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2. Non-typeable Haemophilus influenzae–Moraxella catarrhalis vaccine for the prevention of exacerbations in chronic obstructive pulmonary disease: a multicentre, randomised, placebo-controlled, observer-blinded, proof-of-concept, phase 2b trial

Author

Brusselle, Guy, Corhay, Jean-Louis, Janssens, Eduard, Janssens, Wim, Leys, Mathias, Ferguson, Murdo, Fitzgerald, Mark, Maltais, François, Mayers, Irvin, McNeil, Shelly, Pek, Bonavuth, Bourdin, Arnaud, Boyer, Laurent, Couturaud, Francis, Dussart, Luc, Andreas, Stefan, Illies, Gabriele, Eich, Andreas, Ludwig-Sengpiel, Andrea, Watz, Henrik, Blasi, Francesco, Centanni, Stefano, Papi, Alberto, Pomari, Carlo, Echave-Sustaeta, José Maria, Llorca Martínez, Eleuterio, Narejos Pérez, Silvia, Pascual-Guardia, Sergi, Pérez Vera, Mercè, Puente-Maestu, Luis, Terns Riera, Manuel, Anderson, William, Choudhury, Gourab, De-Soyza, Anthony, Saralaya, Dinesh, Wilkinson, Tom MA, Boscia III, Joseph, Chinsky, Kenneth, Dunn, Leonard, Erb, David, Fogarty, Charles, Downey, Herman Jackson, Kerwin, Edward, Kunz, Craig, Poling, Terry, Sellman, Richard, Sigal, Barry, Southard, John, Spangenthal, Selwyn, Tannous, Ziad, Testa, Marco, Casula, Daniela, Di Maro, Gennaro, Lattanzi, Maria, Moraschini, Luca, Schoonbroodt, Sonia, Tasciotti, Annaelisa, Arora, Ashwani K, and Wilkinson, Tom M A

Published
2022
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5. Early high antibody titre convalescent plasma for hospitalised COVID-19 patients: DAWn-plasma

Author

Devos, Timothy, Van Thillo, Quentin, Compernolle, Veerle, Najdovski, Tomé, Romano, Marta, Dauby, Nicolas, Jadot, Laurent, Leys, Mathias, Maillart, Evelyne, Loof, Sarah, Seyler, Lucie, Moonen, Martial, Moutschen, Michel, Van Regenmortel, Niels, Ariën, Kevin K., Barbezange, Cyril, Betrains, Albrecht, Garigliany, Mutien, Engelen, Matthias M., Gyselinck, Iwein, Maes, Piet, Schauwvlieghe, Alexander, Liesenborghs, Laurens, Belmans, Ann, Verhamme, Peter, Meyfroidt, Geert, DAWn-plasma investigators, [ missing ], Gyselinck, Iwein/0000-0002-4068-7228, Barbezange, Cyril/0000-0001-9606-2983, Dauby, Nicolas/0000-0002-7697-6849, Liesenborghs, Laurens/0000-0001-5616-8548, Devos , Timothy, Van Thillo, Quentin, Compernolle, Veerle, Najdovski, Tome, Romano, Marta, Dauby, Nicolas, Jadot, Laurent, Leys, Mathias, Maillart, Evelyne, Loof, Sarah, Seyler , Lucie, Moonen , Martial, Moutschen, Michel, Van Regenmortel, Niels, Arien, Kevin K., Barbezange, Cyril, Betrains, Albrecht, Garigliany, Mutien, Engelen, Matthias M., Gyselinck, Iwein, Maes, Piet, Schauwvlieghe, Alexander, Liesenborghs, Laurens, Belmans, Ann, Verhamme, Peter, Meyfroidt, Geert, DAWn-plasma investigators, Faculty of Sciences and Bioengineering Sciences, Internal Medicine, Internal Medicine Specializations, and Clinical sciences

