Impact of Certolizumab Pegol on Patient‐Reported Outcomes in Patients With Axial Spondyloarthritis

Abstract

ObjectivePatient‐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 the RAPID axial spondyloarthritis (SpA) trial, a phase 3 trial of axial SpA patients, including both ankylosing spondylitis (AS) and nonradiographic axial SpA patients.MethodsA total of 325 patients with active axial SpA were randomized 1:1:1 to placebo, CZP 200 mg every 2 weeks, or CZP 400 mg every 4 weeks. The primary end point was the Assessment of SpondyloArthritis International Society criteria for 20% improvement in disease activity response at week 12, and has been reported previously. PROs included total back pain, nocturnal back pain, a daily pain diary, the Sleep Problems Index II (SPI) domain of the Medical Outcomes Study (MOS) Sleep Scale, fatigue, the Ankylosing Spondylitis Quality of Life (ASQOL) measure, and the Short Form 36‐item (SF‐36) health survey physical component summary (PCS), mental component summary (MCS), and domains.ResultsPatients treated with CZP reported significant improvements from week 1 for nocturnal back pain (placebo −0.6, CZP 200 mg every 2 weeks −1.9, and CZP 400 mg every 4 weeks −1.6; P < 0.001) and ASQOL (placebo −1.0, CZP 200 mg every 2 weeks −2.3, and CZP 400 mg every 4 weeks −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 nonradiographic axial SpA patients.ConclusionBoth CZP dosing schedules rapidly improved patient well‐being, as measured by PROs, including pain, fatigue, sleep, SF‐36, and ASQOL in both AS and nonradiographic axial SpA patients.

Prevalence and factors associated with disturbed sleep in patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis: a systematic review

“…Across AS studies (excluding 2 studies incorporating nraxSpA populations [ 27,34 ] and 1 study reporting median (IQR) data [ 26 ]) the mean population age in years M (SD) = 36.7 (9.7). The mean disease duration (where reported from age from symptom onset) in years M (SD) = 12.3 (7.5).…”

“…Four of the five studies found that anti-TNF medication was effective in reducing overall sleep scores, with improvement maintained throughout the trial period [ 24,26,33,34 ]. In one study, the median JSEQ further improved to week 52 for those receiving treatment for the full year, indicating that individuals may see continued improvement into the long term [ 24 ].…”

“…All of these studies found significant differences between AS patients and the control subjects. It is likely that poor sleep is also more prevalent in patients with nraxSpA that for control subjects, however, only 2 studies focussed on this research group [ 27,34 ]. In comparison between nraxSpA and AS patients, patients with nraxSpA reported greater sleep disturbance at baseline with greater improvement during treatment with certolizumab pegol [ 34 ].…”

“…Five of them investigated anti-TNF therapy, specifically golimumab [ 24,26 ], etanercept [ 27 ], adalimumab [ 33 ] and certolizumab pegol [ 34 ].…”

“…In one study, the median JSEQ further improved to week 52 for those receiving treatment for the full year, indicating that individuals may see continued improvement into the long term [ 24 ]. Improvements in sleep score from baseline were associated with improved back pain, fatigue, QoL, disease activity and functional ability [ 26,34 ]. One of the descriptive studies grouped individuals depending on current use of anti-TNF medication.…”