80 - A close association of pain freedom with freedom from most bothersome symptom and from migraine-related functional disability in lasmiditan studies SAMURAI and SPARTAN
Li Shen Loo1, Richard Lipton2, Stewart Tepper3, Raghavendra Vasudeva1, Simin Baygani1, Eric Pearlman1, Paula Hauck1, John Krege1
1Eli Lilly and Company, Indianapolis, USA. 2Department of Neurology, Albert Einstein College of Medicine, Bronx, USA. 3Geisel School of Medicine at Dartmouth, Hanover, USA
Purpose Lasmiditan is a selective 5-hydroxytryptamine 1F receptor agonist for the acute treatment of migraine. Lasmiditan has been shown to be superior to placebo on freedom from pain and freedom from most-bothersome symptom (MBS) in 2 Phase 3 studies, SAMURAI (NCT02439320) and SPARTAN (NCT02605174). Methods This post-hoc analysis assessed whether the outcomes of pain freedom (reduction in pain severity from moderate or severe at baseline to none) or mild pain (reduction in pain severity from moderate or severe at baseline to mild were associated with the outcomes of MBS freedom or functional disability freedom in 2 hour pooled data from SAMURAI and SPARTAN (modified intent-to-treat population with moderate or severe pain, MBS and functional disability recorded at time of dosing). MBS freedom is defined as absence of the self-identified MBS [either nausea, phonophobia or photophobia]. Patients who recorded no symptoms present at time of dosing were excluded from the analysis. Functional disability was assessed with the question “How much is your migraine interfering with your normal activities.” Response options were “not at all” (functional disability freedom), “mild interference,” “marked interference,” “need complete bed rest.” Patients who recorded “Not at all” at time of dosing were excluded from the analysis. Patients treated with lasmiditan 200 mg with MBS and functional disability recorded at the time of dosing were assessed at 2 hours postdose. The coexistence of MBS freedom and functional disability freedom was examined in patients with pain freedom or mild pain. Results Patients with pain freedom (N=324) frequently also experienced MBS freedom (91.4%) and functional disability freedom (81.8%). In contrast, patients who experienced mild pain (N=220) showed lower rates of MBS freedom (45.0%; p=<0.001) and functional disability freedom (12.7%; p=<0.001) than pain-free patients In addition, more patients who were pain free experienced both MBS freedom and functional disability freedom (78.7%) compared to those with mild pain (10.0%; p=<0.001). Furthermore, 5.6% of patients experienced pain freedom without achieving MBS freedom or functional disability freedom compared with 52.3% of patients who experienced mild pain alone. Conclusions Achieving pain freedom with lasmiditan was frequently associated with MBS freedom and a return to normal activities.