Subjects
Pulmonary and Respiratory Medicine, Adult, medicine.medical_specialty, Convalescent plasma, Coronavirus disease 2019 (COVID-19), medicine.medical_treatment, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Antibodies, Viral, Antibodies, Viral/blood, Internal medicine, medicine, Medicine and Health Sciences, Humans, Prospective Studies, Antibodies, Neutralizing/blood, Adverse effect, Mechanical ventilation, biology, business.industry, Immunization, Passive, COVID-19, Odds ratio, Sciences bio-médicales et agricoles, Antibodies, Neutralizing, Clinical trial, Hospitalization, Treatment Outcome, DAWn-plasma investigators, biology.protein, Human medicine, Antibody, business, COVID-19/therapy
Abstract

Background Several randomised clinical trials have studied convalescent plasma (CP) for COVID-19 using different protocols, with different SARS-CoV-2 neutralising-antibody-titres, at different time-points and severities of illness. Methods In the prospective multicentre DAWN-plasma trial, adult patients hospitalised with COVID-19 were randomised to 4 units of open-label convalescent plasma combined with standard of care (intervention group) or standard of care alone (control group). Plasma from donors with neutralising-antibody-titres (NT50) ≥1/320 was the product of choice for the study. Results Between May 2nd, 2020 and January 26th, 2021, 320 patients were randomised to convalescent plasma and 163 patients to the control group according to a 2:1 allocation scheme. A median volume of 884 mL convalescent plasma (IQR 806–906 mL) was administered, and 80.68% of the units came from donors with neutralising-antibody-titres (NT50) ≥1/320. Median time from onset of symptoms to randomisation was 7 days. The proportion of patients alive and free of mechanical ventilation on Day 15 was not different between both groups (convalescent plasma: 83.74% (n=267) versus control: 84.05% (n=137) – Odds ratio 0.99 (0.59–1.66) – p-value=0.9772). The intervention did not change the natural course of antibody titres. The number of serious or severe adverse events was similar in both study arms, and transfusion-related side effects were reported in 19/320 patients in the intervention group (5.94%). Conclusions Transfusion of 4 units of convalescent plasma with high neutralising-antibody-titres early in hospitalised COVID-19 patients did not result in a significant improvement of the clinical status, or a reduced mortality., info:eu-repo/semantics/published

Published
2022

6. Non-typeable Haemophilus influenzae–Moraxella catarrhalis vaccine for the prevention of exacerbations in chronic obstructive pulmonary disease: a multicentre, randomised, placebo-controlled, observer-blinded, proof-of-concept, phase 2b trial

Author

Andreas, Stefan, primary, Testa, Marco, additional, Boyer, Laurent, additional, Brusselle, Guy, additional, Janssens, Wim, additional, Kerwin, Edward, additional, Papi, Alberto, additional, Pek, Bonavuth, additional, Puente-Maestu, Luis, additional, Saralaya, Dinesh, additional, Watz, Henrik, additional, Wilkinson, Tom M A, additional, Casula, Daniela, additional, Di Maro, Gennaro, additional, Lattanzi, Maria, additional, Moraschini, Luca, additional, Schoonbroodt, Sonia, additional, Tasciotti, Annaelisa, additional, Arora, Ashwani K, additional, Maltais, François, additional, Corhay, Jean-Louis, additional, Janssens, Eduard, additional, Leys, Mathias, additional, Ferguson, Murdo, additional, Fitzgerald, Mark, additional, Mayers, Irvin, additional, McNeil, Shelly, additional, Bourdin, Arnaud, additional, Couturaud, Francis, additional, Dussart, Luc, additional, Andreas, Stefan, additional, Illies, Gabriele, additional, Eich, Andreas, additional, Ludwig-Sengpiel, Andrea, additional, Blasi, Francesco, additional, Centanni, Stefano, additional, Pomari, Carlo, additional, Echave-Sustaeta, José Maria, additional, Llorca Martínez, Eleuterio, additional, Narejos Pérez, Silvia, additional, Pascual-Guardia, Sergi, additional, Pérez Vera, Mercè, additional, Terns Riera, Manuel, additional, Anderson, William, additional, Choudhury, Gourab, additional, De-Soyza, Anthony, additional, Wilkinson, Tom MA, additional, Boscia III, Joseph, additional, Chinsky, Kenneth, additional, Dunn, Leonard, additional, Erb, David, additional, Fogarty, Charles, additional, Downey, Herman Jackson, additional, Kunz, Craig, additional, Poling, Terry, additional, Sellman, Richard, additional, Sigal, Barry, additional, Southard, John, additional, Spangenthal, Selwyn, additional, and Tannous, Ziad, additional

