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Spinal Diseases: HELP
Articles by Helena Marzo-Ortega
Based on 71 articles published since 2009
(Why 71 articles?)
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Between 2009 and 2019, H. Marzo-Ortega wrote the following 71 articles about Spinal Diseases.
 
+ Citations + Abstracts
Pages: 1 · 2 · 3
1 Guideline 2016 update of the ASAS-EULAR management recommendations for axial spondyloarthritis. 2017

van der Heijde, Désirée / Ramiro, Sofia / Landewé, Robert / Baraliakos, Xenofon / Van den Bosch, Filip / Sepriano, Alexandre / Regel, Andrea / Ciurea, Adrian / Dagfinrud, Hanne / Dougados, Maxime / van Gaalen, Floris / Géher, Pál / van der Horst-Bruinsma, Irene / Inman, Robert D / Jongkees, Merryn / Kiltz, Uta / Kvien, Tore K / Machado, Pedro M / Marzo-Ortega, Helena / Molto, Anna / Navarro-Compàn, Victoria / Ozgocmen, Salih / Pimentel-Santos, Fernando M / Reveille, John / Rudwaleit, Martin / Sieper, Jochen / Sampaio-Barros, Percival / Wiek, Dieter / Braun, Jürgen. ·Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands. · Amsterdam Rheumatology and Immunology Center, Amsterdam, The Netherlands. · Department of Rheumatology, Zuyderland Medical Center, Heerlen, The Netherlands. · Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany. · Department of Rheumatology, Ghent University and Ghent University Hospital, Ghent, Belgium. · NOVA Medical School, Universidade Nova de Lisboa, Lisboa, Portugal. · Department of Rheumatology, University Hospital Zurich, Zurich Switzerland. · Diakonhjemmet Hospital, Oslo, Norway. · Paris Descartes University, Hôpital Cochin, Assistance Publique-Hôpitaux de Paris, Paris, France. · INSERM (U1153), PRES Sorbonne Paris-Cité, Paris, France. · Semmelweis University, Budapest, Hungary. · Department of Rheumatology, VU University Medical Center, Amsterdam, The Netherlands. · University of Toronto, Toronto, Ontario, Canada. · Patient Research Partner, Amsterdam, The Netherlands. · Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway. · Centre for Rheumatology & MRC Centre for Neuromuscular Diseases, University College London, London, UK. · NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust, Leeds, UK. · Leeds Institute of Rheumatic and Musculoskeletal Disease, University of Leeds, Leeds, UK. · Department of Rheumatology, University Hospital La Paz, IdiPaz, Madrid, Spain. · Division of Rheumatology, Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Erciyes University, Kayseri, Turkey. · NOVA Medical School, NOVA University of Lisbon, Lisboa, Portugal. · The University of Texas-Health McGovern Medical School, Dallas, USA. · Klinikum Bielefeld, Bielefeld, Germany. · Gent University, Gent, Belgium. · Charité University Medicine, Berlin, Germany. · Department of Rheumatology, Campus Benjamin Franklin, Charité, Berlin, Germany. · Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil. · EULAR PARE Patient Research Partner and Chair of EULAR PARE, Berlin, Germany. ·Ann Rheum Dis · Pubmed #28087505.

ABSTRACT: To update and integrate the recommendations for ankylosing spondylitis and the recommendations for the use of tumour necrosis factor inhibitors (TNFi) in axial spondyloarthritis (axSpA) into one set applicable to the full spectrum of patients with axSpA. Following the latest version of the European League Against Rheumatism (EULAR) Standardised Operating Procedures, two systematic literature reviews first collected the evidence regarding all treatment options (pharmacological and non-pharmacological) that were published since 2009. After a discussion of the results in the steering group and presentation to the task force, overarching principles and recommendations were formulated, and consensus was obtained by informal voting. A total of 5 overarching principles and 13 recommendations were agreed on. The first three recommendations deal with personalised medicine including treatment target and monitoring. Recommendation 4 covers non-pharmacological management. Recommendation 5 describes the central role of non-steroidal anti-inflammatory drugs (NSAIDs) as first-choice drug treatment. Recommendations 6-8 define the rather modest role of analgesics, and disprove glucocorticoids and conventional synthetic disease-modifying antirheumatic drugs (DMARDs) for axSpA patents with predominant axial involvement. Recommendation 9 refers to biological DMARDs (bDMARDs) including TNFi and IL-17 inhibitors (IL-17i) for patients with high disease activity despite the use (or intolerance/contraindication) of at least two NSAIDs. In addition, they should either have an elevated C reactive protein and/or definite inflammation on MRI and/or radiographic evidence of sacroiliitis. Current practice is to start with a TNFi. Switching to another TNFi or an IL-17i is recommended in case TNFi fails (recommendation 10). Tapering, but not stopping a bDMARD, can be considered in patients in sustained remission (recommendation 11). The final two recommendations (12, 13) deal with surgery and spinal fractures. The 2016 Assessment of SpondyloArthritis international Society-EULAR recommendations provide up-to-date guidance on the management of patients with axSpA.

2 Guideline BSR and BHPR guideline for the treatment of axial spondyloarthritis (including ankylosing spondylitis) with biologics. 2017

Hamilton, Louise / Barkham, Nick / Bhalla, Ashok / Brittain, Robin / Cook, Debbie / Jones, Gareth / Mackay, Kirsten / Marshall, David / Marzo-Ortega, Helena / Murphy, Daniel / Riddell, Claire / Sengupta, Raj / Siebert, Stefan / Van Rossen, Liz / Gaffney, Karl / Anonymous2740879. ·Rheumatology Department, Norfolk and Norwich University Hospital, Norwich louise.hamilton@nnuh.nhs.uk. · Rheumatology Department, New Cross Hospital, Wolverhampton. · Rheumatology Department, Royal National Hospital for Rheumatic Diseases, Bath. · Private residence, Grantham. · National Ankylosing Spondylitis Society, London, UK. · Institute of Applied Health Sciences, University of Aberdeen, Aberdeen. · Rheumatology Department, Torbay Hospital, Torquay. · Rheumatology Department, Inverclyde Royal Hospital, Greenock. · NIHR Leeds Musculoskeletal Biomedical Research Unit, Chapel Allerton Hospital, Leeds. · Honiton Surgery and Rheumatology Department, Royal Devon and Exeter Hospital, Exeter. · Rheumatology Department, Musgrave Park Hospital, Belfast Health and Social Care Trust, Belfast. · Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow. · Rheumatology Department, Kent and Canterbury Hospital, Canterbury. · Rheumatology Department, Norfolk and Norwich University Hospital, Norwich. ·Rheumatology (Oxford) · Pubmed #27558584.

