Real-World Assessment of Baseline Demographic and Clinical Characteristics Among Patients Using INP104 in the United States

Presented at the AHS 65^th Annual Scientific Meeting, June 15-18, 2023, Austin, Texas

Authors: Gokani T, Nguyen L, Vann R, Gutierrez J, Ray S, Aurora S

One sentence summary: A longitudinal, retrospective database study in the United States that assessed the baseline characteristics and comorbidities of migraine patients who were treated with INP104 reports that most patients were female, were between the ages of 36 and 45 years, and had comorbidities that included headache syndromes other than migraine, other neurologic conditions, other pain disorders, sleep disorders, gastrointestinal disorders, and psychiatric disorders.

Background: INP104 is an approved acute therapy for adult migraine patients that is a combination of dihydroergotamine mesylate (DHE) and the Precision Olfactory Delivery (POD®) device, for nasal administration. Safety and exploratory efficacy data for INP104 have been published previously; therefore, real-world data are needed to understand the medication utilization patterns of patients with migraine who were treated with INP104.

Methods: This was a retrospective, longitudinal, observational study designed to assess demographic and clinical characteristics, identify baseline comorbidities and concomitant medication use, and assess treatment patterns among patients with migraine who were treated with INP104 based on medical and pharmacy claims in the United States from the STATinMED database. Eligible patients had a diagnosis of migraine during the study period spanning January 1, 2020, through October 31, 2022; ≥1 pharmacy claim for INP104 use during a patient identification period spanning October 1, 2021, through October 31, 2022; and continuous enrollment with both medical and pharmacy benefits for 12 months pre- and post-index period. Study objectives included analysis of baseline demographic and clinical characteristics, concomitant medication use, and key baseline comorbidities. The baseline period was defined as the 12 months prior to the index period (not including the index period).

Results: A total of 5,661,120 patients had at least 1 migraine diagnosis, with 2,994 patients having ≥1 pharmacy claim for INP104 use and 1,484 patients meeting eligibility criteria included in the final analysis. The majority of patients were female (87.9%), with a mean age (standard deviation [SD]) of 43.4 (11.8) years. Age distribution was 9.3% aged 18-25 years, 16.4% aged 26-35 years, 29.6% aged 36-45 years, 26.3% aged 46-54 years, 16.2% aged 55-64 years, and 2.2% aged ≥65 years. Regional distribution across the United States was 42.1% in the South, 26.8% in the Central North, 21.0% in the Northeast, and 10.2% in the West. The payer channel was mostly commercial (86.5%). The mean (SD) Charlson Comorbidity Index score was 0.31 (0.83). Baseline comorbidities included headache syndromes other than migraine (36.7%), other neurologic conditions (not including epilepsy or seizure, migraine, and other headache syndromes; 25.9%), other pain disorders (fibromyalgia, neck pain, and back pain; 24.8%), sleep disorders (18.8%), gastrointestinal (GI) disorders (15.9%), psychiatric disorders (depression, anxiety disorders, bipolar disorder, substance abuse, and post-traumatic stress disorder; 11.5%), autoimmune disorders (rheumatoid arthritis, hypothyroidism; 8.9%), obesity (8.2%), asthma (7.2%), epilepsy/seizures (5.6%), and cardiovascular diseases (stroke, myocardial infarction, angina; 0.7%).

Conclusion: Real-world evidence demonstrates that most patients with migraine treated with INP104 are female, are between the ages of 36 and 45 years, and have comorbidities that include headache syndromes other than migraine, other neurologic conditions, other pain disorders, sleep disorders, GI disorders, and psychiatric disorders. Unlike in other epidemiological studies, in this real-world patient population, GI comorbidities were more common than those in the psychiatric category.