Poster Number-12 - Treatment Effects of Celecoxib Oral Solution in Migraine With Aura and Without Aura: Post-Hoc Analysis of Results From Two Randomized, Double-Blind Placebo-Controlled Trials

Treatment Effects of Celecoxib Oral Solution in Migraine With Aura and Without Aura: Post-Hoc Analysis of Results From Two Randomized, Double-Blind Placebo-Controlled Trials

Purpose:

Some acute treatments, including sumatriptan, work less well for migraine with aura than for migraine without aura. Celecoxib oral solution (Elyxyb) is a liquid formulation of the cyclooxygenase-2-selective nonsteroidal anti-inflammatory drug indicated for the acute treatment of migraine in adults. In previous research, celecoxib oral solution had a shorter T_max than oral tablets, and a single 120 mg dose was more effective than placebo for the acute treatment of migraine. The objective of this post-hoc analysis was to use pooled data from 2 randomized, double-blind, placebo-controlled trials (NCT03009019; NCT03006276) to compare efficacy of celecoxib oral solution 120 mg with placebo in acute treatment of migraine with and without aura.

Methods:

This was a post-hoc analysis of pooled data from 2 randomized, double-blind, placebo-controlled trials in which adults with migraine treated a single migraine attack of moderate or severe intensity with celecoxib oral solution 120 mg/4.8 mL or an identical placebo. Eligible subjects took a dose of study medication and had a 2-hour assessment for either pain or associated symptoms (ie, nausea, photophobia, phonophobia). Efficacy endpoints included pain freedom, freedom from most bothersome symptom (MBS), and pain relief at 2 hours postdose. Separate regression models were fit to the data for each endpoint to evaluate if treatment efficacy differed across aura subgroups (history of aura vs no history of aura) as tested by a treatment-by-aura interaction.

Results:

The study population (N=1075) had a mean age of 44.5 years; 86.4% of subjects were female. As the Table shows, the analysis groups were demographically balanced at baseline. At 2 hours postdose, celecoxib oral solution 120 mg was more effective than placebo for pain freedom in subjects with aura (31% vs 21%, P< .001) and without aura (36% vs 25%, P< .001); freedom from MBS in subjects with aura (58% vs 44%, P< .001) and without aura (57% vs 43%, P< .001); and pain relief in subjects with aura (68% vs 56%, P< .001) and without aura (74% vs 61%, P< .001). None of the treatment-by-aura interaction terms were significant, reflecting treatment efficacy in both aura subgroups.

Conclusion: Pooled data from 2 randomized, double-blind, placebo-controlled trials indicate that celecoxib oral solution 120 mg was more effective than placebo whether subjects treating attacks in trial had a history of aura or not. Interaction models suggest that the magnitude of the treatment effect relative to placebo did not differ by aura status.

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