Dataset Information

Non-radiographic axial spondyloarthritis patients without initial evidence of inflammation may develop objective inflammation over time.

ABSTRACT:

Objectives

In patients with active axial spondyloarthritis (axSpA), inflammation in the SIJ or spine on MRI, an elevated CRP level or both are considered useful objective assessments for disease activity and initiation of TNF antagonists. The aim of this post hoc analysis of the randomized, double-blind ABILITY-1 study (NCT00939003) was to assess changes in objective inflammation over time.

Methods

Patients with non-radiographic axSpA (nr-axSpA) were randomized to receive adalimumab 40 mg every other week or placebo for 12 weeks in ABILITY-1. MRIs were performed at baseline and week 12; CRP was measured every 4 weeks.

Results

Of 94 placebo-treated ABILITY-1 patients, 29 (30.9%) had a normal MRI of the SIJs and spine, 57 (60.6%) had normal CRP and 20 (21.3%) had a normal MRI of the SIJs and spine and a normal CRP at baseline. After 12 weeks of placebo, 9/29 (31.0%) patients subsequently developed inflammation on MRI, 14/57 (24.6%) patients developed elevated CRP and 10/20 (50.0%) patients developed a positive MRI and/or elevated CRP through week 12.

Conclusions

Patients who have clinically active disease but who lack objective evidence of inflammation initially may benefit from subsequent retesting for inflammation to guide treatment.

SUBMITTER: Baraliakos X

PROVIDER: S-EPMC5850598 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature

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Publications

Non-radiographic axial spondyloarthritis patients without initial evidence of inflammation may develop objective inflammation over time.

Baraliakos Xenofon X Sieper Joachim J Chen Su S Pangan Aileen L AL Anderson Jaclyn K JK

Rheumatology (Oxford, England) 20170701 7

<h4>Objectives</h4>In patients with active axial spondyloarthritis (axSpA), inflammation in the SIJ or spine on MRI, an elevated CRP level or both are considered useful objective assessments for disease activity and initiation of TNF antagonists. The aim of this post hoc analysis of the randomized, double-blind ABILITY-1 study (NCT00939003) was to assess changes in objective inflammation over time.<h4>Methods</h4>Patients with non-radiographic axSpA (nr-axSpA) were randomized to receive adalimum ...[more]

PMID: 28387855

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Project description:Aim of this study was to assess test-retest reliability of candidate instruments for the mandatory domains of the Assessment of Spondyloarthritis international Society (ASAS)-Outcome Measures in Rheumatology core set for axial spondyloarthritis (axSpA). Screening and baseline data from COAST-V, COAST-X and RAPID-axSpA was used to evaluate test-retest reliability of each candidate instrument for the mandatory domains (disease activity, pain, morning stiffness, fatigue, physical function, overall functioning and health). A maximum time interval of 28 days between both visits was used for inclusion in this study. Test-retest reliability was assessed by intraclass correlation coefficient (ICC). Bland and Altman plots provided mean difference and 95% limits of agreement, which were used to calculate the smallest detectable change (SDC). Data were analysed for radiographic and non-radiographic axSpA separately. Good reliability was found for Ankylosing Spondylitis Disease Activity Score (ICC 0.79, SDC 0.6), C reactive protein (ICC 0.72-0.79, SDC 12.3-17.0), Bath Ankylosing Spondylitis Functional Index (ICC 0.87, SDC 1.1) and 36-item Short-Form Health Survey (ICC Physical Component Summary 0.81, SDC 4.7, Mental Component Summary 0.80, SDC 7.3). Moderate reliability was found for Bath Ankylosing Spondylitis Disease Activity Index (ICC 0.72, SDC 1.1), patient global assessment (ICC 0.58, SDC 1.5), total back pain (ICC 0.64, SDC 1.3), back pain at night (ICC 0.67, SDC 1.3), morning stiffness (ICC 0.52-0.63, SDC 1.5-2.2), fatigue (ICC 0.65, SDC 1.3) and ASAS-Health Index (ICC 0.74, SDC 2.5). Reliability and SDC for the radiographic and non-radiographic axSpA subgroups were similar. Overall reliability was good, and comparable levels of reliability were found for patients with radiographic and non-radiographic axSpA, even though most instruments were developed for radiographic axSpA. Composite measures showed higher reliability than single-item measures in assessing disease activity in patients with axSpA.