Published
2022
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10. Early high antibody titre convalescent plasma for hospitalised COVID-19 patients: DAWn-plasma

Author

Devos, Timothy, primary, Van Thillo, Quentin, additional, Compernolle, Veerle, additional, Najdovski, Tomé, additional, Romano, Marta, additional, Dauby, Nicolas, additional, Jadot, Laurent, additional, Leys, Mathias, additional, Maillart, Evelyne, additional, Loof, Sarah, additional, Seyler, Lucie, additional, Moonen, Martial, additional, Moutschen, Michel, additional, Van Regenmortel, Niels, additional, Ariën, Kevin K., additional, Barbezange, Cyril, additional, Betrains, Albrecht, additional, Garigliany, Mutien, additional, Engelen, Matthias M., additional, Gyselinck, Iwein, additional, Maes, Piet, additional, Schauwvlieghe, Alexander, additional, Liesenborghs, Laurens, additional, Belmans, Ann, additional, Verhamme, Peter, additional, and Meyfroidt, Geert, additional

Published
2021
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12. Non-typeable Haemophilus influenzae–Moraxella catarrhalisvaccine for the prevention of exacerbations in chronic obstructive pulmonary disease: a multicentre, randomised, placebo-controlled, observer-blinded, proof-of-concept, phase 2b trial

Author

Andreas, Stefan, Testa, Marco, Boyer, Laurent, Brusselle, Guy, Janssens, Wim, Kerwin, Edward, Papi, Alberto, Pek, Bonavuth, Puente-Maestu, Luis, Saralaya, Dinesh, Watz, Henrik, Wilkinson, Tom M A, Casula, Daniela, Di Maro, Gennaro, Lattanzi, Maria, Moraschini, Luca, Schoonbroodt, Sonia, Tasciotti, Annaelisa, Arora, Ashwani K, Maltais, François, Brusselle, Guy, Corhay, Jean-Louis, Janssens, Eduard, Janssens, Wim, Leys, Mathias, Ferguson, Murdo, Fitzgerald, Mark, Maltais, François, Mayers, Irvin, McNeil, Shelly, Pek, Bonavuth, Bourdin, Arnaud, Boyer, Laurent, Couturaud, Francis, Dussart, Luc, Andreas, Stefan, Illies, Gabriele, Eich, Andreas, Ludwig-Sengpiel, Andrea, Watz, Henrik, Blasi, Francesco, Centanni, Stefano, Papi, Alberto, Pomari, Carlo, Echave-Sustaeta, José Maria, Llorca Martínez, Eleuterio, Narejos Pérez, Silvia, Pascual-Guardia, Sergi, Pérez Vera, Mercè, Puente-Maestu, Luis, Terns Riera, Manuel, Anderson, William, Choudhury, Gourab, De-Soyza, Anthony, Saralaya, Dinesh, Wilkinson, Tom MA, Boscia III, Joseph, Chinsky, Kenneth, Dunn, Leonard, Erb, David, Fogarty, Charles, Downey, Herman Jackson, Kerwin, Edward, Kunz, Craig, Poling, Terry, Sellman, Richard, Sigal, Barry, Southard, John, Spangenthal, Selwyn, Tannous, Ziad, Testa, Marco, Casula, Daniela, Di Maro, Gennaro, Lattanzi, Maria, Moraschini, Luca, Schoonbroodt, Sonia, Tasciotti, Annaelisa, and Arora, Ashwani K

