Eptinezumab for the prevention of chronic migraine: efficacy and safety through 24 weeks of treatment in the phase 3 PROMISE-2 (Prevention of migraine via intravenous ALD403 safety and efficacy–2) study
Background PROMISE-2 was a phase 3, randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of repeat intravenous (IV) doses of the calcitonin gene-related peptide–targeted monoclonal antibody eptinezumab (ALD403) for migraine prevention in adults with chronic migra...
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| Published in | Journal of headache and pain Vol. 21; no. 1; pp. 120 - 12 |
|---|---|
| Main Authors | , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Milan
Springer Milan
06.10.2020
BMC |
| Subjects | |
| Online Access | Get full text |
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| Abstract | Background
PROMISE-2 was a phase 3, randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of repeat intravenous (IV) doses of the calcitonin gene-related peptide–targeted monoclonal antibody eptinezumab (ALD403) for migraine prevention in adults with chronic migraine. This report describes the results of PROMISE-2 through 24 weeks of treatment.
Methods
Patients received up to two 30-min IV administrations of eptinezumab 100 mg, 300 mg, or placebo separated by 12 weeks. Patients recorded migraine and headache endpoints in a daily eDiary. Additional assessments, including patient-reported outcomes, were performed at regularly scheduled clinic visits throughout the 32-week study period (screening, day 0, and weeks 2, 4, 8, 12, 16, 20, 24, and 32).
Results
A total of 1072 adults received treatment: eptinezumab 100 mg,
n
= 356; eptinezumab 300 mg,
n
= 350; placebo,
n
= 366. The reduction in mean monthly migraine days observed during the first dosing interval (100 mg, − 7.7 days; 300 mg, − 8.2 days; placebo, − 5.6 days) was further decreased after an additional dose (100 mg, − 8.2 days; 300 mg, − 8.8 days; placebo, − 6.2 days), with both doses of eptinezumab demonstrating consistently greater reductions from baseline compared to placebo. The ≥50% and ≥ 75% migraine responder rates (MRRs) increased after a second dose, with more eptinezumab-treated patients experiencing migraine response than placebo patients (≥50% MRRs weeks 13–24: 100 mg, 61.0%; 300 mg, 64.0%; placebo, 44.0%; and ≥ 75% MRRs weeks 13–24: 100 mg, 39.3%; 300 mg, 43.1%; placebo, 23.8%). The percentages of patients who improved on patient-reported outcomes, including the Headache Impact Test and Patient Global Impression of Change, increased following the second dose administration at week 12, and were greater with eptinezumab than with placebo at all time points. No new safety concerns were identified with the second dose regarding the incidence, nature, and severity of treatment-emergent adverse events.
Conclusion
Eptinezumab 100 mg or 300 mg administered IV at day 0 and repeated at week 12 provided sustained migraine preventive benefit over a full 24 weeks and demonstrated an acceptable safety profile in patients with chronic migraine.
Trial registration
ClinicalTrials.gov (Identifier:
NCT02974153
). Registered November 23, 2016. |
|---|---|
| AbstractList | PROMISE-2 was a phase 3, randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of repeat intravenous (IV) doses of the calcitonin gene-related peptide-targeted monoclonal antibody eptinezumab (ALD403) for migraine prevention in adults with chronic migraine. This report describes the results of PROMISE-2 through 24 weeks of treatment.
Patients received up to two 30-min IV administrations of eptinezumab 100 mg, 300 mg, or placebo separated by 12 weeks. Patients recorded migraine and headache endpoints in a daily eDiary. Additional assessments, including patient-reported outcomes, were performed at regularly scheduled clinic visits throughout the 32-week study period (screening, day 0, and weeks 2, 4, 8, 12, 16, 20, 24, and 32).
