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Points to consider for the treatment of immune-mediated inflammatory diseases with Janus kinase inhibitors: a consensus statement
OBJECTIVES: Janus kinase inhibitors (JAKi) have been approved for use in various immune-mediated inflammatory diseases. With five agents licensed, it was timely to summarise the current understanding of JAKi use based on a systematic literature review (SLR) on efficacy and safety. METHODS: Existing...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7788060/ https://www.ncbi.nlm.nih.gov/pubmed/33158881 http://dx.doi.org/10.1136/annrheumdis-2020-218398 |
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author | Nash, Peter Kerschbaumer, Andreas Dörner, Thomas Dougados, Maxime Fleischmann, Roy M Geissler, Klaus McInnes, Iain Pope, Janet E van der Heijde, Désirée Stoffer-Marx, Michaela Takeuchi, Tsutomu Trauner, Michael Winthrop, Kevin L de Wit, Maarten Aletaha, Daniel Baraliakos, Xenofon Boehncke, Wolf-Henning Emery, Paul Isaacs, John D Kremer, Joel Lee, Eun Bong Maksymowych, Walter P Voshaar, Marieke Tam, Lai-Shan Tanaka, Yoshiya van den Bosch, Filip Westhovens, René Xavier, Ricardo Smolen, Josef S |
author_facet | Nash, Peter Kerschbaumer, Andreas Dörner, Thomas Dougados, Maxime Fleischmann, Roy M Geissler, Klaus McInnes, Iain Pope, Janet E van der Heijde, Désirée Stoffer-Marx, Michaela Takeuchi, Tsutomu Trauner, Michael Winthrop, Kevin L de Wit, Maarten Aletaha, Daniel Baraliakos, Xenofon Boehncke, Wolf-Henning Emery, Paul Isaacs, John D Kremer, Joel Lee, Eun Bong Maksymowych, Walter P Voshaar, Marieke Tam, Lai-Shan Tanaka, Yoshiya van den Bosch, Filip Westhovens, René Xavier, Ricardo Smolen, Josef S |
author_sort | Nash, Peter |
collection | PubMed |
description | OBJECTIVES: Janus kinase inhibitors (JAKi) have been approved for use in various immune-mediated inflammatory diseases. With five agents licensed, it was timely to summarise the current understanding of JAKi use based on a systematic literature review (SLR) on efficacy and safety. METHODS: Existing data were evaluated by a steering committee and subsequently reviewed by a 29 person expert committee leading to the formulation of a consensus statement that may assist the clinicians, patients and other stakeholders once the decision is made to commence a JAKi. The committee included patients, rheumatologists, a gastroenterologist, a haematologist, a dermatologist, an infectious disease specialist and a health professional. The SLR informed the Task Force on controlled and open clinical trials, registry data, phase 4 trials and meta-analyses. In addition, approval of new compounds by, and warnings from regulators that were issued after the end of the SLR search date were taken into consideration. RESULTS: The Task Force agreed on and developed four general principles and a total of 26 points for consideration which were grouped into six areas addressing indications, treatment dose and comedication, contraindications, pretreatment screening and risks, laboratory and clinical follow-up examinations, and adverse events. Levels of evidence and strengths of recommendations were determined based on the SLR and levels of agreement were voted on for every point, reaching a range between 8.8 and 9.9 on a 10-point scale. CONCLUSION: The consensus provides an assessment of evidence for efficacy and safety of an important therapeutic class with guidance on issues of practical management. |
format | Online Article Text |
