Regional comparison of efficacy and safety for vilobelimab in critically ill, invasively mechanically ventilated COVID-19 patients
Background Vilobelimab, a first in class C5a-specific monoclonal antibody, improved 28-day and 60-day mortality in intubated COVID-19 patients in PANAMO, a phase 3 randomised, double-blind, placebo-controlled multicentre study. All-cause mortality was pre-specified to be analysed pooling by region (...
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2025-04-01
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| author | Gernot Marx Antoine Roquilly Tobias Welte Jean Dellamonica Greet Hermans Martin Witzenrath Michael Bauer Matthias Gründling Ulrich Jaschinski Robert Zerbib Djillali Annane Matthijs C Brouwer Bruno Mourvillier Jean Baptiste Lascarrou Francis Schneider Guillaume Thiéry Diederik van de Beek Carole Schwebel Fabio S. Taccone Luc Desmedt Claire Dupuis Pieter van Paassen Michael Piagnerelli Endry H T Lim Sanne de Bruin Simon Rückinger Claus Thielert Renfeng Guo Bruce P Burnett Camilla Chong Niels C Riedemann Alexander P Vlaar Alexander P. J. Vlaar Leo M. A. Heunks Sanne de Bruin Endry H. T. Lim Matthijs C. Brouwer Pieter R. Tuinman José Francisco K. Saraiva Suzana M. Lobo Rodrigo Boldo Jesus A. Simon-Campos Alexander D. Cornet Anastasia Grebenyuk Johannes M. Engelbrecht Murimisi Mukansi Philippe G. Jorens Korinna Pilz Diederik van de Beek Niels C. Riedemann Pierre Bulpa Marc Diltoer Nikolaas De Neve Antonio T. Freire Felipe D. Pizzol Anna Karolina Marinho Victor H. Sato Clovis Arns da Cunha Mathilde Neuville Jean Luc Diehl Jean Paul Mira Marc Berger Klaus Matschke Roberto Mercado-Longoria Belinda Gomez Quintana Jorge Alberto Zamudio-Lerma |
| author_facet | Gernot Marx Antoine Roquilly Tobias Welte Jean Dellamonica Greet Hermans Martin Witzenrath Michael Bauer Matthias Gründling Ulrich Jaschinski Robert Zerbib Djillali Annane Matthijs C Brouwer Bruno Mourvillier Jean Baptiste Lascarrou Francis Schneider Guillaume Thiéry Diederik van de Beek Carole Schwebel Fabio S. Taccone Luc Desmedt Claire Dupuis Pieter van Paassen Michael Piagnerelli Endry H T Lim Sanne de Bruin Simon Rückinger Claus Thielert Renfeng Guo Bruce P Burnett Camilla Chong Niels C Riedemann Alexander P Vlaar Alexander P. J. Vlaar Leo M. A. Heunks Sanne de Bruin Endry H. T. Lim Matthijs C. Brouwer Pieter R. Tuinman José Francisco K. Saraiva Suzana M. Lobo Rodrigo Boldo Jesus A. Simon-Campos Alexander D. Cornet Anastasia Grebenyuk Johannes M. Engelbrecht Murimisi Mukansi Philippe G. Jorens Korinna Pilz Diederik van de Beek Niels C. Riedemann Pierre Bulpa Marc Diltoer Nikolaas De Neve Antonio T. Freire Felipe D. Pizzol Anna Karolina Marinho Victor H. Sato Clovis Arns da Cunha Mathilde Neuville Jean Luc Diehl Jean Paul Mira Marc Berger Klaus Matschke Roberto Mercado-Longoria Belinda Gomez Quintana Jorge Alberto Zamudio-Lerma |
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| description | Background Vilobelimab, a first in class C5a-specific monoclonal antibody, improved 28-day and 60-day mortality in intubated COVID-19 patients in PANAMO, a phase 3 randomised, double-blind, placebo-controlled multicentre study. All-cause mortality was pre-specified to be analysed pooling by region (western Europe, South America, South Africa/Russia).Methods Critically ill, invasively mechanically ventilated COVID-19 patients were randomised in a 1:1 ratio within 48 hours of intubation to receive vilobelimab treatment (six, 800 mg intravenous infusions) or placebo on top of standard of care. We analysed the efficacy and safety of vilobelimab based on prespecified geographic regions.Results 368 patients were randomised and analysed: 177 in the vilobelimab group and 191 in the placebo group. In western Europe (n=209), 28-day all-cause mortality was significantly lower in the vilobelimab group (21%) compared with placebo (37%) (HR 0.51 (95% CI: 0.30, 0.87), p=0.014). In South America (n=126), mortality was similar between groups (40% vs 37%; HR 0.94 (95% CI: 0.53, 1.67), p=0.83). In South Africa/Russia (n=33), mortality was 69% in the vilobelimab group and 87% in the placebo group (HR 0.62 (95% CI: 0.28, 1.38), p=0.25). Within the Brazilian subpopulation (n=74), a significant age imbalance between the vilobelimab and placebo group was detected (median 53.5 years in the vilobelimab group vs 44.5 years in the placebo group). Occurrence of treatment-emergent adverse events between regions was similar.Conclusion The most apparent 28-day all-cause mortality benefit for vilobelimab was in western Europe. Age imbalance between treatment groups in Brazil may have resulted in a lower efficacy signal for vilobelimab in South America compared with other regions. Overall, vilobelimab demonstrated a favourable safety profile and reduced mortality in critically ill, intubated COVID-19 patients, with regional variations influencing outcomes. |
