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Impact of certolizumab pegol on patient-reported outcomes in patients with axial spondyloarthritis

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Sieper J1, Kivitz A, van Tubergen A, Deodhar A, Coteur G, Woltering F, Landewé R. Arthritis Care Res (Hoboken). 2015 Apr 1. doi: 10.1002/acr.22594. [Epub ahead of print]

Abstract

OBJECTIVE: Patient-reported outcomes (PROs) provide an opportunity to collect important information relating to patient well-being which is often difficult for physicians to measure (e.g. quality of life, pain, fatigue and sleep). Here we evaluate the effects of certolizumab pegol (CZP) on PROs during the 24-week double-blind phase of RAPID-axSpA (NCT01087762), a Phase 3 trial of axial spondyloarthritis (axSpA) patients, including both ankylosing spondylitis (AS) and non-radiographic axSpA (nr-axSpA) patients.

METHODS: 325 patients with active axSpA were randomized 1:1:1 to placebo, CZP 200mg Q2W or CZP 400mg Q4W. The primary endpoint, ASAS20 response at Week 12, has been reported previously. PROs included total back pain, nocturnal back pain, daily pain diary, Sleep Problems Index II domain of MOS Sleep scale (MOS-SPI), fatigue, Ankylosing Spondylitis Quality of Life (ASQoL), and Short Form 36-item health survey (SF-36) physical component summary (PCS), mental component summary (MCS) and domains

RESULTS: Patients treated with CZP reported significant improvements from Week 1 for nocturnal back pain (placebo=-0.6; CZP 200mg Q2W=-1.9; CZP 400mg Q4W=-1.6; p<0.001) and ASQoL (placebo=-1.0; CZP 200mg Q2W=-2.3; CZP 400mg Q4W=-1.9; p<0.05), compared with placebo, while significant improvements in total back pain were seen from Day 2. Patients treated with both CZP dosing regimens also had significantly greater improvements in fatigue, MOS-SPI, SF-36 PCS, MCS and domains compared with placebo. Improvements were similar in both AS and nr-axSpA patients.

CONCLUSION: Both CZP dosing schedules rapidly improved patient well-being as measured by PROs, including pain, fatigue, sleep, SF-36 and ASQoL, in both AS and nr-axSpA patients.