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7. Practical aspects of high resolution esophageal manometry

Author

Ruiz-de-Leon-San-Juan, Antonio, Ciriza-de-los-Rios, Constanza, Perez-de-la-Serna-Bueno, Julio, Canga-Rodriguez-Valcarcel, Fernando, Estremera-Arevalo, Fermin, Garcia-Sanchez, Raquel, Huaman-Rios, Jose Walter, Perez- Fernandez, Maria Teresa, Santander-Vaquero, Cecilio, Serra-Pueyo, Jordi, Sevilla-Mantilla, Concepcion, Barba-Orozco, Elisabeth, Bosque-Lopez, Maria Jose, Casabona- Frances, Sergio, Carrion-Bolorino, Silvia, Castillo-Grau, Pilar, Delgado-Aros, Silvia, Dominguez-Carbajo, Ana Belen, Fernandez-Orcajo, Pilar, Garcia-Lledo, Javier, Giganto-Tome, Froilan, Iglesias-Picazo, Rosa, Lacima-Vidal, Gloria, Lopez-Lopez, Pilar, Llabres- Rossello, Magdalena, Mas-Mercader, Pilar, Mego-Silva, Marianela, Mendarte-Barrenetxea, Maria Usua, Miliani-Molinao Carlos, Oreja-Arrayago, Milagros, Sanchez-Ceballos, Francisco, and Sanchez-Prudencio, Sandra

Published
2017
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8. Budesonide orodispersible tablets for induction of remission in patients with active eosinophilic oesophagitis: A 6-week open-label trial of the EOS-2 Programme

Author

Miehlke, Stephan, Schlag, Christoph, Lucendo, Alfredo J, Biedermann, Luc, Vaquero, Cecilio Santander, Schmoecker, Christoph, Hayat, Jamal, Hruz, Petr, Ciriza de Los Rios, Constanza, Bredenoord, Albert Jan, Vieth, Michael, Schoepfer, Alain, Attwood, Stephen, Mueller, Ralph, Burrack, Sarah, Greinwald, Roland, Straumann, Alex, University of Zurich, and Miehlke, Stephan

Subjects
10219 Clinic for Gastroenterology and Hepatology, 610 Medicine & health, 2730 Oncology, 2715 Gastroenterology
Published
2022

9. Development of a core outcome set for therapeutic studies in eosinophilic esophagitis (COREOS)

Author

Ma, Christopher, Schoepfer, Alain M., Dellon, Evan S., Bredenoord, Albert J., Chehade, Mirna, Collins, Margaret H., Feagan, Brian G., Furuta, Glenn T., Gupta, Sandeep K., Hirano, Ikuo, Jairath, Vipul, Katzka, David A., Pai, Rish K., Rothenberg, Marc E., Straumann, Alex, Aceves, Seema S., Alexander, Jeffrey A., Arva, Nicoleta C., Atkins, Dan, Biedermann, Luc, Blanchard, Carine, Cianferoni, Antonella, Ciriza de los Rios, Constanza, Clayton, Frederic, Davis, Carla M., de Bortoli, Nicola, Dias, Jorge A., Falk, Gary W., Genta, Robert M., Ghaffari, Gisoo, Gonsalves, Nirmala, Greuter, Thomas, Hopp, Russell, Hsu Blatman, Karen S., Jensen, Elizabeth T., Johnston, Doug, Kagalwalla, Amir F., Larsson, Helen M., Leung, John, Louis, Hubert, Masterson, Joanne C., Menard-Katcher, Calies, Menard-Katcher, Paul A., Moawad, Fouad J., Muir, Amanda B., Mukkada, Vincent A., Penagini, Roberto, Pesek, Robert D., Peterson, Kathryn, Putnam, Philip E., Ravelli, Alberto, Savarino, Edoardo V., Schlag, Christoph, Schreiner, Philipp, Simon, Dagmar, Smyrk, Thomas C., Spergel, Jonathan M., Taft, Tiffany H., Terreehorst, Ingrid, Vanuytsel, Tim, Venter, Carina, Vieira, Mario C., Vieth, Michael, Vlieg-Boerstra, Berber, von Arnim, Ulrike, Walker, Marjorie M., Wechsler, Joshua B., Woodland, Philip, Woosley, John T., Yang, Guang-Yu, Zevit, Noam, Safroneeva, Ekaterina, Ma, Christopher, Schoepfer, Alain M., Dellon, Evan S., Bredenoord, Albert J., Chehade, Mirna, Collins, Margaret H., Feagan, Brian G., Furuta, Glenn T., Gupta, Sandeep K., Hirano, Ikuo, Jairath, Vipul, Katzka, David A., Pai, Rish K., Rothenberg, Marc E., Straumann, Alex, Aceves, Seema S., Alexander, Jeffrey A., Arva, Nicoleta C., Atkins, Dan, Biedermann, Luc, Blanchard, Carine, Cianferoni, Antonella, Ciriza de los Rios, Constanza, Clayton, Frederic, Davis, Carla M., de Bortoli, Nicola, Dias, Jorge A., Falk, Gary W., Genta, Robert M., Ghaffari, Gisoo, Gonsalves, Nirmala, Greuter, Thomas, Hopp, Russell, Hsu Blatman, Karen S., Jensen, Elizabeth T., Johnston, Doug, Kagalwalla, Amir F., Larsson, Helen M., Leung, John, Louis, Hubert, Masterson, Joanne C., Menard-Katcher, Calies, Menard-Katcher, Paul A., Moawad, Fouad J., Muir, Amanda B., Mukkada, Vincent A., Penagini, Roberto, Pesek, Robert D., Peterson, Kathryn, Putnam, Philip E., Ravelli, Alberto, Savarino, Edoardo V., Schlag, Christoph, Schreiner, Philipp, Simon, Dagmar, Smyrk, Thomas C., Spergel, Jonathan M., Taft, Tiffany H., Terreehorst, Ingrid, Vanuytsel, Tim, Venter, Carina, Vieira, Mario C., Vieth, Michael, Vlieg-Boerstra, Berber, von Arnim, Ulrike, Walker, Marjorie M., Wechsler, Joshua B., Woodland, Philip, Woosley, John T., Yang, Guang-Yu, Zevit, Noam, and Safroneeva, Ekaterina

