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The body of evidence for the use of Emgality®▼ (galcanezumab)** as a preventive migraine medication is increasing, as shown in several congresses throughout 2020.

Day-to-day function and disability levels in patients with episodic or chronic migraine treated with galcanezumab

Take-home messages:

  • Measures of pain and headache frequency may not be sufficient to evaluate the full impact of migraine1
  • Recent studies re-confirm that galcanezumab reduces migraine‐related disability as well as functioning in patients with episodic or chronic migraine1,2
  • Galcanezumab also improved work productivity and reduced interictal burden versus placebo, in patients who had failed on multiple standard-of-care preventive medications2,3

Based on:

Wietecha L, Ford J et al. Patient gains in daily functioning and reductions in disability with galcanezumab among patients with chronic and episodic migraine. Presented at 13th European Headache Congress, 30 May - 1 June 2019; e-Poster 0491

Tepper S J, Ailani J et al. Effects of galcanezumab on health-related quality of life in patients with treatment-resistant migraine: Results from the CONQUER study. Presented at 6th Congress of European Academy of Neurology (EAN), Virtual 2020, 23-26 May 2020; EPR3051 (Presented by Stewart Tepper)2

García-Azorín D, Ford J et al. Changes in work productivity and interictal burden: results from a randomized, double-blind, placebo-controlled clinical trial evaluating galcanezumab in adults with treatment-resistant migraine (CONQUER). Presented at 6th Congress of European Academy of Neurology (EAN), Virtual 2020, 23-26 May 2020; EPR1100 (Presented by David García-Azorín)3

Only using measures of pain and headache frequency may not be sufficient to fully evaluate the effects of migraine. Assessing patient-reported outcomes allows health-related quality of life and functioning in migraineurs to be studied, including work productivity, activity impairment, headache-related disability and interictal burden.1 Patients treated with galcanezumab for the prevention of episodic migraine (EM) or chronic migraine (CM) have been shown to have lower levels of migraine-related disability and fewer restrictions on daily functioning, compared to patients receiving placebo (EVOLVE-1, EVOLVE-2 and REGAIN phase III clinical trials).4,5

EVOLVE and REGAIN: effect of galcanezumab treatment on headache-related disability and daily functioning1

The Migraine Disability Assessment (MIDAS) measures headache-related disability in terms of missed days or reduced productivity at work, at school and with social activities. Higher scores indicate greater disability, with a score of ≤5 categorised as 'little or no disability'.

The Migraine-Specific Quality of Life questionnaire v2.1 (MSQ) measures the physical and emotional impact of migraine on daily functioning. The instrument consists of 14 items that address three domains: role function-restrictive, role function-preventive and emotional function. The restrictive domain specifically measures disability in relation to the impact on performance of normal activities.6

MIDAS: At the study endpoint, a greater proportion of patients treated with galcanezumab had moved into the 'little or no disability' category compared with placebo:

  • EVOLVE-1/ EVOLVE-2 (EM, 6 months): galcanezumab 51% versus placebo 33%
  • REGAIN (CM, 3 months): galcanezumab ~20% versus placebo 14%

MSQ: At the study endpoint, a significantly greater number of patients treated with galcanezumab showed improvements in all (EM) or most (CM) role-function restrictive item scores compared with placebo.

CONQUER: headache-related disability and daily functioning in patients with treatment-resistant migraine2,3

The effect of galcanezumab on health-related quality of life in patients with treatment-resistant EM or CM was presented at EAN 2020 by Stewart Tepper, Geisel School of Medicine at Dartmouth, US. David García-Azorín, Hospital Clínico Universitario de Valladolid, Spain, presented changes in work productivity and interictal burden observed with galcanezumab treatment. Results were from CONQUER, a phase III trial in patients with previous failure to two, three or four migraine preventative medication categories.

MIDAS is measured over a 3-month period

EM subpopulation

CM subpopulation

Adapted from Tepper S J et al, 20202
*p<0.01 versus placebo; †p<0.05 versus placebo. Treatment comparisons performed using ANCOVA.

