bekker, P, Peh, CA, Chakera, A, Cooper, B, Kurtkoti, J, Langguth, D, Levidiotis, V, Luxton, G, Mount, P, Mudge, D, Noble, E, Phoon, R, Ranganathan, D, Ritchie, A, Ryan, J, Suranyi, M, Rosenkranz, A, Lhotta, K, Kronbichler, A, Demoulin, N, Bovy, C, Hellemans, R, Hougardy, J, Sprangers, B, Wissing, K, Pagnoux, C, Barbour, S, Brachemi, S, Cournoyer, S, Girard, L, Laurin, L, Liang, P, Philibert, D, Walsh, M, Tesar, V, Becvar, R, Horak, P, Rychlik, I, Szpirt, W, Dieperink, H, Gregersen, J, Ivarsen, P, Krarup, E, Lyngsoe, C, Rigothier, C, Augusto, J, Belot, A, Chauveau, D, Cornec, D, Jourde-Chiche, N, Ficheux, M, Karras, A, Klein, A, Maurier, F, Mesbah, R, Moranne, O, Neel, A, Quemeneur, T, Saadoun, D, Terrier, B, Zaoui, P, Schaier, M, Benck, U, Bergner, R, Busch, M, Floege, J, Grundmann, F, Haller, H, Haubitz, M, Hellmich, B, Henes, J, Hohenstein, B, Hugo, C, Iking-Konert, C, Arndt, F, Kubacki, T, Kotter, I, Lamprecht, P, Lindner, T, Halbritter, J, Mehling, H, Schönermarck, U, Venhoff, N, Vielhauer, V, Witzke, O, Szombati, I, Szucs, G, Garibotto, G, Alberici, F, Brunetta, E, Dagna, L, De Vita, S, Emmi, G, Gabrielli, A, Manenti, L, Pieruzzi, F, Roccatello, D, Salvarani, C, Dobashi, H, Atsumi, T, Fujimoto, S, Hagino, N, Ihata, A, Kaname, S, Kaneko, Y, Katagiri, A, Katayama, M, Kirino, Y, Kitagawa, K, Komatsuda, A, Kono, H, Kurasawa, T, Matsumura, R, Mimura, T, Morinobu, A, Murakawa, Y, Naniwa, T, Nanki, T, Ogawa, N, Oshima, H, Sada, K, Sugiyama, E, Takeuchi, T, Taki, H, Tamura, N, Tsukamoto, T, Yamagata, K, Yamamura, M, van Daele, P, Rutgers, A, Teng, Y, Walker, R, Chua, I, Collins, M, Rabindranath, K, de Zoysa, J, Svensson, M, Grevbo, B, Kalstad, S, Little, M, Clarkson, M, Molloy, E, Pamplona, IA, Anton, J, Lucia, VB, Ciggaran, S, Cid, MC, Encarnacion, MD, Oliveras, XF, Soler, MJ, Rusinol, HM, Praga, M, Porras, LQ, Segarra, A, Bruchfeld, A, Segelmark, M, Soveri, I, Thomaidi, E, Westman, K, Neumann, T, Burnier, M, Daikeler, T, Dudler, J, Hauser, T, Seeger, H, Vogt, B, Jayne, D, Burton, J, Al Jayyousi, R, Amin, T, Andrews, J, Baines, L, Brogan, P, Dasgupta, B, Doulton, T, Flossmann, O, Griffin, S, Harper, J, Harper, L, Kidder, D, Klocke, R, Lanyon, P, Luqmani, R, McLaren, J, Makanjuola, D, McCann, L, Nandagudi, A, Selvan, S, O'Riordan, E, Patel, M, Patel, R, Pusey, C & Parks, D 2023, 'Renal Recovery for Patients with ANCA-Associated Vasculitis and Low eGFR in the ADVOCATE Trial of Avacopan', Kidney International Reports, vol. 8, no. 4, pp. 860-870. https://doi.org/10.1016/j.ekir.2023.01.039

TY - JOUR

T1 - Renal Recovery for Patients with ANCA-Associated Vasculitis and Low eGFR in the ADVOCATE Trial of Avacopan

AU - the ADVOCATE Study Group

AU - Cortazar, Frank B.

AU - Niles, John L.

AU - Jayne, David R.W.

AU - Merkel, Peter A.

AU - Bruchfeld, Annette

AU - Yue, Huibin

AU - Schall, Thomas J.

AU - Bekker, Pirow

AU - Peh, C. Au

AU - Chakera, A.

AU - Cooper, B.

AU - Kurtkoti, J.

AU - Langguth, D.

AU - Levidiotis, V.

AU - Luxton, G.

AU - Mount, P.

AU - Mudge, D.