Abstract

Background: End points used to determine treatment efficacy in eosinophilic esophagitis (EoE) have evolved over time. With multiple novel therapies in development for EoE, harmonization of outcomes measures will facilitate evidence synthesis and appraisal when comparing different treatments. Objective: We sought to develop a core outcome set (COS) for controlled and observational studies of pharmacologic and diet interventions in adult and pediatric patients with EoE. Methods: Candidate outcomes were generated from systematic literature reviews and patient engagement interviews and surveys. Consensus was established using an iterative Delphi process, with items voted on using a 9-point Likert scale and with feedback from other participants to allow score refinement.

Published
2022

10. Budesonide orodispersible tablets for induction of remission in patients with active eosinophilic oesophagitis: A 6-week open-label trial of the EOS-2 Programme

Author

Miehlke, Stephan; https://orcid.org/0000-0002-9174-8270, Schlag, Christoph, Lucendo, Alfredo J; https://orcid.org/0000-0003-1183-1072, Biedermann, Luc, Vaquero, Cecilio Santander; https://orcid.org/0000-0001-5492-2535, Schmoecker, Christoph, Hayat, Jamal, Hruz, Petr, Ciriza de Los Rios, Constanza, Bredenoord, Albert Jan, Vieth, Michael, Schoepfer, Alain, Attwood, Stephen, Mueller, Ralph; https://orcid.org/0000-0002-3029-8843, Burrack, Sarah, Greinwald, Roland, Straumann, Alex, Miehlke, Stephan; https://orcid.org/0000-0002-9174-8270, Schlag, Christoph, Lucendo, Alfredo J; https://orcid.org/0000-0003-1183-1072, Biedermann, Luc, Vaquero, Cecilio Santander; https://orcid.org/0000-0001-5492-2535, Schmoecker, Christoph, Hayat, Jamal, Hruz, Petr, Ciriza de Los Rios, Constanza, Bredenoord, Albert Jan, Vieth, Michael, Schoepfer, Alain, Attwood, Stephen, Mueller, Ralph; https://orcid.org/0000-0002-3029-8843, Burrack, Sarah, Greinwald, Roland, and Straumann, Alex

Abstract

BACKGROUND A novel budesonide orodispersible tablet (BOT) has been proven effective in adult patients with active eosinophilic oesophagitis (EoE) in a 6-week placebo-controlled trial (EOS-1). AIMS To report the efficacy of an open-label induction treatment with BOT in a large prospective cohort of EoE patients within the EOS-2 study. METHODS Patients with clinico-histological active EoE were treated with BOT 1 mg BID for 6 weeks. The primary endpoint was clinico-histological remission (≤2 points on numerical rating scales [0-10] each for dysphagia and odynophagia, and peak eosinophil count <16 eos/mm$^{2}$ hpf (corresponds to <5 eos/hpf)). Further study endpoints included clinical and histological remission rates, change in the EEsAI-PRO score, change in peak eosinophil counts, and deep endoscopic remission using a modified Endoscopic Reference Score. RESULTS Among 181 patients enrolled, 126 (69.6%) achieved clinico-histological remission (histological remission 90.1%, clinical remission 75.1%). The mean peak eosinophil counts decreased by 283 eos/mm$^{2}$ hpf (i.e., by 89.0%). Mean EEsAI-PRO score decreased from baseline by 29 points and deep endoscopic remission was achieved in 97 (53.6%) patients. The majority of patients judged tolerability as good or very good (85.6%) and compliance was high (96.5%). Local candidiasis was suspected in 8.3% of patients; all were of mild severity, resolved with treatment and none led to premature withdrawal from the study. CONCLUSIONS In this large prospective trial, a 6-week open-label treatment with BOT 1 mg BID was highly effective and safe in achieving clinico-histological remission of active EoE and confirmed the results of the placebo-controlled EOS-1 trial.

Published
2022

11. Development of a core outcome set for therapeutic studies in eosinophilic esophagitis (COREOS)

Author

COREOS Collaborators, Ma, Christopher, Schoepfer, Alain M, Dellon, Evan S, Bredenoord, Albert J, Chehade, Mirna, Collins, Margaret H, Feagan, Brian G, Furuta, Glenn T, Gupta, Sandeep K, Hirano, Ikuo, Jairath, Vipul, Katzka, David A, Pai, Rish K, Rothenberg, Marc E, Straumann, Alex, Aceves, Seema S, Alexander, Jeffrey A, Arva, Nicoleta C, Atkins, Dan, Biedermann, Luc, Blanchard, Carine, Cianferoni, Antonella, Ciriza de Los Rios, Constanza, Clayton, Frederic, Davis, Carla M, de Bortoli, Nicola, Dias, Jorge A, Falk, Gary W, Genta, Robert M, et al, COREOS Collaborators, Ma, Christopher, Schoepfer, Alain M, Dellon, Evan S, Bredenoord, Albert J, Chehade, Mirna, Collins, Margaret H, Feagan, Brian G, Furuta, Glenn T, Gupta, Sandeep K, Hirano, Ikuo, Jairath, Vipul, Katzka, David A, Pai, Rish K, Rothenberg, Marc E, Straumann, Alex, Aceves, Seema S, Alexander, Jeffrey A, Arva, Nicoleta C, Atkins, Dan, Biedermann, Luc, Blanchard, Carine, Cianferoni, Antonella, Ciriza de Los Rios, Constanza, Clayton, Frederic, Davis, Carla M, de Bortoli, Nicola, Dias, Jorge A, Falk, Gary W, Genta, Robert M, and et al

