Alveolar Hemorrhage in Antineutrophil Cytoplasmic Antibody–Associated Vasculitis: Results of an International Randomized Controlled Trial (PEXIVAS)
Diffuse alveolar hemorrhage (DAH) is a life-threatening manifestation of antineutrophil cytoplasmic antibody-associated vasculitis (AAV). The PEXIVAS (Plasma Exchange and Glucocorticoids in Severe Antineutrophil Cytoplasmic Antibody-Associated Vasculitis) (NCT00987389) trial was the largest in AAV a...
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| Published in | American journal of respiratory and critical care medicine Vol. 209; no. 9; pp. 1141 - 1151 |
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| Main Authors | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
American Thoracic Society
01.05.2024
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| Subjects | |
| Online Access | Get full text |
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| Abstract | Diffuse alveolar hemorrhage (DAH) is a life-threatening manifestation of antineutrophil cytoplasmic antibody-associated vasculitis (AAV). The PEXIVAS (Plasma Exchange and Glucocorticoids in Severe Antineutrophil Cytoplasmic Antibody-Associated Vasculitis) (NCT00987389) trial was the largest in AAV and the first to enroll participants with DAH requiring mechanical ventilation.
Evaluate characteristics, treatment effects, and outcomes for patients with AAV with and without DAH.
PEXIVAS randomized 704 participants to plasma exchange (PLEX) or no-PLEX and reduced or standard-dose glucocorticoids (GC). DAH status was defined at enrollment as no-DAH, nonsevere, or severe (room air oxygen saturation of ⩽ 85% as measured by pulse oximetry, or use of mechanical ventilation).
At enrollment, 191 (27.1%) participants had DAH (61 severe, including 29 ventilated) and were younger, more frequently relapsing, PR3 (proteinase 3)-ANCA positive, and had lower serum creatinine but were more frequently dialyzed than participants without DAH (
= 513; 72.9%). Among those with DAH, 8/95 (8.4%) receiving PLEX died within 1 year versus 15/96 (15.6%) with no-PLEX (hazard ratio, 0.52; confidence interval [CI], 0.21-1.24), whereas 13/96 (13.5%) receiving reduced GC died versus 10/95 (10.5%) with standard GC (hazard ratio, 1.33; CI, 0.57-3.13). When ventilated, ventilator-free days were similar with PLEX versus no-PLEX (medians, 25; interquartile range [IQR], 22-26 vs. 22-27) and fewer with reduced GC (median, 23; IQR, 20-25) versus standard GC (median, 26; IQR, 25-28). Treatment effects on mortality did not vary by presence or severity of DAH. Overall, 23/191 (12.0%) with DAH died within 1 year versus 34/513 (6.6%) without DAH. End-stage kidney disease and serious infections did not differ by DAH status or treatments.
Patients with AAV and DAH differ from those without DAH in multiple ways. Further data are required to confirm or refute a benefit of PLEX or GC dosing on mortality. Original clinical trial registered with www.clinicaltrials.gov (NCT00987389). |
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| AbstractList | Diffuse alveolar hemorrhage (DAH) is a life-threatening manifestation of antineutrophil cytoplasmic antibody-associated vasculitis (AAV). The PEXIVAS (Plasma Exchange and Glucocorticoids in Severe Antineutrophil Cytoplasmic Antibody-Associated Vasculitis) (NCT00987389) trial was the largest in AAV and the first to enroll participants with DAH requiring mechanical ventilation.
Evaluate characteristics, treatment effects, and outcomes for patients with AAV with and without DAH.
PEXIVAS randomized 704 participants to plasma exchange (PLEX) or no-PLEX and reduced or standard-dose glucocorticoids (GC). DAH status was defined at enrollment as no-DAH, nonsevere, or severe (room air oxygen saturation of ⩽ 85% as measured by pulse oximetry, or use of mechanical ventilation).
