Real-World Trends in Characteristics of Patients with Migraine Newly Initiated on Erenumab in the USA: A Retrospective Analysis

DOI: https://doi.org/10.1007/s12325-021-01677-y

Abstract-Summary This retrospective analysis aimed to characterize patients with migraine initiating erenumab and the shifting or trend of patient characteristics over time in a real- world setting.

Patient demographics and characteristics, acute and preventive medications used

prior to initiation of erenumab, and the initial prescriber specialty were examined.

The shifting or trends of patient characteristics over time were analyzed among

subgroups of patients based on when they initiated erenumab.

There was a decrease in mean baseline Elixhauser comorbidity score at ere- numab initiation, an increase in general practitioners prescribing initial erenumab, and increased utilization in patients with less severe migraine overall (a proxy of the declining trend in chronic migraine and triptan use).

Early use of erenumab post approval focused on patients with more severe dis-

ease and a high comorbidity index rating.

Utilization of this preventive medication occurred in a broader population of patients with migraine, with increased use by general practitioners and those out- side of headache centers.

Extended: The initial prescriber specialty on the index date was evaluated. The findings of our study cannot be extrapolated to patients with migraine who

reside outside the USA, wherein different treatment practices might be used.

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4.2 Preventive Treatment

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Introduction Despite the availability of acute and preventive treatment options for patients with migraine, there has been a progressive increase in the prevalence of migraine over the last 3 decades [246].

Preventive migraine treatments include tricyclic antidepressants, anticonvul-

sants, beta blockers, calcium channel blockers, and others [247, 248].

Many traditional preventive therapies, including antidepressants, anticonvul- sants, and beta blockers, were not developed specifically for the treatment of migraine, but have been repurposed for use in migraine.

Calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs) are the

mechanism-specific drugs developed as the preventive treatment of migraine.

They are effective and well tolerated, hence they could be appealing treatment

options for migraine prevention.

Although the efficacy and safety of erenumab have been fully evaluated in mul- tiple clinical trials in patients with both episodic and chronic migraine [4, 67, 154– 226], real-world evidence of its use and the characteristics of patients using erenumab have not been fully investigated.

Methods Patients were included if they were at least 18 years of age, had at least one ere- numab written prescription or administration during the patient identification period, at least 12 months of pre-index clinical activity (index date was defined as the earliest occurring date of erenumab prescription or administration during the identification period; activity indicates patients who had at least one encounter prior to index date and at least 12 months prior to index date) and were included in an integrated delivery network.

The variables assessed included patient demographics (e.g., age, gender, race, ethnicity, insurance type, smoking status), baseline comorbidities using the Elixhauser comorbidity index, and proportion of patients with chronic migraine without aura (CMWA) during the 12 months prior to erenumab initiation.

Data in the following variables were assessed: patient comorbidity status, index prescriber specialty and proportion of patients with CMWA in the 12-month pre- index period, use of triptans, NSAIDS, and opioids in the 3-month pre-index period, use of botulinum toxinA in the 12-month pre-index period, and no use of preventive medication in the 12-month pre-index period.

Results 84.2% of patients received at least one acute medication in the 12 months prior to initiation of erenumab, with 60.7% of patients receiving acute medication on the same date as a migraine diagnosis.

81.5% of patients received at least one preventive medication in the 12 months prior to initiation of erenumab, with 60.0% receiving preventive medication on the same date as a migraine diagnosis at baseline.

Use of botulinum toxin in the 12-month pre-index period The proportion of patients utilizing botulinum toxin in the 12  months before erenumab initiation decreased from 34.0% to 12.5% over time in subgroups of patients who initiated

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4 Treatment

erenuamb at different time periods (from May–July 2018 subgroup to July– September 2019 subgroup).

Discussion Results of this real-world retrospective analysis showed that at the time of regula- tory approval and commercial product launch, the erenumab was prescribed to patients with more severe disease, as reflected by a higher comorbidity burden, more chronic migraines, and a greater use of preventive/acute medications com- pared with patients treated in subsequent time periods.

Further, pre-index comorbidities were low in another retrospective analysis per- formed in 2011–2013 in adult patients with migraine initiating their first preventive migraine medication class (anxiety, 16.4%; depression, 15.4%; CV disease, 8.9%). In another exploratory, retrospective, observational study that aimed to identify the factors predicting preventive migraine medication initiation, the key comorbidi- ties of interest for the overall study population included sleep disorders (10.2%), CV disease (8.3%), allodynia (6.8%), obesity (6.5%), and diabetes mellitus (4.5%) during the 1-year pre-preventive migraine treatment initiation date (including the index day) [249].

Conclusion At launch, erenumab was more commonly prescribed by neurologists/headache specialists in patients experiencing advanced disease, reflected by higher comorbid- ity burden, chronic migraine patient type, and the number of preventive or acute medications.

The prevalence of selected comorbidities and the use of preventive medication during the 12-month pre-index period were both higher in the current study com- pared with previous reports.

Comorbidity score and the use of acute and preventative medications were both shown to decrease over time in subgroups of patients who initiated erenumab at dif- ferent time periods.

Acknowledgement A machine generated summary based on the work of Fang, Juanzhi; Korrer, Stephanie; Johnson, Jonathan C.; Cheadle, Mark A.; Shah, Roshani; Ferraris, Matias L.; Lopez-Lopez, Cristina. 2021 in Advances in Therapy.

Erenumab in highly therapy-refractory migraine patients: First German real-world evidence