A total of 1072 adults received treatment: eptinezumab 100 mg, n = 356; eptinezumab 300 mg, n = 350; placebo, n = 366. The reduction in mean monthly migraine days observed during the first dosing interval (100 mg, - 7.7 days; 300 mg, - 8.2 days; placebo, - 5.6 days) was further decreased after an additional dose (100 mg, - 8.2 days; 300 mg, - 8.8 days; placebo, - 6.2 days), with both doses of eptinezumab demonstrating consistently greater reductions from baseline compared to placebo. The ≥50% and ≥ 75% migraine responder rates (MRRs) increased after a second dose, with more eptinezumab-treated patients experiencing migraine response than placebo patients (≥50% MRRs weeks 13-24: 100 mg, 61.0%; 300 mg, 64.0%; placebo, 44.0%; and ≥ 75% MRRs weeks 13-24: 100 mg, 39.3%; 300 mg, 43.1%; placebo, 23.8%). The percentages of patients who improved on patient-reported outcomes, including the Headache Impact Test and Patient Global Impression of Change, increased following the second dose administration at week 12, and were greater with eptinezumab than with placebo at all time points. No new safety concerns were identified with the second dose regarding the incidence, nature, and severity of treatment-emergent adverse events.
Eptinezumab 100 mg or 300 mg administered IV at day 0 and repeated at week 12 provided sustained migraine preventive benefit over a full 24 weeks and demonstrated an acceptable safety profile in patients with chronic migraine.
ClinicalTrials.gov (Identifier: NCT02974153 ). Registered November 23, 2016. Abstract Background PROMISE-2 was a phase 3, randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of repeat intravenous (IV) doses of the calcitonin gene-related peptide–targeted monoclonal antibody eptinezumab (ALD403) for migraine prevention in adults with chronic migraine. This report describes the results of PROMISE-2 through 24 weeks of treatment. Methods Patients received up to two 30-min IV administrations of eptinezumab 100 mg, 300 mg, or placebo separated by 12 weeks. Patients recorded migraine and headache endpoints in a daily eDiary. Additional assessments, including patient-reported outcomes, were performed at regularly scheduled clinic visits throughout the 32-week study period (screening, day 0, and weeks 2, 4, 8, 12, 16, 20, 24, and 32). Results A total of 1072 adults received treatment: eptinezumab 100 mg, n = 356; eptinezumab 300 mg, n = 350; placebo, n = 366. The reduction in mean monthly migraine days observed during the first dosing interval (100 mg, − 7.7 days; 300 mg, − 8.2 days; placebo, − 5.6 days) was further decreased after an additional dose (100 mg, − 8.2 days; 300 mg, − 8.8 days; placebo, − 6.2 days), with both doses of eptinezumab demonstrating consistently greater reductions from baseline compared to placebo. The ≥50% and ≥ 75% migraine responder rates (MRRs) increased after a second dose, with more eptinezumab-treated patients experiencing migraine response than placebo patients (≥50% MRRs weeks 13–24: 100 mg, 61.0%; 300 mg, 64.0%; placebo, 44.0%; and ≥ 75% MRRs weeks 13–24: 100 mg, 39.3%; 300 mg, 43.1%; placebo, 23.8%). The percentages of patients who improved on patient-reported outcomes, including the Headache Impact Test and Patient Global Impression of Change, increased following the second dose administration at week 12, and were greater with eptinezumab than with placebo at all time points. No new safety concerns were identified with the second dose regarding the incidence, nature, and severity of treatment-emergent adverse events. Conclusion Eptinezumab 100 mg or 300 mg administered IV at day 0 and repeated at week 12 provided sustained migraine preventive benefit over a full 24 weeks and demonstrated an acceptable safety profile in patients with chronic migraine. Trial registration ClinicalTrials.gov (Identifier: NCT02974153 ). Registered November 23, 2016. Background PROMISE-2 was a phase 3, randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of