At enrollment, 191 (27.1%) participants had DAH (61 severe, including 29 ventilated) and were younger, more frequently relapsing, PR3 (proteinase 3)-ANCA positive, and had lower serum creatinine but were more frequently dialyzed than participants without DAH (
= 513; 72.9%). Among those with DAH, 8/95 (8.4%) receiving PLEX died within 1 year versus 15/96 (15.6%) with no-PLEX (hazard ratio, 0.52; confidence interval [CI], 0.21-1.24), whereas 13/96 (13.5%) receiving reduced GC died versus 10/95 (10.5%) with standard GC (hazard ratio, 1.33; CI, 0.57-3.13). When ventilated, ventilator-free days were similar with PLEX versus no-PLEX (medians, 25; interquartile range [IQR], 22-26 vs. 22-27) and fewer with reduced GC (median, 23; IQR, 20-25) versus standard GC (median, 26; IQR, 25-28). Treatment effects on mortality did not vary by presence or severity of DAH. Overall, 23/191 (12.0%) with DAH died within 1 year versus 34/513 (6.6%) without DAH. End-stage kidney disease and serious infections did not differ by DAH status or treatments.
Patients with AAV and DAH differ from those without DAH in multiple ways. Further data are required to confirm or refute a benefit of PLEX or GC dosing on mortality. Original clinical trial registered with www.clinicaltrials.gov (NCT00987389). Fussner et al discuss their study on the characteristics, treatment effects, and outcomes for patients with antineutrophil cytoplasmic antibody-associated vasculitis (AAV)with and without diffuse alveolar hemorrhage (DAH). DAH is a severe manifestation of AAV that can be life-threatening. The PEXIVAS trial included participants with DAH requiring mechanical ventilation, providing an opportunity to study the characteristics and outcomes of these patients. Participants with DAH were younger, more frequently positive for anti-PR3 antibodies, and had more relapsing disease compared to those without DAH. They also had lower baseline creatinine levels but were more frequently on hemodialysis. Participants with DAH had a higher risk of death, particularly within the first 30 days and 3 months. Plasma exchange (PLEX) did not significantly affect survival in participants with DAH, and there was no difference in ventilator-free days between the PLEX and no PLEX groups. The effects of glucocorticoid (GC) dosing regimen on survival were also not significant. Rationale: Diffuse alveolar hemorrhage (DAH) is a life-threatening manifestation of antineutrophil cytoplasmic antibody-associated vasculitis (AAV). The PEXIVAS (Plasma Exchange and Glucocorticoids in Severe Antineutrophil Cytoplasmic Antibody-Associated Vasculitis) (NCT00987389) trial was the largest in AAV and the first to enroll participants with DAH requiring mechanical ventilation. Objectives: Evaluate characteristics, treatment effects, and outcomes for patients with AAV with and without DAH. Methods: PEXIVAS randomized 704 participants to plasma exchange (PLEX) or no-PLEX and reduced or standard-dose glucocorticoids (GC). DAH status was defined at enrollment as no-DAH, nonsevere, or severe (room air oxygen saturation of ⩽ 85% as measured by pulse oximetry, or use of mechanical ventilation). Measurements and Main Results: At enrollment, 191 (27.1%) participants had DAH (61 severe, including 29 ventilated) and were younger, more frequently relapsing, PR3 (proteinase 3)-ANCA positive, and had lower serum creatinine but were more frequently dialyzed than participants without DAH (n = 513; 72.9%). Among those with DAH, 8/95 (8.4%) receiving PLEX died within 1 year versus 15/96 (15.6%) with no-PLEX (hazard ratio, 0.52; confidence interval [CI], 0.21-1.24), whereas 13/96 (13.5%) receiving reduced GC died versus 10/95 (10.5%) with standard GC (hazard ratio, 1.33; CI, 0.57-3.13). When ventilated, ventilator-free days were similar with PLEX versus no-PLEX (medians, 25; interquartile range [IQR], 22-26 vs. 22-27) and fewer with reduced GC (median, 23; IQR, 20-25) versus standard GC (median, 26; IQR, 25-28). Treatment effects on mortality did not vary by presence or severity of DAH. Overall, 23/191 (12.0%) with DAH died within 1 year versus 34/513 (6.6%) without DAH. End-stage kidney disease and serious infections did not differ by DAH status or treatments. Conclusions: Patients with AAV and DAH differ from those without DAH in multiple ways. Further data are required to confirm or refute a benefit of PLEX or GC dosing on mortality. Original clinical trial registered with www.clinicaltrials.gov (NCT00987389).Rationale: Diffuse alveolar hemorrhage (DAH) is a life-threatening manifestation of antineutrophil cytoplasmic antibody-associated vasculitis (AAV). The PEXIVAS (Plasma Exchange and Glucocorticoids in Severe Antineutrophil Cytoplasmic Antibody-Associated Vasculitis) (NCT00987389) trial was the largest in AAV and the first to enroll participants with DAH requiring mechanical ventilation. Objectives: Evaluate characteristics, treatment effects, and outcomes for patients with AAV with and without DAH. Methods: PEXIVAS randomized 704 participants to plasma exchange (PLEX) or no-PLEX and reduced or standard-dose glucocorticoids (GC). DAH status was defined at enrollment as no-DAH, nonsevere, or severe (room air oxygen saturation of ⩽ 85% as measured by pulse oximetry, or use of mechanical ventilation). Measurements and Main Results: At enrollment, 191 (27.1%) participants had DAH (61 severe, including 29 ventilated) and were younger, more frequently relapsing, PR3 (proteinase 3)-ANCA positive, and had lower serum creatinine but were more frequently dialyzed than participants without DAH (n = 513; 72.9%). Among those with DAH, 8/95 (8.4%) receiving PLEX died within 1 year versus 15/96 (15.6%) with no-PLEX (hazard ratio, 0.52; confidence interval [CI], 0.21-1.24), whereas 13/96 (13.5%) receiving reduced GC died versus 10/95 (10.5%) with standard GC (hazard ratio, 1.33; CI, 0.57-3.13). When ventilated, ventilator-free days were similar with PLEX versus no-PLEX (medians, 25; interquartile range [IQR], 22-26 vs. 22-27) and fewer with reduced GC (median, 23; IQR, 20-25) versus standard GC (median, 26; IQR, 25-28). Treatment effects on mortality did not vary by presence or severity of DAH. Overall, 23/191 (12.0%) with DAH died within 1 year versus 34/513 (6.6%) without DAH. End-stage kidney disease and serious infections did not differ by DAH status or treatments. Conclusions: Patients with AAV and DAH differ from those without DAH in multiple ways. Further data are required to confirm or refute a benefit of PLEX or GC dosing on mortality. Original clinical trial registered with www.clinicaltrials.gov (NCT00987389). |
| Author | Carron, Pierre-Louis Egfjord, Martin Perkovic, Vlado Kerr, Peter Tesar, Vladimir Birn, Henrik Habib, Syed Brachemi, Soumeya Morrish, Alicia Siva, Brian Qarni, Muhammad Uwais Ryan, Jessica Ford, Sharon Pavenski, Katerina Vanhille, Philipe Fussner, Lynn A. Jardine, Meg Cox, Gerry Merkel, Peter A. Badve, Sunil V. Perl, Jeffrey Faull, Randall J. Pascoe, Elaine Hruskova, Zdenka Hawley, Carmel Suri, Rita Desmond, Michael Girard, Louis Vilayur, Eswari Reidlinger, Donna Flores-Suárez, Luis Felipe Johnson, David W. Walters, Giles Noble, Euan Rey, Isabelle Carette, Simon Hanrotel-Saliou, Catherine Langham, Robyn Reich, Heather Barth, David Cox, P. Gerard Garg, Amit Cartin-Ceba, Rodrigo Krarup, Elizabeth Nicholls, Kathy Boudville, Neil Copland, Michael Pannu, Neesh Zaoui, Philippe Summers, Shaun Jayne, David R. W. Ibraham, Abu Robins, Diane Dacouris, Niki Gosselin, Morgane Brown, Fiona Mazzetti, Andrea Chantrel, François Kurtkoti, Jadadeesh Chocova, Zdenka Gregersen, Jon Mesbah, Rafik Hughes, Peter de Moreuil, Claire Manns, Braden Mudge, David W. Bataille, Pier |