Project description:BackgroundPatients with axial spondyloarthritis (axSpA) are often compromised by impaired function and mobility. The standardized 2-week inpatient program 'multimodal rheumatologic complex treatment' (MRCT) was designed for patients with axSpA. The Epionics SPINE (ES) is an objective tool validated to assess mobility.ObjectiveTo investigate the impact of MRCT on physical function and mobility including range of motion (RoM) and kinematics (RoK).DesignSingle-center interventional, observational trial.MethodsPatients with axSpA presenting with high disease activity and impaired physical function were consecutively recruited to undergo MRCT. Assessments performed before (V1) and after (V2) the intervention included Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis functional index (BASFI), Bath Ankylosing Spondylitis Metrology Index (BASMI), the ankylosing spondylitis physical performance index (ASPI), the Short Physical Performance Battery (SPPB), and ES measurements.ResultsAt baseline, the 80 patients included had: BASDAI 5.5 ± 1.5, BASFI 5.6 ± 2.0, BASMI 4.2 ± 1.8, SPPB 13.8 ± 1.8, and ASPI 37.3 ± 18.1 s. Clinically relevant improvements between V1 versus V2 were noted for BASFI, BASMI, and all other assessments (p < 0.001), and also for ES measures of RoK (all p < 0.003) and RoM (all p < 0.04), while a positive trend was seen for flexion and extension (RoM). There was no significant effect of changes in medication (all p > 0.05).ConclusionThe 2-weeks MRCT was associated with definite improvements of function and mobility. Importantly, the effect of this extensive physical activity was confirmed by using the ES as an objective tool to assess spinal mobility. The ES demonstrated for the first time that the RoK of spinal mobility can significantly improve related to an exercise intervention.Trial registrationEthical Committee: Ruhr-Universität (reference-number: 19-6735-BR).

Project description:Axial spondyloarthritis (axSpA) is an inflammatory rheumatic disorder that causes chronic pain, primarily in the spine and sacroiliac joints. It is characterized by the presence of type 1 major histocompatibility complex HLA-B27 genetic marker, arthritis in peripheral joints, enthesitis and/or dactylitis and extra-articular manifestations. Current guidelines recommend biological therapy when first-line therapy is not sufficiently effective. The finding that the interleukin (IL)-17 axis is vital for the pathogenesis of axSpA propelled the development of secukinumab, a fully human monoclonal antibody directed against IL-17A. The present review provides evidence on the efficacy and safety of secukinumab in the treatment of radiographic and non-radiographic axSpA from nine randomized controlled phase III trials, as well as evidence from real-world observational analyses. The primary endpoint in six clinical trials was the proportion of patients meeting the Assessment of SpondyloArthritis international Society criteria for either 20% or 40% improvement (ASAS20, ASAS40) at week 16. Significantly more patients achieved the primary endpoint with secukinumab compared with placebo in all the studies except MEASURE 4. Both clinical trials and real-world studies showed significant improvements in the secondary endpoints of disease activity, quality of life, and pain and fatigue relative to placebo. The benefits of secukinumab were generally sustained during longer-term (up to 5 years) treatment. Overall, secukinumab was well tolerated with a low frequency of adverse events and treatment persistence was high in the real-world setting. Although indirect comparisons suggest that secukinumab and adalimumab have comparable efficacy and safety, they are being directly compared in the ongoing SURPASS study. During the current coronavirus disease 2019 (COVID-19) pandemic, it is advisable to continue biological therapy in patients who do not have severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) infection, but interrupt treatment during an infection, reinitiating once the patient has recovered from the infection. In conclusion, secukinumab is a largely safe and effective treatment for radiographic and non-radiographic axSpA.

Dataset Information

Non-radiographic axial spondyloarthritis patients without initial evidence of inflammation may develop objective inflammation over time.

Objectives

Methods

Results

Conclusions

Publications

Non-radiographic axial spondyloarthritis patients without initial evidence of inflammation may develop objective inflammation over time.

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