| format | Article |
| id | doaj-art-00f15e7c7d2341fc8735a48ed815d0b9 |
| institution | Kabale University |
| issn | 2052-4439 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open Respiratory Research |
| spelling | doaj-art-00f15e7c7d2341fc8735a48ed815d0b92025-08-20T03:52:20ZengBMJ Publishing GroupBMJ Open Respiratory Research2052-44392025-04-0112110.1136/bmjresp-2023-002206Regional comparison of efficacy and safety for vilobelimab in critically ill, invasively mechanically ventilated COVID-19 patients Gernot Marx0Antoine Roquilly1Tobias Welte2Jean Dellamonica3Greet Hermans4Martin Witzenrath5Michael Bauer6Matthias Gründling7Ulrich Jaschinski8Robert Zerbib9Djillali Annane10Matthijs C Brouwer11Bruno Mourvillier12Jean Baptiste Lascarrou13Francis Schneider14Guillaume Thiéry15Diederik van de Beek16Carole Schwebel17Fabio S. TacconeLuc DesmedtClaire Dupuis18Pieter van PaassenMichael Piagnerelli19Endry H T Lim20Sanne de Bruin21Simon Rückinger22Claus Thielert23Renfeng Guo24Bruce P Burnett25Camilla Chong26Niels C Riedemann27Alexander P Vlaar28Alexander P. J. VlaarLeo M. A. HeunksSanne de BruinEndry H. T. LimMatthijs C. BrouwerPieter R. TuinmanJosé Francisco K. SaraivaSuzana M. LoboRodrigo BoldoJesus A. Simon-CamposAlexander D. CornetAnastasia GrebenyukJohannes M. EngelbrechtMurimisi MukansiPhilippe G. JorensKorinna PilzDiederik van de BeekNiels C. RiedemannPierre BulpaMarc DiltoerNikolaas De NeveAntonio T. FreireFelipe D. PizzolAnna Karolina MarinhoVictor H. SatoClovis Arns da CunhaMathilde NeuvilleJean Luc DiehlJean Paul MiraMarc BergerKlaus MatschkeRoberto Mercado-LongoriaBelinda Gomez QuintanaJorge Alberto Zamudio-Lerma6 Department of Intensive Care Medicine and Intermediate Care, RWTH University Hospital Aachen, Aachen, GermanySAR, CHU Nantes, Nantes, FranceRespiratory Medicine, Medizinische Hochschule Hannover, Hannover, GermanyMedical ICU, University Hospital Centre Nice, Nice, FranceDepartment of General Internal Medicine, Medical Intensive Care Unit, KU Leuven University Hospitals Leuven, Leuven, BelgiumDivision of Pulmonary Inflammation, and Department of Infectious Diseases and Respiratory Medicine, Charité- Universitätsmedizin Berlin, corporate member of the Freie Universität Berlin and Humboldt-Universität Berlin, Berlin, Germany1 Department of Anesthesiology and Intensive Care Medicine, Jena University Hospital, Friedrich-Schiller-University, Jena, Germany7 Department of Anesthesiology, Greifswald, University Hospital of Greifswald, Greifswald, GermanyDepartment of Anaesthesiology and Surgical Intensive Care Medicine, Universitätsklinikum Augsburg, Augsburg, Germany1Innate Pharma, marseille, FranceIHU PROMETHEUS, General ICU, Raymond Poincaré Hospital, University Paris Saclay campus Versailles, APHP, Garches, FranceDepartment of Neurology, Amsterdam UMC Location AMC, Amsterdam, The NetherlandsCentre Hospitalier Universitaire de Reims, Reims, France1Medical-Surgical Intensive Care Unit, District Hospital Centre, La Roche-sur-Yon, France16 Medical Intensive Care Unit, Hopitaux universitaires de Strasbourg, Strasbourg, FranceService de Médecine Intensive et Réanimation, CHU de Saint-Étienne, Saint-Etienne, Auvergne-Rhône-Alpes, FranceDepartment of Neurology, Amsterdam UMC Location AMC, Amsterdam, The NetherlandsIntensive Care Unit, Grenoble Alpes University Hospital, Grenoble, France1Université Paris Diderot, Paris, FranceService des Soins Intensifs, Centre Hospitalier Universitaire Charleroi, Charleroi, Wallonie, BelgiumDepartment of Intensive Care Medicine, Amsterdam UMC Location AMC, Amsterdam, Noord-Holland, NetherlandsDepartment of Intensive Care Medicine, Amsterdam UMC Location AMC, Amsterdam, Noord-Holland, NetherlandsMetronomia Clinical Research GmbH, Munich, GermanyInflaRx GmbH, Jena, GermanyInflaRx Pharmaceuticals Inc, Ann Arbor, Michigan, USAInflaRx Pharmaceuticals Inc, Ann Arbor, Michigan, USAInflaRx GmbH, Jena, GermanyInflaRx GmbH, Jena, GermanyDepartment of Intensive Care