ABSTRACT: -- No abstract --

3 Guideline European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 update. 2016

Gossec, L / Smolen, J S / Ramiro, S / de Wit, M / Cutolo, M / Dougados, M / Emery, P / Landewé, R / Oliver, S / Aletaha, D / Betteridge, N / Braun, J / Burmester, G / Cañete, J D / Damjanov, N / FitzGerald, O / Haglund, E / Helliwell, P / Kvien, T K / Lories, R / Luger, T / Maccarone, M / Marzo-Ortega, H / McGonagle, D / McInnes, I B / Olivieri, I / Pavelka, K / Schett, G / Sieper, J / van den Bosch, F / Veale, D J / Wollenhaupt, J / Zink, A / van der Heijde, D. ·Sorbonne Universités, UPMC Univ Paris 06, Institut Pierre Louis d'Epidémiologie et de Santé Publique, GRC-UPMC 08 (EEMOIS), Paris, France Department of rheumatology, AP-HP, Pitié Salpêtrière Hospital, Paris, France. · Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria Second Department of Medicine, Hietzing Hospital, Vienna, Austria. · Department of Rheumatology, Leiden University Medical Centre, Leiden, The Netherlands. · EULAR, representing People with Arthritis/Rheumatism in Europe (PARE), London, UK. · Research Laboratory and Clinical Division of Rheumatology, Department of Internal Medicine, University of Genova, Viale Benedetto, Italy. · Medicine Faculty, Paris Descartes University, Paris, France Rheumatology B Department, APHP, Cochin Hospital, Paris, France. · Leeds NIHR Musculoskeletal Biomedical Research Unit, LTHT, Leeds, UK Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK. · Department of Clinical Immunology & Rheumatology, Amsterdam Rheumatology Center, Amsterdam, The Netherlands Atrium Medical Center, Heerlen, The Netherlands. · North Devon, UK. · Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria. · Rheumazentrum Ruhrgebiet, Herne and Ruhr-Universität Bochum, Herne, Germany. · Department of Rheumatology and Clinical Immunology, Charité-University Medicine Berlin, Germany. · Arthritis Unit, Department of Rheumatology, Hospital Clínic and IDIBAPS, Barcelona, Spain. · Belgrade University School of Medicine, Belgrade, Serbia. · Department of Rheumatology, St. Vincent's University Hospital and Conway Institute, University College Dublin, Dublin, Ireland. · Section of Rheumatology, Department of Clinical Sciences, Lund University, Lund, Sweden Sweden and School of Business, Engineering and Science, Halmstad University, Halmstad, Sweden. · Section of Musculoskeletal Disease, Leeds Institute of Molecular Medicine, University of Leeds, Leeds, UK. · Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway. · Laboratory of Tissue Homeostasis and Disease, Skeletal Biology and Engineering Research Center, KU Leuven, Belgium Division of Rheumatology, University Hospitals Leuven, Leuven, Belgium. · Department of Dermatology, University Hospital Münster, Münster, Germany. · A.DI.PSO. (Associazione per la Difesa degli Psoriasici)-PE.Pso.POF (Pan European Psoriasis Patients' Organization Forum), Rome, Italy. · Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, UK. · Rheumatology Department of Lucania, San Carlo Hospital of Potenza and Madonna delle Grazie Hospital of Matera, Potenza, Italy. · Institute and Clinic of Rheumatology Charles University Prague, Czech Republic. · Department of Internal Medicine 3, University of Erlangen-Nuremberg, Erlangen, Germany. · Department of Rheumatology, Campus Benjamin Franklin, Charité, Berlin, Germany. · Ghent University Hospital, Ghent, Belgium. · Centre for Arthritis and Rheumatic Disease, Dublin Academic Medical Centre, St. Vincent's University Hospital, Dublin, Ireland. · Schoen Klinik Hamburg, Rheumatology and Clinical Immunology, Hamburg, Germany. · Department of Rheumatology and Clinical Immunology, German Rheumatism Research Centre Berlin, Charité-University Medicine Berlin, Germany. ·Ann Rheum Dis · Pubmed #26644232.

ABSTRACT: BACKGROUND: Since the publication of the European League Against Rheumatism recommendations for the pharmacological treatment of psoriatic arthritis (PsA) in 2012, new evidence and new therapeutic agents have emerged. The objective was to update these recommendations. METHODS: A systematic literature review was performed regarding pharmacological treatment in PsA. Subsequently, recommendations were formulated based on the evidence and the expert opinion of the 34 Task Force members. Levels of evidence and strengths of recommendations were allocated. RESULTS: The updated recommendations comprise 5 overarching principles and 10 recommendations, covering pharmacological therapies for PsA from non-steroidal anti-inflammatory drugs (NSAIDs), to conventional synthetic (csDMARD) and biological (bDMARD) disease-modifying antirheumatic drugs, whatever their mode of action, taking articular and extra-articular manifestations of PsA into account, but focusing on musculoskeletal involvement. The overarching principles address the need for shared decision-making and treatment objectives. The recommendations address csDMARDs as an initial therapy after failure of NSAIDs and local therapy for active disease, followed, if necessary, by a bDMARD or a targeted synthetic DMARD (tsDMARD). The first bDMARD would usually be a tumour necrosis factor (TNF) inhibitor. bDMARDs targeting interleukin (IL)12/23 (ustekinumab) or IL-17 pathways (secukinumab) may be used in patients for whom TNF inhibitors are inappropriate and a tsDMARD such as a phosphodiesterase 4-inhibitor (apremilast) if bDMARDs are inappropriate. If the first bDMARD strategy fails, any other bDMARD or tsDMARD may be used. CONCLUSIONS: These recommendations provide stakeholders with an updated consensus on the pharmacological treatment of PsA and strategies to reach optimal outcomes in PsA, based on a combination of evidence and expert opinion.

4 Guideline EULAR recommendations for the use of imaging in the diagnosis and management of spondyloarthritis in clinical practice. 2015

Mandl, P / Navarro-Compán, V / Terslev, L / Aegerter, P / van der Heijde, D / D'Agostino, M A / Baraliakos, X / Pedersen, S J / Jurik, A G / Naredo, E / Schueller-Weidekamm, C / Weber, U / Wick, M C / Bakker, P A C / Filippucci, E / Conaghan, P G / Rudwaleit, M / Schett, G / Sieper, J / Tarp, S / Marzo-Ortega, H / Østergaard, M / Anonymous6530825. ·Division of Rheumatology, Medical University of Vienna, Vienna, Austria. · Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands University Hospital La Paz, Madrid, Spain. · Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Copenhagen University Hospital at Glostrup, Copenhagen, Denmark. · Public Health Department, Ambroise Paré Hospital, Boulogne-Billancourt, France. · Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands. · Department of Rheumatology, Ambroise Paré Hospital, Boulogne-Billancourt, France. · Rheumazentrum Ruhrgebiet, Herne, Germany. · Department of Rheumatology, Copenhagen University Hospital at Gentofte, Copenhagen, Denmark. · Department of Radiology, Aarhus University Hospital, Aarhus, Denmark. · Department of Rheumatology, Hospital General Universitario Gregorio Marañón, Madrid, Spain. · Department of Biomedical Imaging and Image-guided Therapy, Medical University of Vienna, Vienna, Austria. · King Christian 10th Hospital for Rheumatic Diseases, Gråsten, Denmark. · Department of Radiology, Karolinska University Hospital, Stockholm, Sweden. · Department of Rheumatology, Università Politecnica delle Marche, Ancona, Italy. · NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK. · Department of Rheumatology, Charité Universitätsmedizin, Berlin, Germany. · Department of Rheumatology and Immunology, University of Erlangen-Nuremberg, Erlangen, Germany. · Musculoskeletal Statistics Unit, Department of Rheumatology, The Parker Institute, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Copenhagen, Denmark. ·Ann Rheum Dis · Pubmed #25837448.

