Lasmiditan efficacy in migraine attacks with mild vs. moderate or severe pain

Abstract

Objective

To evaluate the efficacy of lasmiditan (LTN) in treating migraine attacks of mild vs. moderate or severe pain intensity.

Methods

Pooled data from two single-attack, placebo-controlled studies (SAMURAI [NCT02439320] and SPARTAN [NCT02605174]), and a prospective, randomized, open-label study (GLADIATOR [NCT02565186]) were assessed. Efficacy measures included the proportion of attacks with 2-h pain freedom (PF), 2-h most bothersome symptom (MBS) freedom, and 24-h sustained pain freedom (SPF). Fisher’s exact test was used to compare the proportion of PF, SPF, or MBS freedom outcomes among attacks treated at mild, moderate, or severe pain.

Results

In SAMURAI and SPARTAN, most treated attacks were of moderate (N = 2768) or severe (N = 1147) intensity, compared to mild (N = 65). Numerically greater 2-h PF and 24-h SPF response rates were observed in attacks treated at mild compared to moderate or severe pain. Analysis of GLADIATOR data included 273 (1.5%), 11,644 (65.1%), and 5948 (33.3%) attacks treated when pain was mild, moderate, and severe, respectively. In general, a significantly greater proportion of attacks treated at mild pain achieved 2-h PF and MBS freedom, as well as 24-h SPF. The incidence of treatment-emergent adverse events in LTN treatment groups were similar regardless of baseline head pain intensity.

Conclusions

Data from two placebo-controlled, single-attack trials, and an open-label study including treatment of multiple attacks, suggested a tendency to relatively better efficacy outcomes when LTN treatment was initiated at mild vs. moderate to severe pain. Further research is needed to better understand the relationship of lasmiditan outcomes to the time of administration in the course of a migraine attack.

Keywords:

• Lasmiditan
• migraine attack
• intensity

TRIAL REGISTRATION:

• NCT02439320
• NCT02605174
• NCT02565186

Transparency

Declaration of funding

This work was funded by Eli Lilly and Company. Medical writing support was provided by Shannon E. Gardell, PhD, of Evidera/PPD and was funded by Eli Lilly and Company.

Declaration of financial/other relationships

MFPP has been an advisory board member, and/or speaker, and/or consultant for Allergan, Eurofarma, Libbs, Lilly, Pfizer, Sanofi, Teva, and Novartis. MFPP serves on the editorial board for Headache Medicine (Editor), Arquivos de Neuro-Psiquiatria (editorial board), and Journal of Headache and Pain (editorial board). RV, SKB, and MV are employees and stockholders of Eli Lilly and Company. EBD is an employee and stockholder of Eli Lilly and Company and adjunct faculty at Purdue University. DIF reports advisory board fees from Amgen/Novartis, Biohaven Pharmaceuticals, electroCore, Lilly, Impel, Invex, Lundbeck, Revance, Satsuma, Teva, Theranica, and Zosano; grant support (clinical trial) from Allergan, Eli Lilly, and Zosano; grant support (investigator-initiated) from Merck; and consultant fees from electroCore. DIF serves on the editorial board for Neurology Reviews, medical advisory board for Spinal CSF Leak Foundation and HealthyWomen and is a contributing author to MedLink Neurology. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgements

The authors thank the study participants and investigators who participated in the lasmiditan studies.

Notes

i SAS Institute, Cary, NC, USA.