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. 2021 Sep 25;5(1):50.
doi: 10.1186/s41927-021-00218-y.

Ixekizumab improves sleep and work productivity in patients with non-radiographic axial spondyloarthritis: results from the COAST-X trial at 52 weeks

Atul Deodhar  1 , Philip Mease  2 , Helena Marzo-Ortega  3 , Theresa Hunter  4 , David Sandoval  4 , Andris Kronbergs  4 , Steven Lauzon  4 , Ann Leung  5 , Victoria Navarro-Compán  6
Affiliations

Ixekizumab improves sleep and work productivity in patients with non-radiographic axial spondyloarthritis: results from the COAST-X trial at 52 weeks

Atul Deodhar et al. BMC Rheumatol. .

Abstract

Background: Patients with non-radiographic axial spondyloarthritis experience negative impacts on sleep, work productivity, and activity impairment. Ixekizumab, a monoclonal antibody selectively targeting interleukin-17A, has shown efficacy in treating the signs and symptoms of non-radiographic axial spondyloarthritis. This analysis evaluated the effect of ixekizumab treatment on sleep, work productivity, and activity impairment in patients with non-radiographic axial spondyloarthritis.

Methods: COAST-X ( NCT02757352 ) was a 52-week, phase 3, multicenter, randomised placebo-controlled trial evaluating 80-mg ixekizumab every 2 weeks and every 4 weeks in patients with active non-radiographic axial spondyloarthritis. Sleep disturbance was measured with the Jenkins Sleep Evaluation Questionnaire (JSEQ) and analysed using mixed-effects models for repeated measures. Work productivity and activity impairment were measured using the Work Productivity and Activity Impairment Questionnaire for Spondyloarthritis and analysed using analysis of covariance. Absenteeism, presenteeism, and overall work impairment were assessed for patients reporting paid work; activity impairment was assessed regardless of work status.

Results: Overall, patients treated with both dosing regimens of ixekizumab reported numerically greater improvements in sleep than placebo through Week 52. At Weeks 16 and 52, patients treated with ixekizumab every 4 weeks had significantly greater improvements in presenteeism (p = 0.007 and p = 0.003, respectively) and overall work impairment (p = 0.014 and p = 0.005, respectively) and numeric improvements in absenteeism than placebo. Patients treated with ixekizumab every 2 weeks had numerically greater improvements in absenteeism, presenteeism, and overall work impairment than placebo. Both dosing regimens of ixekizumab were associated with significantly greater improvements in activity impairment than placebo (ixekizumab every 4 weeks: p = 0.003 at Week 16 and p = 0.004 at Week 52; ixekizumab every 2 weeks: p = 0.007 at Week 16 and p = 0.006 at Week 52).

Conclusions: Treatment with ixekizumab improved sleep, work productivity, and activity impairment in patients with nr-axSpA. Improvements in presenteeism and overall work impairment were sustained and consistent in the patients treated with ixekizumab every 4 weeks from Week 16 to Week 52. Improvements in activity impairment were sustained and consistent in both ixekizumab-treated groups from Week 16 to Week 52.

Trial registration: NCT02757352 , May 2, 2016.

Keywords: Activity impairment; Ixekizumab; Non-radiographic axial spondyloarthritis; Sleep; Work productivity.

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Conflict of interest statement

AD has received consulting fees from and has served on the advisory boards of AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly and Company, Galapagos, Glaxo Smith & Kline, Janssen, Novartis, Pfizer, and UCB as well as receiving research grants from AbbVie, Eli Lilly, Glaxo Smith & Kline, Novartis, Pfizer, and UCB. PM has received research grants, consulting fees, and/or speaker fees from Abbvie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly and Company, Galapagos, Gilead, GlaxoSmithKline, Janssen, Novartis, Pfizer, SUN Pharma, and UCB. HMO has received grant or research support from Janssen and Novartis, has received consulting fees from AbbVie, Celgene, Janssen, Eli Lilly and Company, Novartis, Pfizer, and UCB, and has received speaker fees from AbbVie, Biogen, Celgene, Janssen, Eli Lilly and Company, Novartis, Pfizer, Takeda, and UCB. TH, DS, AK, and SL are employees and shareholders of Eli Lilly and Company. AL is an employee of Syneos Health, vendor of Eli Lilly and Company. Victoria Navarro-Compán has consulting fees, speaker fees, and research grants from Abbvie, Bristol Myers Squibb, Janssen, Eli Lilly and Company, MSD, Novartis, Pfizer, Roche, and UCB.

Figures

Fig. 1
Fig. 1
Changes from baseline in sleep as measured by the Jenkins Sleep Evaluation Questionnaire Values are LSM from MMRM. Week 8: PBO, Nx = 101; IXE Q4W, Nx = 95; IXE Q2W, Nx = 101. Week 16: PBO, Nx = 99; IXE Q4W, Nx = 96; IXE Q2W, Nx = 98. Week 36: PBO, Nx = 39; IXE Q4W, Nx = 56; IXE Q2W, Nx = 58. Week 52: PBO, Nx = 34; IXE Q4W, Nx = 53; IXE Q2W, Nx = 52. P values were from MMRM (treatment vs. placebo). * = p < 0.05, ‡ = p < 0.01, † = p < 0.001. IXE Q2W = 80-mg ixekizumab every 2 weeks; IXE Q4W = 80-mg ixekizumab every 4 weeks; IXE Q4W = 80-mg ixekizumab every 2 weeks; LSM = least squares mean; MMRM = mixed-effect model repeated measure; N = number of patients in the treatment group; Nx = number of patients with non-missing values; PBO = placebo
Fig. 2
Fig. 2
Changes from baseline in Work Productivity and Activity Index Spondyloarthritis A) Absenteeism, B) Presenteeism, C) Overall Work Impairment, and D) Activity Impairment at Weeks 16 and 52 Values are LSM (SE) from mBOCF ANCOVA. Absenteeism, presenteeism, and overall work impairment were measured in patients reporting part- or full-time work. Absenteeism at Week 16: PBO, Nx = 50; IXE Q4W, Nx = 50; IXE Q2W, Nx = 53. Absenteeism at Week 52: PBO, Nx = 52; IXE Q4W, Nx = 50; IXE Q2W, Nx = 55. Presenteeism and Overall Work Impairment at Week 16: PBO, Nx = 47; IXE Q4W, Nx = 46; IXE Q2W = 50. Presenteeism and Overall Work Impairment at Week 52: PBO, Nx = 49; IXE Q4W, Nx = 46; IXE Q2W, Nx = 52. Activity Impairment at Weeks 16 and 52: PBO, Nx = 101; IXE Q4W, Nx = 96; IXE Q2W, Nx = 101. P values were from ANCOVA (treatment vs. placebo). * = p < 0.05, ‡ = p < 0.01, † = p < 0.001. ANCOVA = analysis of covariance; IXE Q2W = 80-mg ixekizumab every 2 weeks; IXE Q4W = 80-mg ixekizumab every 4 weeks; IXE Q4W = 80-mg ixekizumab every 2 weeks; LSM = least squares mean; mBOCF = modified baseline observation carried forward; N = number of patients in the treatment group; Nx = number of patients with non-missing values; PBO = placebo
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