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Research ArticleSpondyloarthritis

One-Third of European Patients With Axial Spondyloarthritis Reach Pain Remission With Routine Care Tumor Necrosis Factor Inhibitor Treatment

Lykke Midtbøll Ørnbjerg, Kathrine Rugbjerg, Stylianos Georgiadis, Simon Horskjær Rasmussen, Ulf Lindström, Karel Pavelka, Neslihan Yilmaz, Ennio Giulio Favalli, Michael J. Nissen, Brigitte Michelsen, Elsa Vieira-Sousa, Gareth T. Jones, Ruxandra Ionescu, Heikki Relas, Carlos Sanchez-Piedra, Matija Tomšič, Arni Jon Geirsson, Irene van der Horst-Bruinsma, Johan Askling, Anne Gitte Loft, Lucie Nekvindova, Haner Direskeneli, Florenzo Iannone, Adrian Ciurea, Karen Minde Fagerli, Maria José Santos, Gary J. Macfarlane, Catalin Codreanu, Kari Eklund, Manuel Pombo-Suarez, Ziga Rotar, Bjorn Gudbjornsson, Tamara Rusman, Mikkel Østergaard and Merete Lund Hetland
The Journal of Rheumatology August 2023, 50 (8) 1009-1019; DOI: https://doi.org/10.3899/jrheum.220459
Lykke Midtbøll Ørnbjerg
1L.M. Ørnbjerg, MD, PhD, K. Rugbjerg, MSc, PhD, S. Georgiadis, PhD, S.H. Rasmussen, PhD, Copenhagen Center for Arthritis Research (COPECARE), Centre for Rheumatology and Spine Diseases, Centre of Head and Orthopaedics, Copenhagen University Hospital, Glostrup, Denmark;
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  • For correspondence: lykke.midtboell.oernbjerg@regionh.dk
Kathrine Rugbjerg
1L.M. Ørnbjerg, MD, PhD, K. Rugbjerg, MSc, PhD, S. Georgiadis, PhD, S.H. Rasmussen, PhD, Copenhagen Center for Arthritis Research (COPECARE), Centre for Rheumatology and Spine Diseases, Centre of Head and Orthopaedics, Copenhagen University Hospital, Glostrup, Denmark;
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Stylianos Georgiadis
1L.M. Ørnbjerg, MD, PhD, K. Rugbjerg, MSc, PhD, S. Georgiadis, PhD, S.H. Rasmussen, PhD, Copenhagen Center for Arthritis Research (COPECARE), Centre for Rheumatology and Spine Diseases, Centre of Head and Orthopaedics, Copenhagen University Hospital, Glostrup, Denmark;
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Simon Horskjær Rasmussen
1L.M. Ørnbjerg, MD, PhD, K. Rugbjerg, MSc, PhD, S. Georgiadis, PhD, S.H. Rasmussen, PhD, Copenhagen Center for Arthritis Research (COPECARE), Centre for Rheumatology and Spine Diseases, Centre of Head and Orthopaedics, Copenhagen University Hospital, Glostrup, Denmark;
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Ulf Lindström
2U. Lindström, MD, PhD, Department of Rheumatology and Inflammation Research, University of Gothenburg Sahlgrenska Academy, Gothenburg, Sweden;
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Karel Pavelka
3K. Pavelka, MD, PhD, Institute of Rheumatology, and Department of Rheumatology, First Faculty of Medicine, Charles University, Prague, Czech Republic;
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Neslihan Yilmaz
4N. Yilmaz, MD, Department of Rheumatology, Demiroglu Bilim University, Istanbul, Turkey;
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Ennio Giulio Favalli
5E.G. Favalli, MD, PhD, Division of Clinical Rheumatology, ASST Gaetano Pini-CTO Institute, Milan, Italy;
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Michael J. Nissen
6M.J. Nissen, MD, PhD, Department of Rheumatology, Geneva University Hospital, Geneva, Switzerland;
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Brigitte Michelsen
7B. Michelsen, MD, PhD, Department of Rheumatology and Research, Diakonhjemmet Hospital, Oslo, Norway, and Division of Rheumatology, Department of Medicine, Hospital of Southern Norway Trust, Kristiansand, Norway, and COPECARE, Centre for Rheumatology and Spine Diseases, Centre of Head and Orthopaedics, Copenhagen University Hospital, Glostrup, Denmark;
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Elsa Vieira-Sousa
8E. Vieira-Sousa, MD, Department of Rheumatology, Hospital de Santa Maria, CHULN, Instituto Medicina Molecular, Faculdade de Medicina da Universidade de Lisboa, Centro Académico de Medicina de Lisboa, Lisbon, Portugal;
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Gareth T. Jones
9G.T. Jones, PhD, G.J. Macfarlane, MD, PhD, Aberdeen Centre for Arthritis and Musculoskeletal Health (Epidemiology Group), University of Aberdeen, Aberdeen, United Kingdom;
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Ruxandra Ionescu
10R. Ionescu, MD, PhD, Carol Davila University of Medicine and Pharmacy, Bucharest, Romania;
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Heikki Relas
