FRI0286 IXEKIZUMAB TREATMENT IMPROVES FATIGUE, SPINAL PAIN, STIFFNESS, AND SLEEP IN PATIENTS WITH NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS

Abstract

Background:Common symptoms of axial spondyloarthritis (axSpA) include fatigue, spinal pain, stiffness, and sleep problems, which can impair health-related quality of life. Ixekizumab (IXE) treatment shows efficacy in active non-radiographic axSpA (nr-axSpA).1Objectives:To assess fatigue, spinal pain, stiffness, and sleep with IXE treatment versus (vs) placebo (PBO) in patients (pts) with active nr-axSpA up to 16 and 52 weeks (wks).Methods:In COAST-X, pts with active nr-axSpA were randomized to 52 wks of double-blind IXE 80 mg once every 4 wks (Q4W) or 2 wks (Q2W), or PBO. Data were collected from baseline to Wk 52.Results:At Wk 16, IXE Q4W significantly improved fatigue, spinal pain, and stiffness, and IXE Q2W improved spinal pain, spinal pain at night, and stiffness vs PBO (Table). At Wk 52, IXE Q4W significantly improved stiffness, and IXE Q2W improved spinal pain, spinal pain at night, and stiffness vs PBO. Numeric improvements in sleep were not significant vs PBO. Wk 1, and up to Wk 16, IXE Q4W and Q2W significantly reduced spinal pain and stiffness vs PBO; stiffness was significantly reduced vs PBO up to Wk 52 (Figure).Least squares mean (standard error) change from BL-ITT population (mixed-effect model of repeated measures)MeasureTimepointPBO N=105IXE Q4W N=96IXE Q2W N=102Spinal painaWk 16-1.45 (0.244)-2.35 (0.248)*-2.59 (0.244)†Wk 52-2.29 (0.350)-2.92 (0.305)-3.32 (0.304)*Spinal pain at nightaWk 16-1.71 (0.262)-2.43 (0.267)-2.79 (0.263)*Wk 52-2.25 (0.358)-3.04 (0.312)-3.58 (0.311)*BASDAI-stiffnessb,cWk 16-1.44 (0.242)-2.44 (0.246)*-2.89 (0.242)†Wk 52-1.94 (0.332)-3.15 (0.290)*-3.48 (0.289)†Fatigue severity NRSdWk 16-1.4 (0.24)-2.1 (0.24)*-1.9 (0.24)Wk 52-2.1 (0.38)-2.6 (0.32)-2.7 (0.32)Sleep disturbanceeWk 16-2.3 (0.45)-2.0 (0.45)-2.5 (0.45)Wk 52-2.9 (0.63)-3.6 (0.52)-3.6 (0.53)Pt Global Assessment of Disease ActivityfWk 16-1.30 (0.246)-2.32 (0.251)*-2.64 (0.247)†Wk 52-1.81 (0.378)-2.77 (0.320)-3.30 (0.321)**P<.05 vs PBO;†P≤.001 vs PBO. ITT population: all randomized pts. Pts needing rescue treatment after Wk 16 per investigator could switch to open-label IXE Q2W; observations at visits thereafter not included in analyses. BL values similar across treatments. Numerical improvements in BASDAI-fatigue not significant vs PBO.aScored 0 (no pain) to 10 (most severe pain) on NRSbMean score BASDAI questions 5 (intensity) and 6 (duration)cScored 1–10 on NRSdScored 0 (no fatigue) to 10 (as bad as you can imagine)eJenkins Sleep Evaluation Questionnaire scored 0 to 20: each of 4 items scored 0 (0 days) to 5 (22–30 days)fScored 0 (not active) to 10 (very active) on NRSBASDAI=Bath Ankylosing Spondylitis Disease Activity IndexBL=baselineITT=intent-to-treatIXE=ixekizumabN=number of pts in ITT populationNRS= numeric rating scalePBO=placebopt=patientQ2W=every 2 wksQ4W=every 4 wksvs=versuswk=weekConclusion:IXE Q4W and/or Q2W significantly improved spinal pain, spinal pain at night, and stiffness vs PBO at 16 and 52 wks in pts with nr-axSpA. IXE Q4W also improved fatigue at 16 wks in these pts. Numerical improvements in sleep were not significant vs PBO.