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

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.; 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.; Schonermarck, 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, I. A.; Anton, J.; Lucia, V. B.; Ciggaran, S.; Cid, M. C.; Encarnacion, M. D.; Oliveras, X. F.; Soler, M. J.; Rusinol, H. M.; Praga, M.; Porras, L. Q.; 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.; Rajakariar, R.; Robson, J.; Robson, M.; Salama, A.; Smyth, L.; Sznajd, J.; Taylor, J.; Merkel, P.; Sreih, A.; Belilos, E.; Bomback, A.; Carlin, J.; Chen Lin, Y. C.; Derebail, V.; Dragoi, S.; Dua, A.; Forbess, L.; Geetha, D.; Gipson, P.; Gohh, R.; Greenwood, G. T.; Hugenberg, S.; Jimenez, R.; Kaskas, M.; Kermani, T.; Kivitz, A.; Koening, C.; Langford, C.; Marder, G.; Mohamed, A.; Monach, P.; Neyra, N.; Niemer, G.; Niles, J.; Obi, R.; Owens, C.; Parks, D.; Podoll, A.; Rovin, B.; Sam, R.; Shergy, W.; Silva, A.; Specks, U.; Spiera, R.; Springer, J.; Striebich, C.; Swarup, A.; Thakar, S.; Tiliakos, A.; Tsai, Y.; Waguespack, D.; Wasko, M. C.

doi:10.1016/j.ekir.2023.01.039

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.

Renal Recovery for Patients with ANCA-Associated Vasculitis and Low eGFR in the ADVOCATE Trial of Avacopan / 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., Phoon, R., Ranganathan, D., et al.. - In: KIDNEY INTERNATIONAL REPORTS. - ISSN 2468-0249. - 8:4(2023), pp. 860-870. [10.1016/j.ekir.2023.01.039]

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

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.;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.;Schonermarck 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 I. A.;Anton J.;Lucia V. B.;Ciggaran S.;Cid M. C.;Encarnacion M. D.;Oliveras X. F.;Soler M. J.;Rusinol H. M.;Praga M.;Porras L. Q.;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.;Rajakariar R.;Robson J.;Robson M.;Salama A.;Smyth L.;Sznajd J.;Taylor J.;Merkel P.;Sreih A.;Belilos E.;Bomback A.;Carlin J.;Chen Lin Y. C.;Derebail V.;Dragoi S.;Dua A.;Forbess L.;Geetha D.;Gipson P.;Gohh R.;Greenwood G. T.;Hugenberg S.;Jimenez R.;Kaskas M.;Kermani T.;Kivitz A.;Koening C.;Langford C.;Marder G.;Mohamed A.;Monach P.;Neyra N.;Niemer G.;Niles J.;Obi R.;Owens C.;Parks D.;Podoll A.;Rovin B.;Sam R.;Shergy W.;Silva A.;Specks U.;Spiera R.;Springer J.;Striebich C.;Swarup A.;Thakar S.;Tiliakos A.;Tsai Y.;Waguespack D.;Wasko M. C.

2023

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.

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Scheda completa (DC)

	Anno di pubblicazione
	
				2023
			
	Rivista
	
				KIDNEY INTERNATIONAL REPORTS
			
	N° del Volume
	
				8
			
	Fascicolo
	
				4
			
	Pagina iniziale
	
				860
			
	Pagina finale
	
				870
			
	Codice DOI
	
				https://dx.doi.org/10.1016/j.ekir.2023.01.039
			
	Codice WoS
	
				WOS:000971164400001
			
	Codice Scopus
	
				2-s2.0-85150032852
			
	Citazione
	
				Renal Recovery for Patients with ANCA-Associated Vasculitis and Low eGFR in the ADVOCATE Trial of Avacopan / 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., Phoon, R., Ranganathan, D., et al.. - In: KIDNEY INTERNATIONAL REPORTS. - ISSN 2468-0249. - 8:4(2023), pp. 860-870. [10.1016/j.ekir.2023.01.039]
			
	Tutti gli autori
	
						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.;...espandi
						
	Tipologia
	
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