The FDA-approved migraine therapy lasmiditan showed long-term efficacy and had similar change in Migraine Disability Assessment total score in both 100-mg and 200-mg doses.
Richard B. Lipton, MD
Results from the phase 3, open-label extension GLADIATOR trial showed clinically meaningful responses as well as migraine-related disability improvement with lasmiditan (Reyvow; Eli Lilly) 100-mg and 200-mg treatment in adults with the headache condition.1
Data that were accepted to the American Academy of Neurology (AAN) Annual Meeting showed that both subgroups of patients treated with ladmiditan 100 mg (n = 974) and 200 mg (n = 1063) showed clinically significant (P <.001) decreases from baseline at all time points for all end points.
At 12 months, Migraine Disability Assessment (MIDAS) total score and least square (LS) mean change was -12.5 and -12.2 for the ladmiditan 100-mg and 200-mg groups, respectively. Additionally, the investigators noted reductions of 5.7 and 6.0 headache days, as well as a 1.1- and 1.2-point reduction in headache pain in both ladmiditan groups, respectively.
With regard to a >5-point decrease in MIDAS score from baseline, the proportion of responders increased from upward of 53% at 3 months to at least 70% at 12 months. From months 3 through 12, the proportion of patients with a >50% decrease in MIDAS total score from baseline increased from >30% to >49%. Similar results across subgroups, defined by the baseline headache frequency and initial responses to lasmiditan, represented the change in MIDAS score following treatment.
The 12-month findings for lasmiditan 100 mg were -1.0 for absenteeism and -2.6 for presenteeism, compared to -1.2 and -2.3 for the 200-mg group.
GLADIATOR was an open-label, long-term, phase 3 trial led by senior researcher Richard B. Lipton, MD, director, Montefiore Headache Center, and professor of neurology, Albert Einstein College of Medicine, designed to evaluate the safety and efficacy of lasmiditan for the treatment of multiple migraine attacks for up to 1 year.
In the open-label extension, patients were randomized 1:1 to lasmiditan 100 mg or 200 mg, taken acutely for migraine attacks with at least moderate headache intensity. Changes from baseline on end points such as MIDAS total score, absenteeism, presenteeism, monthly headache days, and average headache pain intensity were all recorded at 3, 6, 9, and 12 months.
Lasmiditian is a selective serotonin 5-HT1F receptor agonist that was granted FDA approval in October 2019 for the acute treatment of migraine with or without aura in adults. The basis of the decision was backed by findings from 2 phase 3, single-attack clinical trial—SAMURAI and SPARTAN— which suggested the drug tablets were associated with a high rate of pain-freedom from migraine, as well as freedom from the most bothersome symptom.
Results showed a higher percentage of patients who received lasmiditan 200 mg (P <.001) who were migraine pain-free at 2 hours post-dose compared to those who received placebo (lasmiditan 200 mg: SAMURAI 32.2%, SPARTAN 38.8% vs placebo: SAMURAI 15.3%, SPARTAN 21.3%). In SAMURAI and SPARTAN, freedom of the most bothersome symptoms occurred in 40.7% and 48.7% of patients who received lasmiditan 200 mg compared to 29.5% and 33.5% on placebo, respectively.2
Reyvow, became available for prescription in January of this year. Lasmiditan, which at the time was the first molecule in the ditan drug class to be approved, became available for prescription in 50 mg and 100 mg tablets.
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1. Loo LS, Buse D, Lombard L, et al. Trajectory of migraine-related disability over 12 months with lasmiditan for acute treatment of migraine in the GLADIATOR study. Neurology. 2020;94(15 Suppl): 0604.
2. Wietecha L, Kuca B, Asafu-Adjei J, et al. Phase 3 Studies (SAMURAI, SPARTAN) of Lasmiditan Compared to Placebo for Acute Treatment of Migraine (S50.008). Neurology. 2018;90. http://n.neurology.org/content/90/15_Supplement/S50.008