Abstract

BACKGROUND End points used to determine treatment efficacy in eosinophilic esophagitis (EoE) have evolved over time. With multiple novel therapies in development for EoE, harmonization of outcomes measures will facilitate evidence synthesis and appraisal when comparing different treatments. OBJECTIVE We sought to develop a core outcome set (COS) for controlled and observational studies of pharmacologic and diet interventions in adult and pediatric patients with EoE. METHODS Candidate outcomes were generated from systematic literature reviews and patient engagement interviews and surveys. Consensus was established using an iterative Delphi process, with items voted on using a 9-point Likert scale and with feedback from other participants to allow score refinement. Consensus meetings were held to ratify the outcome domains of importance and the core outcome measures. Stakeholders were recruited internationally and included adult and pediatric gastroenterologists, allergists, dieticians, pathologists, psychologists, researchers, and methodologists. RESULTS The COS consists of 4 outcome domains for controlled and observational studies: histopathology, endoscopy, patient-reported symptoms, and EoE-specific quality of life. A total of 69 stakeholders (response rate 95.8%) prioritized 42 outcomes in a 2-round Delphi process, and the final ratification meeting generated consensus on 33 outcome measures. These included measurement of the peak eosinophil count, Eosinophilic Esophagitis Histology Scoring System, Eosinophilic Esophagitis Endoscopic Reference Score, and patient-reported measures of dysphagia and quality of life. CONCLUSIONS This interdisciplinary collaboration involving global stakeholders has produced a COS that can be applied to adult and pediatric studies of pharmacologic and diet therapies for EoE and will facilitate meaningful treatment comparisons and improve the quality of data synthesis.

Published
2022

12. Development of a core outcome set for therapeutic studies in eosinophilic esophagitis (COREOS)

Author

Ma, Christopher, primary, Schoepfer, Alain M., additional, Dellon, Evan S., additional, Bredenoord, Albert J., additional, Chehade, Mirna, additional, Collins, Margaret H., additional, Feagan, Brian G., additional, Furuta, Glenn T., additional, Gupta, Sandeep K., additional, Hirano, Ikuo, additional, Jairath, Vipul, additional, Katzka, David A., additional, Pai, Rish K., additional, Rothenberg, Marc E., additional, Straumann, Alex, additional, Aceves, Seema S., additional, Alexander, Jeffrey A., additional, Arva, Nicoleta C., additional, Atkins, Dan, additional, Biedermann, Luc, additional, Blanchard, Carine, additional, Cianferoni, Antonella, additional, Ciriza de los Rios, Constanza, additional, Clayton, Frederic, additional, Davis, Carla M., additional, de Bortoli, Nicola, additional, Dias, Jorge A., additional, Falk, Gary W., additional, Genta, Robert M., additional, Ghaffari, Gisoo, additional, Gonsalves, Nirmala, additional, Greuter, Thomas, additional, Hopp, Russell, additional, Hsu Blatman, Karen S., additional, Jensen, Elizabeth T., additional, Johnston, Doug, additional, Kagalwalla, Amir F., additional, Larsson, Helen M., additional, Leung, John, additional, Louis, Hubert, additional, Masterson, Joanne C., additional, Menard-Katcher, Calies, additional, Menard-Katcher, Paul A., additional, Moawad, Fouad J., additional, Muir, Amanda B., additional, Mukkada, Vincent A., additional, Penagini, Roberto, additional, Pesek, Robert D., additional, Peterson, Kathryn, additional, Putnam, Philip E., additional, Ravelli, Alberto, additional, Savarino, Edoardo V., additional, Schlag, Christoph, additional, Schreiner, Philipp, additional, Simon, Dagmar, additional, Smyrk, Thomas C., additional, Spergel, Jonathan M., additional, Taft, Tiffany H., additional, Terreehorst, Ingrid, additional, Vanuytsel, Tim, additional, Venter, Carina, additional, Vieira, Mario C., additional, Vieth, Michael, additional, Vlieg-Boerstra, Berber, additional, von Arnim, Ulrike, additional, Walker, Marjorie M., additional, Wechsler, Joshua B., additional, Woodland, Philip, additional, Woosley, John T., additional, Yang, Guang-Yu, additional, Zevit, Noam, additional, and Safroneeva, Ekaterina, additional

Published
2022
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14. Development of a Core Outcome Set for Therapeutic Studies in Eosinophilic Esophagitis (COREOS): An International Multidisciplinary Consensus

