The Burden of Migraine in Real Clinical Practice: Clinical and Economic Aspects

Наприенко, М. В.; Smekalkina, L. V.; Safonov, M. I.; Филатова, Е. Г.; Latysheva, N. V.; Екушева, Е. В.; Артеменко, А. Р.; Осипова, В. В.; Baiushkina, Liudmila

doi:10.1007/s11055-019-00862-5

Cited by 2 publications

(5 citation statements)

References 21 publications

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“…On patient-reported outcomes, mean HIT-6 scores at baseline ranged from a mean of 61.2 (SD not reported) (84) 4).…”

Section: Resultsmentioning

confidence: 99%

“…On patient-reported outcomes, mean HIT-6 scores at baseline ranged from a mean of 61.2 (SD not reported) (84) to a mean of 72.1 (±6.0) (85) (Supplementary Table 4). Mean baseline MSQ scores for role-function restrictive domain ranged from 36.2 (±17.8) (86) to 36.7 (SD not reported) (87).…”

Section: Resultsmentioning

confidence: 99%

“…For example, COMPEL observed a mean reduction in number of headache days per month (-10.7 [CI: -11.0, -10.0]) at 108 weeks for onabotulinumtoxinA (43). However real-world data suggested lower treatment effect on this outcome which had also slightly waned over time (-9.21 [CI: -12.48, -5.93]) from among the 11 studies that ranged from four weeks (84,93) to 105 weeks (90). Conversely, compared with the CFB for HIT-6 scores in COMPEL (-7.1 [CI: -7.8, -6.9]) at 108 weeks, two real-world studies (of four weeks [83] and 60 weeks [93] duration, respectively) together showed better improvement at study end (-9.84 [CI: -13.14, -6.55]).…”

Section: Discussionmentioning

confidence: 99%

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Effectiveness of onabotulinumtoxinA (BOTOX®) for the preventive treatment of chronic migraine: A meta-analysis on 10 years of real-world data

et al. 2022

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Background This meta-analysis evaluated the real-world effectiveness of onabotulinumtoxinA (BOTOX®), the first preventive treatment FDA-approved specifically for chronic migraine in 2010. Methods We systematically reviewed onabotulinumtoxinA observational data in chronic migraine published between 1 January 2010 and 31 March 2021. Random-effects models evaluated available data for primary and secondary endpoints defined in onabotulinumtoxinA pivotal trials at approximately 24 weeks and 52 weeks. Results Of the 44 full-text eligible studies (29 prospective; 13 retrospective; 2 other), seven evaluated change from baseline (mean[confidence interval]) at ∼24 weeks and ∼52 weeks, respectively, for onabotulinumtoxinA in: number of headache days/month: (–10.64 [–12.31, –8.97]; –10.32 [−14.92, –5.73]); number of days of acute headache pain medication intake per month (–7.40 [–13.04, –1.77]; overlapping CIs at 52 weeks); total Headache Impact Test-6 score (–11.70 [–13.86, –9.54]); –11.80 [14.70, –8.90]); and Migraine-Specific Quality-of-Life v2.1 score (MSQ; 23.60 [CI: 21.56, 25.64]; 30.90 [CI: 28.29, 33.51]). At ∼24 weeks onabotulinumtoxinA showed total Migraine Disability Assessment score of 44.74 [28.50, 60.99] and ≥50% reduction in migraine days response rate of 46.57% [29.50%, 63.65%]. A sensitivity analysis at study-end suggested durability of onabotulinumtoxinA effectiveness on MSQ. Conclusion The meta-analysis reflecting real-world practice broadly corroborated with evidence from pivotal and long-term open-label studies of onabotulinumtoxinA in chronic migraine preventive treatment.