repeat intravenous (IV) doses of the calcitonin gene-related peptide–targeted monoclonal antibody eptinezumab (ALD403) for migraine prevention in adults with chronic migraine. This report describes the results of PROMISE-2 through 24 weeks of treatment. Methods Patients received up to two 30-min IV administrations of eptinezumab 100 mg, 300 mg, or placebo separated by 12 weeks. Patients recorded migraine and headache endpoints in a daily eDiary. Additional assessments, including patient-reported outcomes, were performed at regularly scheduled clinic visits throughout the 32-week study period (screening, day 0, and weeks 2, 4, 8, 12, 16, 20, 24, and 32). Results A total of 1072 adults received treatment: eptinezumab 100 mg, n = 356; eptinezumab 300 mg, n = 350; placebo, n = 366. The reduction in mean monthly migraine days observed during the first dosing interval (100 mg, − 7.7 days; 300 mg, − 8.2 days; placebo, − 5.6 days) was further decreased after an additional dose (100 mg, − 8.2 days; 300 mg, − 8.8 days; placebo, − 6.2 days), with both doses of eptinezumab demonstrating consistently greater reductions from baseline compared to placebo. The ≥50% and ≥ 75% migraine responder rates (MRRs) increased after a second dose, with more eptinezumab-treated patients experiencing migraine response than placebo patients (≥50% MRRs weeks 13–24: 100 mg, 61.0%; 300 mg, 64.0%; placebo, 44.0%; and ≥ 75% MRRs weeks 13–24: 100 mg, 39.3%; 300 mg, 43.1%; placebo, 23.8%). The percentages of patients who improved on patient-reported outcomes, including the Headache Impact Test and Patient Global Impression of Change, increased following the second dose administration at week 12, and were greater with eptinezumab than with placebo at all time points. No new safety concerns were identified with the second dose regarding the incidence, nature, and severity of treatment-emergent adverse events. Conclusion Eptinezumab 100 mg or 300 mg administered IV at day 0 and repeated at week 12 provided sustained migraine preventive benefit over a full 24 weeks and demonstrated an acceptable safety profile in patients with chronic migraine. Trial registration ClinicalTrials.gov (Identifier: NCT02974153 ). Registered November 23, 2016. PROMISE-2 was a phase 3, randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of repeat intravenous (IV) doses of the calcitonin gene-related peptide-targeted monoclonal antibody eptinezumab (ALD403) for migraine prevention in adults with chronic migraine. This report describes the results of PROMISE-2 through 24 weeks of treatment.BACKGROUNDPROMISE-2 was a phase 3, randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of repeat intravenous (IV) doses of the calcitonin gene-related peptide-targeted monoclonal antibody eptinezumab (ALD403) for migraine prevention in adults with chronic migraine. This report describes the results of PROMISE-2 through 24 weeks of treatment.Patients received up to two 30-min IV administrations of eptinezumab 100 mg, 300 mg, or placebo separated by 12 weeks. Patients recorded migraine and headache endpoints in a daily eDiary. Additional assessments, including patient-reported outcomes, were performed at regularly scheduled clinic visits throughout the 32-week study period (screening, day 0, and weeks 2, 4, 8, 12, 16, 20, 24, and 32).METHODSPatients received up to two 30-min IV administrations of eptinezumab 100 mg, 300 mg, or placebo separated by 12 weeks. Patients recorded migraine and headache endpoints in a daily eDiary. Additional assessments, including patient-reported outcomes, were performed at regularly scheduled clinic visits throughout the 32-week study period (screening, day 0, and weeks 2, 4, 8, 12, 16, 20, 24, and 32).A total of 1072 adults received treatment: eptinezumab 100 mg, n = 356; eptinezumab 300 mg, n = 350; placebo, n = 366. The reduction in mean monthly migraine days observed during the first dosing interval (100 mg, - 7.7 days; 300 mg, - 8.2 