Poster Number-13 - Consistency of Response to Liquid Celecoxib in Adults With Migraine: Post Hoc Analysis of Results From Two Randomized, Placebo-Controlled Studies

Consistency of Response to Liquid Celecoxib in Adults With Migraine: Post Hoc Analysis of Results From Two Randomized, Placebo-Controlled Studies

Purpose:

In the acute treatment of migraine, patients rate consistent efficacy among the most prized attributes of medication; inconsistent efficacy ranks among the most common reasons for dissatisfaction. Yet outcomes with oral formulations can be unpredictable, mainly due to variable absorption over multiple attacks. Celecoxib oral solution (Elyxyb) is an oral liquid formulation of the cyclooxygenase-2 (COX-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 the acute treatment of migraine. The objective of this post hoc analysis was to evaluate pooled data from 2 randomized, double-blind, placebo-controlled trials to compare the consistency of treatment response of celecoxib oral solution 120 mg with placebo in adults with migraine.

Methods:

This was a post-hoc analysis of pooled data from 2 randomized, double-blind, placebo-controlled trials in which adults with migraine completed 2 double-blind randomizations and treatment periods. During the first double-blind period, subjects used celecoxib oral solution to treat a single migraine attack as soon as they experienced moderate to severe headache pain intensity. Within 2 to 7 days of treating the first attack (ie, ≥48 hours of pain and symptom freedom), subjects who remained eligible were rerandomized into a second double-blind period and instructed to treat a single migraine attack of any headache pain intensity. The present analysis included randomized subjects who took ≥1 dose of study drug and had ≥1 postbaseline efficacy assessment for either pain or associated symptoms (ie, nausea, photophobia, phonophobia) in both double blind periods and who received study medication or placebo in both double-blind periods. Subjects who treated an attack with mild headache pain intensity in the second double-blind period were excluded. Efficacy endpoints included pain freedom, freedom from the most bothersome symptoms (MBS), and pain relief at 2 hours postdose. Consistent responders were defined as subjects who achieved treatment success in each of the 2 double-blind periods. A separate regression model was fit to the data for each endpoint. Risk rates (proportions) were presented and significance evaluated using relative risk models.

Results:

Altogether, 1253 subjects were randomized in the first double-blind period, and 1080 (86%) were independently rerandomized to celecoxib (n=521) or placebo (n=517) in the second double-blind period. Mean age was 40.7 years; 85.7% of subjects were female.  Rates of consistent endpoint achievement at 2 hours postdose between celecoxib oral solution 120 mg and placebo across pain freedom, MBS freedom, and pain relief were, respectively, 18% vs 11%, P=.016; 40% vs 32%, P=.033; and 54% vs 45%, P=.012.

Conclusion:

Across multiple attacks in adults with migraine, response to treatment with celecoxib oral solution was consistent on the clinically meaningful endpoints of pain freedom, freedom from the most bothersome symptom, and pain relief at 2 hours postdose.

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