Erenumab efficacy in highly resistant chronic migraine: a real-life study

Pensato, Umberto; Favoni, Valentina; Pascazio, Alessia; Benini, Matteo; Asioli, Gian Maria; Merli, Elena; Calabrò, Calogero; Cortelli, Pietro; Pierangeli, Giulia; Cevoli, Sabina

doi:10.1007/s10072-020-04658-1

Cited by 22 publications

(38 citation statements)

References 3 publications

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“…A German study of erenumab in patients that had failed five oral prophylactics and type A botulinum toxin led to a reduction of 4.7 headache days after three treatment cycles [13]. A number of other recently published studies have shown similar improvements with erenumab [14][15][16][17][18][19][20][21][22][23], although only one has examined its benefit exclusively in BoNTA failures [18]. Our outcomes, recorded up to 9 months, in general exceed those of other studies [14][15][16][17][18]23] and do not rely on retrospective reporting [13,15,21,22], providing more objective evidence of treatment efficacy.…”

Section: Discussionmentioning

confidence: 99%

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Improvements in pain, medication use and quality of life in onabotulinumtoxinA-resistant chronic migraine patients following erenumab treatment – real world outcomes

et al. 2021

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Background The CGRP antagonists offer a novel therapeutic approach in migraine. Their utility in patients with severe forms of chronic migraine is a subject of particular interest. We present outcomes of 9 months of erenumab treatment in a cohort of patients with difficult-to-control chronic migraine, all of whom had prior unsatisfactory response to onabotulinumtoxinA. Methods We offered erenumab to 98 patients with a prior unsatisfactory response to onabotulinumtoxinA. Eighty of 98 had trialled greater occipital nerve injections (82%), 32/98 peripheral neurostimulation (33%) and 18/98 intravenous dihydroergotamine (18%). Thirty eight of 98 (39%) met the definition of triptan overuse and 43/98 (44%) analgesic overuse. All patients met the EHF criteria for ‘resistant migraine’. Outcome measures (recorded monthly) included days with headache limiting activities of daily living (“red”), not limiting (“amber”), headache free (“green”), and requiring triptans or other analgesics. Quality of life scores - headache impact test 6 (HIT-6), patient health questionnaire 9 (PHQ-9) and pain disability index (PDI) - were also measured. Results Mean number of red days improved by − 6.4 days (SE 0.67, 95%CI − 7.7 to − 5.1, p=0.001) at 3 months; − 6.8 days (SE 0.96, 95%CI − 8.80 to − 4.9, p=0.001) at 6 months and − 6.5 days (SE 0.86, 95%CI − 8.3 to − 4.8, p=0.001) at 9 months. Repeated measures ANOVA confirmed improvements in the number of red (p=0.001), green (p=0.001), triptan (p=0.001) and painkiller days (p=0.001) as well as scores of the HIT-6 (p=0.001), PHQ-9 (p=0.001), and PDI (p=0.001) across the duration of study. Conclusion We observed improvements in pain, medication use and quality of life in onabotulinumtoxinA-resistant chronic migraine patients following erenumab treatment.

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Section: Discussionmentioning

confidence: 99%

“…Emerging real-world data suggests that erenumab can be effective in patients with more severe migraine phenotypes, including those with a history of treatment failure [11][12][13][14][15][16][17][18][19][20][21][22][23]. Its utility in patients with a prior unsatisfactory response to onabotulinum toxinA (BoNTA), is of particular interest.…”

Section: Introductionmentioning

confidence: 99%

Improvements in pain, medication use and quality of life in onabotulinumtoxinA-resistant chronic migraine patients following erenumab treatment – real world outcomes

et al. 2021

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“…Moreover, the average number of prior preventive drug failures was 3-to-5 in the Italian study 55 and superior to 7 in ours, which means that our patients are more complex and treatment-refractory than the patients of the Italian study. Despite these differences, both the Italian study 55 and the other real-world experiences [47][48][49][50][51][52][53][54][55][56][57][58][59][60][61][62][63] conclude, like our registry, that erenumab is useful in the prevention of episodic and chronic migraine withs and presents an excellent safety pro le.…”