ABSTRACT: A taskforce comprised of an expert group of 21 rheumatologists, radiologists and methodologists from 11 countries developed evidence-based recommendations on the use of imaging in the clinical management of both axial and peripheral spondyloarthritis (SpA). Twelve key questions on the role of imaging in SpA were generated using a process of discussion and consensus. Imaging modalities included conventional radiography, ultrasound, magnetic resonance imaging, computed tomography (CT), positron emission tomography, single photon emission CT, dual-emission x-ray absorptiometry and scintigraphy. Experts applied research evidence obtained from systematic literature reviews using MEDLINE and EMBASE to develop a set of 10 recommendations. The strength of recommendations (SOR) was assessed by taskforce members using a visual analogue scale. A total of 7550 references were identified in the search process, from which 158 studies were included in the systematic review. Ten recommendations were produced using research-based evidence and expert opinion encompassing the role of imaging in making a diagnosis of axial SpA or peripheral SpA, monitoring inflammation and damage, predicting outcome, response to treatment, and detecting spinal fractures and osteoporosis. The SOR for each recommendation was generally very high (range 8.9-9.5). These are the first recommendations which encompass the entire spectrum of SpA and evaluate the full role of all commonly used imaging modalities. We aimed to produce recommendations that are practical and valuable in daily practice for rheumatologists, radiologists and general practitioners.

5 Guideline European League Against Rheumatism recommendations for the management of psoriatic arthritis with pharmacological therapies. 2012

Gossec, L / Smolen, J S / Gaujoux-Viala, C / Ash, Z / Marzo-Ortega, H / van der Heijde, D / FitzGerald, O / Aletaha, D / Balint, P / Boumpas, D / Braun, J / Breedveld, F C / Burmester, G / Cañete, J D / de Wit, M / Dagfinrud, H / de Vlam, K / Dougados, M / Helliwell, P / Kavanaugh, A / Kvien, T K / Landewé, R / Luger, T / Maccarone, M / McGonagle, D / McHugh, N / McInnes, I B / Ritchlin, C / Sieper, J / Tak, P P / Valesini, G / Vencovsky, J / Winthrop, K L / Zink, A / Emery, P / Anonymous2420706. ·Paris Descartes University, Paris, France. laure.gossec@cch.aphp.fr ·Ann Rheum Dis · Pubmed #21953336.

ABSTRACT: BACKGROUND: Psoriatic arthritis (PsA) is a clinically heterogeneous disease. Clear consensual treatment guidance focused on the musculoskeletal manifestations of PsA would be advantageous. The authors present European League Against Rheumatism (EULAR) recommendations for the treatment of PsA with systemic or local (non-topical) symptomatic and disease-modifying antirheumatic drugs (DMARD). METHODS: The recommendations are based on evidence from systematic literature reviews performed for non-steroidal anti-inflammatory drugs (NSAID), glucocorticoids, synthetic DMARD and biological DMARD. This evidence was discussed, summarised and recommendations were formulated by a task force comprising 35 representatives, and providing levels of evidence, strength of recommendations and levels of agreement. RESULTS: Ten recommendations were developed for treatment from NSAID through synthetic DMARD to biological agents, accounting for articular and extra-articular manifestations of PsA. Five overarching principles and a research agenda were defined. CONCLUSION: These recommendations are intended to provide rheumatologists, patients and other stakeholders with a consensus on the pharmacological treatment of PsA and strategies to reach optimal outcomes, based on combining evidence and expert opinion. The research agenda informs directions within EULAR and other communities interested in PsA.

6 Editorial Expanding the spectrum of inflammatory spinal disease: AS it was, as it is now. 2013

Isdale, Amanda / Keat, Andrew / Barkham, Nick / Bennett, Alexander N / Gaffney, Karl / Marzo-Ortega, Helena / Sengupta, Raj. ·York Teaching Hospital NHS Foundation Trust, Wigginton Road, York YO31 8HE, UK. amanda.isdale@york.nhs.uk. ·Rheumatology (Oxford) · Pubmed #23873819.

ABSTRACT: -- No abstract --

7 Editorial Improving the treatment of ankylosing spondylitis in the UK. 2011

Keat, Andrew / Gaffney, Karl / Marzo-Ortega, Helena / Cornell, Trish / MacKay, Kirsten / Skerrett, Jane / Van Rossen, Liz / Wordsworth, B Paul. · ·Rheumatology (Oxford) · Pubmed #21421686.

ABSTRACT: -- No abstract --

8 Editorial Diagnosing axial spondyloarthropathy. The new Assessment in SpondyloArthritis international Society criteria: MRI entering centre stage. 2009

Bennett, A N / Marzo-Ortega, H / Emery, P / McGonagle, D / Anonymous4680628. · ·Ann Rheum Dis · Pubmed #19435721.

ABSTRACT: -- No abstract --

9 Review The advent of IL-17A blockade in ankylosing spondylitis: secukinumab, ixekizumab and beyond. 2019

Dubash, Sayam / Bridgewood, Charlie / McGonagle, Dennis / Marzo-Ortega, Helena. ·a NIHR Leeds Biomedical Research Centre , Leeds Teaching Hospitals NHS Trust , Leeds , UK. · b Leeds Institute of Rheumatic and Musculoskeletal Medicine , University of Leeds , Leeds , UK. ·Expert Rev Clin Immunol · Pubmed #30576610.

ABSTRACT: INTRODUCTION: Secukinumab, an interleukin-17A (IL-17A) antagonist, is the first non-TNF alpha inhibitor agent licensed for ankylosing spondylitis (AS), which opens up a new era of alternative cytokine targets beyond TNF. Areas covered: This review explores the pathophysiology and scientific evidence behind the use of this new mode of action and discusses the basis for its efficacy and clinical utility in the management of AS. In particular, how the emergent data points towards the efficacy of secukinumab and ixekizumab, a second emergent IL-17A blocker, in AS has helped focus research into the IL-23/17 axis in entheseal driven disease in man and how IL-17A inhibition may be linked to the presence of innate and adaptive immune cell populations capable of IL-17A elaboration in these target tissues. Expert commentary: Collectively these emergent data point towards an efficacious role of IL-17A inhibition strategies targeting AS pathogenesis in a fundamental way whilst carrying a good safety profile.

10 Review Defining the target: clinical aims in axial spondyloarthritis. 2018

Marzo-Ortega, Helena / Gaffney, Katie M / Gaffney, Karl. ·NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust. · Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds. · Rheumatology Department, Norfolk and Norwich University Hospital, Norwich, UK. ·Rheumatology (Oxford) · Pubmed #30445481.

ABSTRACT: Treat-to-target (T2T) is an emerging treatment paradigm in axial spondyloarthritis (axSpA), originally based on evidence from other inflammatory conditions, which aims to direct therapy to a clear target such as disease remission or low disease activity, with the ultimate goal of maximizing quality of life in affected individuals. The 2016 update of the Assessment of Spondyloarthritis International Society/EULAR guidelines for axSpA have recommended that treatment should be guided according to a predefined target but controversy remains as to what this target should be. An international task force has recommended remission or inactive disease as the desired outcome; however, there are many disease outcome measures developed for use in clinical practice in axSpA and the question remains of which is the most appropriate to use. Another important consideration when discussing the T2T paradigm is when to intervene. Although evidence is limited in this respect, the available data suggest that therapy should be commenced at an early stage of the disease, when the process of bone repair expected to occur after an inflammatory phase has not yet started. It has also been argued that the success of the T2T paradigm may depend more on the treatment strategy than the individual therapies utilized. This article will explore the feasibility of using a T2T approach in axSpA clinical practice, the utilization of new composite outcome measures of disease activity such as the ASDAS, and the validity of different treatment strategies to allow for a T2T intervention in these patients.

