Swiss Quality of Life and Health Care Impact Assessment in a Real-World Erenumab-Treated Migraine Population: Results over 2 years

Abstract

Objectives/background: This prospective, multicenter, noninterventional cohort study evaluated the impact of erenumab on the quality of life and migraine-related impairment of adult patients with migraine, as well as the drug's tolerability in a real-world setting over 2 years. Erenumab, a fully human monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) receptor, was licensed in Switzerland for prophylactic treatment of adult patients with migraine in July 2018.

Methods: Adult patients with chronic or episodic migraine who received erenumab treatment as per Swiss label were enrolled from 19 sites across Switzerland between February 2019 and November 2022. Inclusion criteria were defined as the following: a migraine diagnosis per International Classification of Headache Disorders, 3rd edition, patient written informed consent, and adherence to Swiss label guidelines. Exclusion criteria were concomitant use of other investigational drugs or prior treatment with erenumab or any CGRP (receptor)-based therapy. Retrospective and prospective data from patients were collected over 24 months using patient-reported outcome questionnaires (Headache Impact Test-6 [HIT-6], modified Migraine Disability Assessment [mMIDAS], Impact of Migraine on Partners and Adolescent Children [IMPAC]), patient diaries, and medical charts to track migraine days, medication use, and health care utilization. Swiss regulations required patients to maintain migraine diaries 3 months before and during erenumab therapy to record migraine and acute medication days.

Results: A total of 173 patients (84.9% females) were enrolled who had an average age of 44.2 years. Of these, 54.3% were diagnosed with episodic migraine and 45.7% with chronic migraine. At baseline, the participants scored 65.9 ± 4.9 (mean ± SD) on HIT-6. A total of 85.5% had grade III-IV on the mMIDAS and 87% had grade III-IV in IMPAC. Patients reported 16.5 ± 7.2 monthly migraine days and 11.5 ± 7.0 acute migraine-specific medication days per month. After 24 months, the mean HIT-6 score had decreased by 8.1 ± 8.6, mean mMIDAS by 16.6 ± 21.2, monthly migraine days by 8.8 ± 7.6, and mean acute migraine-specific medication days by 5.2 ± 6.8 (all p < 0.001). Reductions of IMPAC by 6.5 ± 6.6 (p < 0.001) showed the beneficial impact of erenumab treatment on the patients' family burden attributed to migraine. Overall, 84 of 173 patients (48.6%) had at least one adverse event and 61 of 173 patients (35.3%) had at least one adverse event related to study drug. The safety profile was in line with the pivotal studies, and no serious adverse events were regarded as being related to erenumab.

Conclusion: Overall, erenumab treatment significantly reduced the burden of migraine, leading to improved quality of life for patients and their families over a treatment period of 2 years.

Keywords: Headache Impact Test‐6; Impact of Migraine on Partners and Adolescent Children; chronic and episodic migraine; drug holiday; medication overuse; monthly migraine days.

FIGURE 1

Study design and visit schedule. mo, month; V, visit. [Colour figure can be viewed at wileyonlinelibrary.com]

FIGURE 2

Mean change of HIT‐6 during erenumab treatment. The full range of HIT‐6 possible scores is shown, with 36 being the lowest possible score (no impact) and 78 the highest possible score (high impact). *Statistical significance at all time points p < 0.001 versus BL. BL, baseline; HIT‐6, Headache Impact Test‐6. [Colour figure can be viewed at wileyonlinelibrary.com]

FIGURE 3

Patient distribution of mMIDAS grades per visit: grade I (little or no disability), grade II (mild disability), grade III (moderate disability), grade IV (severe disability). Significance of reduction versus baseline was p < 0.001 at months 6, 12, 18, and 24 and p = 0.004 at month 15. mMIDAS, modified Migraine Disability Assessment. [Colour figure can be viewed at wileyonlinelibrary.com]

FIGURE 4

Mean IMPAC grades per visit. Grades are defined as mild (grade I), moderate (grade II), severe (grade III), and very severe (grade IV) impact. Significance of reduction versus baseline was p < 0.001 at months 6, 12, 18, and 24 and p = 0.002 at month 15. IMPAC, Impact of Migraine on Partners and Adolescent Children. [Colour figure can be viewed at wileyonlinelibrary.com]

FIGURE 5

(A) Number of MMD per visit over the observational period. *Statistical significance at all time points p < 0.001 versus baseline. (B) MMD response rates, as defined by proportion of patients exhibiting indicated percentage reductions of MMD relative to baseline. BL, baseline; MMD, monthly migraine days. [Colour figure can be viewed at wileyonlinelibrary.com]

FIGURE 6

(A) Mean change of AMSM days during erenumab treatment. *Probability values at all time points p < 0.001 versus baseline. (B) Assessment of patients' perceived health care utilization as visit frequency during the study period. AMSM, acute migraine‐specific medication; BL, baseline. [Colour figure can be viewed at wileyonlinelibrary.com]

FIGURE 7

Number of patients at different doses of erenumab over 24 months at each visit. “No dose” describes patients without erenumab treatment for reasons such as no efficacy, tolerability, or reimbursement issues and other nonspecified reasons. “No dose (mandatory break)” describes patients who underwent the treatment interruption and restarted therapy. “Study completed before last visit” describes patients who had the last dose before the last study visit due to different time intervals of injections (once every 4 weeks equal to 13 injections/year or once monthly equal to 12 injections/year). [Colour figure can be viewed at wileyonlinelibrary.com]