Effects of fremanezumab on the use of acute headache medication and associated symptoms of migraine in patients with episodic migraine
Background Fremanezumab, a fully humanized monoclonal antibody targeting calcitonin gene-related peptide, has demonstrated efficacy for the preventive treatment of migraine in adults. Objective To evaluate the effect of fremanezumab treatment on acute headache medication use and migraine-associated...
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| Veröffentlicht in: | Cephalalgia 2020-04, Vol.40 (5), p.470-477 |
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| creator | Brandes, Jan Lewis Kudrow, David Yeung, Paul P Sakai, Fumihiko Aycardi, Ernesto Blankenbiller, Tricia Grozinski-Wolff, Melissa Yang, Ronghua Ma, Yuju |
| description | Background
Fremanezumab, a fully humanized monoclonal antibody targeting calcitonin gene-related peptide, has demonstrated efficacy for the preventive treatment of migraine in adults.
Objective
To evaluate the effect of fremanezumab treatment on acute headache medication use and migraine-associated symptoms in patients with episodic migraine.
Methods
In the Phase 3 HALO trial, patients with episodic migraine were randomized to receive subcutaneous fremanezumab monthly (225 mg at baseline, weeks 4 and 8), fremanezumab quarterly (675 mg at baseline, placebo at weeks 4 and 8), or placebo over a 12-week period. The secondary endpoint was change from baseline in the monthly number of days with use of any acute headache mediation or migraine-specific acute headache medication; exploratory endpoints were change from baseline in the monthly number of days with nausea or vomiting, photophobia, or phonophobia.
Results
Of 875 patients randomized, 865 were included in the analysis (monthly, n = 287; quarterly, n = 288; placebo, n = 290). Baseline mean ± standard deviation days with: Any acute headache medication use (monthly: 7.7 ± 3.4; quarterly: 7.8 ± 3.7; placebo: 7.7 ± 3.6), migraine-specific acute headache medication use (6.1 ± 3.1; 6.6 ± 3.1; 7.1 ± 3.0), nausea or vomiting (4.5 ± 3.6; 4.9 ± 3.7; 4.5 ± 3.3) and photophobia and phonophobia (5.5 ± 4.1; 6.3 ± 4.1; 6.0 ± 3.9) were similar among treatment arms. Fremanezumab reduced the number of days of acute headache medication use ([least-squares mean change vs. placebo] monthly: −1.4 [95% confidence interval: −1.84, −0.89], p |
| doi_str_mv | 10.1177/0333102419885905 |
| format | Article |
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Fremanezumab, a fully humanized monoclonal antibody targeting calcitonin gene-related peptide, has demonstrated efficacy for the preventive treatment of migraine in adults.
Objective
To evaluate the effect of fremanezumab treatment on acute headache medication use and migraine-associated symptoms in patients with episodic migraine.
Methods
In the Phase 3 HALO trial, patients with episodic migraine were randomized to receive subcutaneous fremanezumab monthly (225 mg at baseline, weeks 4 and 8), fremanezumab quarterly (675 mg at baseline, placebo at weeks 4 and 8), or placebo over a 12-week period. The secondary endpoint was change from baseline in the monthly number of days with use of any acute headache mediation or migraine-specific acute headache medication; exploratory endpoints were change from baseline in the monthly number of days with nausea or vomiting, photophobia, or phonophobia.