Author

Ma, Christopher, primary, Schoepfer, Alain M., additional, Safroneeva, Ekaterina, additional, Ma, Christopher, additional, Dellon, Evan S., additional, Bredenoord, Albert J., additional, Chehade, Mirna, additional, Collins, Margaret H., additional, Feagan, Brian G., additional, Furuta, Glenn T., additional, Gupta, Sandeep K., additional, Hirano, Ikuo, additional, Jairath, Vipul, additional, Katzka, David A., additional, Pai, Rish K., additional, Rothenberg, Marc E., additional, Straumann, Alex, additional, Aceves, Seema S., additional, Alexander, Jeffrey A., additional, Arva, Nicoleta C., additional, Atkins, Dan, additional, Biedermann, Luc, additional, Blanchard, Carine, additional, Cianferoni, Antonella, additional, Ciriza de los Rios, Constanza, additional, Clayton, Frederic, additional, Davis, Carla M., additional, de Bortoli, Nicola, additional, Dias, Jorge A., additional, Falk, Gary W., additional, Genta, Robert M., additional, Ghaffari, Gisoo, additional, Gonsalves, Nirmala, additional, Greuter, Thomas, additional, Hopp, Russell, additional, Hsu Blatman, Karen S., additional, Jensen, Elizabeth T., additional, Johnston, Doug, additional, Kagalwalla, Amir F., additional, Larsson, Helen M., additional, Leung, John, additional, Louis, Hubert, additional, Masterson, Joanne C., additional, Menard-Katcher, Calies, additional, Menard-Katcher, Paul A., additional, Moawad, Fouad J., additional, Muir, Amanda B., additional, Mukkada, Vincent A., additional, Penagini, Roberto, additional, Pesek, Robert D., additional, Peterson, Kathryn, additional, Putnam, Philip E., additional, Ravelli, Alberto, additional, Savarino, Edoardo V., additional, Schlag, Christoph, additional, Schreiner, Philipp, additional, Simon, Dagmar, additional, Smyrk, Thomas C., additional, Spergel, Jonathan M., additional, Taft, Tiffany H., additional, Terreehorst, Ingrid, additional, Vanuytsel, Tim, additional, Venter, Carina, additional, Vieira, Mario C., additional, Vieth, Michael, additional, Vlieg-Boerstra, Berber, additional, von Arnim, Ulrike, additional, Walker, Marjorie M., additional, Wechsler, Joshua B., additional, Woodland, Philip, additional, Woosley, John T., additional, Yang, Guang-Yu, additional, and Zevit, Noam, additional

Published
2021
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15. A Summary of the Meetings of the Development of a Core Outcome Set for Therapeutic Studies in Eosinophilic Esophagitis (COREOS) International Multidisciplinary Consensus

Author

Ma, Christopher, primary, Schoepfer, Alain M., additional, Safroneeva, Ekaterina, additional, Ma, Christopher, additional, Dellon, Evan S., additional, Bredenoord, Albert J., additional, Chehade, Mirna, additional, Collins, Margaret H., additional, Feagan, Brian G., additional, Furuta, Glenn T., additional, Gupta, Sandeep K., additional, Hirano, Ikuo, additional, Jairath, Vipul, additional, Katzka, David A., additional, Pai, Rish K., additional, Rothenberg, Marc E., additional, Straumann, Alex, additional, Aceves, Seema S., additional, Alexander, Jeffrey A., additional, Arva, Nicoleta C., additional, Atkins, Dan, additional, Biedermann, Luc, additional, Blanchard, Carine, additional, Cianferoni, Antonella, additional, Ciriza de los Rios, Constanza, additional, Clayton, Frederic, additional, Davis, Carla M., additional, de Bortoli, Nicola, additional, Dias, Jorge A., additional, Falk, Gary W., additional, Genta, Robert M., additional, Ghaffari, Gisoo, additional, Gonsalves, Nirmala, additional, Greuter, Thomas, additional, Hopp, Russell, additional, Hsu Blatman, Karen S., additional, Jensen, Elizabeth T., additional, Johnston, Doug, additional, Kagalwalla, Amir F., additional, Larsson, Helen M., additional, Leung, John, additional, Louis, Hubert, additional, Masterson, Joanne C., additional, Menard-Katcher, Calies, additional, Menard-Katcher, Paul A., additional, Moawad, Fouad J., additional, Muir, Amanda B., additional, Mukkada, Vincent A., additional, Penagini, Roberto, additional, Pesek, Robert D., additional, Peterson, Kathryn, additional, Putnam, Philip E., additional, Ravelli, Alberto, additional, Savarino, Edoardo V., additional, Schlag, Christoph, additional, Schreiner, Philipp, additional, Simon, Dagmar, additional, Smyrk, Thomas C., additional, Spergel, Jonathan M., additional, Taft, Tiffany H., additional, Terreehorst, Ingrid, additional, Vanuytsel, Tim, additional, Venter, Carina, additional, Vieira, Mario C., additional, Vieth, Michael, additional, Vlieg-Boerstra, Berber, additional, von Arnim, Ulrike, additional, Walker, Marjorie M., additional, Wechsler, Joshua B., additional, Woodland, Philip, additional, Woosley, John T., additional, Yang, Guang-Yu, additional, and Zevit, Noam, additional

Published
2021
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16. A Summary of the Meetings of the Development of a Core Outcome Set for Therapeutic Studies in Eosinophilic Esophagitis (COREOS) International Multidisciplinary Consensus

