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Swiss QUality of life and healthcare impact Assessment in a Real-world Erenumab treated migraine population (SQUARE study): interim results

BACKGROUND: The fully human monoclonal antibody erenumab, which targets the calcitonin gene-related peptide (CGRP) receptor, was licensed in Switzerland in July 2018 for the prophylactic treatment of migraine. To complement findings from the pivotal program, this observational study was designed to...

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Autores principales: Gantenbein, Andreas R., Agosti, Reto, Kamm, Christian P., Landmann, Gunther, Meier, Niklaus, Merki-Feld, Gabriele Susanne, Petersen, Jens A., Pohl, Heiko, Ryvlin, Philippe, Schankin, Christoph J., Viceic, Dragana, Zecca, Chiara, Schäfer, Elisabeth, Meyer, Ina, Arzt, Michael E.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Milan 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9673191/
https://www.ncbi.nlm.nih.gov/pubmed/36401172
http://dx.doi.org/10.1186/s10194-022-01515-8
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author Gantenbein, Andreas R.
Agosti, Reto
Kamm, Christian P.
Landmann, Gunther
Meier, Niklaus
Merki-Feld, Gabriele Susanne
Petersen, Jens A.
Pohl, Heiko
Ryvlin, Philippe
Schankin, Christoph J.
Viceic, Dragana
Zecca, Chiara
Schäfer, Elisabeth
Meyer, Ina
Arzt, Michael E.
author_facet Gantenbein, Andreas R.
Agosti, Reto
Kamm, Christian P.
Landmann, Gunther
Meier, Niklaus
Merki-Feld, Gabriele Susanne
Petersen, Jens A.
Pohl, Heiko
Ryvlin, Philippe
Schankin, Christoph J.
Viceic, Dragana
Zecca, Chiara
Schäfer, Elisabeth
Meyer, Ina
Arzt, Michael E.
author_sort Gantenbein, Andreas R.
collection PubMed
description BACKGROUND: The fully human monoclonal antibody erenumab, which targets the calcitonin gene-related peptide (CGRP) receptor, was licensed in Switzerland in July 2018 for the prophylactic treatment of migraine. To complement findings from the pivotal program, this observational study was designed to collect and evaluate clinical data on the impact of erenumab on several endpoints, such as quality of life, migraine-related impairment and treatment satisfaction in a real-world setting. METHODS: An interim analysis was conducted after all patients completed 6 months of erenumab treatment. Patients kept a headache diary and completed questionnaires at follow up visits. The overall study duration comprises 24 months. RESULTS: In total, 172 adults with chronic or episodic migraine from 19 different sites across Switzerland were enrolled to receive erenumab every 4 weeks. At baseline, patients had 16.6 ± 7.2 monthly migraine days (MMD) and 11.6 ± 7.0 acute migraine-specific medication days per month. After 6 months, erenumab treatment reduced Headache Impact Test (HIT-6™) scores by 7.7 ± 8.4 (p < 0.001), the modified Migraine Disability Assessment (mMIDAS) by 14.1 ± 17.8 (p < 0.001), MMD by 7.6 ± 7.0 (p < 0.001) and acute migraine-specific medication days per month by 6.6 ± 5.4 (p < 0.001). Erenumab also reduced the impact of migraine on social and family life, as evidenced by a reduction of Impact of Migraine on Partners and Adolescent Children (IMPAC) scores by 6.1 ± 6.7 (p < 0.001). Patients reported a mean effectiveness of 67.1, convenience of 82.4 and global satisfaction of 72.4 in the Treatment Satisfaction Questionnaire for Medication (TSQM-9). In total, 99 adverse events (AE) and 12 serious adverse events (SAE) were observed in 62 and 11 patients, respectively. All SAE were regarded as not related to the study medication. CONCLUSIONS: Overall quality of life improved and treatment satisfaction was rated high with erenumab treatment in real-world clinical practice. In addition, the reported impact of migraine on spouses and children of patients was reduced. TRIAL REGISTRATION: BASEC ID 2018–02,375 in the Register of All Projects in Switzerland (RAPS). GRAPHICAL ABSTRACT: [Image: see text] SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s10194-022-01515-8.
