Real-world efficacy and tolerability of fremanezumab in adults with chronic migraine: a 3-month, single-center, prospective, observational study
BackgroundFollowing the promising pre-marketing placebo-controlled randomized clinical trials of fremanezumab, post-marketing studies are necessary to verify efficacy and tolerability in various real-world settings. The present study assessed real-world efficacy and safety of fremanezumab.MethodsA 3...
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Frontiers Media S.A.
2023-08-01
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| Series: | Frontiers in Neurology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fneur.2023.1226591/full |
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| author | Christopher Kjaer Cullum Christopher Kjaer Cullum Basit Ali Chaudhry Basit Ali Chaudhry Thien Phu Do Thien Phu Do Thien Phu Do Faisal Mohammad Amin Faisal Mohammad Amin Faisal Mohammad Amin |
| author_facet | Christopher Kjaer Cullum Christopher Kjaer Cullum Basit Ali Chaudhry Basit Ali Chaudhry Thien Phu Do Thien Phu Do Thien Phu Do Faisal Mohammad Amin Faisal Mohammad Amin Faisal Mohammad Amin |
| author_sort | Christopher Kjaer Cullum |
| collection | DOAJ |
| description | BackgroundFollowing the promising pre-marketing placebo-controlled randomized clinical trials of fremanezumab, post-marketing studies are necessary to verify efficacy and tolerability in various real-world settings. The present study assessed real-world efficacy and safety of fremanezumab.MethodsA 3-month, single-center, prospective, observation study of adults with chronic migraine who were treated with monthly subcutaneous injections of 225 mg fremanezumab in Denmark. The primary outcome was defined as proportion of patients who achieved ≥30% reduction in monthly migraine days (MMDs) from baseline to weeks 9–12. Among secondary outcomes were ≥50 and ≥75% responder rates and the proportion of patients reporting adverse events.ResultsA total of 91 patients with chronic migraine were enrolled and received at least one dose of fremanezumab of whom 89 patients (98%) completed the 3-months treatment period. At baseline, the mean (SD) number of monthly headache days was 24.3 ± 5.8 and mean number of MMDs was 18.5 ± 7.4. The number of patients who achieved ≥30% reduction in MMDs from baseline to weeks 9–12 was 58 (65%), while 45 (51%) and 21 (24%) had ≥50 and 75% reduction in MMD, respectively. Twenty-one patients (23%) reported adverse event, in which the most common were constipation (4.4%), fatigue (4.4%) and dizziness (3.3%). No serious adverse events were reported.ConclusionIn adult chronic migraine patients with previous failure of conventional oral migraine preventives, fremanezumab was found to be effective and well-tolerated. |
| first_indexed | 2024-03-12T15:23:00Z |
| format | Article |
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| institution | Directory Open Access Journal |
| issn | 1664-2295 |
| language | English |
| last_indexed | 2024-03-12T15:23:00Z |
| publishDate | 2023-08-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Neurology |
| spelling | doaj.art-9566461199484b8a829f1c301604ad432023-08-11T01:13:04ZengFrontiers Media S.A.Frontiers in Neurology1664-22952023-08-011410.3389/fneur.2023.12265911226591Real-world efficacy and tolerability of fremanezumab in adults with chronic migraine: a 3-month, single-center, prospective, observational studyChristopher Kjaer Cullum0Christopher Kjaer Cullum1Basit Ali Chaudhry2Basit Ali Chaudhry3Thien Phu Do4Thien Phu Do5Thien Phu Do6Faisal Mohammad Amin7Faisal Mohammad Amin8Faisal Mohammad Amin9Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, DenmarkDepartment of Clinical Medicine, University of Copenhagen, Copenhagen, DenmarkDanish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, DenmarkDepartment of Clinical Medicine, University of Copenhagen, Copenhagen, DenmarkDanish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, DenmarkDepartment of Clinical Medicine, University of Copenhagen, Copenhagen, DenmarkDanish Knowledge Center on Headache Disorders, Rigshospitalet Glostrup, Glostrup, DenmarkDanish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, DenmarkDepartment of Clinical Medicine, University of Copenhagen, Copenhagen, DenmarkDepartment of Neurorehabilitation/Traumatic Brain Injury, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, DenmarkBackgroundFollowing the promising pre-marketing placebo-controlled randomized clinical trials of fremanezumab, post-marketing studies are necessary to verify efficacy and tolerability in various real-world settings. The present study assessed real-world efficacy and safety of fremanezumab.MethodsA 3-month, single-center, prospective, observation study of adults with chronic migraine who were treated with monthly subcutaneous injections of 225 mg fremanezumab in Denmark. The primary outcome was defined as proportion of patients who achieved ≥30% reduction in monthly migraine days (MMDs) from baseline to weeks 9–12. Among secondary outcomes were ≥50 and ≥75% responder rates and the proportion of patients reporting adverse events.ResultsA total of 91 patients with chronic migraine were enrolled and received at least one dose of fremanezumab of whom 89 patients (98%) completed the 3-months treatment period. At baseline, the mean (SD) number of monthly headache days was 24.3 ± 5.8 and mean number of MMDs was 18.5 ± 7.4. The number of patients who achieved ≥30% reduction in MMDs from baseline to weeks 9–12 was 58 (65%), while 45 (51%) and 21 (24%) had ≥50 and 75% reduction in MMD, respectively. Twenty-one patients (23%) reported adverse event, in which the most common were constipation (4.4%), fatigue (4.4%) and dizziness (3.3%). No serious adverse events were reported.ConclusionIn adult chronic migraine patients with previous failure of conventional oral migraine preventives, fremanezumab was found to be effective and well-tolerated.https://www.frontiersin.org/articles/10.3389/fneur.2023.1226591/fullheadachemigraine with auramigraine without auraCGRPmonoclonal CGRP antibodies |
| spellingShingle | Christopher Kjaer Cullum Christopher Kjaer Cullum Basit Ali Chaudhry Basit Ali Chaudhry Thien Phu Do Thien Phu Do Thien Phu Do Faisal Mohammad Amin Faisal Mohammad Amin Faisal Mohammad Amin Real-world efficacy and tolerability of fremanezumab in adults with chronic migraine: a 3-month, single-center, prospective, observational study Frontiers in Neurology headache migraine with aura migraine without aura CGRP monoclonal CGRP antibodies |
| title | Real-world efficacy and tolerability of fremanezumab in adults with chronic migraine: a 3-month, single-center, prospective, observational study |
| title_full | Real-world efficacy and tolerability of fremanezumab in adults with chronic migraine: a 3-month, single-center, prospective, observational study |
| title_fullStr | Real-world efficacy and tolerability of fremanezumab in adults with chronic migraine: a 3-month, single-center, prospective, observational study |
| title_full_unstemmed | Real-world efficacy and tolerability of fremanezumab in adults with chronic migraine: a 3-month, single-center, prospective, observational study |
| title_short | Real-world efficacy and tolerability of fremanezumab in adults with chronic migraine: a 3-month, single-center, prospective, observational study |
| title_sort | real world efficacy and tolerability of fremanezumab in adults with chronic migraine a 3 month single center prospective observational study |
| topic | headache migraine with aura migraine without aura CGRP monoclonal CGRP antibodies |
| url | https://www.frontiersin.org/articles/10.3389/fneur.2023.1226591/full |
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