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The Journal of Headache and Pain
Published in: The Journal of Headache and Pain 1/2022

01-12-2022 | Migraine | Research

Galcanezumab effect on “whole pain burden” and multidimensional outcomes in migraine patients with previous unsuccessful treatments: a real-world experience

Authors: Marcello Silvestro, Alessandro Tessitore, Ilaria Orologio, Rosa De Micco, Lorenzo Tartaglione, Francesca Trojsi, Gioacchino Tedeschi, Antonio Russo

Published in: The Journal of Headache and Pain | Issue 1/2022

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Abstract

Background

Clinical trials have demonstrated galcanezumab as safe and effective in migraine prevention. However, real-life data are still lacking and overlook the impact of galcanezumab on those different migraine facets strongly contributing to migraine burden. Herein we report the clinical experience from an Italian real-world setting using galcanezumab in patients with migraine experiencing previous unsuccessful preventive treatments.

Methods

Forty-three patients with migraine and failure of at least 3 migraine preventive medication classes received monthly galcanezumab 120 mg s.c. At the first administration and after 3 and 6 months, patients underwent extensive interviews to assess clinical parameters of disease severity. Furthermore, validated questionnaires were administered to explore migraine-related disability, impact, and quality of life as well as symptoms of depression or anxiety, pain catastrophizing, sleep quality and the ictal cutaneous allodynia.

Results

After the third and the sixth administration of monthly galcanezumab 120 mg s.c., headache attacks frequency reduced from 20.56 to 7.44 and 6.37 headache days per month, respectively. Moreover, a significant improvement in headache pain intensity (from 8.95 to 6.84 and 6.21) and duration (from 9.03 to 3.75 and 2.38) as well as in scores assessing migraine related disability and impact, depressive and anxious symptoms, and pain catastrophizing was observed. Furthermore, we demonstrated a significant reduction in the values of “whole pain burden”, a composite score derived from the product of the average of headache frequency, intensity, and duration in the last three months.

