The impact of treatment with avacopan on health-related quality of life in antineutrophil cytoplasmic antibody-associated vasculitis: a post-hoc analysis of data from the ADVOCATE trial

作者：Vibeke Strand, David Jayne, Audra Horomanski, Huibin Yue, Pirow Bekker, Peter A. Merkel, Chen Au Peh, Aron Chakera, Bruce A. Cooper, Jagadeesh Kurtkoti, Daman Langguth, Vicki Levidiotis, Grant Luxton, Peter F. Mount, David W. Mudge, Euan Noble, Richard Phoon, Dwarakanathan Ranganathan, Angus Ritchie, Jessica Ryan, Michael Suranyi, Alexander R. Rosenkranz, Karl Lhotta, Andreas Kronbichler, Nathalie Demoulin, Christophe Bovy, Rachel Hellemans, Jean‐Michel Hougardy, Ben Sprangers, Karl Martin Wissing, Christian Pagnoux, Sean Barbour, Soumeya Brachemi, Serge Cournoyer, Louis Girard, Louis‐Philippe Laurin, Patrick Liang, David Philibert, Michael Walsh, Vladimı́r Tesař, Radim Bečvář, Pavel Hořák, Ivan Rychlík, Wladimir Szpirt, Hans Dieperink, Jon Waarst Gregersen, Per Ivarsen, Elizabeth Krarup, Cecilie Lyngsøe, Claire Rigothier, Jean‐François Augusto, Alexandre Bélot, Dominique Chauveau, Divi Cornec, Noémie Jourde‐Chiche, Maxence Ficheux, Alexandre Karras, Alexandre Klein, F. Maurier, Rafik Mesbah, Olivier Moranne, A. Néel, T. Quéméneur, David Saadoun, Benjamin Terrier, Philippe Zaoui, Matthias Schaier, Urs Benck, Raoul Bergner, Martin Busch, J. Floege, Franziska Grundmann, Hermann Haller, Marion Haubitz, Bernhard Hellmich, J. Henes, Bernd Hohenstein, Christian Hugo, Christof Iking‐Konert, Fabian Arndt, Torsten Kubacki, Ina Kötter, Peter Lamprecht, Tom H. Lindner, Jan Halbritter, Heidrun Mehling, Ulf Schönermarck, Nils Venhoff, Volker Vielhauer, Oliver Witzke, István Szombati, Gabriella Szűcs, Giacomo Garibotto, Federico Alberici, Enrico Brunetta, Lorenzo Dagna, Salvatore De Vita, Giacomo Emmi, Armando Gabrielli, Lucio Manenti, Federico Pieruzzi, Dario Roccatello, Carlo Salvarani, Masayoshi Harigai, Hiroaki Dobashi, Tatsuya Atsumi, Shoichi Fujimoto, Noboru Hagino, Atsushi Ihata, Shinya Kaname, Yuko Kaneko, Akira Katagiri, Masao Katayama, Yohei Kirino, Kiyoki Kitagawa, Atsushi Komatsuda, Hajime Kono, Takahiko Kurasawa, Ryutaro Matsumura, Toshihide Mimura, Akio Morinobu, Yohko Murakawa, Taio Naniwa, Toshihiro Nanki, Noriyoshi Ogawa, Hisaji Oshima, Ken‐ei Sada, Eiji Sugiyama, Tohru Takeuchi, Hirofumi Taki, Naoto Tamura, Tatsuo Tsukamoto, Yamagata Kunihiro, Masahiro Yamamura, Paulus L. A. van Daele, Abraham Rutgers, Y K Onno Teng, Robert Walker, Ignatius Chua, Michael P. Collins, Kannaiyan S Rabindranath, Janak de Zoysa, My Svensson, Bard-Waldum Grevbo, Synove Kalstad, Mark A. Little, Michael Clarkson, Eamonn Molloy, Irene Agraz Pamplona, Jordi Antón, Vicente Barrio Lucía, Secundino Ciggaran, María C. Cid, Montserrat M. Díaz Encarnación, Xavier Fulladosa Oliveras, María José Soler, Helena Marco Rusiñol, Manuel Praga, Luis Quintana Porras, Alfons Segarra, Annette Bruchfeld, Mårten Segelmark, Inga Soveri, Eleni Thomaidi, Kerstin Westman, Thomas Neumann, Michel Burnier, Thomas Daikeler, Jean Dudler, Thomas