Galcanezumab Shows Greatest Reduction in Disease Burden Following Switching

Article

Following the initiation or switch to a new migraine preventive medication, patients taking galcanezumab showed numerically greater 3-month improvements for most measures of health-related quality of life and disability.

 Cristina Tassorelli, MD, PhD, professor and chair of neurology at the University of Pavia

Cristina Tassorelli, MD, PhD

Findings from the real-world TRIUMPH study demonstrated that patients with migraine who switched to galcanezumab (Emgality; Eli Lilly) had significantly greater improvements in their disease burden at 3 months relative to other treatment classes or medications. These results provide evidence that galcanezumab, a monoclonal antibody that selectively binds to calcitonin gene-related peptide (CGRP), is a promising treatment to reduce the burden of migraine.1

Patients in the galcanezumab treatment group showed the greatest mean change in Migraine Disability Assessment Test (MIDAS) score (-21.2 [SD, 45.7]) at 3 months from baseline. At the same time, this group also demonstrated the greatest mean change in the Work Productivity and Activity Impairment Questionnaire (WPAI) domains of presenteeism (-22.4 [SD, 29.1]), work productivity (-24.2 [SD, 30.7]), and activity impairment (-23.1 [SD, 30.7]).

“Although all patients presented high but different levels of migraine burden at baseline, those initiating galcanezumab treatment tended to present greater numerical improvement from baseline for majority of the scales than the other drug classes. However, further substantiation of these findings depend on weighted statistical analyses of patient reported outcomes scheduled for subsequent time points with increased sample size,” lead author Cristina Tassorelli, MD, PhD, professor and chair of neurology at the University of Pavia, and colleagues wrote.1

Presented at the 2022 American Headache Society (AHS) Annual Meeting, June 15-18, in Austin, Texas, the study investigated changes in migraine burden among patients who initiated or switched to a new preventive migraine treatment, which included galcanezumab and other CGRP monoclonal antibodies (mAbs), traditional oral migraine preventive medications (TOMP), or botulinum toxin A/B.

This study enrolled 2573 adult patients (mean age, 42.7 [SD, 13.5] years; 85.2% women) with an ICHD-3 diagnosis of migraine with aura (41.1%) or chronic migraine (67.9%) who initiated or switched preventive treatment between February 2020 and August 2022. Patients were instructed to complete self-administered questionnaire including the MIDAS, Migraine-Specific Quality of life questionnaire (MSQ) version 2.1, Patient Global Impression of Severity (PGI-S), and WPAI. Authors noted that the analysis was descriptive in nature and that they used proportions for summarizing the categorical variables until increased sample sizes allowed for weighted statistical analysis. Continuous variables were summarized using means with standard deviations at baseline and 3 months, as well as mean change from baseline.

The patients included in the study were recruited from the United States (51.4 %), Germany (15.4 %), Japan (18.4 %), Italy (7.6 %), United Arab Emirates (2.8%), United Kingdom (2.4%), and Spain (2.0%). In total, 37.0% of patients who initiated or switched to a preventive migraine treatment were on galcanezumab, 46.2% for TOMP, 11.5% for other CGRP mAbs, 3.3% for botulinum toxin A/B, and 1.9% were on other locally approved medications.

At baseline, patients had a mean of 13.2 (SD, 7.2) monthly migraine headache days. Patients in the galcanezumab group showed worse scores than the TOMP group, better scores than the botulinum toxin treatment group, and similar scores to other CGRP mAbs across all measures of burden in migraine. Three months after baseline, the MSQ v2.1 domain scores in the galcanezumab group showed improvement in restrictive [19.6 (SD, 24.3)], preventive [15.9 (SD, 21.0)], and emotional function scores [22.1 (SD, 27.8)]. Notably at the same time, the mean change in PGI-S scores were similar across the treatment groups (galcanezumab, -0.4 [SD, 1.3]; other CGRP mAbs, -0.4 [SD, 1.2]; OTPM, -0.5 [SD, 1.3]; botulinum toxin A/B, -0.4 [SD, 1.3]; other locally approved treatments, -0.5 [SD, 1.3]).

For more context, galcanezumab was FDA approved in September 2018 for the preventive treatment of migraine in adults and is the only CGRP monoclonal antibody with response rates in the episodic migraine headache population on at least 50%, 75% and 100% reduction from baseline in monthly migraine headache days over 1 to 6 months. Following the approval, its indication expanded in June 2019 to include the treatment of episodic cluster headache, a rare form of headache that produces extreme pain and tends to occur in clusters, often at the same time(s) of the day, for several weeks to months.2

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REFERENCES
1. Tassorelli C, Matharu M, Joshi S, et al. The burden of migraine: 3-month findings from TRIUMPH (Preventive TReatment of mIgraine: oUtcoMes for Patients in Real-world Healthcare Systems) Study. Presented at: AHS Annual Meeting, 2023; June 15-18; Austin, TX. P-185.
2. FDA approves first treatment for episodic cluster headache that reduces the frequency of attacks. News release. FDA. June 4, 2019. Accessed June 20, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-episodic-cluster-headache-reduces-frequency-attacks
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