Author

Ma, Christopher, Schoepfer, Alain M., Safroneeva, Ekaterina, Dellon, Evan S., Bredenoord, Albert J., Chehade, Mirna, Collins, Margaret H., Feagan, Brian G., Furuta, Glenn T., Gupta, Sandeep K., Hirano, Ikuo, Jairath, Vipul, Katzka, David A., Pai, Rish K., Rothenberg, Marc E., Straumann, Alex, Aceves, Seema S., Alexander, Jeffrey A., Arva, Nicoleta C., Atkins, Dan, Biedermann, Luc, Blanchard, Carine, Cianferoni, Antonella, Ciriza de los Rios, Constanza, Clayton, Frederic, Davis, Carla M., de Bortoli, Nicola, Dias, Jorge A., Falk, Gary W., Genta, Robert M., Ghaffari, Gisoo, Gonsalves, Nirmala, Greuter, Thomas, Hopp, Russell, Hsu Blatman, Karen S., Jensen, Elizabeth T., Johnston, Doug, Kagalwalla, Amir F., Larsson, Helen M., Leung, John, Louis, Hubert, Masterson, Joanne C., Menard-Katcher, Calies, Menard-Katcher, Paul A., Moawad, Fouad J., Muir, Amanda B., Mukkada, Vincent A., Penagini, Roberto, Pesek, Robert D., Peterson, Kathryn, Putnam, Philip E., Ravelli, Alberto, Savarino, Edoardo V., Schlag, Christoph, Schreiner, Philipp, Simon, Dagmar, Smyrk, Thomas C., Spergel, Jonathan M., Taft, Tiffany H., Terreehorst, Ingrid, Vanuytsel, Tim, Venter, Carina, Vieira, Mario C., Vieth, Michael, Vlieg-Boerstra, Berber, von Arnim, Ulrike, Walker, Marjorie M., Wechsler, Joshua B., Woodland, Philip, Woosley, John T., Yang, Guang-Yu, Zevit, Noam, Ma, Christopher, Schoepfer, Alain M., Safroneeva, Ekaterina, Dellon, Evan S., Bredenoord, Albert J., Chehade, Mirna, Collins, Margaret H., Feagan, Brian G., Furuta, Glenn T., Gupta, Sandeep K., Hirano, Ikuo, Jairath, Vipul, Katzka, David A., Pai, Rish K., Rothenberg, Marc E., Straumann, Alex, Aceves, Seema S., Alexander, Jeffrey A., Arva, Nicoleta C., Atkins, Dan, Biedermann, Luc, Blanchard, Carine, Cianferoni, Antonella, Ciriza de los Rios, Constanza, Clayton, Frederic, Davis, Carla M., de Bortoli, Nicola, Dias, Jorge A., Falk, Gary W., Genta, Robert M., Ghaffari, Gisoo, Gonsalves, Nirmala, Greuter, Thomas, Hopp, Russell, Hsu Blatman, Karen S., Jensen, Elizabeth T., Johnston, Doug, Kagalwalla, Amir F., Larsson, Helen M., Leung, John, Louis, Hubert, Masterson, Joanne C., Menard-Katcher, Calies, Menard-Katcher, Paul A., Moawad, Fouad J., Muir, Amanda B., Mukkada, Vincent A., Penagini, Roberto, Pesek, Robert D., Peterson, Kathryn, Putnam, Philip E., Ravelli, Alberto, Savarino, Edoardo V., Schlag, Christoph, Schreiner, Philipp, Simon, Dagmar, Smyrk, Thomas C., Spergel, Jonathan M., Taft, Tiffany H., Terreehorst, Ingrid, Vanuytsel, Tim, Venter, Carina, Vieira, Mario C., Vieth, Michael, Vlieg-Boerstra, Berber, von Arnim, Ulrike, Walker, Marjorie M., Wechsler, Joshua B., Woodland, Philip, Woosley, John T., Yang, Guang-Yu, and Zevit, Noam

Abstract

The Core Outcome Set for Therapeutic Studies in Eosinophilic Esophagitis (COREOS) collaborators are a group of more than 70 gastroenterologists, pathologists, allergists, researchers, dietitians, psychologists, and methodologists who convened in a series of in-person and virtual meetings between 2018 and 2020 with the aim of developing a core outcome set (COS) for use in therapeutic studies of pharmacologic and dietary therapies for the treatment of eosinophilic esophagitis (EoE). Given heterogeneity in reported outcomes and uncertainties regarding the most appropriate end points for use in both randomized controlled trials (RCTs) and observational studies involving EoE patients, the EoE experts launched the COREOS exercise in 2018 to standardize outcome definitions using methods established by the Core Outcome Measures in Effectiveness Trials (COMET) initiative.1,2 The COS was developed using a multiphase approach, which is summarized in Figure 1. In the first phase, systematic reviews of the literature and patient engagement surveys were conducted to identify candidate outcomes that have been previously measured and are important to patients with EoE. Next, this information was used to build a framework of different outcome domains, and working groups for each domain were assembled to review the literature for relevant end points.3–6 The relative importance of these domains was categorized in a Delphi survey as core, important, and research agenda domains, and discussed in a moderated in-person meeting on May 17, 2019 at Digestive Disease Week (San Diego, CA). In phase 3, a comprehensive list of outcome measures within each of the core domains was evaluated by the COREOS collaborators in a 2-round Delphi survey and, finally, outcomes were ratified in a virtual meeting on December 8, 2020. In this meeting summary, we highlight the major points of discussion that occurred during the development of the EoE COS.

Published
2021

17. Budesonide Orodispersible Tablets Maintain Remission in a Randomized, Placebo-Controlled Trial of Patients With Eosinophilic Esophagitis

Author

Straumann, Alex, Lucendo, Alfredo J, Miehlke, Stephan, Vieth, Michael, Schlag, Christoph, Biedermann, Luc, Vaquero, Cecilio Santander, Ciriza de Los Rios, Constanza, Schmoecker, Christoph, Madisch, Ahmed, Hruz, Petr, Hayat, Jamal, von Arnim, Ulrike, Bredenoord, Albert Jan, Schubert, Stefan, Mueller, Ralph, Greinwald, Roland, Schoepfer, Alain, Attwood, Stephen, International EOS-2 Study Group, Straumann, Alex, Lucendo, Alfredo J, Miehlke, Stephan, Vieth, Michael, Schlag, Christoph, Biedermann, Luc, Vaquero, Cecilio Santander, Ciriza de Los Rios, Constanza, Schmoecker, Christoph, Madisch, Ahmed, Hruz, Petr, Hayat, Jamal, von Arnim, Ulrike, Bredenoord, Albert Jan, Schubert, Stefan, Mueller, Ralph, Greinwald, Roland, Schoepfer, Alain, Attwood, Stephen, and International EOS-2 Study Group