days; placebo, - 5.6 days) was further decreased after an additional dose (100 mg, - 8.2 days; 300 mg, - 8.8 days; placebo, - 6.2 days), with both doses of eptinezumab demonstrating consistently greater reductions from baseline compared to placebo. The ≥50% and ≥ 75% migraine responder rates (MRRs) increased after a second dose, with more eptinezumab-treated patients experiencing migraine response than placebo patients (≥50% MRRs weeks 13-24: 100 mg, 61.0%; 300 mg, 64.0%; placebo, 44.0%; and ≥ 75% MRRs weeks 13-24: 100 mg, 39.3%; 300 mg, 43.1%; placebo, 23.8%). The percentages of patients who improved on patient-reported outcomes, including the Headache Impact Test and Patient Global Impression of Change, increased following the second dose administration at week 12, and were greater with eptinezumab than with placebo at all time points. No new safety concerns were identified with the second dose regarding the incidence, nature, and severity of treatment-emergent adverse events.RESULTSA total of 1072 adults received treatment: eptinezumab 100 mg, n = 356; eptinezumab 300 mg, n = 350; placebo, n = 366. The reduction in mean monthly migraine days observed during the first dosing interval (100 mg, - 7.7 days; 300 mg, - 8.2 days; placebo, - 5.6 days) was further decreased after an additional dose (100 mg, - 8.2 days; 300 mg, - 8.8 days; placebo, - 6.2 days), with both doses of eptinezumab demonstrating consistently greater reductions from baseline compared to placebo. The ≥50% and ≥ 75% migraine responder rates (MRRs) increased after a second dose, with more eptinezumab-treated patients experiencing migraine response than placebo patients (≥50% MRRs weeks 13-24: 100 mg, 61.0%; 300 mg, 64.0%; placebo, 44.0%; and ≥ 75% MRRs weeks 13-24: 100 mg, 39.3%; 300 mg, 43.1%; placebo, 23.8%). The percentages of patients who improved on patient-reported outcomes, including the Headache Impact Test and Patient Global Impression of Change, increased following the second dose administration at week 12, and were greater with eptinezumab than with placebo at all time points. No new safety concerns were identified with the second dose regarding the incidence, nature, and severity of treatment-emergent adverse events.Eptinezumab 100 mg or 300 mg administered IV at day 0 and repeated at week 12 provided sustained migraine preventive benefit over a full 24 weeks and demonstrated an acceptable safety profile in patients with chronic migraine.CONCLUSIONEptinezumab 100 mg or 300 mg administered IV at day 0 and repeated at week 12 provided sustained migraine preventive benefit over a full 24 weeks and demonstrated an acceptable safety profile in patients with chronic migraine.ClinicalTrials.gov (Identifier: NCT02974153 ). Registered November 23, 2016.TRIAL REGISTRATIONClinicalTrials.gov (Identifier: NCT02974153 ). Registered November 23, 2016. |
| ArticleNumber | 120 |
| Author | Biondi, David M. Schaeffler, Barbara Hindiyeh, Nada A. Silberstein, Stephen Smith, Jeff Hirman, Joe Pederson, Susan Diamond, Merle Cady, Roger Allan, Brent |
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/33023473$$D View this record in MEDLINE/PubMed |
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| References | SilbersteinSDLeeLGandhiKFitzgeraldTBellJCohenJMHealth care resource utilization and migraine disability along the migraine continuum among patients treated for migraineHeadache.2018581579159210.1111/head.1342130375650 BakerBSchaefflerBBeliveauMRubetsIPedersonSTrinhMPopulation pharmacokinetic and exposure-response analysis of eptinezumab in the treatment of episodic and chronic migrainePharmacol Res Perspect20208e0056710.1002/prp2.567321553177064329 Forbes RB, McCarron M, Cardwell CR (2020) Efficacy and contextual (placebo) effects of CGRP antibodies for migraine: systematic review and meta-analysis. Headache. https://doi.org/10.1111/head.13907 ScuteriDCorasanitiMTToninPBagettaGEptinezumab for the treatment of migraineDrugs Today (Barc)2019556957031:STN:280:DC%2BB3MbgsVOltw%3D%3D10.1358/dot.2019.55.11.3069864 BigalMESerranoDBuseDScherAStewartWFLiptonRBAcute migraine medications and evolution from episodic to chronic migraine: a longitudinal population-based studyHeadache.2008481157116810.1111/j.1526-4610.2008.01217.x18808500 MitsikostasDDBenedettiFPlacebos and Nocebos in headaches: springer international publishing201910.1007/978-3-030-02976-0 Di BlasiZHarknessEErnstEGeorgiouAKleijnenJInfluence of context effects on health outcomes: a systematic reviewLancet.200135775776210.1016/s0140-6736(00)04169-611253970 Guy W. ECDEU Assessment Manual for Psychopharmacology: U.S. Department of Health, Education, and Welfare, Public Health Service, Alcohol, Drug Abuse, and Mental Health Administration, National Institute of Mental Health, Psychopharmacology Research Branch, Division of Extramural Research Programs; 1976 Posner K, Brent D, Lucas C, Gould M, Stanley B, Brown G et al. Columbia-Suicide Severity Rating Scale (C-SSRS). Columbia University. Updated 14 January 2009. Accessed 2 Oct 2015. Available at: http://www.cssrs.columbia.edu/scales_practice_cssrs.html BuseDCManackASerranoDTurkelCLiptonRBSociodemographic and comorbidity profiles of chronic migraine and episodic migraine sufferersJ Neurol Neurosurg Psychiatry2010814284321:STN:280:DC%2BC3c3ivFGisA%3D%3D10.1136/jnnp.2009.19249220164501 DodickDWGoadsbyPJSilbersteinSDLiptonRBOlesenJAshinaMSafety and efficacy of ALD403, an antibody to calcitonin gene-related peptide, for the prevention of frequent episodic migraine: a randomised, double-blind, placebo-controlled, exploratory phase 2 trialLancet Neurol201413110011071:CAS:528:DC%2BC2cXhslagsb%2FK10.1016/s1474-4422(14)70209-125297013 YangMRendas-BaumRVaronSFKosinskiMValidation of the headache impact test (HIT-6) across episodic and chronic migraineCephalalgia.20113135736710.1177/0333102410379890208198423057423 LeonardiMRaggiAA narrative review on the burden of migraine: when the burden is the impact on people's lifeJ Headache Pain2019204110.1186/s10194-019-0993-0310232266734273 BaylissMSBatenhorstASThe HIT-6™: a User’s guide2002Lincoln, RIQualityMetric Incorporated MartellettiPSchwedtTJLanteri-MinetMQuintanaRCarboniVDienerHCMy migraine voice survey: a global study of disease burden among individuals with migraine for whom preventive treatments have failedJ Headache Pain.20181911510.1186/s10194-018-0946-z304821816755592 HoutsCRWirthRMcGinleyJSGwaltneyCCadyRValidity evidence of the HIT-6 total score in a sample of patients with chronic migraineCephalalgia.201939246247 LiptonRBGoadsbyPJSmithJSchaefflerBABiondiDMHirmanJEfficacy and safety of eptinezumab in patients with chronic migraine. PROMISE-2Neurology.202094e1365e1e771:CAS:528:DC%2BB3cXlvVGns7Y%3D10.1212/WNL.0000000000009169322096507274916 KosinskiMBaylissMSBjornerJBWareJEJrGarberWHBatenhorstAA six-item short-form survey for measuring headache impact: the HIT-6Qual Life Res2003129639741:STN:280:DC%2BD3srmtlOnsg%3D%3D10.1023/A:102611933119314651415 Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018;38:1–211. doi: https://doi.org/10.1177/0333102417738202 BuseDCScherAIDodickDWReedMLFanningKMManack AdamsAImpact of migraine on the family: perspectives of people with migraine and their spouse/domestic partner in the CaMEO studyMayo Clin Proc20169159661110.1016/j.mayocp.2016.02.013 KatsaravaZBuseDCManackANLiptonRBDefining the differences between episodic migraine and chronic migraineCurr Pain Headache Rep201216869210.1007/s11916-011-0233-z22083262 WirthRMcGinleyJSHirmanJSnapinnSHoutsCRCadyRItem response theory analysis of the HIT-6 in a chronic migraine populationCephalalgia.201939246 AIMOVIGPackage insert2020Thousand Oaks, CAAmgen Inc. AshinaMSaperJCadyRSchaefflerBBiondiDMHirmanJEptinezumab in episodic migraine: a randomized, double-blind, placebo-controlled study (PROMISE-1)Cephalalgia.20204024125410.1177/0333102420905132320754067066477 HeppZBloudekLMVaronSFSystematic review of migraine