Section: Discussionmentioning

confidence: 82%

“…A huge number of real-world experiences analysing erenumab in migraine prevention are being published around the world [47][48][49][50][51][52][53][54][55][56][57][58][59][60][61][62][63] , already including more than 2.000 patients with migraine. Among them, we can nd eleven one-centre studies (seven prospectives 48,53,54,56,57,59,61 and four retrospectives 50,51,52,62 ) and ve multicentre (four prospectives 49,55,58,60 and one retrospective 63 ). Our registry includes the second largest sample of migraine patients treated with erenumab in a multicentric prospective registry.…”

Section: Discussionmentioning

confidence: 99%

“…Mild constipation, u-like symptoms, transient pruritus at the injection site and fatigue were the only adverse events with incidences superior to 2%. We only collected two severe adverse events related to erenumab treatment (two skin rash after injection) that represent 0.9% of our patients, a similar gure to that of clinical trials and real-world experiences (1-3%) [44][45][46][47][48][49][50][51][52][53][54][55][56][57][58][59][60][61][62] .…”

Section: Discussionmentioning

confidence: 99%

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Mab-Mig: Registry of the Spanish Neurological Society of Erenumab for Migraine Prevention. Three-Months Results

Belvís¹,

Irimia

Pozo‐Rosich³

et al. 2021

Preprint

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Background Erenumab was approved in Europe for migraine prevention in patients with ≥4 monthly migraine days (MMD). In Spain, Novartis started a personalized managed access program which allowed free access to erenumab before official reimbursement. The Headache Study Group of the Spanish Neurological Society started a registry to monitor real-world safety and efficacy, and all Spanish headache experts were invited to participate. Methods Patients fulfilled ICHD3 criteria for migraine and had ≥ 4MMD. Sociodemographic and clinical data were registered as well as MMD, headache frequency (MHD), prior and concomitant preventive treatment, medication overuse headache (MOH), migraine evolution, adverse events, and PROs: HIT6, MIDAS, and PGIC. A >50% reduction of MMD after 3 months was considered as response. Results We included 210 patients (female 86.7%, mean age 46.4 years old) from 22 hospitals from February 2019 – to – June 2020. Most patients (89.5%) suffered from chronic migraine with a mean evolution of 8.6 years. MOH was present in 70% of patients, and 17.1% had migraine with aura. Average of prior preventive treatment failure was >7 (BoNT/A had been used by 95.2%). Most patients (67,6%) started with erenumab 70mg. 61% of patients were also taking oral preventive drugs or getting simultaneous BoNT/A (27.6%). Responder rate was 37.1% and the mean reduction of MMD was -6.28 and MHD: -8.6. Regarding PROs: MIDAS: -35 p., HIT6: -11.6 p., PIGC: 4.7 p. Predictors of good response were: HIT6 score ( p =0.01), prior preventive treatment failures ( p =0.026), absence of MOH ( p =0.039), and simultaneous BoNT/A treatment ( p <0.001). 20% had adverse event, but only two of them were severe (0.9%) which led to treatment discontinuation. Mild constipation was the most frequent adverse event (8.1%). Conclusion In real-life, in a personalized managed access program, erenumab shows a good profile of efficacy and an excellent safety in migraine prevention in our cohort of refractory patients.

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Real-World Data, Clinical Practice So Far

Ornello

Sacco

2021

Monoclonal Antibodies in Headache

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Erenumab efficacy in highly resistant chronic migraine: a real-life study

Cited by 22 publications

References 3 publications

Improvements in pain, medication use and quality of life in onabotulinumtoxinA-resistant chronic migraine patients following erenumab treatment – real world outcomes

Improvements in pain, medication use and quality of life in onabotulinumtoxinA-resistant chronic migraine patients following erenumab treatment – real world outcomes

Mab-Mig: Registry of the Spanish Neurological Society of Erenumab for Migraine Prevention. Three-Months Results

Real-World Data, Clinical Practice So Far

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