11 Review The problem in differentiation between psoriatic-related polyenthesitis and fibromyalgia. 2018

Marchesoni, Antonio / De Marco, Gabriele / Merashli, Mira / McKenna, Frank / Tinazzi, Ilaria / Marzo-Ortega, Helena / McGonagle, Dennis G. ·UOC Day Hospital of Rheumatology, ASST Gaetano Pini-CTO Hospital, Milano, Italy. · NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust. · Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Chapel Allerton Hospital, Leeds, UK. · Division of Rheumatology, Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon. · Rheumatology Department, Central Manchester University Hospitals NHS Trust, Trafford General Hospital, Manchester, UK. · Unit of Rheumatology, Sacro Cuore Don Calabria Hospital, Negrar, Italy. ·Rheumatology (Oxford) · Pubmed #28387854.

ABSTRACT: The recognition of the primacy of enthesitis in animal models of spondyloarthritis and the prevalence of clinically occult enthesopathy in psoriatic subjects and of persistent joint pain in PsA subjects who have ostensibly good reduction of joint swelling under biological therapy has highlighted the potential impact of polyenthesitis in psoriatic disease. In daily practice, the formal demonstration of enthesitis is challenging for the following reasons: the relatively avascular nature of enthesis, often leading to the absence of overt clinical inflammatory signs; the frequent lack of elevation of inflammatory markers; and finally, the limitations of current imaging techniques to provide supportive evidence for inflammation in these areas. Consequently, enthesitis may present as widespread pain indistinguishable from FM or may emerge as the dominant feature after successful biological therapy for suppression of synovitis. The unmet needs in the differentiation between FM and enthesitis in psoriatic disease patients are highlighted and critically evaluated in this article.

12 Review Should axial spondyloarthritis without radiographic changes be treated with anti-TNF agents? 2017

Keat, Andrew / Bennett, Alexander N / Gaffney, Karl / Marzo-Ortega, Helena / Sengupta, Raj / Everiss, Tamara. ·Rheumatology Department, Arthritis Centre, Northwick Park Hospital, Harrow, Middlesex, HA1 3UJ, UK. a.keat@nhs.net. · NIHR-Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust and Leeds Institute of Rheumatic and Musculoskeletal Disease, University of Leeds, Leeds, UK. · Academic Department of Military Rehabilitation, Defence Medical Rehabilitation Centre, Headley Court, Epsom, Surrey, UK. · Rheumatology Department, Norfolk and Norwich University Hospital NHS Foundation Trust, Norwich, Norfolk, UK. · Royal National Hospital for Rheumatic Diseases, Bath, UK. · Pfizer Ltd, Tadworth, Surrey, UK. ·Rheumatol Int · Pubmed #28035438.

ABSTRACT: A spectrum of disease extends beyond the rigid confines of ankylosing spondylitis (AS). Axial spondyloarthritis (axSpA) encompasses non-radiographic axSpA (nr-axSpA) in individuals without established radiographic changes but with other clinical/imaging axSpA features and AS in those with definite sacroiliac joint changes on pelvic X-rays. A broad consensus about the management of nr-axSpA is emerging among clinicians, but the evidence base remains open to question. To explore whether nr-axSpA and AS should be treated similarly, we examined the literature on their prevalence, natural history, disease burden, and treatment. There is strong evidence that nr-axSpA and AS are expressions of the same disease. Approximately 10% of patients with nr-axSpA will develop radiographic disease over 2 years; after >20 years, the figure may exceed 80%. Nr-axSpA patients have lower CRP and less spinal inflammation on MRI than AS patients but similar disease activity, pain, and quality-of-life impairment. Most patients with nr-axSpA manage well with conservative treatment, but a minority has severe disabling symptoms. Anti-TNF therapy has demonstrated similar efficacy and safety in nr-axSpA and AS. Current evidence does not clearly indicate that anti-TNF treatment can inhibit or limit bony progression of AS, the basis of conservative and anti-TNF treatment is control of symptoms and function. For some patients with nr-axSpA, the need for powerful treatments is as great as in some with AS; thus, treatment of axSpA should be consistent across the axSpA spectrum with anti-TNF agents being available, irrespective of radiographic change, according to the same criteria as those applied to AS.

13 Review Tumour necrosis factor-α inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis: a systematic review and economic evaluation. 2016

Corbett, Mark / Soares, Marta / Jhuti, Gurleen / Rice, Stephen / Spackman, Eldon / Sideris, Eleftherios / Moe-Byrne, Thirimon / Fox, Dave / Marzo-Ortega, Helena / Kay, Lesley / Woolacott, Nerys / Palmer, Stephen. ·Centre for Reviews and Dissemination, University of York, York, UK. · Centre for Health Economics, University of York, York, UK. · Division of Rheumatic and Musculoskeletal Disease, Chapel Allerton Hospital, Leeds Teaching Hospitals NHS Trust and University of Leeds, Leeds, UK. ·Health Technol Assess · Pubmed #26847392.

ABSTRACT: BACKGROUND: Tumour necrosis factor (TNF)-α inhibitors (anti-TNFs) are typically used when the inflammatory rheumatologic diseases ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-AxSpA) have not responded adequately to conventional therapy. Current National Institute for Health and Care Excellence (NICE) guidance recommends treatment with adalimumab, etanercept and golimumab in adults with active (severe) AS only if certain criteria are fulfilled but it does not recommend infliximab for AS. Anti-TNFs for patients with nr-AxSpA have not previously been appraised by NICE. OBJECTIVE: To determine the clinical effectiveness, safety and cost-effectiveness within the NHS of adalimumab, certolizumab pegol, etanercept, golimumab and infliximab, within their licensed indications, for the treatment of severe active AS or severe nr-AxSpA (but with objective signs of inflammation). DESIGN: Systematic review and economic model. DATA SOURCES: Fifteen databases were searched for relevant studies in July 2014. REVIEW METHODS: Clinical effectiveness data from randomised controlled trials (RCTs) were synthesised using Bayesian network meta-analysis methods. Results from other studies were summarised narratively. Only full economic evaluations that compared two or more options and considered both costs and consequences were included in the systematic review of cost-effectiveness studies. The differences in the approaches and assumptions used across the studies, and also those in the manufacturer's submissions, were examined in order to explain any discrepancies in the findings and to identify key areas of uncertainty. A de novo decision model was developed with a generalised framework for evidence synthesis that pooled change in disease activity (BASDAI and BASDAI 50) and simultaneously synthesised information on function (BASFI) to determine the long-term quality-adjusted life-year and cost burden of the disease in the economic model. The decision model was developed in accordance with the NICE reference case. The model has a lifetime horizon (60 years) and considers costs from the perspective of the NHS and personal social services. Health effects were expressed in terms of quality-adjusted life-years. RESULTS: In total, 28 eligible RCTs were identified and 26 were placebo controlled (mostly up to 12 weeks); 17 extended into open-label active treatment-only phases. Most RCTs were judged to have a low risk of bias overall. In both AS and nr-AxSpA populations, anti-TNFs produced clinically important benefits to patients in terms of improving function and reducing disease activity; for AS, the relative risks for ASAS 40 ranged from 2.53 to 3.42. The efficacy estimates were consistently slightly smaller for nr-AxSpA than for AS. Statistical (and clinical) heterogeneity was more apparent in the nr-AxSpA analyses than in the AS analyses; both the reliability of the nr-AxSpA meta-analysis results and their true relevance to patients seen in clinical practice are questionable. In AS, anti-TNFs are approximately equally effective. Effectiveness appears to be maintained over time, with around 50% of patients still responding at 2 years. Evidence for an effect of anti-TNFs delaying disease progression was limited; results from ongoing long-term studies should help to clarify this issue. Sequential treatment with anti-TNFs can be worthwhile but the drug survival response rates and benefits are reduced with second and third anti-TNFs. The de novo model, which addressed many of the issues of earlier evaluations, generated incremental cost-effectiveness ratios ranging from £19,240 to £66,529 depending on anti-TNF and modelling assumptions. CONCLUSIONS: In both AS and nr-AxSpA populations anti-TNFs are clinically effective, although more so in AS than in nr-AxSpA. Anti-TNFs may be an effective use of NHS resources depending on which assumptions are considered appropriate. FUTURE WORK RECOMMENDATIONS: Randomised trials are needed to identify the nr-AxSpA population who will benefit the most from anti-TNFs. STUDY REGISTRATION: This study is registered as PROSPERO CRD42014010182. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

