Burden of Migraine in Patients With Preventive Treatment Failure Attending European Headache Specialist Centers: Real-World Evidence From the BECOME Study

DOI: https://doi.org/10.1007/s40122- 021- 00331- 3

Abstract-Summary Patients with difficult-to-treat migraine often cycle through different preventive therapies, but real-world prospective evidence describing the burden of migraine in patients with prior preventive treatment failure (PPTF) in Europe is limited.

In BECOME, we aimed to characterize and assess the prevalence and burden of migraine in patients with PPTF attending specialist headache centers in Europe and Israel.

In part 2, patients from part 1 with ≥ 1 PPTF and ≥4 MMD were enrolled, and impact of migraine on patient-reported outcomes, and healthcare resource utiliza- tion (HRU) were examined.

In part 1 (n = 20,837), 62.2% of patients reported ≥ 1 PPTF. In part 2 (n = 2419), 15.3% of patients reported ≥ 4 PPTF. In part 2, the migraine burden measured by the EuroQoL 5 dimensions 5 level (EQ-5D-5L) questionnaire indicated an impact of at least moderate severity in per- forming usual activities in 26.5% of patients, pain/discomfort in 51.2%, and 26.1% reported being at least moderately anxious/depressed.

Most patients reported a severe impact on daily activities and disability due to

migraine.

In part 2, analysis of HRU showed 21.2% patients visited an emergency depart-

ment and 8.4% were hospitalized for headache/migraine in the past year.

This study provides real-world evidence of the high personal, social, and HRU

burden of migraine in Europe and Israel.

Extended: These findings demonstrate an unmet need for the management of

difficult-to-treat migraine.

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Introduction While the burden of migraine in Europe has been previously reported [10–131, 137, 138], the evidence relating to the burden in patients with prior preventive treatment failure (PPTF) is limited.

An acknowledged limitation of these burden studies has been the extent to which

migraine has been correctly diagnosed in all cases.

1.2

Personal and Societal Burden

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We aimed to describe the disease characteristics, especially in terms of monthly migraine days (MMD) and treatment failures, among patients who visited specialty care centers across Europe and Israel.

We investigated the disease burden and healthcare resource utilization (HRU)

among patients who had failed standard of care preventive treatments.

Methods Part 1 of the study was designed to prospectively assess the prevalence of new and follow-up patient visits to specialist headache centers and to ascertain the healthcare infrastructure of the participating headache specialist care sites.

Other endpoints in part 1 included the proportion of patients visiting headache sites within a 3-month period stratified according to (1) frequency of MMD (<4, 4–7, and 8–14 MMD, or ≥ 15 headache days per month, at least eight of which are migraine days), (2) new versus follow-up visit, (3) inpatient versus outpatient, and (4) medication overuse and medication overuse headache [139].

The burden of migraine was assessed according to 1 PPTF/> 4 PPTFs in the overall group of patients with CM and in subgroups designated as low-frequency CM (LFCM; ≥ 15 monthly headache days [MHD], of which 8–14 are MMD) and high-frequency CM (HFCM; ≥ 15 MHD, of which ≥15 are MMD). Results Of the 20,837 patients with migraine examined during the 3 months in part 1 of the study, 74.3% (15,479/20,837) reported more than 4 MMD and 22.9% (4767/20,837) suffered from CM.

Within a given MMD category, the proportion of patients who reported at least

moderate problems increased with increasing PPTF.

For the anxiety or depression domains, the proportion of patients who reported at least moderate anxiety or depression tended to increase with increasing MMD, and no consistent association with PPTF was found.

In both the HFEM and HFCM categories, a higher number of PPTFs was associ- ated with a lower proportion of patients reporting anxiety, perhaps reflecting adapta- tion to the condition in a population likely to have longer-standing disease.

The mean MSQ-RFP score of 59.2 (58.2–60.1) indicated that patients had to cancel or needed help in their social and work-related lives because of migraine symptoms.

Discussion In part 1 of the study, comprising patients visiting headache centers during a 3-month period, 62.2% of patients reported failure of at least one prior preventive therapy and 74.3% of patients reported ≥4 MMD, representing a high burden of the disease.

In this study, we found high proportions of patients consulting for a follow-up visit (77.0%) and reporting ED visits (21.2%; mean [SD] visits per patient, 3.0 [5.4]) for their migraine and hospitalization due to migraine (8.4%; mean [SD], 1.5 [2.3]) in the previous 12 months.

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1 Public Health

The specific aim of this study was to assess the burden of migraine in patients

with at least one PPTF visiting the specialist centers in Europe and Israel.

Conclusions The BECOME study demonstrates the high prevalence of PPTF among patients with migraine who visited headache clinics and confirms the significant and increas- ing HRQoL and societal burden in patients with increasing disease severity due to migraine.

Both PRO and HRU data revealed that the disease burden increases with MMD. Our results indicate that the number of PPTFs add to the burden of migraine.

Acknowledgement A machine generated summary based on the work of Pozo-Rosich, Patricia; Lucas, Christian; Watson, David P. B.; Gaul, Charly; Ramsden, Emma; Ritter, Shannon; Martelletti, Paolo; Snellman, Josefin. 2021 in Pain and Therapy.

Global assessment of migraine severity measure: preliminary evidence of construct validity