Results
Of 875 patients randomized, 865 were included in the analysis (monthly, n = 287; quarterly, n = 288; placebo, n = 290). Baseline mean ± standard deviation days with: Any acute headache medication use (monthly: 7.7 ± 3.4; quarterly: 7.8 ± 3.7; placebo: 7.7 ± 3.6), migraine-specific acute headache medication use (6.1 ± 3.1; 6.6 ± 3.1; 7.1 ± 3.0), nausea or vomiting (4.5 ± 3.6; 4.9 ± 3.7; 4.5 ± 3.3) and photophobia and phonophobia (5.5 ± 4.1; 6.3 ± 4.1; 6.0 ± 3.9) were similar among treatment arms. Fremanezumab reduced the number of days of acute headache medication use ([least-squares mean change vs. placebo] monthly: −1.4 [95% confidence interval: −1.84, −0.89], p < 0.001; quarterly: −1.3 [−1.76, −0.82], p < 0.001) and migraine-specific acute headache medication use (monthly: −2.2 [−2.80, −1.56], p < 0.001; quarterly: −2.2 [−2.81, −1.58], p < 0.001) compared with placebo. Fremanezumab also reduced nausea or vomiting, photophobia, and phonophobia compared with placebo.
Conclusions
Fremanezumab reduced the need for acute headache medications, including migraine-specific medications, while treating migraine-associated symptoms in patients with episodic migraine.
Trial registration
Clinicaltrials.gov NCT02629861</description><identifier>ISSN: 0333-1024</identifier><identifier>EISSN: 1468-2982</identifier><identifier>DOI: 10.1177/0333102419885905</identifier><identifier>PMID: 31752521</identifier><language>eng</language><publisher>London, England: SAGE Publications</publisher><ispartof>Cephalalgia, 2020-04, Vol.40 (5), p.470-477</ispartof><rights>International Headache Society 2019</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c337t-39b13cc7251b25c5bb79fd7ba2846be6637625adffbf6d131df4107c5bbb7ef23</citedby><cites>FETCH-LOGICAL-c337t-39b13cc7251b25c5bb79fd7ba2846be6637625adffbf6d131df4107c5bbb7ef23</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://journals.sagepub.com/doi/pdf/10.1177/0333102419885905$$EPDF$$P50$$Gsage$$H</linktopdf><linktohtml>$$Uhttps://journals.sagepub.com/doi/10.1177/0333102419885905$$EHTML$$P50$$Gsage$$H</linktohtml><link.rule.ids>314,776,780,21945,27830,27901,27902,44921,45309</link.rule.ids><linktorsrc>$$Uhttps://journals.sagepub.com/doi/full/10.1177/0333102419885905?utm_source=summon&utm_medium=discovery-provider$$EView_record_in_SAGE_Publications$$FView_record_in_$$GSAGE_Publications</linktorsrc><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31752521$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Brandes, Jan Lewis</creatorcontrib><creatorcontrib>Kudrow, David</creatorcontrib><creatorcontrib>Yeung, Paul P</creatorcontrib><creatorcontrib>Sakai, Fumihiko</creatorcontrib><creatorcontrib>Aycardi, Ernesto</creatorcontrib><creatorcontrib>Blankenbiller, Tricia</creatorcontrib><creatorcontrib>Grozinski-Wolff, Melissa</creatorcontrib><creatorcontrib>Yang, Ronghua</creatorcontrib><creatorcontrib>Ma, Yuju</creatorcontrib><title>Effects of fremanezumab on the use of acute headache medication and associated symptoms of migraine in patients with episodic migraine</title><title>Cephalalgia</title><addtitle>Cephalalgia</addtitle><description>Background
Fremanezumab, a fully humanized monoclonal antibody targeting calcitonin gene-related peptide, has demonstrated efficacy for the preventive treatment of migraine in adults.
Objective
To evaluate the effect of fremanezumab treatment on acute headache medication use and migraine-associated symptoms in patients with episodic migraine.
Methods
In the Phase 3 HALO trial, patients with episodic migraine were randomized to receive subcutaneous fremanezumab monthly (225 mg at baseline, weeks 4 and 8), fremanezumab quarterly (675 mg at baseline, placebo at weeks 4 and 8), or placebo over a 12-week period. The secondary endpoint was change from baseline in the monthly number of days with use of any acute headache mediation or migraine-specific acute headache medication; exploratory endpoints were change from baseline in the monthly number of days with nausea or vomiting, photophobia, or phonophobia.
