A close association of freedom from pain, migraine-related functional disability, and other outcomes: results of a post hoc analysis of randomized lasmiditan studies SAMURAI and SPARTAN

Abstract

Background While pain freedom at 2\u2009h is a key primary outcome for current trials for acute treatment of migraine, the relationship between the degree of head pain and other efficacy measures at 2\u2009h has rarely been explored. Following lasmiditan treatment of a migraine attack with moderate or severe head pain, we contrast those who achieve pain freedom with those who achieve mild pain but not pain freedom 2\u2009h post dosing. Methods Patient-level data were pooled across studies and treatment arms from two Phase 3 trials comparing lasmiditan and placebo, SAMURAI and SPARTAN. This post hoc analysis assessed freedom from the most bothersome symptom (MBS), freedom from migraine-related functional disability (disability), and improved patient global impression of change (PGIC) in patients who achieved 2\u2009h pain freedom compared to those who experienced 2\u2009h mild pain. Mild pain differs from pain relief which is defined as either mild pain or pain freedom. Results Patients who achieved 2\u2009h pain freedom ( N \xa0=\u2009913), in comparison with those with 2\u2009h mild pain ( N \xa0=\u2009864), were significantly more likely to experience MBS freedom (91.9% vs. 44.9%), disability freedom (87.1% and 13.4%), and improved PGIC (86.5% and 31.5%) ( p \xa0<\u20090.001 for all combinations). In addition, more patients who were pain free experienced both 2\u2009h MBS freedom and 2\u2009h functional disability freedom (83.6%) compared to those with mild pain (10.8%; p \xa0<\u20090.001). The proportion of patients with pain freedom who did not achieve either MBS or disability freedom (4.6%) was lower than in patients with mild pain (52.4%). Lastly, 55.2% of patients experienced mild pain before disability freedom compared to 72.1% who experienced pain freedom and disability freedom at the same time. Conclusions This study demonstrated that, at 2\u2009h post treatment, patients who were pain free were more likely to achieve other outcomes including freedom from their MBS, freedom from migraine-related functional disability, and improved PGIC compared to those with mild pain, confirming that 2\u2009h pain freedom is more robustly associated with other clinical outcomes than the 2\u2009h mild pain endpoint. Trial Registration SAMURAI ( NCT02439320 ); SPARTAN ( NCT02605174 ).