Assessing the comparative efficacy of INP104 for acute treatment of migraine attacks: a matching-adjusted indirect comparison
posted in Presentations by Brooke Eger
Poster presented at the 2021 American Headache Society (AHS) Virtual Annual Scientific Meeting.
Authors: Shivang Joshi, Sheena Aurora, Sisi Wang, Julie Park, Ping Wu, Sam Keeping, Stephanie Bariahtaris, Steve Shrewsbury
One Sentence Summary:
A matching-adjusted indirect comparison (MAIC) was conducted to estimate the comparative clinical outcomes of INP104, a drug-device combination of dihydroergotamine mesylate, versus gepants and DHE nasal spray.
INP104, a drug-device combination of dihydroergotamine mesylate (DHE 1.45mg) administered to the upper nasal space using Precision Olfactory Delivery technology, was evaluated in the STOP 301 open-label safety study for the acute treatment of migraine.
The MAIC is a standard health economic technique using individual patient-level data to produce reliable comparisons among treatments when a common treatment intervention is not available but the trials have similar patient populations and design. We aimed to estimate the comparative clinical outcomes of INP104 versus gepants and DHE nasal spray via MAIC for pain-related and non-pain related endpoints.The analysis included individual patient data from the STOP 301 study and published aggregate data from comparator trials identified from a systematic literature review (SLR). Weights for patients in STOP 301 were estimated from a propensity score model to match key prognostic factors from the comparator trials, then pairwise comparisons were conducted using the balanced populations.
The SLR identified 15 unique randomized controlled trials that assessed rimegepant, ubrogepant and DHE nasal spray 4 mg/mL. The MAIC showed INP104 improved pain-related outcomes relative to the gepants, with significantly higher rates of pain freedom (PF) at 2 hours (rimegepant OR: 1.81 [95%CI: 1.37-2.41]; ubrogepant OR: 1.92 [95%CI: 1.43-2.59]), sustained PF from 2 to 48 hours (rimegepant OR: 2.53 [95%CI: 1.86-3.44]; ubrogepant OR: 2.00 [95%CI: 1.22-3.26]). Similar findings were seen for symptom-related outcomes, with INP104 showing higher rates of freedom from most bothersome symptom at 2 hours (rimegepant OR: 1.93 [95%CI: 1.52-2.45]; ubrogepant OR: 1.83 [95%CI: 1.42-2.35]). Only 1 of the 3 DHE nasal spray studies reported PF, and none reported sustained pain- or most bothersome symptom-freedom; pain relief at 2 hours and nausea did not show statistically significant differences. Safety outcomes from the comparator trials observed either a single migraine or two migraines confounding the ability to make adequate comparisons to the STOP 301 study across multiple attacks over 24 and 52 weeks.
INP104 was associated with greater reductions in pain and other migraine-related symptoms in an indirect comparison with gepants.
Joshi S, Aurora S, Wang S, Park J, Wu P, Keeping S, Bariahtaris S, Shrewsbury S, Assessing the comparative efficacy of INP104 for acute treatment of migraine attacks: a matching-adjusted indirect comparison, 2021 American Headache Society (AHS) Virtual Annual Scientific Meeting.