MSQ is measured over the previous 4 weeks

Role-function restrictive

Role-function preventive

Emotional function

MSQ total

Adapted from Tepper S J et al, 20202
‡p≤0.0001.
Treatment comparisons performed using MMRM.

The Work Productivity and Activity Impairment questionnaire (WPAI) measures the impact of any specific health problem on work productivity and regular activities, and is assessed over the previous 7 days. Scores range from 0-100, and are calculated as impairment percentages: absenteeism, presenteeism (impairment while working), overall work productivity loss, and activity impairment (non-work related). A higher percentage indicates greater impairment and less productivity.

Total population

Adapted from García-Azorín D et al, 20203
‡p<0.001 (presenteeism p=0.0004; overall work impairment p=0.0003; activity impairment p<0.0001).
Treatment comparisons performed using ANCOVA.

Statistically significant differences in percentage change from baseline of presenteeism, overall work impairment and activity impairment were also observed for both the EM and CM subpopulations.

The Migraine Interictal Burden Scale (MIBS-4) measures burden related to headache in the time between attacks, including disruption at work and school, diminished family and social life, difficulty planning, and emotional difficulty. It is measured over the previous 4 weeks on days without a headache attack, and each response has a numerical score, ranging from 0 to 12. Categories: 0 = none; 1-2 = mild; 3-4 = moderate; and >5 = severe.6

Reduction in interictal burden, as assessed by change from baseline in total MIBS-4 score, was found to be superior in galcanezumab-treated patients compared with placebo, at Months 1, 2 and 3.

Conclusion1-3

In patients with episodic or chronic migraine, including those with failures to multiple previous preventative medications, galcanezumab has been shown to have a superior effect, compared with placebo, on patient functioning and headache-related disability scores. Analysis of the CONQUER data also revealed galcanezumab to have a more positive effect than placebo on work productivity and interictal burden.

**Emgality (galcanezumab) is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.8

ANCOVA: analysis of covariance; CM: chronic migraine; EM: episodic migraine; GMB: galcanezumab; LS: least square; MIDAS: Migraine Disability and Assessment; MMRM: mixed model repeated measures; MSQ: Migraine-Specific Quality of Life questionnaire version 2.1; PBO: placebo.

References
  1. Wietecha L, Ford J et al. Patient gains in daily functioning and reductions in disability with galcanezumab among patients with chronic and episodic migraine. Presented at 13th European Headache Congress, 30 May - 1 June 2019; e-Poster 049
  2. Tepper S J, Ailani J et al. Effects of galcanezumab on health-related quality of life in patients with treatment-resistant migraine: Results from the CONQUER study. Presented at 6th Congress of European Academy of Neurology (EAN), Virtual 2020, 23-26 May 2020; EPR3051
  3. García-Azorín D, Ford J et al. Changes in work productivity and interictal burden: results from a randomized, double-blind, placebo-controlled clinical trial evaluating galcanezumab in adults with treatment-resistant migraine (CONQUER). Presented at 6th Congress of European Academy of Neurology (EAN), Virtual 2020, 23-26 May 2020
  4. Ford J H, Ayer D W et al. Two randomized migraine studies of galcanezumab: effects on patient functioning and disability. Neurology 2019;93(5): e508-e517
  5. Detke H C, Goadsby P J et al. Galcanezumab in chronic migraine: the randomized, double-blind, placebo-controlled REGAIN study. Neurology 2018;91(24):e2211-e2221
  6. Buse D C, Rupnow M F, Lipton R B. Assessing and managing all aspects of migraine: migraine attacks, migraine-related functional impairment, common comorbidities, and quality of life. Mayo Clin Proc 2009;84(5):422-435
  7. ClinicalTrials.gov. A study of galcanezumab (LY2951742) in adults with treatment-resistant migraine (CONQUER). Available at: clinicaltrials.gov. Accessed May 2021
  8. Emgality: Brazilian label approved by Anvisa. Available from: consultas.anvisa.gov.br. Accessed May 2021

