Poster Number-14 - Efficacy of Celecoxib Oral Solution in Adults With and Without Baseline Nausea: Post-Hoc Analysis of Results From Two Randomized, Double-Blind Placebo-Controlled Trials in the Acute Treatment of Migraine

Efficacy of Celecoxib Oral Solution in Adults With and Without Baseline Nausea: Post-Hoc Analysis of Results From Two Randomized, Double-Blind Placebo-Controlled Trials in the Acute Treatment of Migraine

Purpose:

In adults with migraine, nausea can influence timing and likelihood of oral medication use, as well as the probability of a positive outcome, in acute treatment of migraine. 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. In this post-hoc analysis, we pooled data from 2 randomized, double-blind, placebo-controlled trials (NCT03009019; NCT03006276) to compare efficacy of celecoxib oral solution 120 mg with placebo in the acute treatment of migraine attacks with and without nausea at baseline.

Methods:

We 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. Efficacy endpoints at 2 hours postdose included pain freedom, freedom from the most bothersome symptom, and pain relief. The population was stratified by the presence or absence of nausea at baseline. Separate regression models were fit to the data for each endpoint to evaluate if treatment efficacy differed across nausea subgroups (nausea at baseline vs no nausea at baseline) as tested by a treatment-by-nausea interaction. In addition, a regression model was fit to subjects with no nausea at baseline to evaluate treatment-emergent nausea at 2 hours postdose.

Results: The study population (N=1075) had a mean age of 40.5 years; 86.4% of subjects were female. The analysis groups were demographically balanced at baseline (Table). Nausea was present in 20.2% (111/550) of subjects treated with celecoxib oral solution and 19.6% (103/525) of subjects treated with placebo. At 2 hours postdose, celecoxib oral solution 120 mg was superior to placebo for pain freedom in subjects with baseline nausea (22% vs 15%, P< .001) and without baseline nausea (37% vs 25%, P< .001); freedom from the most bothersome symptom in subjects with baseline nausea (53% vs 40%, P< .001) and without baseline nausea (59% vs 44%, P< .001); and pain relief in subjects with baseline nausea (63% vs 51%, P< .001) and without baseline nausea (74%% vs 60%, P< .001). Across all 3 regression models, none of the treatment-by-nausea interaction terms was significant, reflecting treatment efficacy in both nausea subgroups. Among subjects without nausea at baseline, the incidence of treatment-emergent nausea at 2 hours postdose was numerically higher with placebo than celecoxib oral solution, but the difference was not statistically significant (32.3% vs 23.7%, P=.065).

Conclusion:

Celecoxib oral solution 120 mg was equally effective on pain freedom, freedom from the most bothersome symptom, and pain relief at 2 hours postdose in patients with or without nausea at baseline. Celecoxib oral solution did not cause treatment-emergent nausea, and a nonsignificant trend suggested that it may prevent treatment-emergent nausea.

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