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Layout Maureen V2.Indd UvA-DARE (Digital Academic Repository) Towards new measures of inflammation in spondyloarthritis Turina, M.C. Publication date 2016 Document Version Final published version Link to publication Citation for published version (APA): Turina, M. C. (2016). Towards new measures of inflammation in spondyloarthritis. General rights It is not permitted to download or to forward/distribute the text or part of it without the consent of the author(s) and/or copyright holder(s), other than for strictly personal, individual use, unless the work is under an open content license (like Creative Commons). Disclaimer/Complaints regulations If you believe that digital publication of certain material infringes any of your rights or (privacy) interests, please let the Library know, stating your reasons. In case of a legitimate complaint, the Library will make the material inaccessible and/or remove it from the website. Please Ask the Library: https://uba.uva.nl/en/contact, or a letter to: Library of the University of Amsterdam, Secretariat, Singel 425, 1012 WP Amsterdam, The Netherlands. You will be contacted as soon as possible. UvA-DARE is a service provided by the library of the University of Amsterdam (https://dare.uva.nl) Download date:26 Sep 2021 Towards new measures of inflammation in spondyloarthritis Maureen Cindy Turina in spondyloarthritis Maureen of inflammation measures new Towards TOWARDS NEW MEASURES OF INFLAMMATION IN SPONDYLOARTHRITIS UITNODIGING Voor het bijwonen van de openbare verdediging van het proefschrift van Maureen Turina op vrijdag 1 april 2016 om 12:00 uur in de Agnietenkapel Oudezijds Voorburgwal 231, Amsterdam Receptie ter plaatse na afloop van de promotie Towards new measures of Paranimfen Jacky Paramarta: inflammation in spondyloarthritis [email protected] Maureen Turina Talia Latuhihin: [email protected] TOWARDS NEW MEASURES OF INFLAMMATION IN SPONDYLOARTHRITIS Maureen Cindy Turina ISBN: 978-94-6233-234-8 Maureen Turina was supported by a fellowship of Janssen. Printing of this thesis was financially supported by ABBVIE B.V., AMC-UvA, the Dutch Arthritis Foundation (het Reumafonds), Janssen-Cilag B.V., Pfizer B.V., and UCB Pharma B.V., which is gratefully acknowledged. Cover design and thesis layout: Midas Mentink (www.thesisexpert.nl) Printing: Gildeprint – Enschede (www.gildeprint.nl) Copyright © 2015 by M.C. Turina All rights reserved. No part of this book may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, without permission of the author. TOWARDS NEW MEASURES OF INFLAMMATION IN SPONDYLOARTHRITIS ACADEMISCH PROEFSCHRIFT ter verkrijging van de graad van doctor aan de Universiteit van Amsterdam op gezag van de Rector Magnificus prof. dr. D.C. van den Boom ten overstaan van een door het College voor Promoties ingestelde commissie, in het openbaar te verdedigen in de Agnietenkapel op vrijdag 1 april 2016, te 12:00 uur door Maureen Cindy Turina geboren te Rotterdam PROMOTIECOMMISSIE: Promotores: Prof. dr. D.L.P. Baeten Universiteit van Amsterdam Prof. dr. R.B.M. Landewé Universiteit van Amsterdam Overige leden: Prof. dr. D. van Schaardenburg Universiteit van Amsterdam Prof. dr. P.I. Spuls Universiteit van Amsterdam Prof. dr. G.R.A.M. D’Haens Universiteit van Amsterdam Prof. dr. P.L.C.M. van Riel Radboud Universiteit Nijmegen Dr. F.A. van Gaalen Universiteit Leiden Faculteit der Geneeskunde TABLE OF CONTENTS Chapter 1 General introduction 9 Chapter 2 Serum biomarkers in spondyloarthritis-related diseases: 19 lessons from psoriasis and inflammatory bowel diseases Chapter 3 Serum inflammatory biomarkers fail to identify early axial 43 spondyloartritis: results from the SpondyloArthritis Caught Early (SPACE)-cohort Chapter 4 Clinical and imaging signs of spondyloarthritis in first-degree 55 relatives of HLA-B27 positive ankylosing spondylitis patients: the pre-spondyloarthritis (Pre-SpA) cohort Chapter 5 Calprotectin (S100A8/9) as serum biomarker for clinical 75 response in proof-of-concept trials in axial and peripheral spondyloarthritis Chapter 6 A psychometric analysis of outcome measures in peripheral 91 spondyloarthritis Chapter 7 Calprotectin serum level is an independent marker for 107 radiographic spinal progression in axial spondyloarthritis Chapter 8 General discussion and summary 113 Appendices Nederlandse samenvatting 135 Dankwoord 143 PhD portfolio 147 Curriculum vitae 151 List of publications 153 General introduction 1 SPONDYLOARTHRITIS Spondyloarthritis (SpA) is a chronic inflammatory disease affecting the axial skeleton, the peripheral joints, and extra-articular organs such as eye, gut, and skin. An important symptom of axial SpA is inflammatory back pain with pain at night and morning stiffness. Spinal inflammation can be accompanied by excessive