Session Type: Poster Session (Monday)
Session Time: 9:00AM-11:00AM
Background/Purpose: Pain, fatigue, morning stiffness and impaired sleep are some of the main symptoms contributing to reduced quality of life (QoL) in patients (pts) with non-radiographic axial spondyloarthritis (nr-axSpA).1 Additionally, pts who are poor sleepers have been shown to have higher disease activity, fatigue scores and nocturnal back pain.2 Certolizumab pegol (CZP) treatment has demonstrated improvements in multiple manifestations of nr-axSpA disease, including pt-reported outcomes (PROs) and QoL.3,4 We report PROs for nr-axSpA pts treated with CZP or placebo (PBO) from the C‑axSpAnd study – the first 52-week (Wk) PBO-controlled study to investigate the efficacy of an anti-TNF agent in a population with active nr-axSpA and objective signs of inflammation (elevated CRP and/or MRI positive).
Methods: C-axSpAnd (NCT02552212) is a 3-year, phase 3, multicenter study including a 52-Wk double-blind (DB), PBO-controlled period (completed); patients who had an inadequate response to ≥2 non-steroidal anti-inflammatory drugs were randomized 1:1 to PBO or CZP (400 mg at Wks 0/2/4, then 200 mg every 2 wks).3 Clinical PROs collected included: Sleep Problems Index scores I (6 items) and II (9 items) from the Medical Outcomes Study Sleep Scale (which assesses sleep disturbance, adequacy, somnolence, quantity, snoring, and awakening short of breath or with a headache),5 nocturnal spinal pain (numerical rating scale [NRS]), fatigue (BASDAI Q1), and morning stiffness (average of BASDAI Q5 and Q6). Post-hoc analyses of minimal clinically important differences (MCID [≥1-point improvement]) for fatigue and nocturnal spinal pain were conducted.6 Variables were analyzed using an ANCOVA model including baseline score as a covariate and fixed effects for treatment group, region and MRI/CRP classification. All p-values were nominal. Missing values or data at time points following the discontinuation of the DB study treatment were imputed using last observation carried forward.
Results: 317 pts with nr-axSpA were randomized to CZP (n=159) or PBO (n=158); 54 (34%) and 125 (79%) patients treated with PBO or CZP, respectively, completed Wk 52. Pts treated with CZP showed greater improvements (indicated by higher scores) in Sleep Problems Index II scores vs PBO-treated pts at Wk 12 (mean change from baseline: 4.8 [CZP] vs 2.2 [PBO]; p< 0.001). Improvements were also seen in other clinical PROs (Table). By Wk 12, greater proportions of pts treated with CZP vs PBO experienced at least a MCID response in fatigue (85.4% vs 57.6%, respectively) and nocturnal spinal pain (82.8% vs 58.9%, respectively); results were sustained through Wk 52.
Conclusion: Nr-axSpA patients treated with CZP showed substantial improvements in sleep quality and other clinical outcomes important to patients; future analyses of these data will explore associations between sleep quality and other clinical PROs.
1. Boonen A. Semin Arthritis Rheum 2015;44:556–62; 2. Wadeley A. Clin Rheumatol. 2018 Apr;37(4):1045-1052; 3. Deodhar A. Arthritis Rheumatol 2018;70(S9):2073–4; 4. van der Heijde D. Rheumatology (Oxford) 2017;56:1498–509; 5. Hays R. Sleep Med 2005;6:41–4; 6. Dworkin RH. J Pain. 2008;9(2):105-21.
To cite this abstract in AMA style:Gensler L, Kay J, Maksymowych W, Haroon N, Bauer L, Hoepken B, de Peyrecave N, Kumke T, Deodhar A. Certolizumab Pegol-Treated Patients with Non-Radiographic Axial Spondyloarthritis Demonstrate Improvements in Sleep Quality and Other Patient Reported Outcomes [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/certolizumab-pegol-treated-patients-with-non-radiographic-axial-spondyloarthritis-demonstrate-improvements-in-sleep-quality-and-other-patient-reported-outcomes/. Accessed November 25, 2020.
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