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/38346237$$D View this record in MEDLINE/PubMed |
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| ContentType | Journal Article |
| Contributor | Carron, Pierre-Louis Egfjord, Martin Perkovic, Vlado Kerr, Peter Tesar, Vladimir Birn, Henrik Habib, Syed Brachemi, Soumeya Morrish, Alicia Siva, Brian Qarni, Muhammad Uwais Ryan, Jessica Mudge, David W Ford, Sharon Pavenski, Katerina Vanhille, Philipe Jardine, Meg Cox, Gerry Gatault, Philippe Perl, Jeffrey Pascoe, Elaine Hruskova, Zdenka Hawley, Carmel Suri, Rita Desmond, Michael Girard, Louis Vilayur, Eswari Reidlinger, Donna Aniort, Julien Walters, Giles Faull, Randall J Noble, Euan Rey, Isabelle Huart, Antoine Carette, Simon Hanrotel-Saliou, Catherine Langham, Robyn Reich, Heather Barth, David Garg, Amit Krarup, Elizabeth Chauveau, Dominique Ribes, David Nicholls, Kathy Boudville, Neil Copland, Michael Pannu, Neesh Zaoui, Philippe Summers, Shaun Ibraham, Abu Robins, Diane Dacouris, Niki Johnson, David W Gosselin, Morgane Brown, Fiona Mazzetti, Andrea Chantrel, François Kurtkoti, Jadadeesh Chocova, Zdenka Gregersen, Jon Mesbah, Rafik Hughes, Peter de Moreuil, Claire Manns, Braden Bataille, Pierre Ficheux, Maxence Clark, William Povlsen, Johan Cass, |
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| Copyright | Copyright American Thoracic Society May 1, 2024 Copyright © 2024 by the American Thoracic Society 2024 |
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| Keywords | respiratory failure glucocorticoids diffuse alveolar hemorrhage plasma exchange |
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| License | This article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives License 4.0. For commercial usage and reprints, please e-mail Diane Gern (dgern@thoracic.org). |
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| Snippet | Diffuse alveolar hemorrhage (DAH) is a life-threatening manifestation of antineutrophil cytoplasmic antibody-associated vasculitis (AAV). The PEXIVAS (Plasma... Fussner et al discuss their study on the characteristics, treatment effects, and outcomes for patients with antineutrophil cytoplasmic antibody-associated... Rationale: Diffuse alveolar hemorrhage (DAH) is a life-threatening manifestation of antineutrophil cytoplasmic antibody-associated vasculitis (AAV). The... |
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| SubjectTerms | Adult Aged Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis - complications Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis - drug therapy Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis - mortality Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis - therapy Antibodies Autoimmune diseases Clinical outcomes Female Glucocorticoids - therapeutic use Hemorrhage Hemorrhage - etiology Hemorrhage - therapy Humans Inflammatory diseases Lung diseases Lung Diseases - etiology Lung Diseases - therapy Male Middle Aged Original Plasma Exchange - methods Pulmonary Alveoli Respiration, Artificial - statistics & numerical data Side effects Treatment Outcome Vein & artery diseases |
| Title | Alveolar Hemorrhage in Antineutrophil Cytoplasmic Antibody–Associated Vasculitis: Results of an International Randomized Controlled Trial (PEXIVAS) |
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