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.

References:

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.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/certolizumab-pegol-treated-patients-with-non-radiographic-axial-spondyloarthritis-demonstrate-improvements-in-sleep-quality-and-other-patient-reported-outcomes/