id | pubmed-7788060 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-77880602021-01-14 Points to consider for the treatment of immune-mediated inflammatory diseases with Janus kinase inhibitors: a consensus statement Nash, Peter Kerschbaumer, Andreas Dörner, Thomas Dougados, Maxime Fleischmann, Roy M Geissler, Klaus McInnes, Iain Pope, Janet E van der Heijde, Désirée Stoffer-Marx, Michaela Takeuchi, Tsutomu Trauner, Michael Winthrop, Kevin L de Wit, Maarten Aletaha, Daniel Baraliakos, Xenofon Boehncke, Wolf-Henning Emery, Paul Isaacs, John D Kremer, Joel Lee, Eun Bong Maksymowych, Walter P Voshaar, Marieke Tam, Lai-Shan Tanaka, Yoshiya van den Bosch, Filip Westhovens, René Xavier, Ricardo Smolen, Josef S Ann Rheum Dis Recommendation OBJECTIVES: Janus kinase inhibitors (JAKi) have been approved for use in various immune-mediated inflammatory diseases. With five agents licensed, it was timely to summarise the current understanding of JAKi use based on a systematic literature review (SLR) on efficacy and safety. METHODS: Existing data were evaluated by a steering committee and subsequently reviewed by a 29 person expert committee leading to the formulation of a consensus statement that may assist the clinicians, patients and other stakeholders once the decision is made to commence a JAKi. The committee included patients, rheumatologists, a gastroenterologist, a haematologist, a dermatologist, an infectious disease specialist and a health professional. The SLR informed the Task Force on controlled and open clinical trials, registry data, phase 4 trials and meta-analyses. In addition, approval of new compounds by, and warnings from regulators that were issued after the end of the SLR search date were taken into consideration. RESULTS: The Task Force agreed on and developed four general principles and a total of 26 points for consideration which were grouped into six areas addressing indications, treatment dose and comedication, contraindications, pretreatment screening and risks, laboratory and clinical follow-up examinations, and adverse events. Levels of evidence and strengths of recommendations were determined based on the SLR and levels of agreement were voted on for every point, reaching a range between 8.8 and 9.9 on a 10-point scale. CONCLUSION: The consensus provides an assessment of evidence for efficacy and safety of an important therapeutic class with guidance on issues of practical management. BMJ Publishing Group 2021-01 2020-11-06 /pmc/articles/PMC7788060/ /pubmed/33158881 http://dx.doi.org/10.1136/annrheumdis-2020-218398 Text en © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ http://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. |
spellingShingle | Recommendation Nash, Peter Kerschbaumer, Andreas Dörner, Thomas Dougados, Maxime Fleischmann, Roy M Geissler, Klaus McInnes, Iain Pope, Janet E van der Heijde, Désirée Stoffer-Marx, Michaela Takeuchi, Tsutomu Trauner, Michael Winthrop, Kevin L de Wit, Maarten Aletaha, Daniel Baraliakos, Xenofon Boehncke, Wolf-Henning Emery, Paul Isaacs, John D Kremer, Joel Lee, Eun Bong Maksymowych, Walter P Voshaar, Marieke Tam, Lai-Shan Tanaka, Yoshiya van den Bosch, Filip Westhovens, René Xavier, Ricardo Smolen, Josef S Points to consider for the treatment of immune-mediated inflammatory diseases with Janus kinase inhibitors: a consensus statement |
title | Points to consider for the treatment of immune-mediated inflammatory diseases with Janus kinase inhibitors: a consensus statement |
title_full | Points to consider for the treatment of immune-mediated inflammatory diseases with Janus kinase inhibitors: a consensus statement |
title_fullStr | Points to consider for the treatment of immune-mediated inflammatory diseases with Janus kinase inhibitors: a consensus statement |
title_full_unstemmed | Points to consider for the treatment of immune-mediated inflammatory diseases with Janus kinase inhibitors: a consensus statement |
title_short | Points to consider for the treatment of immune-mediated inflammatory diseases with Janus kinase inhibitors: a consensus statement |
title_sort | points to consider for the treatment of immune-mediated inflammatory diseases with janus kinase inhibitors: a consensus statement |
topic | Recommendation |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7788060/ https://www.ncbi.nlm.nih.gov/pubmed/33158881 http://dx.doi.org/10.1136/annrheumdis-2020-218398 |
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