The efficacy of lasmiditan is similar across subgroups of patients, including those typically considered difficult to treat, according to study results published in Headache.

In a post hoc analysis of data from the phase 3 SAMURAI and SPARTAN trials (ClinicalTrials.gov identifiers: NCT02439320 and NCT02605174), investigators aimed to determine the patient and disease characteristics associated with response to lasmiditan.

Data from 3981 trial participants (84.3% women; 79.3% white) were analyzed. Patients had been randomized to receive 50 mg lasmiditan (n=598), 100 mg lasmiditan (n=1133), 200 mg lasmiditan (n=1120), or placebo (n=1130).

Outcomes of interest included headache pain freedom or freedom from the most bothersome symptom at 2 hours after treatment.


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Headache pain freedom was achieved by 28.3% of study participants receiving 50 mg lasmiditan (odds ratio [OR], 1.57; 95% CI, 1.23-2.00; P <.001), 29.7% in those receiving 100 mg lasmiditan (OR, 1.90; 95% CI, 1.56-2.32; P <.001), and 35.4% in those receiving 250 mg lasmiditan (OR, 2.46; 95% CI, 2.03-3.00; P <.001) compared with 18.2% of patients in the placebo group.

No baseline patient characteristics were predictive of headache pain freedom across all dose groups. A modest difference in response was observed between men and women (P =.03). This appeared to be primarily driven by a lower response to treatment in men receiving the 50 mg dose of lasmiditan. Sex was not predictive of headache pain freedom at any other dose. No migraine disease characteristics were predictive of headache pain freedom either.

Freedom from the most bothersome symptom was achieved in 40.7% of study participants receiving 50 mg lasmiditan (OR, 1.35; 95% CI, 1.08-1.69; P =.004), 43.0% in of study participants receiving 100 mg lasmiditan (OR, 1.63; 95% CI, 1.36-1.94; P <.001), and 44.3% of study participants receiving 250 mg lasmiditan (OR, 1.72; 95% CI, 1.44-2.06; P <.001) compared with 31.6% of patients in the placebo group.

White race was the only patient or disease characteristic found to be predictive for freedom from most bothersome symptom at 2 hours (P =.016). This difference was largely driven by a high placebo response rate in non-white patients.

The efficacy of lasmiditan was also evaluated in various difficult-to-treat patient subgroups. Compared with placebo, lasmiditan improved rates of headache pain freedom and freedom from most bothersome symptom at 100- and 200-mg doses in patients with severe headache or nausea at the time of treatment, as well as in those who waited ≥2 hours to initiate treatment.

All doses of lasmiditan effectively achieve headache pain freedom in patients with rapidly escalating attack compared with placebo. Freedom from the most bothersome symptom was achieved at the 100 and 200 mg doses of lasmiditan. Lasmiditan efficacy was reduced in the group of patients who rated their functional disability as “needs complete bed rest”.

 The researchers noted that the small sample size of certain subgroups, including geriatric patients and men, may have limited the identification of predictors of response in these groups.

“[T]he efficacy of lasmiditan at 2 hours following a single dose was similar for subgroups of patients defined by baseline demographics, migraine disease characteristics, and migraine attack characteristics,” the study authors concluded. “Furthermore, treatment effects of lasmiditan 100 or 200 mg were seen for the primary endpoints in most subgroup analyses, suggesting that lasmiditan may be an effective alternative for the types of migraine headache that are historically referred to as ‘difficult-to-treat’.”

Disclosures: This research was funded by Eli Lilly and Company. Several authors reported affiliations with the pharmaceutical industry. Please see the original reference for a full list of disclosures.

Reference

Tepper SJ, Vasudeva R, Krege JH, et al. Evaluation of 2-hour post-dose efficacy of lasmiditan for the acute treatment of difficult-to-treat migraine attacks [published online July 7, 2020]. Headache. doi:10.1111/head.13897