Conclusion

Real-world data support monthly galcanezumab 120 mg s.c. as a safe and effective preventive treatment in reducing headache frequency, intensity, and duration as well as comorbid depressive or anxious symptoms, pain catastrophizing and quality of life in both episodic and chronic migraine patients with previous unsuccessful preventive treatments. Furthermore, we demonstrated that monthly galcanezumab 120 mg s.c. is able to induce a significant improvement in the scores of “whole pain burden”. The latter is a reliable and easy-to-handle tool to be employed in clinical setting to evaluate the effectiveness of preventive drugs (in this case, galcanezumab) or when the decision of continuing the treatment with anti-CGRP mAbs is mandatory.
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Literature
1.
Vandervorst F, Van Deun L, Van Dycke A et al (2021) CGRP monoclonal antibodies in migraine: an efficacy and tolerability comparison with standard prophylactic drugs. J Headache Pain. 22(1):128PubMedPubMedCentralCrossRef
2.
Vécsei L, Majláth Z, Szok D et al (2015) Drug safety and tolerability in prophylactic migraine treatment. Expert Opin Drug Saf 14(5):667–681PubMedCrossRef
3.
Silberstein SD, Holland S, Freitag F et al (2012) Quality standards Subcommittee of the American Academy of neurology and the American headache society. 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. 78(17):1337–1345PubMedPubMedCentralCrossRef
4.
Goadsby PJ, Sprenger T (2010) Current practice and future directions in the prevention and acute management of migraine. Lancet Neurol 9(3):285–298PubMedCrossRef
5.
Mulleners WM, Kim BK, Láinez MJA et al (2020) Safety and efficacy of galcanezumab in patients for whom previous migraine preventive medication from two to four categories had failed (CONQUER): a multicentre, randomised, double-blind, placebo-controlled, phase 3b trial. Lancet Neurol 19(10):814–825PubMedCrossRef
6.
Stauffer VL, Dodick DW, Zhang Q et al (2018) Evaluation of Galcanezumab for the prevention of episodic migraine: the EVOLVE-1 randomized clinical trial. JAMA Neurol 75(9):1080–1088PubMedPubMedCentralCrossRef
7.
Skljarevski V, Matharu M, Millen BA et al (2018) Efficacy and safety of galcanezumab for the prevention of episodic migraine: results of the EVOLVE-2 phase 3 randomized controlled clinical trial. Cephalalgia. 38(8):1442–1454PubMedCrossRef
8.
Detke HC, Goadsby PJ, Wang S et al (2018) Galcanezumab in chronic migraine: the randomized, double-blind, placebo-controlled REGAIN study. Neurology. 91(24):e2211–e2221PubMedPubMedCentralCrossRef
9.
Vernieri F, Altamura C, Brunelli N et al (2021) GARLIT study group. Galcanezumab for the prevention of high frequency episodic and chronic migraine in real life in Italy: a multicenter prospective cohort study (the GARLIT study). J Headache Pain 22(1):35PubMedPubMedCentralCrossRef
10.
Russo A, Silvestro M, Scotto di Clemente F et al (2020) Multidimensional assessment of the effects of erenumab in chronic migraine patients with previous unsuccessful preventive treatments: a comprehensive real-world experience. J Headache Pain. 21(1):69PubMedPubMedCentralCrossRef
11.
Headache Classification Committee of the International Headache Society (IHS) (2018) The international classification of headache disorders, 3rd edition. Cephalalgia. 38(1):1–211CrossRef
12.
Sacco S, Bendtsen L, Ashina M et al (2019) European headache federation guideline on the use of monoclonal antibodies acting on the calcitonin gene related peptide or its receptor for migraine prevention. J Headache Pain. 20(1):6PubMedPubMedCentralCrossRef
13.
Stewart WF, Lipton RB, Dowson AJ, Sawyer J (2001) Development and testing of the migraine disability assessment (MIDAS) questionnaire to assess headache-related disability. Neurology. 56(6 Suppl 1):S20–S28PubMedCrossRef
14.
Kosinski M, Bayliss MS, Bjorner JB et al (2003) A six-item short-form survey for measuring headache impact: the HIT-6. Qual Life Res 12(8):963–974PubMedCrossRef
15.
Beck AT, Steer RA, Brown GK (1996) BDI-II: Beck depression inventory manual, 2nd edn. Psychological Corporation, San Antonio
16.
Worboys M (2013) The Hamilton rating scale for depression: the making of a “gold standard” and the unmaking of a chronic illness, 1960-1980. Chronic Illn 9(3):202–219PubMedPubMedCentralCrossRef
17.
Maier W, Buller R, Philipp M, Heuser I (1988) The Hamilton anxiety scale: reliability, validity and sensitivity to change in anxiety and depressive disorders. J Affect Disord 14(1):61–68PubMedCrossRef
18.
Allen RP, Kosinski M, Hill-Zabala CE, Calloway MO (2009) Psychometric evaluation and tests of validity of the medical outcomes study 12-item sleep scale (MOS sleep). Sleep Med 10(5):531–539PubMedCrossRef
19.
Jhingran P, Osterhaus JT, Miller DW et al (1998) Development and validation of the migraine-specific quality of life questionnaire. Headache 38(4):295–302PubMedCrossRef
20.
Jakubowski M, Silberstein S, Ashkenazi A et al (2005) Can allodynic migraine patients be identified interictally using a questionnaire? Neurology. 65:1419–1422PubMedCrossRef
21.
Sullivan MJL, Bishop SR, Pivik J (1995) The pain catastrophizing scale: development and validation. Psychol Assess 7(4):524CrossRef
22.
Elm EV, Altman DG, Egger M et al (2007) Strengthening the reporting of observational studies in epidemiology (STROBE) statement: guidelines for reporting observational studies. BMJ 335:806CrossRef
23.
