Real-World Assessment of Concomitant Medication Use in Patients Using INP104 in the United States

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

Authors: Gill N, Ahmed Z, Vann R, Gutierrez J, Ray S, Aurora S

One sentence summary: A longitudinal, retrospective database study in the United States demonstrated that concomitant preventive and acute medication use generally decreased after patients initiated INP104 (dihydroergotamine mesylate and the Precision Olfactory Delivery device) over a 90-day period.

Background: INP104 is a drug-device combination product composed of dihydroergotamine mesylate (DHE) and the Precision Olfactory Delivery device administered nasally that was approved by the FDA in 2021 for the acute treatment of migraine in adults. Although Phase 3 data has been published previously on the safety and exploratory efficacy of INP104, an evaluation of treatment patterns associated with INP104 use is needed to better understand its impact on clinical utilization in a real-world setting.

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 in the United States who were treated with INP104 based on medical and pharmacy claims 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 reported here included analysis of baseline concomitant medication use among patients with migraine who were treated with INP104. The baseline period was the 12 months prior to the index period (not including the index period) and the follow-up period was 12 months after the index period (and including the index period). Preliminary results for the 90-day follow-up period are reported here.

Results: A total of 5,661,120 patients had at least 1 migraine diagnosis and 2,994 patients had ≥1 pharmacy claim for INP104 use. Of these, 1,484 patients met eligibility criteria in this analysis. During the 12-month baseline period, 49.7% of patients used a migraine preventive medication. Of those patients who used a preventive medication during the 12-month baseline period, 32.2% used a gepant (rimegepant or atogepant), 24.5% used an anticonvulsant, 18.4% used a beta-blocker, 15.0% used an anti-calcitonin gene-related peptide (CGRP) monoclonal antibody, 11.7% used topiramate, and 11.5% used a selective serotonin reuptake inhibitor (SSRI; <10% in each category). During the 90-day follow-up period with INP104 use, 42.5% used a concomitant migraine preventive medication. Of those patients who used a concomitant preventive medication with INP104 during the 90-day follow-up period, 23.3% used a gepant (rimegepant or atogepant), 17.9% used an anticonvulsant, 14.9% used an anti-CGRP monoclonal antibody, 9.8% used a beta-blocker, 8.3% used an SSRI, and 6.8% used topiramate. Among the patients who used an acute medication for migraine during the 12-month baseline period, 32.2% used a gepant (ubrogepant or rimegepant), 28.4% used a nonsteroidal anti-inflammatory drug (NSAID), 21.5% used a triptan, 18.4% used an opioid, 5.0% used a ditan, 4.7% used a barbiturate, 2.0% used acetaminophen, 0.7% used DHE or ergot derivative, and 0% used domperidone. During the 90-day follow-up period with INP104 use, 23.3% used a gepant (ubrogepant or rimegepant), 15.4% used an NSAID, 9.9% used a triptan, 8.1% used an opioid, 3.1% used a barbiturate, 2.6% used a ditan, 0.4% used acetaminophen, and 0% used domperidone as acute medications for migraine. During the 12-month baseline period, 23.0% of patients used an antinausea or antiemetic medication, which decreased to 9.9% during the 90-day follow-up period with INP104 use.

Conclusion: Real-world evidence in patients with migraine suggests a treatment gap may remain, with approximately half of patients not receiving appropriate preventive medication; however, the frequency and severity of migraine need to be considered to determine who is a good candidate for preventive therapy. Most patients were not using DHE prior to INP104 use. Following INP104 use, concomitant preventive (with the exception of the anti-CGRP monoclonal antibody class) and acute medication use generally decreased between the 12-month baseline and 90-day follow-up period, which suggests that INP104 may be an effective acute therapy for managing migraine. Importantly, an increase in antinausea medications was not observed following INP104 use, whereas these medications are commonly used with DHE administered intravenously. Since this study is preliminary and based on claims data, clinical relevance is to be further elucidated.