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“…On patient-reported outcomes, mean HIT-6 scores at baseline ranged from a mean of 61.2 (SD not reported) (84) 4).…”

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Effectiveness of onabotulinumtoxinA (BOTOX®) for the preventive treatment of chronic migraine: A meta-analysis on 10 years of real-world data

et al. 2022

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“…The reduction from baseline in monthly headache days and monthly migraine days at all time points was statistically significant with all interventions. A single study [ 27 ] comparing onabotulinumtoxinA with topiramate (NOS quality rating, 5/9) reported that patients treated with onabotulinumtoxinA had significantly fewer monthly headache days compared with topiramate at 3 months (13.8 days versus 14.9 days, p < 0.05).…”

Section: Resultsmentioning

confidence: 99%

“…Reduction in HIT-6 score from baseline was statistically significant at all time points for all interventions. The single study comparing onabotulinumtoxinA with topiramate (NOS quality rating, 5/9) reported that patients treated with onabotulinumtoxinA had a significantly lower score on the HIT-6 scale compared with topiramate at 3 months (39.5 versus 43.2; p < 0.05) [ 27 ]. The abstract comparing onabotulinumtoxinA and multiple CGRP mAbs (NOS quality rating, N/A) showed that 35.0% of those treated with onabotulinumtoxinA and 44.0% of those treated with multiple CGRP mAbs experienced at least one severity class improvement according to HIT-6 score at 1 year; this difference was not significant [ 16 ].…”

Section: Resultsmentioning

confidence: 99%

Effectiveness and Safety of Chronic Migraine Preventive Treatments: A Systematic Literature Review

Blumenfeld¹,

Kaur²,

Mahajan³

et al. 2022

Pain Ther

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Introduction Numerous medications are used for the preventive treatment of chronic migraine (CM), including oral treatments, onabotulinumtoxinA (onabotA; BOTOX), and calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs). Despite substantial clinical trial evidence, less is published about the real-world experience of these treatments based on data routinely collected from a variety of sources. This systematic review assessed real-world evidence on the effectiveness and safety of preventive treatments for CM in adults. Methods A systematic search of MEDLINE, Embase, and the Cochrane library with back-referencing and supplementary searches retrieved data published between January 2010 and February 2020. Publications were screened, extracted, and quality assessed. Data were narratively synthesized. Search criteria included preventive medications for CM. Evidence was available for topiramate, onabotulinumtoxinA, CGRP mAbs (erenumab, galcanezumab, and fremanezumab). OnabotulinumtoxinA was most commonly assessed (55 studies), followed by erenumab (six studies), multiple CGRP mAbs (one study), and topiramate (one study). Long-term data (> 1 year) were available for onabotulinumtoxinA only, with erenumab reported up 6 months, topiramate up to 3 months, and multiple CGRP mAbs up to 12 months. Results Substantial data demonstrated that onabotulinumtoxinA reduces the number/frequency of headaches, concomitant acute medication use, and impact of headaches on well-being and daily activity. More limited evidence showed benefits for the same parameters with erenumab. Single studies suggested topiramate and multiple CGRP mAbs decrease the number/frequency of headaches and impact of headaches. To date, onabotulinumtoxinA is the only preventive treatment for CM that has long-term safety data in real-world settings reporting treatment-related adverse events of up to 3 years. Conclusion While substantial real-world evidence supports the long-term effectiveness and safety of onabotulinumtoxinA, real-world data on other preventive treatments of CM are currently limited to short term effectiveness due to their more recent approvals. Supplementary Information The online version contains supplementary material available at 10.1007/s40122-022-00452-3.

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The Burden of Migraine in Real Clinical Practice: Clinical and Economic Aspects

Cited by 2 publications

References 21 publications

Effectiveness of onabotulinumtoxinA (BOTOX®) for the preventive treatment of chronic migraine: A meta-analysis on 10 years of real-world data

Effectiveness of onabotulinumtoxinA (BOTOX®) for the preventive treatment of chronic migraine: A meta-analysis on 10 years of real-world data

Effectiveness and Safety of Chronic Migraine Preventive Treatments: A Systematic Literature Review

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