Lasmiditan was efficacious across a number of doses in patients with migraine regardless of prior good or insufficient response to triptan administration.
Kerry Knievel, DO
A post-hoc analysis of 2 phase 3 trials of lasmiditan demonstrate the drug’s high efficacy in patients with migraine who were previously administered triptans with good or insufficient response, as well as those who were triptan-naïve.
In October, the FDA approved lasmiditan for the acute treatment of migraine with or without aura in adults. It was approved based on the findings of both aforementioned clinical trials, SAMURAI and SPARTAN, which suggested that lasmiditan tablets showed significant progress improving in pain-freedom as well as freedom from the most bothersome symptom of migraine.
In this trial, investigators, including Kerry Knievel, DO, neurologist, Barrow Neurological Institute, Dignity Health St. Joseph’s Hospital and Medical Center, pooled data from the SAMURAI (NCT02433920) and SPARTAN (NCT02605174). The randomized, double-blind, placebo-controlled studies included a combined 3981 total patients followed over an 11-week period.
“Unmet needs with acute therapy for migraine remain high, with some patients unable to achieve optimal outcomes with current therapies,” Knievel and colleagues wrote. “Lasmiditan might offer an effective acute treatment option for these patients and would expand the therapeutic choices available both for people with migraine and their treating physicians.”
Patients enrolled would receive an initial dose randomized with lasmiditan 50 mg, 100 mg or 200 mg, or placebo. Each study tested the efficacy of lasmiditan 100 mg, 200 mg, and placebo, though only patients enrolled in SPARTAN received the lasmiditan 50 mg dose. Investigators recorded outcomes such as most bothersome symptom-freedom (MBS-freedom), headache pain freedom, and headache pain relief 2 hours post-first dose compared to placebo.
Patients assessed in both trials had a history of 3—8 migraine attacks per month, had a Migraine Disability Assessment (MIDAS) score of >11, and had a history of disabling migraine for at least 1 year. Patients who had a well-known history of coronary artery disease, clinically significant arrhythmia, or uncontrolled hypertension were excluded from the SAMURAI trial.
Patients were obligated to record their experience with previous migraine medication as “good,” “poor,” or “none.” Between each study, 45% of patients had used at least 1 triptan previously at some point. Of the 1786 triptan experienced patients, 88.5% of them were female and had a mean time since migraine diagnosis of 21.5 years.
In the 4 groups observed, lasmiditan showed significant improvements on all of the patient outcomes. Notably, more patients who found triptans to be insufficient experienced a higher rate of success in all endpoints across all 4 groups, including placebo.
For the pain freedom outcome, a similar proportion of patients in the lasmiditan 100 and 200 mg groups experienced significant improvement over placebo. For the 100 mg group, 29.6% and 24.3% of the “insufficient” and “good” triptan responders, respectively, experienced improvements, compared to 13% and 13.8% for the placebo groups, respectively (P <.001 for both). Likewise, in the 200 mg group, 32.3% and 35.4%, respectively, experienced pain freedom (P <.001 for both).
This was also the case for MBS freedom, with the 2 higher doses experiencing statistically significant differences from placebo. Those in the placebo groups who were “insufficient” and “good” responders experienced MBS freedom at rates of 24% and 29.8%, respectively, compared to 40.4% and 40.3% in the 100 mg groups (P <.01 for both) and 47.4% and 45% in the 200 mg groups (P <.001 for both).
The largest statistical jump for pain relief came in the lasmiditan 200 mg group, where 66.4% of patients who reported their previous triptan use as “good” experienced headache pain relief compared to 38.8% of the placebo group (P <.001). Similarly, f those in the 100-mg group, 60% (P <.001) experienced pain relief, while 56.7% (P <.001) in the 50 mg group did so. Patients in the triptan-naïve subgroup experienced significant differences in all outcomes when administered lasmiditan 50 mg and 100 mg compared to placebo (P < .05).
Although data was not shown, investigators noted similar treatment-emergent AE profiles in patients receiving lasmiditan regardless of prior triptan use.
Knievel K, Buchanan AS, Lombard L, et al. Lasmiditan for the acute treatment of migraine: subgroup analyses by prior response to triptans. Cephalagia. Published online November 19, 2019. doi:10.1177/0333102419889350