Background and importance Galcanezumab is a monoclonal antibody used for migraine prevention. Its approval was based on demonstrated efficacy through reduction of migraine days and impact on quality of life. However, this last variable is not routinely monitored in real practice
Aim and objectives To determine the improvement of the quality of life of patients with migraine in treatment with galcanezumab and correlate this with effectiveness in real practice.
Material and methods Prospective study between February 2020 and September 2021. To determine quality of life we used the Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ). MSQ comprised three domains: role function restrictive (RR) (7 items related to limits on social/work activities), role function preventive (PR) (4 items connected with preventing activities) and emotional function (EF) (3 items associated with emotional state). Score 0–100, such that a higher score indicates a greater quality of life. The questionnaire was carried out in weeks 0, 4 and 12, and the mean of the differences with respect to week 0 was determined. Response for RR domain was defined as a change from baseline to week 12 of ≥17 points according to trials. To evaluate effectiveness we used the number of episodes per month, defined as a change from baseline of ≥25% migraine days, and discontinued treatment due to ineffectiveness.
Results Thirty patients were enrolled, 90% women. 73% chronic migraine and 27% episodic migraine. Treatment duration was 10 (4–18) months. The mean score of the questionnaire at week 0 was 41 (7;98), at week 4 was 56 (16;98) and at week 12 was 57 (26;98). The mean difference between weeks 0 and 4 was 1 (–15;+98) and between weeks 0 and 12 was 8 (–14;+60). At week 12, 27% patients presented negative differences with respect to baseline, worsening quality of life. 17% patients obtained response for RR. Median number of episodes was 10 (8–17) at the beginning and 9 (1–17) after 12 weeks. 33% reduced ≥25% migraine days, 27% patients reduced to 50%. 13% patients discontinued treatment due to ineffectiveness.
Conclusion and relevance After 12 weeks only 17% patients obtained response for the RR domain; and 1 of 4 patients experienced worsening quality of life. Effectiveness was obtained in a few patients which appears to correlate with quality of life. Therefore, quality of life questionaries should be one more tool used to evaluate treatment effectiveness.
Conflict of interest No conflict of interest
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