Swiss QUality of life and healthcare impact Assessment in a Real-world Erenumab treated migraine population (SQUARE study): interim results
Abstract 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 desi...
| Main Authors: | , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2022-11-01
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| Series: | The Journal of Headache and Pain |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s10194-022-01515-8 |
| _version_ | 1797984082923094016 |
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| author | Andreas R. Gantenbein Reto Agosti Christian P. Kamm Gunther Landmann Niklaus Meier Gabriele Susanne Merki-Feld Jens A. Petersen Heiko Pohl Philippe Ryvlin Christoph J. Schankin Dragana Viceic Chiara Zecca Elisabeth Schäfer Ina Meyer Michael E. Arzt |
| author_facet | Andreas R. Gantenbein Reto Agosti Christian P. Kamm Gunther Landmann Niklaus Meier Gabriele Susanne Merki-Feld Jens A. Petersen Heiko Pohl Philippe Ryvlin Christoph J. Schankin Dragana Viceic Chiara Zecca Elisabeth Schäfer Ina Meyer Michael E. Arzt |
| author_sort | Andreas R. Gantenbein |
| collection | DOAJ |
| description | Abstract 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 |
| first_indexed | 2024-04-11T06:56:56Z |
| format | Article |
| id | doaj.art-93d53abc25c24c17abc9abfa5668b7c5 |
| institution | Directory Open Access Journal |
| issn | 1129-2369 1129-2377 |
| language | English |
| last_indexed | 2024-04-11T06:56:56Z |
| publishDate | 2022-11-01 |
| publisher | BMC |
| record_format | Article |
| series | The Journal of Headache and Pain |
| spelling | doaj.art-93d53abc25c24c17abc9abfa5668b7c52022-12-22T04:39:01ZengBMCThe Journal of Headache and Pain1129-23691129-23772022-11-0123111010.1186/s10194-022-01515-8Swiss QUality of life and healthcare impact Assessment in a Real-world Erenumab treated migraine population (SQUARE study): interim resultsAndreas R. Gantenbein0Reto Agosti1Christian P. Kamm2Gunther Landmann3Niklaus Meier4Gabriele Susanne Merki-Feld5Jens A. Petersen6Heiko Pohl7Philippe Ryvlin8Christoph J. Schankin9Dragana Viceic10Chiara Zecca11Elisabeth Schäfer12Ina Meyer13Michael E. Arzt14Department of Neurology and Neurorehabilitation, ZURZACH CareKopfwehzentrum HirslandenDepartment of Neurology, Inselspital, University Hospital Bern and University of BernCenter for Pain MedicineDepartment of Neurology, Spital ThunDepartment of Reproductive Endocrinology, University Hospital ZurichNeurozentrum BernDepartment of Neurology, University Hospital ZurichDepartment of Clinical Neurosciences, CHUVDepartment of Neurology, Inselspital, University Hospital Bern and University of BernPrivate PracticeNeurocenter of Southern Switzerland, Ente Ospedaliero Cantonale (EOC)Novartis Pharma Schweiz AGNovartis Pharma Schweiz AGNovartis Pharma Schweiz AGAbstract 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 Abstracthttps://doi.org/10.1186/s10194-022-01515-8ErenumabMigraineReal-world evidenceQuality of lifeHealthcare impactSwitzerland |
| spellingShingle | Andreas R. Gantenbein Reto Agosti Christian P. Kamm Gunther Landmann Niklaus Meier Gabriele Susanne Merki-Feld Jens A. Petersen Heiko Pohl Philippe Ryvlin Christoph J. Schankin Dragana Viceic Chiara Zecca Elisabeth Schäfer Ina Meyer Michael E. Arzt Swiss QUality of life and healthcare impact Assessment in a Real-world Erenumab treated migraine population (SQUARE study): interim results The Journal of Headache and Pain Erenumab Migraine Real-world evidence Quality of life Healthcare impact Switzerland |
| 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 | Erenumab Migraine Real-world evidence Quality of life Healthcare impact Switzerland |
| url | https://doi.org/10.1186/s10194-022-01515-8 |
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