Medicine, Amsterdam UMC Location AMC, Amsterdam, Noord-Holland, NetherlandsBackground Vilobelimab, a first in class C5a-specific monoclonal antibody, improved 28-day and 60-day mortality in intubated COVID-19 patients in PANAMO, a phase 3 randomised, double-blind, placebo-controlled multicentre study. All-cause mortality was pre-specified to be analysed pooling by region (western Europe, South America, South Africa/Russia).Methods Critically ill, invasively mechanically ventilated COVID-19 patients were randomised in a 1:1 ratio within 48 hours of intubation to receive vilobelimab treatment (six, 800 mg intravenous infusions) or placebo on top of standard of care. We analysed the efficacy and safety of vilobelimab based on prespecified geographic regions.Results 368 patients were randomised and analysed: 177 in the vilobelimab group and 191 in the placebo group. In western Europe (n=209), 28-day all-cause mortality was significantly lower in the vilobelimab group (21%) compared with placebo (37%) (HR 0.51 (95% CI: 0.30, 0.87), p=0.014). In South America (n=126), mortality was similar between groups (40% vs 37%; HR 0.94 (95% CI: 0.53, 1.67), p=0.83). In South Africa/Russia (n=33), mortality was 69% in the vilobelimab group and 87% in the placebo group (HR 0.62 (95% CI: 0.28, 1.38), p=0.25). Within the Brazilian subpopulation (n=74), a significant age imbalance between the vilobelimab and placebo group was detected (median 53.5 years in the vilobelimab group vs 44.5 years in the placebo group). Occurrence of treatment-emergent adverse events between regions was similar.Conclusion The most apparent 28-day all-cause mortality benefit for vilobelimab was in western Europe. Age imbalance between treatment groups in Brazil may have resulted in a lower efficacy signal for vilobelimab in South America compared with other regions. Overall, vilobelimab demonstrated a favourable safety profile and reduced mortality in critically ill, intubated COVID-19 patients, with regional variations influencing outcomes.https://bmjopenrespres.bmj.com/content/12/1/e002206.full |
| spellingShingle | Gernot Marx Antoine Roquilly Tobias Welte Jean Dellamonica Greet Hermans Martin Witzenrath Michael Bauer Matthias Gründling Ulrich Jaschinski Robert Zerbib Djillali Annane Matthijs C Brouwer Bruno Mourvillier Jean Baptiste Lascarrou Francis Schneider Guillaume Thiéry Diederik van de Beek Carole Schwebel Fabio S. Taccone Luc Desmedt Claire Dupuis Pieter van Paassen Michael Piagnerelli Endry H T Lim Sanne de Bruin Simon Rückinger Claus Thielert Renfeng Guo Bruce P Burnett Camilla Chong Niels C Riedemann Alexander P Vlaar Alexander P. J. Vlaar Leo M. A. Heunks Sanne de Bruin Endry H. T. Lim Matthijs C. Brouwer Pieter R. Tuinman José Francisco K. Saraiva Suzana M. Lobo Rodrigo Boldo Jesus A. Simon-Campos Alexander D. Cornet Anastasia Grebenyuk Johannes M. Engelbrecht Murimisi Mukansi Philippe G. Jorens Korinna Pilz Diederik van de Beek Niels C. Riedemann Pierre Bulpa Marc Diltoer Nikolaas De Neve Antonio T. Freire Felipe D. Pizzol Anna Karolina Marinho Victor H. Sato Clovis Arns da Cunha Mathilde Neuville Jean Luc Diehl Jean Paul Mira Marc Berger Klaus Matschke Roberto Mercado-Longoria Belinda Gomez Quintana Jorge Alberto Zamudio-Lerma Regional comparison of efficacy and safety for vilobelimab in critically ill, invasively mechanically ventilated COVID-19 patients BMJ Open Respiratory Research |
| title | Regional comparison of efficacy and safety for vilobelimab in critically ill, invasively mechanically ventilated COVID-19 patients |
| title_full | Regional comparison of efficacy and safety for vilobelimab in critically ill, invasively mechanically ventilated COVID-19 patients |
| title_fullStr | Regional comparison of efficacy and safety for vilobelimab in critically ill, invasively mechanically ventilated COVID-19 patients |
| title_full_unstemmed | Regional comparison of efficacy and safety for vilobelimab in critically ill, invasively mechanically ventilated COVID-19 patients |
| title_short | Regional comparison of efficacy and safety for vilobelimab in critically ill, invasively mechanically ventilated COVID-19 patients |
| title_sort | regional comparison of efficacy and safety for vilobelimab in critically ill invasively mechanically ventilated covid 19 patients |
| url | https://bmjopenrespres.bmj.com/content/12/1/e002206.full |
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