Results
Of 875 patients randomized, 865 were included in the analysis (monthly, n = 287; quarterly, n = 288; placebo, n = 290). Baseline mean ± standard deviation days with: Any acute headache medication use (monthly: 7.7 ± 3.4; quarterly: 7.8 ± 3.7; placebo: 7.7 ± 3.6), migraine-specific acute headache medication use (6.1 ± 3.1; 6.6 ± 3.1; 7.1 ± 3.0), nausea or vomiting (4.5 ± 3.6; 4.9 ± 3.7; 4.5 ± 3.3) and photophobia and phonophobia (5.5 ± 4.1; 6.3 ± 4.1; 6.0 ± 3.9) were similar among treatment arms. Fremanezumab reduced the number of days of acute headache medication use ([least-squares mean change vs. placebo] monthly: −1.4 [95% confidence interval: −1.84, −0.89], p < 0.001; quarterly: −1.3 [−1.76, −0.82], p < 0.001) and migraine-specific acute headache medication use (monthly: −2.2 [−2.80, −1.56], p < 0.001; quarterly: −2.2 [−2.81, −1.58], p < 0.001) compared with placebo. Fremanezumab also reduced nausea or vomiting, photophobia, and phonophobia compared with placebo.
Conclusions
Fremanezumab reduced the need for acute headache medications, including migraine-specific medications, while treating migraine-associated symptoms in patients with episodic migraine.
Trial registration
Clinicaltrials.gov NCT02629861</description><issn>0333-1024</issn><issn>1468-2982</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><recordid>eNp1kE1LxDAURYMoOo7uXUmWbqr5mCTtUsQvENzouiTpy0yGaVObFNEf4O82ddSF4Crw7nknvIvQCSXnlCp1QTjnlLAFrcpSVETsoBldyLJgVcl20WyKiyk_QIcxrgkhQhK5jw44VYIJRmfo49o5sCni4LAboNUdvI-tNjh0OK0AjxGmSNsxAV6BbrTN0xYab3XyGdJdg3WMwXqdoMHxre1TaL98rV8O2neAfYf7TEOX_3n1aYWh9zFkxS9yhPac3kQ4_n7n6Pnm-unqrnh4vL2_unwoLOcqFbwylFurmKCGCSuMUZVrlNGsXEgDUnIlmdCNc8bJhnLauAUlagKNAsf4HJ1tvf0QXkaIqW59tLDZ5LvDGGs2NVNJXomMki1qhxDjAK7uB9_q4a2mpJ7ar_-2n1dOv-2jyRX9LvzUnYFiC0S9hHodxqHL1_4v_ATPiI7y</recordid><startdate>202004</startdate><enddate>202004</enddate><creator>Brandes, Jan Lewis</creator><creator>Kudrow, David</creator><creator>Yeung, Paul P</creator><creator>Sakai, Fumihiko</creator><creator>Aycardi, Ernesto</creator><creator>Blankenbiller, Tricia</creator><creator>Grozinski-Wolff, Melissa</creator><creator>Yang, Ronghua</creator><creator>Ma, Yuju</creator><general>SAGE Publications</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>202004</creationdate><title>Effects of fremanezumab on the use of acute headache medication and associated symptoms of migraine in patients with episodic migraine</title><author>Brandes, Jan Lewis ; Kudrow, David ; Yeung, Paul P ; Sakai, Fumihiko ; Aycardi, Ernesto ; Blankenbiller, Tricia ; Grozinski-Wolff, Melissa ; Yang, Ronghua ; Ma, Yuju</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c337t-39b13cc7251b25c5bb79fd7ba2846be6637625adffbf6d131df4107c5bbb7ef23</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Brandes, Jan Lewis</creatorcontrib><creatorcontrib>Kudrow, David</creatorcontrib><creatorcontrib>Yeung, Paul P</creatorcontrib><creatorcontrib>Sakai, Fumihiko</creatorcontrib><creatorcontrib>Aycardi, Ernesto</creatorcontrib><creatorcontrib>Blankenbiller, Tricia</creatorcontrib><creatorcontrib>Grozinski-Wolff, Melissa</creatorcontrib><creatorcontrib>Yang, Ronghua</creatorcontrib><creatorcontrib>Ma, Yuju</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Cephalalgia</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext_linktorsrc</fulltext></delivery><addata><au>Brandes, Jan