14 Review Defining active sacroiliitis on MRI for classification of axial spondyloarthritis: update by the ASAS MRI working group. 2016

Lambert, Robert G W / Bakker, Pauline A C / van der Heijde, Désirée / Weber, Ulrich / Rudwaleit, Martin / Hermann, K G / Sieper, Joachim / Baraliakos, Xenofon / Bennett, Alex / Braun, Jürgen / Burgos-Vargas, Rubén / Dougados, Maxime / Pedersen, Susanne Juhl / Jurik, Anne Grethe / Maksymowych, Walter P / Marzo-Ortega, Helena / Østergaard, Mikkel / Poddubnyy, Denis / Reijnierse, Monique / van den Bosch, Filip / van der Horst-Bruinsma, Irene / Landewé, Robert. ·Department of Radiology and Diagnostic Imaging, University of Alberta, Edmonton, Alberta, Canada. · Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands. · King Christian 10th Hospital for Rheumatic Diseases, Gråsten, Denmark South Jutland Hospital and Institute of Regional Health Services Research, University of Southern Denmark, Odense, Denmark. · Endokrinologikum Berlin and Charité University Medicine, Berlin, Germany. · Department of Radiology, Charité Universitätsmedizin, Berlin, Germany. · Charité Universitätsmedizin, Berlin, Germany. · Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany. · Defence Medical Rehabilitation Centre, Surry, UK. · Department of Rheumatology, Hospital General de México and Faculty of Medicine, Universidad Nacional Autónoma de México, Mexico City, Mexico. · Department of Rheumatology, Hôpital Cochin, Paris Descartes University, Clinical Epidemiology and Biostatistics, PRES Sorbonne Paris-Cité, Paris, France. · Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark. · Department of Radiology, Aarhus University Hospital, Aarhus, Denmark. · Department of Medicine, University of Alberta, Edmonton, Alberta, Canada. · Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust, Leeds, UK. · Department of Radiology, Leiden University Medical Center, Leiden, The Netherlands. · Ghent University Hospital, Ghent, Belgium. · Department of Rheumatology, VU University Medical Centre, Amsterdam, The Netherlands. · Amsterdam Rheumatology & Immunology Center, Academic Medical Center, Amsterdam, The Netherlands. ·Ann Rheum Dis · Pubmed #26768408.

ABSTRACT: OBJECTIVES: To review and update the existing definition of a positive MRI for classification of axial spondyloarthritis (SpA). METHODS: The Assessment in SpondyloArthritis International Society (ASAS) MRI working group conducted a consensus exercise to review the definition of a positive MRI for inclusion in the ASAS classification criteria of axial SpA. Existing definitions and new data relevant to the MRI diagnosis and classification of sacroiliitis and spondylitis in axial SpA, published since the ASAS definition first appeared in print in 2009, were reviewed and discussed. The precise wording of the existing definition was examined in detail and the data and a draft proposal were presented to and voted on by the ASAS membership. RESULTS: The clear presence of bone marrow oedema on MRI in subchondral bone is still considered to be the defining observation that determines the presence of active sacroiliitis. Structural damage lesions seen on MRI may contribute to a decision by the observer that inflammatory lesions are genuinely due to SpA but are not required to meet the definition. The existing definition was clarified adding guidelines and images to assist in the application of the definition. CONCLUSION: The definition of a positive MRI for classification of axial SpA should continue to primarily depend on the imaging features of 'active sacroiliitis' until more data are available regarding MRI features of structural damage in the sacroiliac joint and MRI features in the spine and their utility when used for classification purposes.

15 Review Emerging drugs for axial spondyloarthritis including ankylosing spondylitis. 2013

Busquets-Perez, Noemi / Marzo-Ortega, Helena / Emery, Paul. ·Hospital General de Granollers, Department of Medicine, Granollers, Spain. ·Expert Opin Emerg Drugs · Pubmed #23253176.

ABSTRACT: INTRODUCTION: Only non-steroidal anti-inflammatories (NSAIDs) and TNF inhibitors (TNFi) are effective in ankylosing spondylitis (AS). However, not all patients successfully respond to these drugs and a subset may have contraindications to their use. AREAS COVERED: In the last decade, an earlier diagnosis of AS has been achieved due to the increasing availability of MRI. This has led to prompt treatment initiation with improved outcomes. NSAIDs and TNFi are the current treatments for AS which lead to sustained clinical responses in the long term. Recent studies have shown other potential biomarkers in AS, such as the IL-17/IL-23 axis. This has translated into the development of new drugs which interfere with these pathways, such as apremilast and secukinumab, which have shown efficacy in early clinical trials. EXPERT OPINION: AS carries considerable short- and long-term disabilities. Anti-TNF-α therapies reduce pain, improve function and decrease inflammation as seen by MRI. New treatment options are being developed which may prove efficacious on those patients not responding to anti-TNF. The ultimate research goal should focus on treatments to prevent and stop new bone formation.

16 Review A systematic literature review of drug therapies for the treatment of psoriatic arthritis: current evidence and meta-analysis informing the EULAR recommendations for the management of psoriatic arthritis. 2012

Ash, Zoe / Gaujoux-Viala, Cécile / Gossec, Laure / Hensor, Elizabeth M A / FitzGerald, Oliver / Winthrop, Kevin / van der Heijde, Désirée / Emery, Paul / Smolen, Josef S / Marzo-Ortega, Helena. ·Section of Musculoskeletal Disease, Leeds Institute of Molecular Medicine, University of Leeds, Leeds, UK. ·Ann Rheum Dis · Pubmed #21803753.

ABSTRACT: OBJECTIVES: To review the available evidence for the efficacy and safety of non-steroidal anti-inflammatory drugs (NSAIDs), synthetic and biological drug therapies for the different clinical manifestations of psoriatic arthritis (PsA) in order to provide data for the development of treatment recommendations by the European League Against Rheumatism (EULAR) taskforce. METHODS: A systematic literature review (SLR) of available treatments for PsA was performed using the largest electronic databases (MEDLINE, EMBASE and COCHRANE) by two working groups formed within the EULAR taskforce. This comprised a comprehensive sample of rheumatologists, dermatologists, epidemiologists and patients. The available evidence was reviewed for NSAIDs, synthetic disease modifying antirheumatic drugs (DMARDs), local and systemic corticosteroids and biologic drugs. All articles and abstracts published between 1962 and January 2010 were reviewed and considered and a meta-analysis of data on biological therapies was performed. RESULTS: While little data are available on NSAIDs, glucocorticoids and synthetic DMARDs, the available evidence suggests an acceptable efficacy and safety profile of both NSAIDs and synthetic DMARDs (methotrexate, cyclosporine A, sulfasalazine and leflunomide) in PsA. More evidence is available (level 1B) supporting the efficacy of anti-tumour necrosis factor (anti-TNF) agents (adalimumab, etanercept, golimumab and infliximab) in treating the signs and symptoms of PsA as well as reducing radiographic progression. Registry data show no new safety concerns, although the numbers studied to date are relatively small. CONCLUSIONS: This SLR reveals some evidence to support the use of NSAIDs and synthetic DMARDs and good evidence for the efficacy of anti-TNF therapy in PsA.

