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. 2020 Apr 7;21(1):32.
doi: 10.1186/s10194-020-01102-9.

Real-life data on the efficacy and safety of erenumab in the Abruzzo region, central Italy

Raffaele Ornello  1 , Alfonsina Casalena  2 , Ilaria Frattale  1 , Amleto Gabriele  3 , Giannapia Affaitati  4 , Maria Adele Giamberardino  4 , Maurizio Assetta  2 , Maurizio Maddestra  5 , Fabio Marzoli  5 , Stefano Viola  6 , Davide Cerone  7 , Carmine Marini  8 , Francesca Pistoia  1   7 , Simona Sacco  9
Affiliations

Real-life data on the efficacy and safety of erenumab in the Abruzzo region, central Italy

Raffaele Ornello et al. J Headache Pain. .

Abstract

Background: We aimed to assess the efficacy and safety of erenumab, a fully human monoclonal antibody inhibiting the calcitonin gene-related peptide receptor (CGRPr), for the prevention of migraine in a real-life setting.

Main body: We included in our observational study all patients with episodic or chronic migraine treated with erenumab during the year 2019 in the Abruzzo region, central Italy, and with a 6-month follow-up. We included 89 patients; 76 (85.4%) received 6 doses of erenumab, 11 (12.4%) autonomously withdrew the drug due to perceived inefficacy, and 2 (2.2%) due to adverse events. Seventy-eight patients (87.6%) were female, with a mean age of 46.8 ± 11.2 years; 84 (94.4%) had chronic migraine, and 64 (71.9%) medication overuse. All patients had ≥2 prior preventive treatment failures. Fifty-three patients (69.7%) had a 50% decrease in monthly migraine days (MMDs) within the first three doses; 46 (71.9%) of 64 patients withdrew medication overuse. In the 76 patients who completed a 6-dose treatment, erenumab decreased median MMDs from 19 (interquartile range [IQR] 12-27.5) to 4 (IQR 2-9.5; P < 0.001), median monthly days of analgesic use from 10 (IQR 4.5-20) to 2 IQR 0-5; P < 0.001), and median monthly days of triptan use from 5 (IQR 0-15.5) to 1 (IQR 0-4; P < 0.001). We recorded 27 adverse events in 20 (22.5%) patients, the most common being constipation (13.5%). One adverse event, i.e. allergic reaction, led to treatment discontinuation in one patient.

Conclusions: Our real-life data confirm the efficacy and tolerability of erenumab for the prevention of migraine in a difficult-to-treat population of patients with a high prevalence of chronic migraine and medication overuse.

Keywords: Calcitonin gene-related peptide; Erenumab; Migraine; Migraine prevention; Monoclonal antibodies; Real-life study.

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Conflict of interest statement

RO has received sponsorship to attend meetings from Novartis and Teva; SS had a financial relationship (lecturer or member of advisory board) with Abbott, Allergan, Novartis, Teva, and Eli Lilly; GA has received funds for congress participation from Innovet Italia Srl, Epitech Group and Lusofarmaco; MAG received funds for congress participation from IBSA; AC, IF, AG, MA, MM, FM, SV, DC, CM, and FP declare no competing interests.

Figures

Fig. 1
Fig. 1
Erenumab dose escalation during the study period
Fig. 2
Fig. 2
Response to each erenumab dose in the study patients
Fig. 3
Fig. 3
Decrease in median monthly migraine days (MMDs), analgesic use days (ADs), and triptan use days (TDs) among the 76 patients who completed treatment (panel a); six-month decrease in median scale scores in patients with available data (Panel b). All comparisons with a double asterisk have a P value < 0.001, while the comparison with a single asterisk has a P value = 0.001. ASC indicates Allodynia Symptom Checklist; BDI, Beck Depression Inventory; GAD-7, Generalized Anxiety Disorder Questionnaire; HIT-6, Headache Impact Test; MIDAS, Migraine Impact and Disability Assessment Score; NRS, Numerical Rating Scale
Fig. 4
Fig. 4
Proportion of patients withdrawing medication overuse according to erenumab dosing
Fig. 5
Fig. 5
Proportion of responders among patients with chronic migraine who had failed treatment with botulinum toxin A (n = 44)
See this image and copyright information in PMC

References

    1. Lipton RB, Bigal ME, Diamond M, Freitag F, Reed ML, Stewart WF, et al. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology. 2007;68(5):343–349. doi: 10.1212/01.wnl.0000252808.97649.21. - DOI - PubMed
    1. Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018;38(1):1–211. doi: 10.1177/0333102417738202. - DOI - PubMed
    1. GBD 2017 Disease and Injury Incidence and Prevalence Collaborators Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018;392(10159):1789–1858. doi: 10.1016/S0140-6736(18)32279-7. - DOI - PMC - PubMed
    1. Steiner TJ, Stovner LJ, Vos T, Jensen R, Katsarava Z. Migraine is first cause of disability in under 50s: will health politicians now take notice? J Headache Pain. 2018;19(1):17. doi: 10.1186/s10194-018-0846-2. - DOI - PMC - PubMed
    1. Silberstein SD, Holland S, Freitag F, Dodick DW, Argoff C, Ashman E, et al. Evidence-based guideline update: pharmacologic treatment for episodic migraine prevention in adults: report of the quality standards Subcommittee of the American Academy of neurology and the American headache society. Neurology. 2012;78(17):1337–1345. doi: 10.1212/WNL.0b013e3182535d20. - DOI - PMC - PubMed

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