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spelling pubmed-96731912022-11-18 Swiss QUality of life and healthcare impact Assessment in a Real-world Erenumab treated migraine population (SQUARE study): interim results Gantenbein, Andreas R. Agosti, Reto Kamm, Christian P. Landmann, Gunther Meier, Niklaus Merki-Feld, Gabriele Susanne Petersen, Jens A. Pohl, Heiko Ryvlin, Philippe Schankin, Christoph J. Viceic, Dragana Zecca, Chiara Schäfer, Elisabeth Meyer, Ina Arzt, Michael E. J Headache Pain Research BACKGROUND: The fully human monoclonal antibody erenumab, which targets the calcitonin gene-related peptide (CGRP) receptor, was licensed in Switzerland in July 2018 for the prophylactic treatment of migraine. To complement findings from the pivotal program, this observational study was designed to collect and evaluate clinical data on the impact of erenumab on several endpoints, such as quality of life, migraine-related impairment and treatment satisfaction in a real-world setting. METHODS: An interim analysis was conducted after all patients completed 6 months of erenumab treatment. Patients kept a headache diary and completed questionnaires at follow up visits. The overall study duration comprises 24 months. RESULTS: In total, 172 adults with chronic or episodic migraine from 19 different sites across Switzerland were enrolled to receive erenumab every 4 weeks. At baseline, patients had 16.6 ± 7.2 monthly migraine days (MMD) and 11.6 ± 7.0 acute migraine-specific medication days per month. After 6 months, erenumab treatment reduced Headache Impact Test (HIT-6™) scores by 7.7 ± 8.4 (p < 0.001), the modified Migraine Disability Assessment (mMIDAS) by 14.1 ± 17.8 (p < 0.001), MMD by 7.6 ± 7.0 (p < 0.001) and acute migraine-specific medication days per month by 6.6 ± 5.4 (p < 0.001). Erenumab also reduced the impact of migraine on social and family life, as evidenced by a reduction of Impact of Migraine on Partners and Adolescent Children (IMPAC) scores by 6.1 ± 6.7 (p < 0.001). Patients reported a mean effectiveness of 67.1, convenience of 82.4 and global satisfaction of 72.4 in the Treatment Satisfaction Questionnaire for Medication (TSQM-9). In total, 99 adverse events (AE) and 12 serious adverse events (SAE) were observed in 62 and 11 patients, respectively. All SAE were regarded as not related to the study medication. CONCLUSIONS: Overall quality of life improved and treatment satisfaction was rated high with erenumab treatment in real-world clinical practice. In addition, the reported impact of migraine on spouses and children of patients was reduced. TRIAL REGISTRATION: BASEC ID 2018–02,375 in the Register of All Projects in Switzerland (RAPS). GRAPHICAL ABSTRACT: [Image: see text] SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s10194-022-01515-8. Springer Milan 2022-11-18 /pmc/articles/PMC9673191/ /pubmed/36401172 http://dx.doi.org/10.1186/s10194-022-01515-8 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research
Gantenbein, Andreas R.
Agosti, Reto
Kamm, Christian P.
Landmann, Gunther
Meier, Niklaus
Merki-Feld, Gabriele Susanne
Petersen, Jens A.
Pohl, Heiko
Ryvlin, Philippe
Schankin, Christoph J.
Viceic, Dragana
Zecca, Chiara
Schäfer, Elisabeth
Meyer, Ina
Arzt, Michael E.
Swiss QUality of life and healthcare impact Assessment in a Real-world Erenumab treated migraine population (SQUARE study): interim results
title Swiss QUality of life and healthcare impact Assessment in a Real-world Erenumab treated migraine population (SQUARE study): interim results
title_full Swiss QUality of life and healthcare impact Assessment in a Real-world Erenumab treated migraine population (SQUARE study): interim results
title_fullStr Swiss QUality of life and healthcare impact Assessment in a Real-world Erenumab treated migraine population (SQUARE study): interim results
title_full_unstemmed Swiss QUality of life and healthcare impact Assessment in a Real-world Erenumab treated migraine population (SQUARE study): interim results
title_short Swiss QUality of life and healthcare impact Assessment in a Real-world Erenumab treated migraine population (SQUARE study): interim results
title_sort swiss quality of life and healthcare impact assessment in a real-world erenumab treated migraine population (square study): interim results
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9673191/
https://www.ncbi.nlm.nih.gov/pubmed/36401172
http://dx.doi.org/10.1186/s10194-022-01515-8
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