17 Review Optical coherence tomography: a new tool to assess nail disease in psoriasis? 2011

Aydin, Sibel Zehra / Ash, Zoe / Del Galdo, Francesco / Marzo-Ortega, Helena / Wakefield, Richard J / Emery, Paul / McGonagle, Dennis. ·NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust, Leeds, UK. drsibelaydin@gmail.com ·Dermatology · Pubmed #21791896.

ABSTRACT: BACKGROUND: Nail disease is a characteristic manifestation of the psoriatic disease spectrum but is poorly understood. OBJECTIVE: Given the intrinsically high spatial resolution imaging capabilities of optical coherence tomography (OCT), we assessed its value in psoriatic nail disease compared to high-resolution ultrasonography (US). METHODS: All fingernails in a psoriatic arthritis patient with nail changes were scanned with OCT, and findings were compared with high-resolution US. RESULTS: US showed loss of trilaminar appearance in all nails, resulting in the nail plate being visualized as a single hyperechoic layer with inhomogeneous thickness. The OCT images showed much higher-resolution changes with prominent thickening in the ventral plate at the nail bed which was grossly inhomogeneous, 'eroded' and irregularly fused with the underlying epidermis, which correlated with the clinical observation of subungal hyperakeratosis. CONCLUSION: OCT has considerable potential for the evaluation of psoriatic nail disease and may be superior to US.

18 Review Magnetic resonance imaging in spondyloarthritis. 2010

Marzo-Ortega, Helena / McGonagle, Dennis / Bennett, Alexander N. ·Leeds Institute of Molecular Medicine, University of Leeds, Leeds, UK. medhmo@leeds.ac.uk ·Curr Opin Rheumatol · Pubmed #20386452.

ABSTRACT: PURPOSE OF REVIEW: The study of the early involvement of the axial skeleton has dominated the research map in spondyloarthritides (SpA) in recent months. MRI remains the imaging method of choice to visualize the sacroiliac joint and spine as recognized by the new classification criteria for axial SpA. This review synthesises the most recently published data and offers a critical appraisal of findings. RECENT FINDINGS: MRI studies of inflammatory back pain of short duration have identified disease starting simultaneously in the lumbar spine and sacroiliac joints in a proportion of patients and confirm MRI as a reliable measure to assess efficacy of biologic agents in early axial SpA. The new Assessment of SpondyloArthritis International Society classification criteria can be applied in the presence and absence of radiographic abnormalities of the sacroiliac joints. Imaging studies of the spine have confirmed the diagnostic utility of spinal MRI in SpA and have described highly specific lesions such as inflammatory vertebral and posterior element lesions or the postinflammatory fatty Romanus lesions. SUMMARY: MRI in axial SpA is the most rapidly expanding area of translational research in SpA. The publication of the new Assessment of SpondyloArthritis International Society classification criteria for axial SpA heralds a new era for the identification of early disease and mirrors the existing use of MRI in clinical practice for the evaluation of inflammatory back pain.

19 Review The evidence for whole-spine MRI in the assessment of axial spondyloarthropathy. 2010

Bennett, Alexander N / Marzo-Ortega, Helena / Rehman, Amer / Emery, Paul / McGonagle, Dennis / Anonymous830648. ·Leeds Institute of Molecular Medicine, University of Leeds, Chapel Allerton Hospital, Leeds LS7 4SA, UK. ·Rheumatology (Oxford) · Pubmed #20064871.

ABSTRACT: In the past decade, fat-suppression MRI techniques have been increasingly used for the assessment of axial-SpA. Indeed, newly proposed classification criteria have suggested the inclusion of fat-suppression MRI for the evaluation of the SI joint in inflammatory back pain (IBP) of suspected axial-SpA. However, recent data on the whole spine have identified certain MRI spinal lesions to be highly diagnostic of axial-SpA; that the SI joint can be spared in axial-SpA; and that IBP may originate in the lumbar spine rather than SI joint. Therefore, it is proposed that MRI of the whole spine and not just the SI joint should now become a routine part of the assessment of axial-SpA. Not only is spinal MRI of great diagnostic utility in axial-SpA but there is also increasing evidence to suggest that it can play a significant role in the management, in particular directing anti-TNF therapy in AS, and also it may be prognostically useful in axial-SpA. With the wider availability, improving technology and falling cost of MRI, and the difficulty that clinical assessment of axial-SpA poses, especially in early disease, there is now a strong case for the use of whole-spine MRI in the diagnosis and management of axial-SpA.

20 Clinical Trial The GOLMePsA study protocol: an investigator-initiated, double-blind, parallel-group, randomised, controlled trial of GOLimumab and methotrexate versus methotrexate in early diagnosed psoriatic arthritis using clinical and whole body MRI outcomes. 2017

De Marco, Gabriele / Helliwell, Philip / McGonagle, Dennis / Emery, Paul / Coates, Laura C / Hensor, Elizabeth M A / Marzo-Ortega, Helena. ·NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, West Yorkshire, UK. · Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Chapel Allerton Hospital, 2nd Floor Chapeltown Road, Leeds, West Yorkshire, LS7 4SA, UK. · Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Chapel Allerton Hospital, 2nd Floor Chapeltown Road, Leeds, West Yorkshire, LS7 4SA, UK. medhmo@leeds.ac.uk. ·BMC Musculoskelet Disord · Pubmed #28720139.

ABSTRACT: BACKGROUND: Psoriatic arthritis (PsA) is a chronic inflammatory arthritis which impacts significantly on the quality of life and work capacity of affected individuals. Recent evidence has shown that early control of inflammation in PsA leads to improved long-term outcomes. It is postulated that prompt intervention after diagnosis using a remission-induction treatment strategy will lead to improved outcomes and optimal disease control of PsA. The aim of the present study was to compare the clinical efficacy of a treatment strategy in newly diagnosed, treatment naïve PsA subjects, using the combination of golimumab (GOL), methotrexate (MTX) and steroids versus standard care (MTX monotherapy plus steroids). METHODS/DESIGN: GOLMePsA is an investigator initiated, phase IIIb, single-centre, randomised, double-blind, placebo-controlled, two-armed, parallel-group, imaging-supplemented study. Eighty-eight PsA patients, diagnosed within 24 months prior to screening and treatment naïve, will be randomised at baseline to receive: (arm 1) the combination of intramuscular/intra-articular prednisolone, MTX and GOL or (arm 2) the combination of intramuscular/intra-articular prednisolone, MTX and placebo for 24 weeks (interventional period). Primary outcome measure is clinical improvement (at least 1 unit difference) in the Psoriatic ArthritiS Disease Activity Score (PASDAS) composite index. Reflecting a "step down" therapeutic approach, all participants successfully completing the interventional period will be followed up for a further 28 weeks. During this observational period, stable maintenance MTX monotherapy will continue for both arms, unless in case of intolerance or PsA relapse. In the latter case, additional treatment will be provided. Overall, the GOLMePsA study length is planned to be 52 weeks. DISCUSSION: The hypothesis underlining this study is that very early treatment with first-line GOL reduces disease activity in PsA, in comparison to conventional therapy. TRIAL REGISTRATION: EudraCT 2013-004122-28 . 24/09/2013.