prophylaxis adherence and persistenceJ Manag Care Spec Pharm201420223310.18553/jmcp.2014.20.1.22 MeissnerKFässlerMRückerGDifferential effectiveness of placebo treatments: a systematic review of migraine prophylaxisJAMA Intern Med20131731941195110.1001/jamainternmed.2013.1039124126676 HoutsCRWirthRJMcGinleyJSGwaltneyCKasselESnapinnSContent validity of HIT-6 as a measure of headache impact in people with migraine: a narrative reviewHeadache.202060283910.1111/head.1370131811654 DodickDWLiptonRBSilbersteinSGoadsbyPJBiondiDHirmanJEptinezumab for prevention of chronic migraine: a randomized phase 2b clinical trialCephalalgia.2019391075108510.1177/033310241985835531234642 PorterJKDi TannaGLLiptonRBSapraSVillaGCosts of acute headache medication use and productivity losses among patients with migraine: insights from three randomized controlled trialsPharmacoecon Open2019341141710.1007/s41669-018-0105-030377991 B Baker (1186_CR26) 2020; 8 M Leonardi (1186_CR23) 2019; 20 M Kosinski (1186_CR7) 2003; 12 Z Katsarava (1186_CR3) 2012; 16 DD Mitsikostas (1186_CR19) 2019 MS Bayliss (1186_CR13) 2002 CR Houts (1186_CR10) 2020; 60 1186_CR8 DW Dodick (1186_CR22) 2019; 39 1186_CR14 1186_CR1 1186_CR20 R Wirth (1186_CR11) 2019; 39 Z Di Blasi (1186_CR17) 2001; 357 DC Buse (1186_CR25) 2016; 91 ME Bigal (1186_CR2) 2008; 48 SD Silberstein (1186_CR15) 2018; 58 CR Houts (1186_CR12) 2019; 39 D Scuteri (1186_CR27) 2019; 55 Z Hepp (1186_CR29) 2014; 20 P Martelletti (1186_CR24) 2018; 19 DW Dodick (1186_CR21) 2014; 13 AIMOVIG (1186_CR28) 2020 JK Porter (1186_CR16) 2019; 3 K Meissner (1186_CR18) 2013; 173 DC Buse (1186_CR4) 2010; 81 M Ashina (1186_CR5) 2020; 40 M Yang (1186_CR9) 2011; 31 RB Lipton (1186_CR6) 2020; 94 |
| References_xml | – reference: Posner K, Brent D, Lucas C, Gould M, Stanley B, Brown G et al. Columbia-Suicide Severity Rating Scale (C-SSRS). Columbia University. Updated 14 January 2009. Accessed 2 Oct 2015. Available at: http://www.cssrs.columbia.edu/scales_practice_cssrs.html – reference: Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018;38:1–211. doi: https://doi.org/10.1177/0333102417738202 – reference: DodickDWLiptonRBSilbersteinSGoadsbyPJBiondiDHirmanJEptinezumab for prevention of chronic migraine: a randomized phase 2b clinical trialCephalalgia.2019391075108510.1177/033310241985835531234642 – reference: BakerBSchaefflerBBeliveauMRubetsIPedersonSTrinhMPopulation pharmacokinetic and exposure-response analysis of eptinezumab in the treatment of episodic and chronic migrainePharmacol Res Perspect20208e0056710.1002/prp2.567321553177064329 – reference: DodickDWGoadsbyPJSilbersteinSDLiptonRBOlesenJAshinaMSafety and efficacy of ALD403, an antibody to calcitonin gene-related peptide, for the prevention of frequent episodic migraine: a randomised, double-blind, placebo-controlled, exploratory phase 2 trialLancet Neurol201413110011071:CAS:528:DC%2BC2cXhslagsb%2FK10.1016/s1474-4422(14)70209-125297013 – reference: KatsaravaZBuseDCManackANLiptonRBDefining the differences between episodic migraine and chronic migraineCurr Pain Headache Rep201216869210.1007/s11916-011-0233-z22083262 – reference: AshinaMSaperJCadyRSchaefflerBBiondiDMHirmanJEptinezumab in episodic migraine: a randomized, double-blind, placebo-controlled study (PROMISE-1)Cephalalgia.20204024125410.1177/0333102420905132320754067066477 – reference: MartellettiPSchwedtTJLanteri-MinetMQuintanaRCarboniVDienerHCMy migraine voice survey: a global study of disease burden among individuals with migraine for whom preventive treatments have failedJ Headache Pain.20181911510.1186/s10194-018-0946-z304821816755592 – reference: BuseDCManackASerranoDTurkelCLiptonRBSociodemographic and comorbidity profiles of chronic migraine and episodic migraine sufferersJ Neurol Neurosurg Psychiatry2010814284321:STN:280:DC%2BC3c3ivFGisA%3D%3D10.1136/jnnp.2009.19249220164501 – reference: LiptonRBGoadsbyPJSmithJSchaefflerBABiondiDMHirmanJEfficacy and safety of eptinezumab in patients with chronic