Clinical characteristics of importance to outcome in patients with axial spondyloarthritis: protocol for a prospective descriptive and exploratory cohort study

Rikke Asmussen Andreasen, Lars Erik Kristensen, Torkell Ellingsen, Robin Christensen, Xenofon Baraliakos, Jimmi Wied, Claus Aalykke, Thomas Ulstrup, Berit Schiøttz-Christensen, Hans Christian Horn, Amir Emamifar, Bent Duerlund, Lars Fischer, Inger Marie Jensen Hansen

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Abstract

INTRODUCTION: Spondyloarthritis (SpA) is a heterogeneous spectrum of rheumatic diseases with either predominantly axial inflammatory symptoms of the spine and sacroiliac joints or predominantly peripheral arthritis. The two main entities of axial SpA (axSpA) are ankylosing spondylitis or non-radiographic axSpA (nr-axSpA). Tumour necrosis factor-α inhibitors have revolutionised the treatment of patients with axSpA who failed to respond to non-steroidal anti-inflammatory drugs and physical therapy. Chronic pain is common in patients with SpA and may still persist despite the lack of signs of inflammation. This has led researchers to hypothesise that central pain sensitisation may play a role in the generation of chronic pain in SpA. The painDETECT Questionnaire (PDQ) is a screening tool developed to detect neuropathic pain components. The primary objective is to explore the prognostic value of the PDQ regarding treatment response in patients with axSpA 3 months after initiating a biological agent. Secondary aim is to evaluate the impact of extra-articular manifestations, comorbidities and patient-reported outcomes and elucidate if these factors influence treatment response.

METHOD AND ANALYSIS: We will include 60 participants (≥18 years of age) diagnosed with axSpA independent of main entity, who initiate or switch treatment of a biologic. Data will be collected at baseline and at endpoint following Danish clinical practice (≥3 months) of treatment with biologics. We will explore whether the PDQ and other phenotypical patient characteristics are prognostically important for response to biological therapy according to established response criteria like 50% improvement in the Bath Ankylosing Spondylitis Disease Activity Index (50%) and Ankylosing Spondylitis Disease Activity Score.

ETHICS AND DISSEMINATION: The study is approved by the Region of Southern Denmark's Ethics committee (S-20160094) and has been designed in cooperation with patient representatives. The study is registered at clinicaltrials.gov (NCT02948608, pre-results). Dissemination will occur through publication(s) in international peer-reviewed journal(s).

Original languageEnglish
Article numbere015536
JournalBMJ Open
Volume7
Issue number7
Number of pages11
ISSN2044-6055
DOIs
Publication statusPublished - 10. Jul 2017

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Cohort Studies
Chronic Pain
Central Nervous System Sensitization
Patient Advocacy
Sacroiliac Joint
Ethics Committees
Denmark
Rheumatic Diseases
Publications
Comorbidity
Tumor Necrosis Factor-alpha
Joints
Research Personnel
Surveys and Questionnaires

Keywords

  • Journal Article

Cite this

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title = "Clinical characteristics of importance to outcome in patients with axial spondyloarthritis: protocol for a prospective descriptive and exploratory cohort study",
abstract = "INTRODUCTION: Spondyloarthritis (SpA) is a heterogeneous spectrum of rheumatic diseases with either predominantly axial inflammatory symptoms of the spine and sacroiliac joints or predominantly peripheral arthritis. The two main entities of axial SpA (axSpA) are ankylosing spondylitis or non-radiographic axSpA (nr-axSpA). Tumour necrosis factor-α inhibitors have revolutionised the treatment of patients with axSpA who failed to respond to non-steroidal anti-inflammatory drugs and physical therapy. Chronic pain is common in patients with SpA and may still persist despite the lack of signs of inflammation. This has led researchers to hypothesise that central pain sensitisation may play a role in the generation of chronic pain in SpA. The painDETECT Questionnaire (PDQ) is a screening tool developed to detect neuropathic pain components. The primary objective is to explore the prognostic value of the PDQ regarding treatment response in patients with axSpA 3 months after initiating a biological agent. Secondary aim is to evaluate the impact of extra-articular manifestations, comorbidities and patient-reported outcomes and elucidate if these factors influence treatment response.METHOD AND ANALYSIS: We will include 60 participants (≥18 years of age) diagnosed with axSpA independent of main entity, who initiate or switch treatment of a biologic. Data will be collected at baseline and at endpoint following Danish clinical practice (≥3 months) of treatment with biologics. We will explore whether the PDQ and other phenotypical patient characteristics are prognostically important for response to biological therapy according to established response criteria like 50{\%} improvement in the Bath Ankylosing Spondylitis Disease Activity Index (50{\%}) and Ankylosing Spondylitis Disease Activity Score.ETHICS AND DISSEMINATION: The study is approved by the Region of Southern Denmark's Ethics committee (S-20160094) and has been designed in cooperation with patient representatives. The study is registered at clinicaltrials.gov (NCT02948608, pre-results). Dissemination will occur through publication(s) in international peer-reviewed journal(s).",
keywords = "Journal Article",
author = "Andreasen, {Rikke Asmussen} and Kristensen, {Lars Erik} and Torkell Ellingsen and Robin Christensen and Xenofon Baraliakos and Jimmi Wied and Claus Aalykke and Thomas Ulstrup and Berit Schi{\o}ttz-Christensen and Horn, {Hans Christian} and Amir Emamifar and Bent Duerlund and Lars Fischer and Hansen, {Inger Marie Jensen}",
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Clinical characteristics of importance to outcome in patients with axial spondyloarthritis : protocol for a prospective descriptive and exploratory cohort study. / Andreasen, Rikke Asmussen; Kristensen, Lars Erik; Ellingsen, Torkell; Christensen, Robin; Baraliakos, Xenofon; Wied, Jimmi; Aalykke, Claus; Ulstrup, Thomas; Schiøttz-Christensen, Berit; Horn, Hans Christian; Emamifar, Amir; Duerlund, Bent; Fischer, Lars; Hansen, Inger Marie Jensen.