21 Clinical Trial Secukinumab and Sustained Improvement in Signs and Symptoms of Patients With Active Ankylosing Spondylitis Through Two Years: Results From a Phase III Study. 2017

Marzo-Ortega, H / Sieper, J / Kivitz, A / Blanco, R / Cohen, M / Martin, R / Readie, A / Richards, H B / Porter, B / Anonymous6660897. ·Leeds Teaching Hospitals Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK. · University Clinic Benjamin Franklin, Berlin, Germany. · Altoona Center for Clinical Research, Duncansville, Pennsylvania. · Hospital Universitario Marqués de Valdecilla, ​Instituto de Investigación Marqués de Valdecilla-IDIVAL​, Santander, Spain. · McGill University, Montreal, Canada. · Novartis Pharmaceuticals Corporation, East Hanover, New Jersey. · Novartis Pharma AG, Basel, Switzerland. ·Arthritis Care Res (Hoboken) · Pubmed #28235249.

ABSTRACT: OBJECTIVE: Secukinumab improved the signs and symptoms of ankylosing spondylitis (AS) over 52 weeks in the phase III MEASURE 2 study. Here, we report longer-term (104 weeks) efficacy and safety results. METHODS: Patients with active AS were randomized to subcutaneous secukinumab 150 mg, 75 mg, or placebo at baseline; weeks 1, 2, and 3; and every 4 weeks from week 4. The primary end point was the Assessment of SpondyloArthritis international Society criteria for 20% improvement (ASAS20) response rate at week 16. Other end points included ASAS40, high-sensitivity C-reactive protein, ASAS5/6, Bath Ankylosing Spondylitis Disease Activity Index, Short Form 36 health survey physical component summary, ASAS partial remission, EuroQol 5-domain measure, and Functional Assessment of Chronic Illness Therapy fatigue subscale. End points were assessed through week 104, with multiple imputation for binary variables and a mixed-effects model repeated measures for continuous variables. RESULTS: Of 219 randomized patients, 60 of 72 (83.3%) and 57 of 73 (78.1%) patients completed 104 weeks of treatment with secukinumab 150 mg and 75 mg, respectively; ASAS20/ASAS40 response rates at week 104 were 71.5% and 47.5% with both secukinumab doses, respectively. Clinical improvements with secukinumab were sustained through week 104 across all secondary end points. Across the entire treatment period (mean secukinumab exposure 735.6 days), exposure-adjusted incidence rates for serious infections and infestations, Crohn's disease, malignant or unspecified tumors, and major adverse cardiac events with secukinumab were 1.2, 0.7, 0.5, and 0.7 per 100 patient-years, respectively. No cases of tuberculosis reactivation, opportunistic infections, or suicidal ideation were reported. CONCLUSION: Secukinumab provided sustained improvement through 2 years in the signs and symptoms of AS, with a safety profile consistent with previous reports.

22 Clinical Trial Secukinumab efficacy in anti-TNF-naive and anti-TNF-experienced subjects with active ankylosing spondylitis: results from the MEASURE 2 Study. 2017

Sieper, Joachim / Deodhar, Atul / Marzo-Ortega, Helena / Aelion, Jacob A / Blanco, Ricardo / Jui-Cheng, Tseng / Andersson, Mats / Porter, Brian / Richards, Hanno B / Anonymous50880. ·Charité University Medicine Berlin, Berlin, Germany. · Oregon Health & Science University, Portland, Oregon, USA. · NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust and Leeds Institute for Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK. · Arthritis Clinic, Jackson, Tennessee, USA. · Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain. · Kaohsiung Veterans General Hospital, Kaohsiung City, Taiwan. · Novartis Pharma AG, Basel, Switzerland. · Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA. ·Ann Rheum Dis · Pubmed #27582421.

ABSTRACT: BACKGROUND: There is significant unmet need in patients with ankylosing spondylitis (AS) who have inadequate response or intolerance to anti-tumour necrosis factor (TNF) treatment. Secukinumab, an anti-interleukin-17A monoclonal antibody, significantly improved signs and symptoms of AS in the MEASURE 2 study (NCT01649375). METHODS: Subjects with active AS (N=219) received secukinumab (150 or 75 mg) or placebo at baseline, weeks 1, 2, 3 and 4, and every 4 weeks thereafter. Randomisation was stratified by prior anti-TNF use: anti-TNF-naive or inadequate response/intolerance to one anti-TNF (anti-TNF-IR). The primary endpoint was Assessment of SpondyloArthritis International Society criteria (ASAS) 20 at week 16. RESULTS: At week 16, 68.2% of anti-TNF-naive subjects treated with secukinumab 150 mg achieved ASAS20 compared with 31.1% treated with placebo (p<0.001). In the anti-TNF-IR group, 50.0% of subjects treated with secukinumab 150 mg achieved an ASAS20 response compared with 24.1% treated with placebo (p<0.05). Numerically greater improvements were observed with secukinumab than with placebo for most secondary endpoints. Clinical responses were sustained through week 52. CONCLUSIONS: Secukinumab 150 mg provided sustained improvements in signs and symptoms of AS in anti-TNF-naive and anti-TNF-IR subjects through 52 weeks of therapy. TRIAL REGISTRATION NUMBER: NCT01649375.

23 Clinical Trial A Phase III, Randomized, Controlled Trial of Apremilast in Patients with Psoriatic Arthritis: Results of the PALACE 2 Trial. 2016

Cutolo, Maurizio / Myerson, Gary E / Fleischmann, Roy M / Lioté, Frédéric / Díaz-González, Federico / Van den Bosch, Filip / Marzo-Ortega, Helena / Feist, Eugen / Shah, Kamal / Hu, ChiaChi / Stevens, Randall M / Poder, Airi. ·From the Research Laboratory and Division of Clinical Rheumatology, University of Genoa, Genoa, Italy; Arthritis and Rheumatology of Georgia, Atlanta, Georgia; Metroplex Clinical Research Center, Dallas, Texas, USA; AP-HP, Hôpital Lariboisière, Rheumatology Department, Université Paris Diderot, Paris, France; University of La Laguna, Hospital Universitario de Canarias, La Laguna, Spain; UZ Gent, Ghent, Belgium; UK National Institute for Health Research (NIHR) Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK; Charité - Universitätsmedizin Berlin, Department for Rheumatology and Clinical Immunology, Berlin, Germany; Celgene Corp., Summit, New Jersey, USA; Clinical Research Centre Ltd., Tartu, Estonia.M. Cutolo, MD, University of Genoa; G.E. Myerson, MD, Arthritis and Rheumatology of Georgia; R.M. Fleischmann, MD, Metroplex Clinical Research Center; F. Lioté, MD, AP-HP, Hôpital Lariboisière, Université Paris Diderot; F. Diaz-González, MD, University of La Laguna, Hospital Universitario de Canarias; F. Van den Bosch, MD, UZ Gent; H. Marzo-Ortega, MD, NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; E. Feist, MD, Charité - Universitätsmedizin Berlin; K. Shah, MD, Celgene Corp.; C. Hu, EdM, MS, Celgene Corp.; R.M. Stevens, MD, Celgene Corp.; A. Poder, MD, Clinical Research Centre Ltd. ·J Rheumatol · Pubmed #27422893.