Steiner TJ, Stovner LJ, Jensen R et al (2020) Lifting the burden: the global campaign against headache. Migraine remains second among the world's causes of disability, and first among young women: findings from GBD2019. J Headache Pain. 21(1):137PubMedPubMedCentralCrossRef
24.
Cevoli S, D'Amico D, Martelletti P et al (2009) Underdiagnosis and undertreatment of migraine in Italy: a survey of patients attending for the first time 10 headache centres. Cephalalgia. 29(12):1285–1293PubMedCrossRef
25.
Minen MT, Loder E, Tishler L, Silbersweig D (2016) Migraine diagnosis and treatment: a knowledge and needs assessment among primary care providers. Cephalalgia. 36(4):358–370PubMedCrossRef
26.
Ishii R, Schwedt TJ, Dumkrieger G et al (2021) Chronic versus episodic migraine: the 15-day threshold does not adequately reflect substantial differences in disability across the full spectrum of headache frequency. Headache. 61(7):992–1003PubMedCrossRef
27.
Burch R (2021) Preventive migraine treatment. Continuum (Minneap Minn) 27(3):613–632
28.
Parikh SK, Silberstein SD (2019) Preventive treatment for episodic migraine. Neurol Clin 37(4):753–770PubMedCrossRef
29.
30.
Pozo-Rosich P, Samaan KH, Schwedt TJ et al (2021) Galcanezumab provides consistent efficacy throughout the dosing interval among patients with episodic and chronic migraine: a post hoc analysis. Adv Ther 38(6):3154–3165PubMedPubMedCentralCrossRef
31.
Iannone LF, Fattori D, Benemei S et al (2022) Long-term effectiveness of three anti-CGRP monoclonal antibodies in resistant chronic migraine patients based on the MIDAS score. CNS Drugs 36:191–202PubMedPubMedCentralCrossRef
32.
Buse DC, Manack A, Serrano D et al (2010) Sociodemographic and comorbidity profiles of chronic migraine and episodic migraine sufferers. J Neurol Neurosurg Psychiatry 81(4):428–432PubMedCrossRef
33.
34.
Louter MA, Pijpers JA, Wardenaar KJ et al (2015) Symptom dimensions of affective disorders in migraine patients. J Psychosom Res 79(5):458–463PubMedCrossRef
35.
36.
Mortazavi Nasiri FS, Pakdaman S, Dehghani M, Togha M (2017) The relationship between pain catastrophizing and headache-related disability: the mediating role of pain intensity. Jpn Psychol Res 59(4):266–274CrossRef
37.
Silvestro M, Tessitore A, Scotto di Clemente F et al (2021) Refractory migraine profile in CGRP-monoclonal antibodies scenario. Acta Neurol Scand 144(3):325–333PubMedPubMedCentralCrossRef
38.
Peters ML, Vlaeyen JW, Weber WE (2005) The joint contribution of physical pathology, pain-related fear and catastrophizing to chronic back pain disability. Pain. 113:45–50PubMedCrossRef
39.
Severeijns R, Vlaeyen JW, van den Hout MA et al (2001) Pain catastrophizing predicts pain intensity, disability, and psychological distress independent of the level of physical impairment. Clin J Pain 17:165–172PubMedCrossRef
40.
Kim SJ, Han KT, Jang SY et al (2018) The association between migraine and types of sleep disorder. Int J Environ Res Public Health 15(12):2648PubMedCentralCrossRef
41.
Kelman L, Rains JC (2005) Headache and sleep: examination of sleep patterns and complaints in a large clinical sample of migraineurs. Headache. 45(7):904–910PubMedCrossRef
42.
Sancisi E, Cevoli S, Vignatelli L et al (2010) Increased prevalence of sleep disorders in chronic headache: a case-control study. Headache. 50(9):1464–1472PubMedCrossRef
43.
Lipton RB, Fanning KM, Buse DC et al (2019) Migraine progression in subgroups of migraine based on comorbidities: results of the CaMEO study. Neurology. 93(24):e2224–e2236PubMedPubMedCentralCrossRef
44.
Louter MA, Bosker JE, van Oosterhout WP et al (2013) Cutaneous allodynia as a predictor of migraine chronification. Brain. 136(Pt 11):3489–3496PubMedCrossRef
45.
Caronna E, Gallardo VJ, Alpuente A et al (2021) Anti-CGRP monoclonal antibodies in chronic migraine with medication overuse: real-life effectiveness and predictors of response at 6 months. J Headache Pain. 22(1):120PubMedPubMedCentralCrossRef
46.
Ailani J, Andrews JS, Rettiganti M et al (2020) Nicholson RA. Impact of galcanezumab on total pain burden: findings from phase 3 randomized, double-blind, placebo-controlled studies in patients with episodic or chronic migraine (EVOLVE-1, EVOLVE-2, and REGAIN trials). J Headache Pain. 21(1):123PubMedPubMedCentralCrossRef
47.
Gil-Gouveia R, Oliveira AG (2022) Are PROMs passing the message? A reflection with real-life migraine patients. Cephalalgia 42(2):162–165PubMedCrossRef
48.
Cernuda-Morollón E, Martínez-Camblor P, Ramón C et al (2014) CGRP and VIP levels as predictors of efficacy of Onabotulinumtoxin type a in chronic migraine. Headache. 54(6):987–995PubMedCrossRef
49.
Bottiroli S, De Icco R, Vaghi G et al (2021) Psychological predictors of negative treatment outcome with Erenumab in chronic migraine: data from an open label long-term prospective study. J Headache Pain. 22(1):114PubMedCrossRef
50.
Concato J, Shah N, Horwitz RI (2000) Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med 342(25):1887–1892PubMedPubMedCentralCrossRef
Metadata
Title
Galcanezumab effect on “whole pain burden” and multidimensional outcomes in migraine patients with previous unsuccessful treatments: a real-world experience
Authors
Marcello Silvestro
Alessandro Tessitore
Ilaria Orologio
Rosa De Micco
Lorenzo Tartaglione
Francesca Trojsi
Gioacchino Tedeschi
Antonio Russo
Publication date
01-12-2022
Publisher
Springer Milan
Published in
The Journal of Headache and Pain / Issue 1/2022
Print ISSN: 1129-2369
Electronic ISSN: 1129-2377
DOI
https://doi.org/10.1186/s10194-022-01436-6

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