Real-world assessment of concomitant migraine medication use in patients using INP104 (Trudhesa®) in the United States

This was a retrospective, longitudinal, observational study based on medical and pharmacy claims from the STATinMED database. Eligible patients had a diagnosis of migraine during the study period; ≥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 date. 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 date (does not include index date) and follow-up period was 12 months after and including the index date. A total of 5,661,120 patients had at least 1 migraine diagnosis and 2,994 patients had ≥1 pharmacy claim for INP104 use. Preliminary results for the 90-day follow-up period are reported here.

Results: 1,484 patients met eligibility criteria. During baseline, 49.7% of patients used a migraine preventive medication (32.2% gepants; 24.5% anticonvulsants; 18.4% beta-blockers; 15% CGRP mAbs; 11.7% topiramate; 11.5% SSRIs). During follow-up with INP104, 42.5% used a concomitant migraine preventive medication (23.3% gepants, 17.9% anticonvulsants, 9.8% beta-blockers, 14.9% CGRP mAbs, 6.8% topiramate, and 8.3% SSRIs). During baseline, acute migraine medication use was as follows: 32.2% gepants; 28.4% NSAIDs; 21.5% triptans; 18.4% opioids; 5.0% ditan; 4.7% barbiturate; 2.0% acetaminophen. During follow-up, acute migraine medication use was as follows: 23.3% gepants; 15.4% NSAIDs; 9.9% triptans; 8.1% opioids; 2.6% ditan; 3.1% barbiturates; 0.39% acetaminophen.

Conclusions: Real-world evidence in patients with migraine suggests a treatment gap remains with approximately half of patients not receiving appropriate preventive medication. Most patients were not using DHE prior to INP104 use. Following INP104 use, concomitant preventive (with the exception of the CGRP mAb 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. Since this study is preliminary and based on claims data, clinical relevance is to be further elucidated.

References: 1. Smith TR, et al. Headache. 2021; 61(8):1214-1226.
2. TRUDHESA®. Package insert. Impel Pharmaceuticals; 2021.
3. Grant J, et al. Presented at: AHS; June 9-12, 2022; Denver, CO, USA.