ABSTRACT: OBJECTIVE: Apremilast, an oral phosphodiesterase 4 inhibitor, downregulates intracellular inflammatory mediator synthesis by elevating cyclic adenosine monophosphate levels. The PALACE 2 trial evaluated apremilast efficacy and safety in patients with active psoriatic arthritis (PsA) despite prior conventional disease-modifying antirheumatic drugs and/or biologic therapy. METHODS: Eligible patients were randomized (1:1:1) to placebo, apremilast 20 mg BID, or apremilast 30 mg BID. At Week 16, patients with swollen and tender joint count improvement < 20% entered early escape, with placebo patients rerandomized (1:1) to apremilast 20 mg BID or 30 mg BID while apremilast patients continued on their initial apremilast dose. At Week 24, patients remaining on placebo were rerandomized to apremilast 20 mg BID or 30 mg BID. The primary endpoint was the proportion of patients achieving > 20% improvement in American College of Rheumatology response criteria (ACR20) at Week 16. RESULTS: In the intent-to-treat population (N = 484), ACR20 at Week 16 was achieved by more patients receiving apremilast 20 mg BID [37.4% (p = 0.0002)] and 30 mg BID [32.1% (p = 0.0060)] versus placebo (18.9%). Clinically meaningful improvements in signs and symptoms of PsA, physical function, and psoriasis were observed with apremilast through Week 52. The most common adverse events were diarrhea, nausea, headache, and upper respiratory tract infection. Diarrhea and nausea generally occurred early and usually resolved spontaneously with continued treatment. Laboratory abnormalities were infrequent and transient. CONCLUSION: Apremilast demonstrated clinical improvements in PsA for up to 52 weeks, including signs and symptoms, physical function, and psoriasis. No new safety signals were observed. ClinicalTrials.gov identifier: NCT01212757.

24 Clinical Trial Observed Incidence of Uveitis Following Certolizumab Pegol Treatment in Patients With Axial Spondyloarthritis. 2016

Rudwaleit, M / Rosenbaum, J T / Landewé, R / Marzo-Ortega, H / Sieper, J / van der Heijde, D / Davies, O / Bartz, H / Hoepken, B / Nurminen, T / Deodhar, A. ·Klinikum Bielefeld, Bielefeld, Germany. · Devers Eye Institute, Legacy Health System, Portland, Oregon, and Oregon Health & Science University, Portland. · Academic Medical Center, Amsterdam and Atrium Medical Center, Heerlen, the Netherlands. · Leeds Teaching Hospitals NHS Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK. · University Hospital Charité, Berlin, Germany. · Leiden University Medical Centre, Leiden, the Netherlands. · UCB Pharma, Slough, UK. · UCB Pharma, Monheim, Germany. · Oregon Health & Science University, Portland. ·Arthritis Care Res (Hoboken) · Pubmed #26815944.

ABSTRACT: OBJECTIVE: Axial spondyloarthritis (axial SpA) is characterized by inflammation of the spine and sacroiliac joints and can also affect extraarticular sites, with the most common manifestation being uveitis. Here we report the incidence of uveitis flares in axial SpA patients from the RAPID-axSpA trial, including ankylosing spondylitis (AS) and nonradiographic (nr) axial SpA. METHODS: The RAPID-axSpA (NCT01087762) trial is double-blind and placebo-controlled to week 24, dose-blind to week 48, and open-label to week 204. Patients were randomized to certolizumab pegol (CZP) or placebo. Placebo patients entering the dose-blind phase were re-randomized to CZP. Uveitis events were recorded on extraarticular manifestation or adverse event forms. Events were analyzed in patients with/without history of uveitis, and rates reported per 100 patient-years. RESULTS: At baseline, 38 of 218 CZP-randomized patients (17.4%) and 31 of 107 placebo-randomized patients (29.0%) had past uveitis history. During the 24-week double-blind phase, the rate of uveitis flares was lower in CZP (3.0 [95% confidence interval (95% CI) 0.6-8.8] per 100 patient-years) than in placebo (10.3 [95% CI 2.8-26.3] per 100 patient-years). All cases observed during the 24-week double-blind phase were in patients with a history of uveitis; in these patients, rates were similarly lower for CZP (17.1 [95% CI 3.5-50.1] per 100 patient-years) than placebo (38.5 [95% CI 10.5-98.5] per 100 patient-years). Rates of uveitis flares remained low up to week 96 (4.9 [95% CI 3.2-7.4] per 100 patient-years) and were similar between AS (4.4 [95% CI 2.3-7.7] per 100 patient-years) and nr-axial SpA (5.6 [95% CI 2.9-9.8] per 100 patient-years). CONCLUSION: The rate of uveitis flares was lower for axial SpA patients treated with CZP than placebo during the randomized controlled phase. Incidence of uveitis flares remained low to week 96 and was comparable to rates reported for AS patients receiving other anti-tumor necrosis factor antibodies.

25 Article Ixekizumab improves patient-reported outcomes in patients with active psoriatic arthritis and inadequate response to tumour necrosis factor inhibitors: SPIRIT-P2 results to 52 weeks. 2019

Kavanaugh, Arthur / Marzo-Ortega, Helena / Vender, Ronald / Wei, Cheng-Chung / Birt, Julie / Adams, David H / Benichou, Olivier / Lin, Chen-Yen / Nash, Peter. ·Division of Rheumatology, Allergy, and Immunology, University of California, San Diego (UCSD) School of Medicine, San Diego, CA, USA. akavanaugh@ucsd.edu. · NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust and LIRMM, University of Leeds, UK. · Dermatrials Research, Inc, Hamilton, Ontario, Canada. · Institute of Medicine, Chung Shan Medical University; Chung Shan Medical University Hospital; Graduate Institute of Integrated Medicine, Division of Allergy, Immunology and Rheumatology, China Medical University, Taichung, Taiwan. · Eli Lilly and Company, Global Patient Outcomes and Real World Evidence, Indianapolis, IN, USA. · Eli Lilly and Company, Global Medical, Indianapolis, IN, USA. · Eli Lilly and Company, Real-world Analytics-Immunology, Global Statistical Science, Indianapolis, IN, USA. · Department of Medicine, Rheumatology Research Unit, University of Queensland, Sunshine Coast, QLD, Australia. ·Clin Exp Rheumatol · Pubmed #30557128.

ABSTRACT: OBJECTIVES: To report patient-reported outcomes (PROs) of ixekizumab-treated patients with psoriatic arthritis (PsA) and an inadequate response (IR) or intolerance to tumour necrosis factor inhibitors (TNFi) to 52 weeks. METHODS: In SPIRIT-P2, patients with active PsA and an IR or intolerance to TNFi were randomised to ixekizumab 80 mg every 4 weeks (IXEQ4W; N=122) or every 2 weeks (IXEQ2W; N=123), or placebo (PBO; N=118) during the initial 24-week double-blind treatment period. At Week 16, background therapy was modified for IRs; additionally, IRs in the placebo group were re-randomised (1:1) to IXEQ2W or IXEQ4W. Patients receiving ixekizumab at Week 24 received the same dose during the study remainder. Patients completed several PROs for PsA disease activity, skin, health-related quality of life (HRQOL, and work through Week 52. RESULTS: Ixekizumab-treated patients reported significant improvements versus PBO in 36-Item Short Form Health Survey version 2, European Quality of Life 5 Dimensions visual analogue scale, Bath Ankylosing Spondylitis Disease Activity Index (total score and question 2), and Work Productivity and Activity Impairment Questionnaire-Specific Health Problem (3 of 4 domains) through Week 24. At Week 24, 9% (PBO), 52% (IXEQ4W), and 50% (IXEQ2W) of patients reported Dermatology Life Quality Index scores of 0 or 1; 0% (PBO) and 24% (IXEQ4W and IXEQ2W) reported Itch Numeric Rating Scale score of 0. Where data were collected, improvements persisted through Week 52. CONCLUSIONS: In patients with PsA and an IR or intolerance to TNFi, ixekizumab significantly improved disease activity, skin symptoms, HRQOL, and work productivity to 52 weeks.

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