Abstract

Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are associated with changes in the sputum microbiome, including an increased prevalence of pathogenic bacteria. Vaccination against the most frequent bacteria identified in AECOPD might reduce exacerbation frequency. We assessed the efficacy, safety, and immunogenicity of a candidate vaccine containing surface proteins from non-typeable Haemophilus influenzae(NTHi) and Moraxella catarrhalis(Mcat) in patients with COPD.

Published
2022
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16. Uveitis as a window to diagnosis of sarcoidosis – case report and review of the literature

Author

Dhont, Sebastiaan, Leys, Mathias, De Sutter, Edward, Alaerts, Herwig, and Van Moerkercke, Wouter

Abstract

ABSTRACTSarcoidosis is a multisystem disease of unclear etiology with a variable clinical profile characterized by the presence of non-caseating granuloma in involved organs. The diagnosis is often challenging and based on clinical, radiological and anatomopathological data. Sarcoidosis can be benign and self-limiting, but some cases may follow a chronic, progressive course and result in severe morbidity. The disease has a predilection for the lungs and thoracic lymph nodes but can involve nearly any part of the body, possible more commonly in areas with contact to the external environment, such as the eyes and the skin. This paper is based on a case in which a recurrent uveitis led to the diagnosis of an underlying sarcoidosis.

Published
2020
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17. Hypocalcemia after Denosumab in a Pulmonary Hypertension Patient Receiving Epoprostenol.

Author

De Muynck, Benedicte, Leys, Mathias, Cuypers, Joke, Vanderschueren, Dirk, Delcroix, Marion, and Belge, Catharina

Subjects
*DENOSUMAB, *DIARRHEA, *HYPERPARATHYROIDISM, *HYPOCALCEMIA, *MALABSORPTION syndromes, *MONOCLONAL antibodies, *OSTEOMALACIA, *OSTEOPOROSIS, *PROSTACYCLIN, *PULMONARY hypertension, *PARESTHESIA, *DIAGNOSIS
Abstract

We report the case of a 50-year-old woman with anorexigen-induced pulmonary arterial hypertension treated with epoprostenol, who presented with Trousseau’s sign, leading to the diagnosis of severe hypocalcemia for which substitution was started (initially orally, followed by intravenous substitution). After further analysis, we assume that epoprostenol-induced diarrhea caused malabsorption (as other reasons were excluded), leading to nutritional osteomalacia with secondary hyperparathyroidism. We discovered that even more severe hypocalcemia was induced by the treatment with the anti-osteoporotic drug denosumab, which was started after the diagnosis of osteoporosis on bone densitometry. In our opinion, clinicians have to be aware that in patients with malabsorption, antiresorptive therapy can induce dangerous and even life-threatening hypocalcemia, even in patients with normal renal function. [ABSTRACT FROM AUTHOR]

Published
2018
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18. A 64-year-old woman with interstitial lung disease and positive antibodies against aminoacyl-transfer RNA synthetases in the absence of myositis: presentation of an anti-PL-12 positive antisynthetase syndrome

Author

Ghysen, Katrien and Leys, Mathias

Abstract

AbstractIntroductionThe antisynthetase syndrome is a rare autoimmune disease described by the presence of inflammatory myositis, interstitial lung disease and antibodies against aminoacyl-transfer RNA synthetases. Interstitial lung disease can be the only manifestation in the absence of an inflammatory myositis. Other clinical signs are Raynaud phenomenon, hyperkeratotic skin lesions, fever and inflammatory polyarthritis.Case presentationWe report the case of a 64-year old woman who complained of a dry cough, progressive dyspnea and arthralgia since 2 years, with no other systemic symptoms. High resolution computed tomography (HRCT) of the thorax showed the presence of bilateral ground glass opacities, reticular opacities and some traction bronchiectasis. Further biochemical testing revealed the presence of anti-PL12 antibodies.ManagementThe diagnosis of antisynthetase syndrome was made and the patient was treated with steroids and azathioprine with a good response.ConclusionThe search for antisynthetase antibodies should always be considered in patients with an interstitial lung disease without any other clinical symptoms or signs of an underlying connective tissue disease.