In: BMJ Open, Vol. 7, No. 7, e015536, 10.07.2017.

Research output: Contribution to journalJournal articleResearchpeer-review

TY - JOUR

T1 - Clinical characteristics of importance to outcome in patients with axial spondyloarthritis

T2 - protocol for a prospective descriptive and exploratory cohort study

AU - Andreasen, Rikke Asmussen

AU - Kristensen, Lars Erik

AU - Ellingsen, Torkell

AU - Christensen, Robin

AU - Baraliakos, Xenofon

AU - Wied, Jimmi

AU - Aalykke, Claus

AU - Ulstrup, Thomas

AU - Schiøttz-Christensen, Berit

AU - Horn, Hans Christian

AU - Emamifar, Amir

AU - Duerlund, Bent

AU - Fischer, Lars

AU - Hansen, Inger Marie Jensen

N1 - © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

PY - 2017/7/10

Y1 - 2017/7/10

N2 - INTRODUCTION: Spondyloarthritis (SpA) is a heterogeneous spectrum of rheumatic diseases with either predominantly axial inflammatory symptoms of the spine and sacroiliac joints or predominantly peripheral arthritis. The two main entities of axial SpA (axSpA) are ankylosing spondylitis or non-radiographic axSpA (nr-axSpA). Tumour necrosis factor-α inhibitors have revolutionised the treatment of patients with axSpA who failed to respond to non-steroidal anti-inflammatory drugs and physical therapy. Chronic pain is common in patients with SpA and may still persist despite the lack of signs of inflammation. This has led researchers to hypothesise that central pain sensitisation may play a role in the generation of chronic pain in SpA. The painDETECT Questionnaire (PDQ) is a screening tool developed to detect neuropathic pain components. The primary objective is to explore the prognostic value of the PDQ regarding treatment response in patients with axSpA 3 months after initiating a biological agent. Secondary aim is to evaluate the impact of extra-articular manifestations, comorbidities and patient-reported outcomes and elucidate if these factors influence treatment response.METHOD AND ANALYSIS: We will include 60 participants (≥18 years of age) diagnosed with axSpA independent of main entity, who initiate or switch treatment of a biologic. Data will be collected at baseline and at endpoint following Danish clinical practice (≥3 months) of treatment with biologics. We will explore whether the PDQ and other phenotypical patient characteristics are prognostically important for response to biological therapy according to established response criteria like 50% improvement in the Bath Ankylosing Spondylitis Disease Activity Index (50%) and Ankylosing Spondylitis Disease Activity Score.ETHICS AND DISSEMINATION: The study is approved by the Region of Southern Denmark's Ethics committee (S-20160094) and has been designed in cooperation with patient representatives. The study is registered at clinicaltrials.gov (NCT02948608, pre-results). Dissemination will occur through publication(s) in international peer-reviewed journal(s).

AB - INTRODUCTION: Spondyloarthritis (SpA) is a heterogeneous spectrum of rheumatic diseases with either predominantly axial inflammatory symptoms of the spine and sacroiliac joints or predominantly peripheral arthritis. The two main entities of axial SpA (axSpA) are ankylosing spondylitis or non-radiographic axSpA (nr-axSpA). Tumour necrosis factor-α inhibitors have revolutionised the treatment of patients with axSpA who failed to respond to non-steroidal anti-inflammatory drugs and physical therapy. Chronic pain is common in patients with SpA and may still persist despite the lack of signs of inflammation. This has led researchers to hypothesise that central pain sensitisation may play a role in the generation of chronic pain in SpA. The painDETECT Questionnaire (PDQ) is a screening tool developed to detect neuropathic pain components. The primary objective is to explore the prognostic value of the PDQ regarding treatment response in patients with axSpA 3 months after initiating a biological agent. Secondary aim is to evaluate the impact of extra-articular manifestations, comorbidities and patient-reported outcomes and elucidate if these factors influence treatment response.METHOD AND ANALYSIS: We will include 60 participants (≥18 years of age) diagnosed with axSpA independent of main entity, who initiate or switch treatment of a biologic. Data will be collected at baseline and at endpoint following Danish clinical practice (≥3 months) of treatment with biologics. We will explore whether the PDQ and other phenotypical patient characteristics are prognostically important for response to biological therapy according to established response criteria like 50% improvement in the Bath Ankylosing Spondylitis Disease Activity Index (50%) and Ankylosing Spondylitis Disease Activity Score.ETHICS AND DISSEMINATION: The study is approved by the Region of Southern Denmark's Ethics committee (S-20160094) and has been designed in cooperation with patient representatives. The study is registered at clinicaltrials.gov (NCT02948608, pre-results). Dissemination will occur through publication(s) in international peer-reviewed journal(s).

KW - Journal Article

U2 - 10.1136/bmjopen-2016-015536

DO - 10.1136/bmjopen-2016-015536

M3 - Journal article

C2 - 28698330

VL - 7

JO - B M J Open

JF - B M J Open

SN - 2044-6055

IS - 7

M1 - e015536

ER -