AU - Noble, E.

AU - Phoon, R.

AU - Ranganathan, D.

AU - Ritchie, A.

AU - Ryan, J.

AU - Suranyi, M.

AU - Rosenkranz, A.

AU - Lhotta, K.

AU - Kronbichler, A.

AU - Demoulin, N.

AU - Bovy, C.

AU - Hellemans, R.

AU - Hougardy, J.

AU - Sprangers, B.

AU - Wissing, K.

AU - Pagnoux, C.

AU - Barbour, S.

AU - Brachemi, S.

AU - Cournoyer, S.

AU - Girard, L.

AU - Laurin, L.

AU - Liang, P.

AU - Philibert, D.

AU - Walsh, M.

AU - Tesar, V.

AU - Becvar, R.

AU - Horak, P.

AU - Rychlik, I.

AU - Szpirt, W.

AU - Dieperink, H.

AU - Gregersen, J.

AU - Ivarsen, P.

AU - Krarup, E.

AU - Lyngsoe, C.

AU - Rigothier, C.

AU - Augusto, J.

AU - Belot, A.

AU - Chauveau, D.

AU - Cornec, D.

AU - Jourde-Chiche, N.

AU - Ficheux, M.

AU - Karras, A.

AU - Klein, A.

AU - Maurier, F.

AU - Mesbah, R.

AU - Moranne, O.

AU - Neel, A.

AU - Quemeneur, T.

AU - Saadoun, D.

AU - Terrier, B.

AU - Zaoui, P.

AU - Schaier, M.

AU - Benck, U.

AU - Bergner, R.

AU - Busch, M.

AU - Floege, J.

AU - Grundmann, F.

AU - Haller, H.

AU - Haubitz, M.

AU - Hellmich, B.

AU - Henes, J.

AU - Hohenstein, B.

AU - Hugo, C.

AU - Iking-Konert, C.

AU - Arndt, F.

AU - Kubacki, T.

AU - Kotter, I.

AU - Lamprecht, P.

AU - Lindner, T.

AU - Halbritter, J.

AU - Mehling, H.

AU - Schönermarck, U.

AU - Venhoff, N.

AU - Vielhauer, V.

AU - Witzke, O.

AU - Szombati, I.

AU - Szucs, G.

AU - Garibotto, G.

AU - Alberici, F.

AU - Brunetta, E.

AU - Dagna, L.

AU - De Vita, S.

AU - Emmi, G.

AU - Gabrielli, A.

AU - Manenti, L.

AU - Pieruzzi, F.

AU - Roccatello, D.

AU - Salvarani, C.

AU - Dobashi, H.

AU - Atsumi, T.

AU - Fujimoto, S.

AU - Hagino, N.

AU - Ihata, A.

AU - Kaname, S.

AU - Kaneko, Y.

AU - Katagiri, A.

AU - Katayama, M.

AU - Kirino, Y.

AU - Kitagawa, K.

AU - Komatsuda, A.

AU - Kono, H.

AU - Kurasawa, T.

AU - Matsumura, R.

AU - Mimura, T.

AU - Morinobu, A.

AU - Murakawa, Y.

AU - Naniwa, T.

AU - Nanki, T.

AU - Ogawa, N.

AU - Oshima, H.

AU - Sada, K.

AU - Sugiyama, E.

AU - Takeuchi, T.

AU - Taki, H.

AU - Tamura, N.

AU - Tsukamoto, T.

AU - Yamagata, K.

AU - Yamamura, M.

AU - van Daele, P.

AU - Rutgers, A.

AU - Teng, Y.

AU - Walker, R.

AU - Chua, I.

AU - Collins, M.

AU - Rabindranath, K.

AU - de Zoysa, J.

AU - Svensson, M.

AU - Grevbo, B.

AU - Kalstad, S.

AU - Little, M.

AU - Clarkson, M.

AU - Molloy, E.

AU - Pamplona, I. Agraz

AU - Anton, J.

AU - Lucia, V. Barrio

AU - Ciggaran, S.

AU - Cid, M. Cinta

AU - Encarnacion, M. Diaz

AU - Oliveras, X. Fulladosa

AU - Soler, M. Jose

AU - Rusinol, H. Marco

AU - Praga, M.

AU - Porras, L. Quintana

AU - Segarra, A.

AU - Bruchfeld, A.

AU - Segelmark, M.

AU - Soveri, I.

AU - Thomaidi, E.

AU - Westman, K.

AU - Neumann, T.

AU - Burnier, M.

AU - Daikeler, T.

AU - Dudler, J.

AU - Hauser, T.

AU - Seeger, H.

AU - Vogt, B.

AU - Jayne, D.

AU - Burton, J.

