Universität zu Köln

Jayne, David R. W., Bruchfeld, Annette N., Harper, Lorraine, Schaier, Matthias ORCID: 0000-0003-1040-1150, Venning, Michael C., Hamilton, Patrick ORCID: 0000-0001-6703-3745, Burst, Volker, Grundmann, Franziska, Jadoul, Michel, Szombati, Istvan, Tesar, Vladimir, Segelmark, Marten, Potarca, Antonia, Schall, Thomas J. and Bekker, Pirow (2017). Randomized Trial of C5a Receptor Inhibitor Avacopan in ANCA-Associated Vasculitis. J. Am. Soc. Nephrol., 28 (9). S. 2756 - 2768. WASHINGTON: AMER SOC NEPHROLOGY. ISSN 1533-3450

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Abstract

Alternative C activation is involved in the pathogenesis of ANCA-associated vasculitis. However, glucocorticoids used as treatment contribute to the morbidity and mortality of vasculitis. We determined whether avacopan (CCX168), an orally administered, selective C5a receptor inhibitor, could replace oral glucocorticoids without compromising efficacy. In this randomized, placebo-controlled trial, adults with newly diagnosed or relapsing vasculitis received placebo plus prednisone starting at 60 mg daily (control group), avacopan (30 mg, twice daily) plus reduced-dose prednisone (20 mg daily), or avacopan (30 mg, twice daily) without prednisone. All patients received cyclophosphamide or rituximab. The primary efficacy measure was the proportion of patients achieving a >= 50% reduction in Birmingham Vasculitis Activity Score by week 12 and no worsening in any body system. We enrolled 67 patients, 23 in the control and 22 in each of the avacopan groups. Clinical response at week 12 was achieved in 14 of 20 (70.0%) control patients, 19 of 22 (86.4%) patients in the avacopan plus reduced-dose prednisone group (difference from control 16.4%; two-sided 90% confidence limit, -4.3% to 37.1%; P=0.002 for noninferiority), and 17 of 21 (81.0%) patients in the avacopan without prednisone group (difference from control 11.0%; two-sided 90% confidence limit, -11.0% to 32.9%; P=0.01 for noninferiority). Adverse events occurred in 21 of 23 (91%) control patients, 19 of 22 (86%) patients in the avacopan plus reduced-dose prednisone group, and 21 of 22 (96%) patients in the avacopan without prednisone group. In conclusion, C5a receptor inhibition with avacopan was effective in replacing high-dose glucocorticoids in treating vasculitis.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Jayne, David R. W. UNSPECIFIED UNSPECIFIED UNSPECIFIED Bruchfeld, Annette N. UNSPECIFIED UNSPECIFIED UNSPECIFIED Harper, Lorraine UNSPECIFIED UNSPECIFIED UNSPECIFIED Schaier, Matthias UNSPECIFIED orcid.org/0000-0003-1040-1150 UNSPECIFIED Venning, Michael C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hamilton, Patrick UNSPECIFIED orcid.org/0000-0001-6703-3745 UNSPECIFIED Burst, Volker UNSPECIFIED UNSPECIFIED UNSPECIFIED Grundmann, Franziska UNSPECIFIED UNSPECIFIED UNSPECIFIED Jadoul, Michel UNSPECIFIED UNSPECIFIED UNSPECIFIED Szombati, Istvan UNSPECIFIED UNSPECIFIED UNSPECIFIED Tesar, Vladimir UNSPECIFIED UNSPECIFIED UNSPECIFIED Segelmark, Marten UNSPECIFIED UNSPECIFIED UNSPECIFIED Potarca, Antonia UNSPECIFIED UNSPECIFIED UNSPECIFIED Schall, Thomas J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Bekker, Pirow UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-220967
DOI:	10.1681/ASN.2016111179
Journal or Publication Title:	J. Am. Soc. Nephrol.
Volume:	28
Number:	9
Page Range:	S. 2756 - 2768
Date:	2017
Publisher:	AMER SOC NEPHROLOGY
Place of Publication:	WASHINGTON
ISSN:	1533-3450
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language MONOCYTE CHEMOATTRACTANT PROTEIN-1; WEGENERS-GRANULOMATOSIS; CYCLOPHOSPHAMIDE; SURVIVAL; RITUXIMAB; THERAPY; DECLINE; RELAPSE; MARKER; INJURY Multiple languages Urology & Nephrology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/22096