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Clinical characteristics of importance to outcome in patients with axial spondyloarthritis: protocol for a prospective descriptive and exploratory cohort study.
BMJ Open 2017; 7(7):e015536BO

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).

Authors+Show Affiliations

Department of Medicine, Section of Rheumatology, Odense University Hospital, Svendborg, Denmark. Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.Patient Data Explorative Network (OPEN), Odense University Hospital, Odense, Denmark. Department of Rheumatology, Odense University Hospital, Odense, Denmark.Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Bochum, Germany.Department of Ophthalmology, Odense University Hospital, Odense, Denmark.Department of Medicine, Section of Gastroenterology, Odense University Hospital, Svendborg, Denmark.Department of Medicine, Section of Gastroenterology, Odense University Hospital, Svendborg, Denmark.Department of Spine Centre of Southern Denmark, Hospital Lillebaelt, Institute of Regional Health Research, University of Southern Denmark, Middelfart, Denmark.Department of Rheumatology, Odense University Hospital, Odense, Denmark.Department of Medicine, Section of Rheumatology, Odense University Hospital, Svendborg, Denmark.Department of Medicine, Section of Rheumatology, Odense University Hospital, Svendborg, Denmark.Department of Medicine, Section of Rheumatology, Odense University Hospital, Svendborg, Denmark.Department of Medicine, Section of Rheumatology, Odense University Hospital, Svendborg, Denmark. Department of Clinical Research, University of Southern Denmark, Odense, Denmark.

Pub Type(s)

Journal Article
Observational Study

Language

eng

PubMed ID

28698330

Citation

Andreasen, Rikke Asmussen, et al. "Clinical Characteristics of Importance to Outcome in Patients With Axial Spondyloarthritis: Protocol for a Prospective Descriptive and Exploratory Cohort Study." BMJ Open, vol. 7, no. 7, 2017, pp. e015536.
Andreasen RA, Kristensen LE, Ellingsen T, et al. Clinical characteristics of importance to outcome in patients with axial spondyloarthritis: protocol for a prospective descriptive and exploratory cohort study. BMJ Open. 2017;7(7):e015536.
Andreasen, R. A., Kristensen, L. E., Ellingsen, T., Christensen, R., Baraliakos, X., Wied, J., ... Hansen, I. M. J. (2017). Clinical characteristics of importance to outcome in patients with axial spondyloarthritis: protocol for a prospective descriptive and exploratory cohort study. BMJ Open, 7(7), pp. e015536. doi:10.1136/bmjopen-2016-015536.
Andreasen RA, et al. Clinical Characteristics of Importance to Outcome in Patients With Axial Spondyloarthritis: Protocol for a Prospective Descriptive and Exploratory Cohort Study. BMJ Open. 2017 Jul 10;7(7):e015536. PubMed PMID: 28698330.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Clinical characteristics of importance to outcome in patients with axial spondyloarthritis: 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, Y1 - 2017/07/10/ PY - 2017/7/13/entrez PY - 2017/7/13/pubmed PY - 2018/5/2/medline KW - ankylosing spondylitis KW - pain KW - prognostic factors KW - spinal diseases KW - spondyloarthritis SP - e015536 EP - e015536 JF - BMJ open JO - BMJ Open VL - 7 IS - 7 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). SN - 2044-6055 UR - https://www.unboundmedicine.com/medline/citation/28698330/Clinical_characteristics_of_importance_to_outcome_in_patients_with_axial_spondyloarthritis:_protocol_for_a_prospective_descriptive_and_exploratory_cohort_study_ L2 - http://bmjopen.bmj.com/cgi/pmidlookup?view=long&pmid=28698330 DB - PRIME DP - Unbound Medicine ER -