new bone formation leading to fusion of vertebral bodies and spinal ankylosis. The prototypical and best known form of axial SpA is ankylosing spondylitis (AS). Peripheral SpA may manifest as peripheral arthritis, enthesitis, and/or dactylitis. Peripheral arthritis is characterized by pain, swelling, redness, and stiffness of the joints; the arthritis is mainly of the oligoarticular (1-5 joints) type, with asymmetrical distribution, preferably affecting the large joints of the lower limbs. Peripheral arthritis can be associated with both bone destruction and new bone formation, as described in psoriatic arthritis, being the prototypical form of peripheral SpA. Enthesitis often affects the fascia plantaris and the Achilles tendon. Dactylitis is swelling of an entire digit of the hands (sausage finger) or feet (sausage toe). Extra-articular manifestations include acute anterior uveitis, inflammatory bowel disease (Crohn’s disease and ulcerative colitis) and skin psoriasis. The inflammatory musculoskeletal symptoms of SpA are often effectively treated with nonsteroidal anti-inflammatory drugs (NSAIDs) and, if refractory to NSAIDs, tumor necrosis factor (TNF) inhibitors. TNF inhibitors do inhibit bone destruction in psoriatic arthritis. In contrast, it is still unclear if TNF-inhibitors inhibit new bone formation as seen in both axial and peripheral SpA. Unmet needs in the management of SpA Although the management of SpA has improved remarkably in the past years, mainly due to TNF inhibitors, several unmet needs still remain. A first unmet need is the time required to diagnose SpA. For axial disease, for example, until recently, it took ten years on average from the start of signs and symptoms to diagnose SpA.1,2 This delay has decreased significantly by optimizing the referral strategies from the general practitioner to the rheumatologist,3–5 and by introducing the magnetic resonance imaging (MRI) that is able to depict inflammation of the sacroiliiac joints (SI-joints). Still, however, the average delay between first symptoms and diagnosis of axial SpA remains 5-10 years,6,7 reflecting a long period of uncontrolled signs and symptoms. Comparable data for peripheral SpA are not available. Therefore, we need to study the earlier (yet undiagnosed) phases of clinically established SpA. In addition, the study of the subclinical phases of SpA (i.e. individuals without the symptoms of SpA but already with certain abnormalities specific for SpA (imaging, laboratory tests)) may further help to reduce the unwarranted diagnostic delay. Two main arguments explain why any delay in diagnosing SpA is unwarranted: 1) effective treatment is available to immediately improve signs and symptoms of the disease without further delay,8–14 and 2) treatment during the early phases of the disease may 10 GENERAL INTRODUCTION better halt new bone formation and the progression thereof than late-onset treatment after significant diagnostic delay (window of opportunity in SpA).15–17 1 A second unmet need is the lack of alternative therapeutic options beyond TNF inhibitors. Despite their major efficacy, TNF inhibitors have several limitations: 1) approximately 40% of the patients do not respond well to TNF inhibitor treatment;8,10–13 2) contra-indications for TNF inhibitors usage and/or side-effects occurring during TNF inhibitor-use limit the clinical potential of this class of treatments; 3) while TNF blockade can halt joint destruction, it likely does not halt new bone formation;15–17 and 4) long-term drug-free remission can still not be achieved.18,19 Clinical studies of novel drugs therefore remain necessary but are rapidly becoming ethically challenging: sufficiently large, long-term placebo controlled trials are ethically disputable in the era of TNF blockade, and difficult to enrol. Therefore, there is a need for alternative strategies to quickly provide go or no-go signals on whether a new drug may show efficacy at the group level in small-scale short-term proof of concept clinical trials (PoCs) before proceeding with larger phase-2b/3 randomized controlled trials. A third and partially related unmet need is to find valid outcome measures that adequately reflect treatment responses in peripheral disease. In axial SpA, well validated outcome measures such as the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)20 and the Ankylosing Spondylitis Diseases Activity Score (ASDAS)21 exist and are widely used in clinical studies, including therapeutic trials. In peripheral SpA, such outcome measures are lacking, with the exception of psoriatic arthritis: the outcome measures for psoriatic arthritis were either derived from measures originally developed for rheumatoid arthritis (e.g. American College of Rheumatology criteria,
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