migraine. PROMISE-2Neurology.202094e1365e1e771:CAS:528:DC%2BB3cXlvVGns7Y%3D10.1212/WNL.0000000000009169322096507274916 – reference: MitsikostasDDBenedettiFPlacebos and Nocebos in headaches: springer international publishing201910.1007/978-3-030-02976-0 – reference: HoutsCRWirthRMcGinleyJSGwaltneyCCadyRValidity evidence of the HIT-6 total score in a sample of patients with chronic migraineCephalalgia.201939246247 – reference: BaylissMSBatenhorstASThe HIT-6™: a User’s guide2002Lincoln, RIQualityMetric Incorporated – reference: HeppZBloudekLMVaronSFSystematic review of migraine prophylaxis adherence and persistenceJ Manag Care Spec Pharm201420223310.18553/jmcp.2014.20.1.22 – reference: BigalMESerranoDBuseDScherAStewartWFLiptonRBAcute migraine medications and evolution from episodic to chronic migraine: a longitudinal population-based studyHeadache.2008481157116810.1111/j.1526-4610.2008.01217.x18808500 – reference: HoutsCRWirthRJMcGinleyJSGwaltneyCKasselESnapinnSContent validity of HIT-6 as a measure of headache impact in people with migraine: a narrative reviewHeadache.202060283910.1111/head.1370131811654 – reference: Di BlasiZHarknessEErnstEGeorgiouAKleijnenJInfluence of context effects on health outcomes: a systematic reviewLancet.200135775776210.1016/s0140-6736(00)04169-611253970 – reference: YangMRendas-BaumRVaronSFKosinskiMValidation of the headache impact test (HIT-6) across episodic and chronic migraineCephalalgia.20113135736710.1177/0333102410379890208198423057423 – reference: KosinskiMBaylissMSBjornerJBWareJEJrGarberWHBatenhorstAA six-item short-form survey for measuring headache impact: the HIT-6Qual Life Res2003129639741:STN:280:DC%2BD3srmtlOnsg%3D%3D10.1023/A:102611933119314651415 – reference: AIMOVIGPackage insert2020Thousand Oaks, CAAmgen Inc. – reference: SilbersteinSDLeeLGandhiKFitzgeraldTBellJCohenJMHealth care resource utilization and migraine disability along the migraine continuum among patients treated for migraineHeadache.2018581579159210.1111/head.1342130375650 – reference: LeonardiMRaggiAA narrative review on the burden of migraine: when the burden is the impact on people's lifeJ Headache Pain2019204110.1186/s10194-019-0993-0310232266734273 – reference: PorterJKDi TannaGLLiptonRBSapraSVillaGCosts of acute headache medication use and productivity losses among patients with migraine: insights from three randomized controlled trialsPharmacoecon Open2019341141710.1007/s41669-018-0105-030377991 – reference: Forbes RB, McCarron M, Cardwell CR (2020) Efficacy and contextual (placebo) effects of CGRP antibodies for migraine: systematic review and meta-analysis. Headache. https://doi.org/10.1111/head.13907 – reference: BuseDCScherAIDodickDWReedMLFanningKMManack AdamsAImpact of migraine on the family: perspectives of people with migraine and their spouse/domestic partner in the CaMEO studyMayo Clin Proc20169159661110.1016/j.mayocp.2016.02.013 – reference: WirthRMcGinleyJSHirmanJSnapinnSHoutsCRCadyRItem response theory analysis of the HIT-6 in a chronic migraine populationCephalalgia.201939246 – reference: MeissnerKFässlerMRückerGDifferential effectiveness of placebo treatments: a systematic review of migraine prophylaxisJAMA Intern Med20131731941195110.1001/jamainternmed.2013.1039124126676 – reference: Guy W. ECDEU Assessment Manual for Psychopharmacology: U.S. Department of Health, Education, and Welfare, Public Health Service, Alcohol, Drug Abuse, and Mental Health Administration, National Institute of Mental Health, Psychopharmacology Research Branch, Division of Extramural Research Programs; 1976 – reference: ScuteriDCorasanitiMTToninPBagettaGEptinezumab for the treatment of migraineDrugs Today (Barc)2019556957031:STN:280:DC%2BB3MbgsVOltw%3D%3D10.1358/dot.2019.55.11.3069864 – volume: 8 start-page: e00567 year: 2020 ident: 1186_CR26 publication-title: Pharmacol Res Perspect doi: 10.1002/prp2.567 – volume: 94 start-page: e1365 year: 2020 ident: 1186_CR6 publication-title: Neurology. doi: 