Galcanezumab, a monoclonal antibody against calcitonin gene-related peptide, may significantly improve daily functioning, disability, and health-related quality of life (HRQoL) in a rapid and sustained fashion in patients with migraine, according to study findings published in Neurology.
While most migraine clinical trials focus on reduction in monthly migraine days, limited data are available regarding the benefits of preventive treatment on HRQoL and disability. In this study, researchers report data from two randomized, placebo-controlled, double-blind, phase 3 studies: Evaluation of LY2951742 in the Prevention of Episodic Migraine studies (EVOLVE-1, ClinicalTrials.gov Identifier: NCT02614183; EVOLVE-2 ClinicalTrials.gov Identifier: NCT02614196), with two different dose regimens of galcanezumab (120 and 240 mg).
Both trials had identical designs and a primary research goal of assessing treatment with galcanezumab on patient function and disability after six months of treatment. The Migraine-Specific Quality of Life Questionnaire v2.1 (MSQv2.1) was used to assess the effect of migraine on work and daily activities, relationships with family and friends, leisure time, productivity, concentration, energy, and feelings. The Migraine Disability Assessment (MIDAS) was used to quantify headache-related disability over a three-month period. Data from both were collected at baseline and during the treatment period; MSQv2.1 data was collected monthly, while MIDAS was completed at three and six months.
EVOLVE-1 included 210 patients treated with galcanezumab 120 mg, 208 patients with galcanezumab 240 mg, and 425 patients who were given placebo. EVOLVE-2 included 226 patients treated with galcanezumab 120 mg, 220 patients with galcanezumab 240 mg, and 450 patients who were given placebo.
Baseline findings from MSQv2.1 revealed considerable functional impairment due to migraine in daily activities. After six months of galcanezumab treatment, MSQv2.1 total scores in both studies increased by 23.0 to 28.9 points, with consistent and clinically significant improvement greater than that seen with placebo. Compared with placebo, treatment with galcanezumab was associated with significant improvement in MSQv2.1 outcomes, beginning at month 1 and persisting for the duration of the study.
Greater reductions in MIDAS total score was found in patients treated with galcanezumab. More than 70% of galcanezumab-treated patients compared with approximately 55% of placebo-treated patients met the criteria for response (50% reduction in MIDAS total score).
As the studies tested galcanezumab only as monotherapy, lack of information regarding the effect of combining galcanezumab with other medications may have limited the findings of this study.
“These results provide important evidence for clinicians and health care policy makers that, beyond decreasing the number of [migraine headache days], galcanezumab improved patients’ health-related quality of life scores and improved disability scores in a rapid and sustained fashion,” concluded the researchers.
Disclosure: This clinical trial was supported by Eli Lilly and Company, Indianapolis,
Indiana. Please see the original reference for a full list of authors’ disclosures.
Ford JH, Ayer DW, Zhang Q, et al. Two randomized migraine studies of galcanezumab: Effects on patient functioning and disability. Neurology. 2019 Jul 30;93(5):e508-e517. doi:10.1212/WNL.0000000000007856