Abstract

BACKGROUND & AIMS Eosinophilic esophagitis (EoE) is a chronic inflammatory disorder. Swallowed topical-acting corticosteroids are effective in bringing active EoE into remission. However, it is not clear if these drugs are effective for long-term maintenance of remission. METHODS We performed a double-blind trial to compare the efficacy and safety of 2 doses of a budesonide orodispersible tablet (BOT) vs placebo in maintaining remission of EoE. Maintenance of remission was defined as absence of clinical and histological relapse and no premature withdrawal for any reason. Two hundred and four adults with EoE in clinical and histologic remission, from 29 European study sites, were randomly assigned to groups given BOT 0.5 mg twice daily (n=68), BOT 1.0 mg twice daily (n=68), or placebo twice daily (n=68) for up to 48 weeks. RESULTS At end of treatment, 73.5% of patients receiving BOT 0.5 mg twice daily and 75% receiving BOT 1.0 mg twice daily were in persistent remission, compared with 4.4% of patients in the placebo group (P<.001 for both comparisons of BOT with placebo). Median time to relapse in the placebo group was 87 days. The frequency of adverse events was similar in the BOT and placebo groups. Morning serum levels of cortisol were in the normal range at baseline and did not significantly change during treatment. Four patients receiving BOT developed asymptomatic, low serum levels of cortisol. Clinically manifested candidiasis was suspected in 16.2% of patients in the BOT 0.5 mg group and in 11.8% of patients in the BOT 1.0 mg group; all infections resolved with treatment. CONCLUSIONS In a phase 3 trial, up to 48 weeks of treatment with BOT (.5 mg or 1.0 mg, twice daily) was superior to placebo in maintaining remission of EoE. Both dosages were equally effective and well tolerated. (Funded by Dr. Falk Pharma GmbH; EudraCT number; 2014-001485-99; ClinicalTrials.gov number, NCT02434029.).

Published
2020

18. Budesonide Orodispersible Tablets Maintain Remission in a Randomized, Placebo-Controlled Trial of Patients With Eosinophilic Esophagitis

Author

Straumann, Alex, primary, Lucendo, Alfredo J., additional, Miehlke, Stephan, additional, Vieth, Michael, additional, Schlag, Christoph, additional, Biedermann, Luc, additional, Vaquero, Cecilio Santander, additional, Ciriza de los Rios, Constanza, additional, Schmoecker, Christoph, additional, Madisch, Ahmed, additional, Hruz, Petr, additional, Hayat, Jamal, additional, von Arnim, Ulrike, additional, Bredenoord, Albert Jan, additional, Schubert, Stefan, additional, Mueller, Ralph, additional, Greinwald, Roland, additional, Schoepfer, Alain, additional, Attwood, Stephen, additional, Tack, Jan, additional, Bajbouj, Monther, additional, Brückner, Stefan, additional, Fibbe, Christiane, additional, Haag, Sebastian, additional, Schmöcker, Christoph, additional, Hartmann, Dirk, additional, Lammert, Frank, additional, Reinshagen, Max, additional, Börner, Norbert, additional, Witzemann, Dieter, additional, Caca, Karel, additional, Albert, Jörg, additional, Zeuzem, Stefan, additional, Wiedbrauck, Felix, additional, Messmann, Helmut, additional, Verdonk, Robert, additional, Wolfhagen, Franciscus, additional, Villarin, Alfredo Lucendo, additional, de los Ríos, Constanza Ciriza, additional, Juan, Antonia Perelló, additional, Martinez, Isabel Perez, additional, Sanchez-Migallon, Joaquin Rodriguez, additional, Andrés, Jesús Barrio, additional, Aisa, ÁngelesPérez, additional, Straumann, Alex, additional, and Dhar, Anjan, additional

Published
2020
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19. Efficacy of Budesonide Orodispersible Tablets as Induction Therapy for Eosinophilic Esophagitis in a Randomized Placebo-Controlled Trial

