Abstract
PurposeMigraine can negatively impact patient functioning and quality of life. Here, we report the effects of galcanezumab (GMB), a humanized monoclonal antibody that binds to calcitonin gene-related peptide, on patient-reported outcome (PRO) measures in migraine.MethodsCGAJ was a Phase III, randomized, open-label study (12-month open-label and 4-month post-treatment follow-up) in patients with episodic or chronic migraine. Patients aged 18–65 years with diagnosis of migraine (≥ 4 migraine headache days per month) as defined by International Classification of Headache Disorders (ICHD)-3 beta guidelines were included in the study. Patients were randomized 1:1 with subcutaneous GMB 120 mg (with a loading dose of 240 mg) or GMB 240 mg given once monthly for 12 months. Changes from baseline in PRO measures such as Migraine-Specific Quality of Life Questionnaire v2.1 (MSQ) and Migraine Disability Assessment (MIDAS) were assessed.ResultsA total of 135 patients were randomized to each galcanezumab dose group. Mean (SD) baseline MSQ total scores were 53.85 (20.34) [GMB 120 mg] and 53.69 (18.79) [GMB 240 mg]. For MIDAS, mean (SD) total scores were 45.77 (42.06) [GMB 120 mg] and 53.96 (61.24) [GMB 240 mg]. Within-group mean improvement from baseline on MSQ and MIDAS total scores and all individual item/domain scores were statistically significant for both GMB dose groups, at all-time points during the treatment phase (p < 0.001). For MSQ domain scores, greatest improvement was observed in the Role function-restrictive (RF-R) domain (overall least squares (LS) mean change ± SE: 31.55 ± 1.20 [GMB 120 mg] and 33.40 ± 1.16 [GMB 240 mg]). For MIDAS, the overall LS mean change ± SE from baseline across the entire 12-month treatment phase in total scores were: −33.58 ± 2.11 (GMB 120 mg) and −32.67 ± 2.04 (GMB 240 mg).ConclusionGalcanezumab was associated with statistically significant changes from baseline in the PRO measures across the entire 12-month treatment period. These results indicate improved health-related quality of life and decreased disability among patients treated with galcanezumab.
Highlights
Migraine is a debilitating neurological disease with an estimated global prevalence of approximately 11.5% [1, 2]
Patients had to maintain a daily log of their headaches, migraine headaches and medications taken for treatment of acute episodes; this was reviewed at each monthly visit
This paper focuses on changes from baseline in the total score as well as each of the three domains of the MSQv2.1 for each collection point (Month 1–3, 6 and 12); and Migraine Disability Assessment (MIDAS) total scores for each collection point (Month 3, 6, 9, 12) as well as changes from baseline for each item at month 12
Summary
Migraine is a debilitating neurological disease with an estimated global prevalence of approximately 11.5% [1, 2]. The disability and functional impairment associated with migraine disrupts daily living as reported in a multi-country cross-sectional survey study of adults with migraine. This includes a strain in personal relationships, difficulty caring for children, and missed days of work or social events [5]. The burden or impact of migraine was observed to be higher in patients with migraine compared to nonheadache patients or patients with tension-type headache across domains; these included impact on work or school activities, impact on family life, interictal burden, economic burden [7]. Goals of migraine prevention include reducing disability, improving patient functioning and enhancing overall health-related quality of life [9]
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