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CDS29ABR19

EMGALITY® (galcanezumabe) Indicações: EMGALITY é indicado para a profilaxia da enxaqueca em adultos que apresentam pelo menos quatro dias de enxaqueca por mês. EMGALITY é indicado para a prevenção de crises durante o período de salvas em adultos com cefaleia em salvas episódica. Contraindicações: EMGALITY é contraindicado para pacientes com hipersensibilidade grave conhecida a galcanezumabe ou a qualquer um de seus excipientes. Advertências e Precauções: reações graves de hipersensibilidades foram relatadas. Se ocorrer uma reação grave de hipersensibilidade, descontinuar EMGALITY imediatamente e iniciar a terapia apropriada. Do mesmo modo que com todas as proteínas terapêuticas, existe o potencial de imunogenicidade com EMGALITY. Pacientes com certas doenças cardiovasculares graves foram excluídos dos estudos clínicos de cefaleia em salvas episódica, portanto, não há dados de segurança disponíveis nesses pacientes. Há dados insuficientes em humanos para estabelecer a segurança de EMGALITY durante a gestação. EMGALITY deve ser utilizado na gestação somente se o benefício potencial justificar o possível risco à mãe ou ao feto. Os benefícios da amamentação para o desenvolvimento e a saúde devem ser considerados, junto à necessidade clínica da mãe por EMGALITY e qualquer potencial efeito adverso no bebê amamentado. EMGALITY pode ter uma pequena influência sobre a capacidade de conduzir e utilizar máquinas. Vertigem pode ocorrer após a administração de EMGALITY. A segurança e a eficácia de EMGALITY não foram estabelecidas em pacientes pediátricos menores de 18 anos de idade. Enxaqueca: há informações limitadas em pacientes geriátricos maiores de 65 anos de idade. Cefaleia em salvas: os estudos clínicos de galcanezumabe não incluíram número suficiente de pacientes com 65 anos ou mais para determinar se eles respondem diferentemente de pacientes mais jovens. Interações medicamentosas: interações medicamentosas farmacocinéticas não são esperadas, com base nas características de EMGALITY. Nenhum estudo foi conduzido para investigar possível interação entre EMGALITY e plantas medicinais, álcool, nicotina e exames laboratoriais e não laboratoriais. Posologia e modo de usar: EMGALITY é para administração subcutânea. Enxaqueca: a dose recomendada é de 120 mg, injetada pela via subcutânea uma vez por mês, com uma dose de ataque de 240 mg como dose inicial. O benefício do tratamento deve ser avaliado em até 3 meses após o seu início. A decisão de continuar o tratamento deverá ser tomada individualmente para cada paciente. Posteriormente, é recomendada a avaliação da necessidade de continuar o tratamento regularmente. Cefaleia em salvas: a dose recomendada é de 300 mg (três injeções subcutâneas consecutivas de 100 mg cada), injetada pela via subcutânea uma vez por mês, durante o período de salvas. Reações adversas: dados de estudos clínicos - muito comum ≥ 10%: dor no local da injeção e reações no local da injeção (excluindo dor); comum (≥ 1% e < 10%): vertigem, constipação e prurido. Dados pós-comercialização - comum (≥ 1% e < 10%): rash. Venda sob prescrição médica. Registro MS - 1.1260.0200. Documentação científica e/ou informações adicionais à classe médica sobre o produto mediante solicitação. Para mais informações, consulte a bula completa do produto ou o Serviço de Atendimento ao Cliente Lilly SAC 0800 701 0444, e-mail: sac_brasil@lilly.com. 13/05/2020, 06/01/2020. Contraindicações: EMGALITY é contraindicado para pacientes com hipersensibilidade grave conhecida a galcanezumabe ou a qualquer um de seus excipientes. Interações medicamentosas: interações medicamentosas farmacocinéticas não são esperadas, com base nas características de EMGALITY. Nenhum estudo foi conduzido para investigar possível interação entre EMGALITY e plantas medicinais, álcool, nicotina e exames laboratoriais e não laboratoriais.

Material destinado exclusivamente a profissionais de saúde habilitados a prescrever e dispensar medicamentos.