Author

Lucendo, Alfredo J., primary, Miehlke, Stephan, additional, Schlag, Christoph, additional, Vieth, Michael, additional, von Arnim, Ulrike, additional, Molina-Infante, Javier, additional, Hartmann, Dirk, additional, Bredenoord, Albert Jan, additional, Ciriza de los Rios, Constanza, additional, Schubert, Stefan, additional, Brückner, Stefan, additional, Madisch, Ahmed, additional, Hayat, Jamal, additional, Tack, Jan, additional, Attwood, Stephen, additional, Mueller, Ralph, additional, Greinwald, Roland, additional, Schoepfer, Alain, additional, Straumann, Alex, additional, Vanuytsel, Tim, additional, Louis, Hubert, additional, Musala, Carmen, additional, Frederking, Dorothea, additional, Bajbouj, Monther, additional, Nennstiel, Simon, additional, Schmelz, Renate, additional, Heimerl, Schmelz, additional, Stephan, Anna-Magdalena, additional, Fibbe, Christiane, additional, Liedtke (née Laschinsky), Niels, additional, Keller, Jutta, additional, Rosien, Ulrich, additional, Haag, Sebastian, additional, Schneider, Arne, additional, Schmöcker, Christoph, additional, Buchholz, Hendrik, additional, Lammert, Frank, additional, Casper, Markus, additional, Reichert, Matthias, additional, Sommer, Dirk, additional, Mönnikes, Hubert, additional, Stengel, Miriam, additional, Schmidtmann, Marco, additional, Müller, Michaela, additional, Eckardt, Alexander, additional, Wehrmann, Till, additional, Armerding, Peter, additional, Hofmann, Wolf Peter, additional, Liceni, Thomas, additional, Kandulski, Arne, additional, Weigt, Jochen, additional, Börner, Norbert, additional, Lutz-Vorderbrügge, Anne, additional, Albert, Jörg, additional, Zeuzem, Stefan, additional, Blumenstein, Irina, additional, Sprinzl, Kathrin, additional, Hausmann, Johannes, additional, Bredenoord, Arjan, additional, Warners, Marijn, additional, Villarin, Alfredo Lucendo, additional, Arias, Ángel Arias, additional, Tejero Bustos, Maria Ángeles, additional, Carrillo Ramos, María Jesús, additional, Olalla Gallardo, José María, additional, Tosina, Rocío Juárez, additional, Zamorano, José, additional, Vaquero, Cecilio Santander, additional, Francés, Sergio Casabona, additional, Pérez, Teresa, additional, Rodriguez, Teresa, additional, Ciriza de los Ríos, Constanza, additional, Rodríguez-Valcárcel, Fernando Canga, additional, Castel de Lucas, Isabel, additional, Juan, Antonia Perelló, additional, Barenys, Merce, additional, Pons, Carlos, additional, Martinez, Isabel Perez, additional, Lauret, M. Eugenia, additional, García, Andrés Castaño, additional, Rubio, Esmeralda, additional, Hruz, Petr, additional, Brunner, Simon, additional, and Poullis, Andrew, additional

Published
2019
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20. An expert consensus definition of failure of a treatment to provide adequate relief (F-PAR) for chronic constipation - an international Delphi survey

Author

Tack, J., Boardman, H., Layer, P., Schiefke, I., Jayne, D., Scarpignato, C., Fox, M., Frieling, T., Ducrotte, P., S. , H.a.m.d. Y, Gill, K., Ciriza de los Rios, C., Felt Bersma, R., De Looze, D., Stanghellini, V., Drewes, A. Mohr, Simrén, M., Pehl, C., Hoheisel, T., Leodolter, A., Rey, E., Dalrymple, J., Emmanuel, A, Tack, Jan, Layer, Peter, Schiefke, Ingolf, Jayne, David, Emmanuel, Anton, Felt Bersma, Richelle, De Looze, Danny, Mohr Drewes, Asbjørn, Ducrotte, Philippe, Frieling, Thomas, Pehl, Christian, Hoheisel, Torsten, Leodolter, Andreas, Scarpignato, Carmelo, Ciriza de los Rios, Constanza, Rey, Enrique, Simrén, Magnus, Shaheen, H.a.m.d. Y, Fox, Mark, Gill, Kathryn, Dalrymple, Jamie, STANGHELLINI, VINCENZO, UCL, Université Catholique de Louvain - Gut Peptide Research Lab, Translational Research Center for Gastrointestinal Disorders, Department of Clinical & Experimental Medicine, Louvain, Belgique, Broad Institute of MIT and Harvard (BROAD INSTITUTE), Harvard Medical School [Boston] (HMS)-Massachusetts Institute of Technology (MIT)-Massachusetts General Hospital [Boston], Department of Medicine, Israelitic Hospital, Hamburg, Germany, Department of Internal Medicine II, University of Leipzig, Leipzig, Germany, Department of Surgery, University of Leeds and Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom., Institute of Pharmacology, School of Medicine and Dentistry, University of Parma, Italy., Astrophysics Group, Blackett Laboratory, Imperial College London-Imperial College London, Hepatologie und Infektiologie, Heinrich-Heine-Universität, Düsseldorf., Service d'Hépato-Gastroentérologie [CHU Rouen], Hôpital Charles Nicolle [Rouen]-CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), Nutrition, inflammation et dysfonctionnement de l'axe intestin-cerveau (ADEN), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institute for Research and Innovation in Biomedicine (IRIB), Normandie Université (NU)-Normandie Université (NU)-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM), UNIROUEN - UFR Santé (UNIROUEN UFR Santé), Normandie Université (NU)-Normandie Université (NU), Gastroenterology, Salford Royal NHS Foundation Trust, Salford, UK., Division of Diabetes, Endocrinology & Gastroenterology, Neurogastroenterology Unit, Wythenshawe Hospital, University of Manchester, Manchester, UK., European Organization for Nuclear Research (CERN), Hospital Universitario 12 de Octubre, Avda. Córdoba s/n., Madrid, Spain, Department of Gastroenterology and Hepatology, VU University Medical Centre, Amsterdam, The Netherlands, Ghent University Hospital [Ghent, Belgium], Institute of Clinical Medicine and Gastroenterology, University of Bologna, Italy., Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg, Denmark., Department of Clinical Medicine, Aalborg University, Aalborg, Denmark., Department of Internal Medicine, Sahlgrenska University Hospital, Göteburg, Sweden., Department of Gastroenterology, Hospital Bogenhausen, Munich, Germany., Ecole Polytechnique Fédérale de Lausanne (EPFL), Department of Gastroenterology, Hepatology and Infectious Diseases, University of Magdeburg, Germany., Centre de recherche de l'Institut universitaire de gériatrie de Montreal (CRIUGM), Université de Montréal (UdeM), Norwich Medical School, University of East Anglia, Norwich, UK., Physiology Unit, University College Hospital, London, UK, Gastroenterology and hepatology, AGEM - Digestive immunity, Amsterdam Movement Sciences - Restoration and Development, Tack, J., Boardman, H., Layer, P., Schiefke, I., Jayne, D., Scarpignato, C., Fox, M., Frieling, T., Ducrotte, P., S., Hamd.Y, Gill, K., Ciriza de los Rios, C., Felt-Bersma, R., De Looze, D., Stanghellini, V., Drewes, A. Mohr, Simrén, M., Pehl, C., Hoheisel, T., Leodolter, A., Rey, E., Dalrymple, J., Emmanuel, A, Tack, Jan, Layer, Peter, Schiefke, Ingolf, Jayne, David, Emmanuel, Anton, Felt-Bersma, Richelle, De Looze, Danny, Mohr-Drewes, Asbjørn, Ducrotte, Philippe, Frieling, Thoma, Pehl, Christian, Hoheisel, Torsten, Leodolter, Andrea, Stanghellini, Vincenzo, Scarpignato, Carmelo, Ciriza de los Rios, Constanza, Rey, Enrique, Simrén, Magnu, Shaheen, Hamd.Y, Fox, Mark, Gill, Kathryn, Dalrymple, Jamie, and University of Zurich

