Patient-Reported Outcomes for Migraine in the US and Europe: Burden Associated with Multiple Preventive Treatment Failures

Abstract

Purpose: To evaluate patient-reported outcomes (PROs) among patients with migraine, including those who were preventive-naïve and preventive-treated.

Methods: This was a point-in-time, real-world study of patients with migraine in the US and EU5 (France, Germany, Spain, Italy, and UK) and their physicians using data from the Adelphi Migraine Disease Specific Programme (DSP™). Physicians completed patient record forms (PRFs) for the next nine consulting patients with migraine plus a tenth patient, who did not need to be consecutive, for whom prior preventive migraine treatments had failed at least once, in order to achieve oversampling of such patients. Patients were given self-completion (PSC) forms that included the Migraine-Specific Quality of Life Questionnaire v2.1 (MSQ), Migraine Disability Assessment Scale (MIDAS), and Work Productivity and Activity Impairment (WPAI) questionnaire. Populations of interest included preventive-naïve and preventive-treated patients defined by the number of treatment lines (1-2 or 3+ preventive regimens). Continuous variables were compared using t-test or ANOVA if normally distributed and Mann-Whitney if not. Chi-squared was used for categorical variables.

Results: During August-December 2017, 615 physicians (359 PCPs, 256 neurologists) completed PRFs for 5785 patients (71% female; mean age 40 (±14) years; 65% in full- or part-time employment). Of these, 2798 completed a PSC (preventive-naïve/1-2/3+ preventive lines, n=1707/1034/57). Preventive-treated patients had a greater patient-reported burden across multiple measures versus preventive-naïve patients. Preventive-treated patients had lower MSQ scores indicating greater functional impairment, higher MIDAS scores indicating greater migraine-associated disability, and higher WPAI scores indicating greater overall work and activity impairment than preventive-naïve patients. The magnitude of difference was greatest for the 3+ preventive-treatments cohort. Patterns were similar in the US and EU5.

Conclusion: Among patients with migraine who are preventive-treated, including those with multiple lines of therapy, there remain considerable unmet needs in terms of restoring patient function.

Keywords: migraine; patient-reported outcomes; preventive; real-world.

Figure 1

Migraine-Specific Quality of Life Questionnaire (MSQ) domain scores according to number of lines of preventive treatments ever received. The number of patients with data varied by group size (see Table 1). Across all three groups, the response rate for this instrument was 98% (2748 of 2798) of patients who completed a patient self-completion form.

Figure 2

Migraine Disability Assessment Scale (MIDAS) scores according to number of lines of preventive treatments ever received. Higher scores indicate greater disability. The number of patients with data varied by group size (see Table 1). Across all groups, the response rate for this instrument was 83% (2316 of 2798) of patients who completed a patient self-completion form. Trends were consistent across regions (US + EU).

Figure 3

EQ-5D-5L scores according to number of lines of migraine preventive treatments (A) mean EQ-5D 5-level score cross-walked to 3-level score and (B) mean VAS score. Patients completed the 5-level EQ-5D; scores were cross-walked to the 3-level version., The number of patients with data varied by group size; the response rate for this instrument was 99% (2763 of 2798 patients who completed a patient self-completion form).

Figure 4

WPAI in the overall patient population according to number of lines of migraine preventive treatments. The number of patients with data varied by group size; the response rate for this instrument was 54% for work productivity impairment (patients in employment only; 1440 of 2798 patients who completed a PSC) and 94% for activity impairment (2633 of 2798 patients who completed a patient self-completion form).