10.1212/WNL.0000000000009169 – volume: 55 start-page: 695 year: 2019 ident: 1186_CR27 publication-title: Drugs Today (Barc) doi: 10.1358/dot.2019.55.11.3069864 – volume: 3 start-page: 411 year: 2019 ident: 1186_CR16 publication-title: Pharmacoecon Open doi: 10.1007/s41669-018-0105-0 – volume: 173 start-page: 1941 year: 2013 ident: 1186_CR18 publication-title: JAMA Intern Med doi: 10.1001/jamainternmed.2013.10391 – ident: 1186_CR20 doi: 10.1111/head.13907 – volume: 40 start-page: 241 year: 2020 ident: 1186_CR5 publication-title: Cephalalgia. doi: 10.1177/0333102420905132 – volume: 12 start-page: 963 year: 2003 ident: 1186_CR7 publication-title: Qual Life Res doi: 10.1023/A:1026119331193 – volume: 16 start-page: 86 year: 2012 ident: 1186_CR3 publication-title: Curr Pain Headache Rep doi: 10.1007/s11916-011-0233-z – ident: 1186_CR1 doi: 10.1177/0333102417738202 – volume: 39 start-page: 246 year: 2019 ident: 1186_CR11 publication-title: Cephalalgia. – ident: 1186_CR14 – ident: 1186_CR8 – volume: 31 start-page: 357 year: 2011 ident: 1186_CR9 publication-title: Cephalalgia. doi: 10.1177/0333102410379890 – volume: 60 start-page: 28 year: 2020 ident: 1186_CR10 publication-title: Headache. doi: 10.1111/head.13701 – volume: 81 start-page: 428 year: 2010 ident: 1186_CR4 publication-title: J Neurol Neurosurg Psychiatry doi: 10.1136/jnnp.2009.192492 – volume: 39 start-page: 1075 year: 2019 ident: 1186_CR22 publication-title: Cephalalgia. doi: 10.1177/0333102419858355 – volume: 39 start-page: 246 year: 2019 ident: 1186_CR12 publication-title: Cephalalgia. – volume: 357 start-page: 757 year: 2001 ident: 1186_CR17 publication-title: Lancet. doi: 10.1016/s0140-6736(00)04169-6 – volume: 20 start-page: 41 year: 2019 ident: 1186_CR23 publication-title: J Headache Pain doi: 10.1186/s10194-019-0993-0 – volume-title: Package insert year: 2020 ident: 1186_CR28 – volume: 19 start-page: 115 year: 2018 ident: 1186_CR24 publication-title: J Headache Pain. doi: 10.1186/s10194-018-0946-z – volume: 20 start-page: 22 year: 2014 ident: 1186_CR29 publication-title: J Manag Care Spec Pharm doi: 10.18553/jmcp.2014.20.1.22 – volume-title: The HIT-6™: a User’s guide year: 2002 ident: 1186_CR13 – volume: 58 start-page: 1579 year: 2018 ident: 1186_CR15 publication-title: Headache. doi: 10.1111/head.13421 – volume: 91 start-page: 596 year: 2016 ident: 1186_CR25 publication-title: Mayo Clin Proc doi: 10.1016/j.mayocp.2016.02.013 – volume-title: Placebos and Nocebos in headaches: springer international publishing year: 2019 ident: 1186_CR19 doi: 10.1007/978-3-030-02976-0 – volume: 13 start-page: 1100 year: 2014 ident: 1186_CR21 publication-title: Lancet Neurol doi: 10.1016/s1474-4422(14)70209-1 – volume: 48 start-page: 1157 year: 2008 ident: 1186_CR2 publication-title: Headache. doi: 10.1111/j.1526-4610.2008.01217.x |
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PROMISE-2 was a phase 3, randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of repeat intravenous (IV) doses... PROMISE-2 was a phase 3, randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of repeat intravenous (IV) doses of the... Abstract Background PROMISE-2 was a phase 3, randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of repeat intravenous... |
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| SubjectTerms | Adult Antibodies, Monoclonal, Humanized Calcitonin Gene-Related Peptide Chronic migraine Double-Blind Method Efficacy Eptinezumab Humans Internal Medicine Medicine Medicine & Public Health Migraine Disorders - drug therapy Migraine Disorders - prevention & control Neurology Pain Medicine Research Article Safety Treatment Outcome |
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| Title | Eptinezumab for the prevention of chronic migraine: efficacy and safety through 24 weeks of treatment in the phase 3 PROMISE-2 (Prevention of migraine via intravenous ALD403 safety and efficacy–2) study |
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