Published
2018
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19. Encephalopathy and severe metabolic acidosis in a schizophrenic patient

Author

Van Moerkercke, Wouter, Leys, Mathias, and Meersseman, Philippe

Subjects
Encephalopathy -- Diagnosis, Encephalopathy -- Case studies, Acidosis -- Diagnosis, Acidosis -- Case studies, Schizophrenics -- Medical examination, Environmental issues, Health, Pharmaceuticals and cosmetics industries
Published
2010

20. Early high antibody titre convalescent plasma for hospitalised COVID-19 patients: DAWn-plasma.

Author

Devos T, Van Thillo Q, Compernolle V, Najdovski T, Romano M, Dauby N, Jadot L, Leys M, Maillart E, Loof S, Seyler L, Moonen M, Moutschen M, Van Regenmortel N, Ariën KK, Barbezange C, Betrains A, Garigliany M, Engelen MM, Gyselinck I, Maes P, Schauwvlieghe A, Liesenborghs L, Belmans A, Verhamme P, and Meyfroidt G

Subjects
Adult, Antibodies, Neutralizing blood, Hospitalization, Humans, Prospective Studies, Treatment Outcome, COVID-19 Serotherapy, Antibodies, Viral blood, COVID-19 therapy, Immunization, Passive
Abstract

Background: Several randomised clinical trials have studied convalescent plasma for coronavirus disease 2019 (COVID-19) using different protocols, with different severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) neutralising antibody titres, at different time-points and severities of illness., Methods: In the prospective multicentre DAWn-plasma trial, adult patients hospitalised with COVID-19 were randomised to 4 units of open-label convalescent plasma combined with standard of care (intervention group) or standard of care alone (control group). Plasma from donors with neutralising antibody titres (50% neutralisation titre (NT 50 )) ≥1/320 was the product of choice for the study., Results: Between 2 May 2020 and 26 January 2021, 320 patients were randomised to convalescent plasma and 163 patients to the control group according to a 2:1 allocation scheme. A median (interquartile range) volume of 884 (806-906) mL) convalescent plasma was administered and 80.68% of the units came from donors with neutralising antibody titres (NT 50 ) ≥1/320. Median time from onset of symptoms to randomisation was 7 days. The proportion of patients alive and free of mechanical ventilation on day 15 was not different between both groups (convalescent plasma 83.74% (n=267) versus control 84.05% (n=137)) (OR 0.99, 95% CI 0.59-1.66; p=0.9772). The intervention did not change the natural course of antibody titres. The number of serious or severe adverse events was similar in both study arms and transfusion-related side-effects were reported in 19 out of 320 patients in the intervention group (5.94%)., Conclusions: Transfusion of 4 units of convalescent plasma with high neutralising antibody titres early in hospitalised COVID-19 patients did not result in a significant improvement of clinical status or reduced mortality., Competing Interests: Conflict of interest: All authors report support for the present manuscript from the Belgian Healthcare Knowledge Center (KCE). Q. Van Thillo reports grants from Fonds Wetenschappelijk Onderzoek (FWO)–Vlaanderen Basic Research 2019–2021 outside the submitted work. G. Meyfroidt reports a FWO–Vlaanderen Senior Clinical Researcher Grant outside the submitted work., (Copyright ©The authors 2022.)

Published
2022
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