Patients on lasmiditan had 3.8–7.2 times greater odds of achieving pain freedom at 2 hours compared to placebo in at least 2 out of 3 migraine attacks.
Newly released data from the phase 3 CENTURION study revealed that treatment with lasmiditan (Reyvow; Eli Lilly) met the co-primary end points and achieved superior pain freedom at 2 hours post-treatment compared to those taking placebo in at least 2 out of 3 migraine attacks.
Patients within the study who received doses of 200-mg lasmiditan had 7.2 times greater odds of achieving pain freedom at 2 hours in at least 2 of 3 migraine attacks than those on placebo (24.4% vs 4.3%; odds ratio [OR], 7.2; P <.001). Those in the 100-mg lasmiditan dose group had 3.8 times greater odds than study participants on placebo (14.4% vs 4.3%; P <.001). As a result, the co-primary end points translated to therapeutic gains, or differences between lasmiditan and placebo groups of approximately 10% to 20%.
Results of the study were presented virtually by study investigator Messoud Ashina, MD, PhD, DMSc, professor of neurology, Danish Headache Center, department of neurology, University of Copenhagen, and Uwe Reuter, MD, PhD, professor of neurology, Charite University Hospital of Berlin, at the 18th Migraine Trust International Symposium (MTIS), October 11, 2020.
"Healthcare professionals, advocacy groups and people with migraine have made it clear that one of the most important things they want from an acute treatment is consistent efficacy during the first and subsequent attacks," Mark Mintun, MD, vice president of pain and neurodegeneration, Eli Lilly, said in a statement. "Not being able to rely on their migraine treatment causes frustration and disappointment when their medicine doesn't work consistently.”
In total, 66.7% and 62.3% of patients in the lasmiditan 200- and 100-mg groups achieved pain relief at 2 hours in at least 2 of 3 attacks, respectively, compared to 36.9% of those on placebo (P <.001). Pain freedom and pain relief, respectively, were defined as reduction of pain at baseline to no pain, and headache pain that reduced mild or resolved completely.
Safety findings reported from the study were consistent with previous lasmiditan trials. Dizziness, paresthesia, fatigue, nausea, vertigo, somnolence, hypoesthesia, muscle weakness, asthenia, and feeling abnormal were among the most frequent treatment-emergent adverse events (TEAEs) observed over all 4 attacks in the study. TEAE incidence was noticeably highest during the first attack.
A subgroup of patients with prior triptan history showed similar effects with treatment with lasmiditan. Nearly 2 out of every 3 persons taking lasmiditan 200-mg (62.7%) and more than half of the participants taking 100-mg (55.6%) achieved pain relief at 2 hours in at least 2 of 3 migraine attacks compared to 1 out of every 3 patients (33.6%) on placebo (P <.001).
"These latest findings are encouraging news for patients and their healthcare providers when discussing personalized treatment goals such as consistency of response. Migraine attacks can be debilitating so it's imperative patients have acute treatment options that can help them achieve the outcomes that matter to them," Ashina said in a statement.
CENTURION assessed the efficacy and safety of lasmiditan in 1471 people with migraine. Study participants treated a migraine attack when their pain was at least of moderate severity and within 4 hours of pain onset. Patients recorded results into an electronic diary at 30 and 60 minutes, as well as 2, 4, 6, 24 and 48 hours after dosing.
Lasmiditan, an oral, selective serotonin 5-HT1F agonist, was FDA-approved for the acute treatment of migraine with or without aura in adults in October 2019. With the approval, lasmiditan became the first and only FDA-approved ditan.
Ilya Yuffa, president of Lilly BioMedicines, concluded in a statement, “We are delighted that REYVOW demonstrated consistent and superior efficacy across multiple migraine attacks compared to placebo. These are meaningful insights for patients and their healthcare providers, and we look forward to sharing the findings with health regulatory authorities in Europe, Japan and China.”