AU - Al Jayyousi, R.

AU - Amin, T.

AU - Andrews, J.

AU - Baines, L.

AU - Brogan, P.

AU - Dasgupta, B.

AU - Doulton, T.

AU - Flossmann, O.

AU - Griffin, S.

AU - Harper, J.

AU - Harper, L.

AU - Kidder, D.

AU - Klocke, R.

AU - Lanyon, P.

AU - Luqmani, R.

AU - McLaren, J.

AU - Makanjuola, D.

AU - McCann, L.

AU - Nandagudi, A.

AU - Selvan, S.

AU - O'Riordan, E.

AU - Patel, M.

AU - Patel, R.

AU - Pusey, C.

AU - Parks, D.

PY - 2023/4

Y1 - 2023/4

N2 - Introduction: In the 330-patient ADVOCATE trial of avacopan for the treatment of antineutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis, in which 81% of patients had renal involvement, estimated glomerular filtration rate (eGFR) increased on average 7.3 ml/min per 1.73 m2 in the avacopan group and 4.1 ml/min per 1.73 m2 in the prednisone group (P = 0.029) at week 52. This new analysis examines the results in the patient subgroup with severe renal insufficiency at enrollment into the trial, i.e., eGFR ≤20 ml/min per 1.73 m2. Methods: eGFR was determined at baseline and over the course of the trial. Changes in eGFR were compared between the 2 treatment groups. Results: In ADVOCATE, 27 of 166 patients (16%) in the avacopan group and 23 of 164 patients (14%) in the prednisone group had a baseline eGFR ≤20 ml/min per 1.73 m2. At week 52, eGFR increased on average 16.1 and 7.7 ml/min per 1.73 m2 in the avacopan and prednisone groups, respectively (P = 0.003). The last eGFR value measured during the 52-week treatment period was ≥2-fold higher than baseline in 41% of patients in the avacopan group compared to 13% in the prednisone group (P = 0.030). More patients in the avacopan group versus prednisone group had increases in eGFR above 20, 30, and 45 ml/min per 1.73 m2, respectively. Serious adverse events occurred in 13 of 27 patients (48%) in the avacopan group and 16 of 23 patients (70%) in the prednisone group. Conclusion: Among patients with baseline eGFR ≤20 ml/min per 1.73 m2 in the ADVOCATE trial, eGFR improved more in the avacopan group than in the prednisone group.

AB - Introduction: In the 330-patient ADVOCATE trial of avacopan for the treatment of antineutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis, in which 81% of patients had renal involvement, estimated glomerular filtration rate (eGFR) increased on average 7.3 ml/min per 1.73 m2 in the avacopan group and 4.1 ml/min per 1.73 m2 in the prednisone group (P = 0.029) at week 52. This new analysis examines the results in the patient subgroup with severe renal insufficiency at enrollment into the trial, i.e., eGFR ≤20 ml/min per 1.73 m2. Methods: eGFR was determined at baseline and over the course of the trial. Changes in eGFR were compared between the 2 treatment groups. Results: In ADVOCATE, 27 of 166 patients (16%) in the avacopan group and 23 of 164 patients (14%) in the prednisone group had a baseline eGFR ≤20 ml/min per 1.73 m2. At week 52, eGFR increased on average 16.1 and 7.7 ml/min per 1.73 m2 in the avacopan and prednisone groups, respectively (P = 0.003). The last eGFR value measured during the 52-week treatment period was ≥2-fold higher than baseline in 41% of patients in the avacopan group compared to 13% in the prednisone group (P = 0.030). More patients in the avacopan group versus prednisone group had increases in eGFR above 20, 30, and 45 ml/min per 1.73 m2, respectively. Serious adverse events occurred in 13 of 27 patients (48%) in the avacopan group and 16 of 23 patients (70%) in the prednisone group. Conclusion: Among patients with baseline eGFR ≤20 ml/min per 1.73 m2 in the ADVOCATE trial, eGFR improved more in the avacopan group than in the prednisone group.

KW - ANCA-associated vasculitis

KW - avacopan

KW - complement

KW - complement 5a receptor

KW - low eGFR

KW - renal recovery

UR - http://www.scopus.com/inward/record.url?scp=85150032852&partnerID=8YFLogxK

U2 - 10.1016/j.ekir.2023.01.039

DO - 10.1016/j.ekir.2023.01.039

M3 - Article

C2 - 37069984

AN - SCOPUS:85150032852

SN - 2468-0249

VL - 8

SP - 860

EP - 870

JO - Kidney International Reports

JF - Kidney International Reports

IS - 4

ER -

Renal Recovery for Patients with ANCA-Associated Vasculitis and Low eGFR in the ADVOCATE Trial of Avacopan

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