Lewis</au><au>Kudrow, David</au><au>Yeung, Paul P</au><au>Sakai, Fumihiko</au><au>Aycardi, Ernesto</au><au>Blankenbiller, Tricia</au><au>Grozinski-Wolff, Melissa</au><au>Yang, Ronghua</au><au>Ma, Yuju</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effects of fremanezumab on the use of acute headache medication and associated symptoms of migraine in patients with episodic migraine</atitle><jtitle>Cephalalgia</jtitle><addtitle>Cephalalgia</addtitle><date>2020-04</date><risdate>2020</risdate><volume>40</volume><issue>5</issue><spage>470</spage><epage>477</epage><pages>470-477</pages><issn>0333-1024</issn><eissn>1468-2982</eissn><abstract>Background
Fremanezumab, a fully humanized monoclonal antibody targeting calcitonin gene-related peptide, has demonstrated efficacy for the preventive treatment of migraine in adults.
Objective
To evaluate the effect of fremanezumab treatment on acute headache medication use and migraine-associated symptoms in patients with episodic migraine.
Methods
In the Phase 3 HALO trial, patients with episodic migraine were randomized to receive subcutaneous fremanezumab monthly (225 mg at baseline, weeks 4 and 8), fremanezumab quarterly (675 mg at baseline, placebo at weeks 4 and 8), or placebo over a 12-week period. The secondary endpoint was change from baseline in the monthly number of days with use of any acute headache mediation or migraine-specific acute headache medication; exploratory endpoints were change from baseline in the monthly number of days with nausea or vomiting, photophobia, or phonophobia.
Results
Of 875 patients randomized, 865 were included in the analysis (monthly, n = 287; quarterly, n = 288; placebo, n = 290). Baseline mean ± standard deviation days with: Any acute headache medication use (monthly: 7.7 ± 3.4; quarterly: 7.8 ± 3.7; placebo: 7.7 ± 3.6), migraine-specific acute headache medication use (6.1 ± 3.1; 6.6 ± 3.1; 7.1 ± 3.0), nausea or vomiting (4.5 ± 3.6; 4.9 ± 3.7; 4.5 ± 3.3) and photophobia and phonophobia (5.5 ± 4.1; 6.3 ± 4.1; 6.0 ± 3.9) were similar among treatment arms. Fremanezumab reduced the number of days of acute headache medication use ([least-squares mean change vs. placebo] monthly: −1.4 [95% confidence interval: −1.84, −0.89], p < 0.001; quarterly: −1.3 [−1.76, −0.82], p < 0.001) and migraine-specific acute headache medication use (monthly: −2.2 [−2.80, −1.56], p < 0.001; quarterly: −2.2 [−2.81, −1.58], p < 0.001) compared with placebo. Fremanezumab also reduced nausea or vomiting, photophobia, and phonophobia compared with placebo.
Conclusions
Fremanezumab reduced the need for acute headache medications, including migraine-specific medications, while treating migraine-associated symptoms in patients with episodic migraine.
Trial registration
Clinicaltrials.gov NCT02629861</abstract><cop>London, England</cop><pub>SAGE Publications</pub><pmid>31752521</pmid><doi>10.1177/0333102419885905</doi><tpages>8</tpages></addata></record> |
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| title | Effects of fremanezumab on the use of acute headache medication and associated symptoms of migraine in patients with episodic migraine |
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