For patients with migraine, the therapeutic gain for 2-hour pain freedom is an important outcome to assess efficacy of novel acute migraine therapies, including lasmiditan, ubrogepant and rimegepant, according to a letter to the editor published in Headache.

There are 3 newly approved acute treatments for migraine, lasmiditan, ubrogepant, and rimegepant. However, there are no head-to-head data to comparing their relative efficacy. In previous studies, ubrogepant and rimegepant showed a late benefit, in the 3- to 8-hours post-dose period. However, the US Food and Drug Administration and the International Headache Society Clinical Trials Standing Committee support assessing efficacy of acute therapies for migraine at 2 hours post-dose. Therefore, it is important to assess the impact of lasmiditan, ubrogepant and rimegepant at and beyond 2 hours.

At 2 hours post-dose, the therapeutic gain, defined as difference between active and placebo groups in percent of patients pain free, was 15-21% (depending on dose) with lasmiditan, 8-10% with ubrogepant, and 7% with rimegepant. After 2 hours, the efficacy of the 3 medications was similar.

These analyses had several limitations, including post-hoc design to assess the late effects of the medications, inability to perform a meta-analysis, and lack of data on drug safety.


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“In the evaluation of the clinical and economic value of acute treatment for migraine, more emphasis should be placed on rapid and complete pain freedom,” wrote the authors of the editorial.  

Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.

Reference

Doty EG, Krege JH, Pohl G, Case M, Dowsett SA, Tepper SJ. Pain freedom at 2 to 8 hours with lasmiditan: A comparison with rimegepant and ubrogpant. Published online July 20, 2020. Headache. doi:10.1111/head.13899