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.

Improvement of Functioning and Health With Ixekizumab in the Treatment of Active Nonradiographic Axial Spondyloarthritis in a 52‐Week, Randomized, Controlled Trial

“…The positive overall functioning and health outcomes reported by patients with nonradiographic axial SpA in this 52‐week placebo‐controlled trial are consistent with results from phase III placebo‐controlled studies with anti‐TNF agents in nonradiographic axial SpA ( 12 , 15 , 32 , 33 , 34 , 35 ). However, 29–48% of patients with nonradiographic axial SpA still have active disease (based on ASAS20 responses at week 12) despite TNFi treatment ( 12 , 13 , 14 , 15 ); therefore, alternative treatments for TNFi are valuable.…”

Effects of Intravenous Golimumab on Health-Related Quality of Life in Patients with Ankylosing Spondylitis: 28-Week Results of the GO-ALIVE Trial

“…Improvements in HRQoL have also been observed with the other anti-TNF agents: adalimumab, 14 certolizumab, 15 etanercept, 16 infliximab, 17 and subcutaneous golimumab. 18 There are many therapies currently available for treating AS, and several factors are considered, including patient preferences, as part of a shared decision-making process.…”

Sustained efficacy, safety and patient-reported outcomes of certolizumab pegol in axial spondyloarthritis: 4-year outcomes from RAPID-axSpA

“…Back pain, the quintessential symptom of axSpA, was previously shown to improve rapidly following treatment with CZP in RAPID-axSpA, with clinically relevant improvements observed in the overall axSpA population from day 2, compared with placebo [ 25 ]. Improvements of 3–4 points on the NRS, between baseline and week 24 (LOCF and OC), were sustained through to week 204 with CZP treatment ( Table 1 ).…”