CONSISTENT EFFICACY OF ONCE-NIGHTLY SODIUM OXYBATE ACROSS PATIENT DEMOGRAPHIC AND BASELINE DISEASE CHARACTERISTICS
Recommended Citation
Thorpy MJ, Roth T, Kushida C, Morse AM, Harsh J, Ortiz LE, Gudeman J, Dauvilliers Y. CONSISTENT EFFICACY OF ONCE-NIGHTLY SODIUM OXYBATE ACROSS PATIENT DEMOGRAPHIC AND BASELINE DISEASE CHARACTERISTICS. Sleep 2024; 47:A268.
Document Type
Conference Proceeding
Publication Date
5-1-2024
Publication Title
Sleep
Abstract
Introduction: Once-nightly sodium oxybate (ON-SXB; LUMRYZ™) was investigated in patients with narcolepsy type 1 (NT1) or 2 (NT2) in the phase 3 REST-ON trial; treatment with 6, 7.5, and 9 g demonstrated significant improvements vs placebo (all P< 0.001) for the coprimary endpoints of change from baseline in mean sleep latency on the Maintenance of Wakefulness Test (MWT), Clinical Global Impression-Improvement (CGI-I) rating, and weekly number of cataplexy episodes (NCA), and the secondary endpoint Epworth Sleepiness Scale (ESS) score. This post-hoc analysis assessed ON-SXB efficacy in various subgroups. Methods: REST-ON (NCT02720744) participants aged ≥16 years with NT1 or NT2 were randomized 1:1 to ON-SXB (4.5 g, 1 week; 6 g, 2 weeks; 7.5 g, 5 weeks; 9 g, 5 weeks) or placebo for 13 weeks. Least squares mean differences (LSMDs) in changes from baseline for ON-SXB vs placebo for mean sleep latency on MWT, NCA (NT1 only), and ESS, and odds ratios for much / very much improved on CGI-I, were compared among baseline demographic (age, sex, race, body mass index [BMI] category) and narcolepsy disease characteristic (NT1/NT2; concomitant alerting agent use) subgroups. Results: The modified intent-to-treat population included 190 participants (ON-SXB, n=97; placebo, n=93). LSMDs for ON-SXB 9 g vs placebo in change from baseline on the MWT at week 13 revealed significant improvements (P< 0.05) for subgroups based on age, sex, race, BMI, narcolepsy type, and alerting agent/no alerting agent use. Odds ratios were significant in favor of ON-SXB 9 g vs placebo for much or very much improved on CGI-I at week 13 (P< 0.05) for both low/high age, female sex, white/non-white, high BMI, NT1, and alerting agent/no alerting agent use. LSMDs were significant in favor of ON-SXB 9 g vs placebo for change from baseline in NCA (P< 0.05) in all subgroups, except non-white and male. For the ESS, all subgroups exhibited significant improvements (P< 0.05) with ON-SXB 9 g vs placebo, except NT2. Comparable differences were found with the 6-g dose at Week 3 and the 7.5-g dose at Week 8. Conclusion: Post-hoc subgroup analyses demonstrate the robust efficacy of ON-SXB across demographic and clinical subgroups.
Volume
47
First Page
A268