Häuser, Harald Seeger, Bruno Vogt, James O. Burton, Reem Al Jayyousi, Tania Amin, Jacqueline Andrews, Laura Anne Baines, Paul Brogan, Bhaskar Dasgupta, Timothy William Ronald Doulton, Oliver Floßmann, Siân Griffin, Janice Marian Harper, Lorraine Harper, Dana Kidder, Rainer Klocke, Peter Lanyon, Raashid Luqmani, John S McLaren, David Makanjuola, Liza McCann, Anupama Nandagudi, Shilpa Selvan, Edmond O’Riordan, Mumtaz Patel, Rajan K. Patel, Charles D. Pusey, Ravindra Rajakariar, Joanna Robson, Michael G. Robson, Alan D. Salama, Lucy Smyth, J Sznajd, Joanne Taylor, Antonie G. Sreih, Elise Belilos, Andrew S. Bomback, Jeffrey Carlin, Yih Chang Lin, Vimal K. Derebail, Serban Dragoi, Anisha B. Dua, Lindsy Forbess, Duvuru Geetha, Patrick E. Gipson, Reginald Gohh, Gregory Todd Greenwood, Steven T. Hugenberg, Richard A.H. Jimenez, Marwan Omar Kaskas, Tanaz A. Kermani, Alan Kivitz, Curry L. Koening, Carol A. Langford, Galina Marder, Amr Ahmed El-Huesseini Mohamed, Paul A. Monach, Nilda Roxana Neyra, Gregory W. Niemer, John L. Niles, Reginald Obi, Charles Owens, Deborah L. Parks, Amber S. Podoll, Brad H. Rovin, R. Sam, William Julius Shergy, Arnold Lawrence Silva, Ulrich Specks, Robert Spiera, Jason Springer, Christopher Charles Striebich, Areena Swarup, Surabhi Thakar, Athan N. Tiliakos, Yong Tsai, Dia R. Waguespack, Mary Chester Wasko · 发表于：The Lancet Rheumatology · 年份：2023 · DOI：10.1016/s2665-9913(23)00092-9 · 被引用次数：31 · 研究领域：Vasculitis and related conditions、Systemic Sclerosis and Related Diseases、Autoimmune Bullous Skin Diseases

BACKGROUND: Antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis is characterised by inflammation and destruction of small to medium sized blood vessels. In the previously reported ADVOCATE study, a phase 3 double-blind, double-dummy randomised controlled trial of patients with newly diagnosed or relapsing ANCA-associated vasculitis, the oral selective complement 5a receptor inhibitor avacopan was shown to be non-inferior with regard to remission induction at week 26 and superior with regard to sustained remission at week 52, compared with a prednisone taper in a standard of care regimen. In this Article, we report an in-depth analysis of prespecified and exploratory patient-reported outcomes from the ADVOCATE study, measuring health-related quality of life and health utilities. METHODS: We did a post-hoc analysis of patient-reported outcome data from the ADVOCATE study (NCT02994927) of patients with newly diagnosed or relapsing ANCA-associated vasculitis. We analysed summary scores and individual domain scores for the prespecified health-related quality of life outcomes from ADVOCATE, which were evaluated at weeks 26 and 52 by use of the Medical Outcomes Survey 36-Item Short Form Health Survey (SF-36) version 2, the EuroQol 5-Dimensions 5-Levels Questionnaire (EQ-5D-5L), and the EQ-5D health utility measure, assessed in the modified intention-to-treat population. We also calculated the Short Form 6 Dimension (SF-6D) score as an additional health utility measure. ...