Subjects
medicine.medical_specialty, Constipation, Consensus, Internationality, Delphi Technique, Delphi method, Alternative medicine, 610 Medicine & health, Likert scale, 03 medical and health sciences, 0302 clinical medicine, Rating scale, Surveys and Questionnaires, 2736 Pharmacology (medical), Medicine, Humans, 2715 Gastroenterology, Pharmacology (medical), Treatment Failure, Expert Testimony, ComputingMilieux_MISCELLANEOUS, Chronic constipation, Hepatology, business.industry, Remission Induction, Gastroenterology, [SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology, Focus Groups, Focus group, 3. Good health, Clinical trial, 10219 Clinic for Gastroenterology and Hepatology, 030220 oncology & carcinogenesis, Chronic Disease, Physical therapy, 2721 Hepatology, 030211 gastroenterology & hepatology, medicine.symptom, business
Abstract

BACKGROUND: As treatments for constipation become increasingly available, it is important to know when to progress along the treatment algorithm if the patient is not better.AIM: To establish the definition of failure of a treatment to provide adequate relief (F-PAR) to support this management and referral process in patients with chronic constipation.METHODS: We conducted an international Delphi Survey among gastroenterologists and general practitioners with a special interest in chronic constipation. An initial questionnaire based on recognised rating scales was developed following a focus group. Data were collected from two subsequent rounds of questionnaires completed by all authors. Likert scales were used to establish a consensus on a shorter list of more severe symptoms.RESULTS: The initial focus group yielded a first round questionnaire with 84 statements. There was good consensus on symptom severity and a clear severity response curve, allowing 67 of the symptom-severity pairings to be eliminated. Subsequently, a clear consensus was established on further reduction to eight symptom statements in the final definition, condensed by the steering committee into five diagnostic statements (after replicate statements had been removed).CONCLUSIONS: We present an international consensus on chronic constipation, of five symptoms and their severities, any of which would be sufficient to provide clinical evidence of treatment failure. We also provide data representing an expert calibration of commonly used rating scales, thus allowing results of clinical trials expressed in terms of those scales to be converted into estimates of rates of provision of adequate relief.

Published
2016

22. Budesonide orodispersible tablets for induction of remission in patients with active eosinophilic oesophagitis: A 6-week open-label trial of the EOS-2 Programme.

Author

Miehlke S, Schlag C, Lucendo AJ, Biedermann L, Vaquero CS, Schmoecker C, Hayat J, Hruz P, Ciriza de Los Rios C, Bredenoord AJ, Vieth M, Schoepfer A, Attwood S, Mueller R, Burrack S, Greinwald R, and Straumann A

Subjects
Adult, Budesonide adverse effects, Humans, Prospective Studies, Remission Induction, Tablets therapeutic use, Deglutition Disorders, Eosinophilic Esophagitis diagnosis, Eosinophilic Esophagitis drug therapy, Eosinophilic Esophagitis pathology
Abstract

Background: A novel budesonide orodispersible tablet (BOT) has been proven effective in adult patients with active eosinophilic oesophagitis (EoE) in a 6-week placebo-controlled trial (EOS-1)., Aims: To report the efficacy of an open-label induction treatment with BOT in a large prospective cohort of EoE patients within the EOS-2 study., Methods: Patients with clinico-histological active EoE were treated with BOT 1 mg BID for 6 weeks. The primary endpoint was clinico-histological remission (≤2 points on numerical rating scales [0-10] each for dysphagia and odynophagia, and peak eosinophil count <16 eos/mm 2 hpf (corresponds to <5 eos/hpf)). Further study endpoints included clinical and histological remission rates, change in the EEsAI-PRO score, change in peak eosinophil counts, and deep endoscopic remission using a modified Endoscopic Reference Score., Results: Among 181 patients enrolled, 126 (69.6%) achieved clinico-histological remission (histological remission 90.1%, clinical remission 75.1%). The mean peak eosinophil counts decreased by 283 eos/mm 2 hpf (i.e., by 89.0%). Mean EEsAI-PRO score decreased from baseline by 29 points and deep endoscopic remission was achieved in 97 (53.6%) patients. The majority of patients judged tolerability as good or very good (85.6%) and compliance was high (96.5%). Local candidiasis was suspected in 8.3% of patients; all were of mild severity, resolved with treatment and none led to premature withdrawal from the study., Conclusions: In this large prospective trial, a 6-week open-label treatment with BOT 1 mg BID was highly effective and safe in achieving clinico-histological remission of active EoE and confirmed the results of the placebo-controlled EOS-1 trial., (© 2022 The Authors. United European Gastroenterology Journal published by Wiley Periodicals LLC on behalf of United European Gastroenterology.)

Published
2022
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