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P-085 - Efficacy of celecoxib oral solution in participants with insufficient response to triptans for the acute treatment of migraine: pooled results from a post-hoc analysis of 2 phase 3 randomized clinical trials

POSTER ABSTRACT
Location:  Exhibit Hall
Abstract Title: Efficacy of celecoxib oral solution in participants with insufficient response to triptans for the acute treatment of migraine: pooled results from a post-hoc analysis of 2 phase 3 randomized clinical trials


Background: Many patients with migraine who receive a prescription for sumatriptan or another serotonin 5-HT1B/1D receptor agonist (triptan) experience inadequate efficacy, relapse within 24 hours after the first dose, or treatment-emergent adverse events. If a second triptan is prescribed, migraine pain and disability typically do not improve. Celecoxib 120 mg oral solution (Elyxyb) is a liquid formulation of the cyclooxygenase-2-selective nonsteroidal anti-inflammatory drug in a unique self-microemulsifying drug delivery system for the acute treatment of migraine. Previously, the efficacy of celecoxib oral solution was demonstrated in two randomized, double-blind, placebo-controlled clinical trials.

Purpose/Objectives: The objective of this study was to compare the efficacy of celecoxib oral solution with placebo in participants based on their historical response to triptans.


Methods: This post hoc analysis was based on pooled data from 2 methodologically identical 2-period, randomized, double-blind, placebo-controlled clinical trials (NCT03006276; NCT03009019). Triptan insufficient response was defined on two criteria (poor response and recurrence) among participants reporting that a triptan was the primary medication used to treat migraine using participant-reported retrospective report in the trial CRF. Poor response was defined among participants reporting that at 2 hours postdose, headache pain was either not reduced at all or only slightly reduced, or headache pain was completely gone or significantly reduced, but only after 2 hours postdose. Recurrence was defined among participants reporting that they achieve pain freedom within 2 hours postdose but headache always or sometimes recurred within 24 hours. Participants satisfying either criterion were defined as triptan insufficient responders (effect group) and the complement were defined as triptan responders (reference group). Odds ratios for achieving 2-hour pain freedom and differences between the subgroups were obtained from logistic regression models. The first double-blind treatment period of both trials was analyzed. The efficacy endpoint of interest was pain freedom at 2 hours postdose.

Results: Demographics were similar among triptan insufficient responders and responders (Table). Among triptan insufficient responders, celecoxib 120 mg oral solution was more effective than placebo for 2-hour pain freedom (33.3% [33/99] vs 14.3% [12/84]), and the odds of achieving pain freedom were 200% greater with celecoxib 120 mg oral solution than with placebo (OR=3.0, p=0.0036). Among triptan responders, rates of 2-hour pain freedom were also higher for celecoxib 120 mg oral solution than for placebo (33.3% [13/39] vs 14.6% [6/41]), and the odds of achieving 2-hour pain freedom was 192% greater with celecoxib 120 mg oral solution than with placebo (OR=2.92, p=0.0548); the difference between the groups was nonsignificant due to the small sample size. There was no difference in the odds of achieving 2-hour pain freedom between the subgroups (OR=1.03, p=0.9666).

Conclusions/Implications for future research and/or clinical care: Participants treated with celecoxib oral solution 120 mg were more likely than those treated with placebo to achieve pain freedom at 2 hours postdose regardless of their historical response to triptans.

References: Lipton RB, Munjal S, Tepper SJ, Iaconangelo C, Serrano D. Journal of Pain Research 2021:14 2529–2542.
Lipton RB, Munjal S, Brand-Scheiber E, Tepper SJ, Dodick DW. Headache 2020;60:58-70.