11H. Relas, MD, PhD, K. Eklund, MD, PhD, Inflammation Center, Department of Rheumatology, Helsinki University Hospital, Helsinki, Finland;
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Carlos Sanchez-Piedra
12C. Sanchez-Piedra, MD, PhD, Research Unit, Spanish Society of Rheumatology, Madrid, Spain;
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Matija Tomšič
13M. Tomšič, MD, PhD, Z. Rotar, MD, PhD, Department of Rheumatology, University Medical Centre Ljubljana, and Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia;
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Arni Jon Geirsson
14A.J. Geirsson, MD, Department of Rheumatology, University Hospital, Reykjavik, Iceland;
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Irene van der Horst-Bruinsma
15I. van der Horst-Bruinsma, MD, PhD, Department of Rheumatology, Radboud University Medical Center, Nijmegen, the Netherlands;
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Johan Askling
16J. Askling, MD, PhD, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden;
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Anne Gitte Loft
17A.G. Loft, MD, PhD, Department of Rheumatology, Aarhus University Hospital, and Department of Clinical Medicine, Aarhus University, Aarhus, Denmark;
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Lucie Nekvindova
18L. Nekvindova, MD, PhD, Department of Rheumatology, First Faculty of Medicine, Charles University, Prague, and Institute of Biostatistics and Analyses, Ltd., Brno, Czech Republic;
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Haner Direskeneli
19H. Direskeneli, MD, Department of Rheumatology, Marmara University School of Medicine, Istanbul, Turkey;
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Florenzo Iannone
20F. Iannone, MD, PhD, Rheumatology Unit, DETO, University of Bari, Italy;
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Adrian Ciurea
21A. Ciurea, MD, Department of Rheumatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland;
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Karen Minde Fagerli
22K.M. Fagerli, MD, PhD, Department of Rheumatology and Research, Diakonhjemmet Hospital, Oslo, Norway;
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Maria José Santos
23M.J. Santos, MD, PhD, Department of Rheumatology, Hospital Garcia de Orta, Almada, Portugal;
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Gary J. Macfarlane
9G.T. Jones, PhD, G.J. Macfarlane, MD, PhD, Aberdeen Centre for Arthritis and Musculoskeletal Health (Epidemiology Group), University of Aberdeen, Aberdeen, United Kingdom;
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Catalin Codreanu
24C. Codreanu, MD, PhD, Center for Rheumatic Diseases, University of Medicine and Pharmacy, Bucharest, Romania;
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Kari Eklund
11H. Relas, MD, PhD, K. Eklund, MD, PhD, Inflammation Center, Department of Rheumatology, Helsinki University Hospital, Helsinki, Finland;
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Manuel Pombo-Suarez
25M. Pombo-Suarez, MD, PhD, Rheumatology Service, Hospital Clinico Universitario, Santiago de Compostela, Spain;
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Ziga Rotar
13M. Tomšič, MD, PhD, Z. Rotar, MD, PhD, Department of Rheumatology, University Medical Centre Ljubljana, and Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia;
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Bjorn Gudbjornsson
26B. Gudbjornsson, MD, PhD, Centre for Rheumatology Research, Landspitali University Hospital, and Faculty of Medicine, University of Iceland, Reykjavik, Iceland;
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Tamara Rusman
27T. Rusman, MSc, Department of Rheumatology, Amsterdam UMC, VU University Medical Centre, Amsterdam, the Netherlands;
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Mikkel Østergaard
28M. Østergaard, MD, PhD, DMSc, M.L. Hetland, MD, PhD, DMSc, COPECARE, Centre for Rheumatology and Spine Diseases, Centre of Head and Orthopaedics, Copenhagen University Hospital, Glostrup, and Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
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Merete Lund Hetland
28M. Østergaard, MD, PhD, DMSc, M.L. Hetland, MD, PhD, DMSc, COPECARE, Centre for Rheumatology and Spine Diseases, Centre of Head and Orthopaedics, Copenhagen University Hospital, Glostrup, and Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
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Abstract

Objective To investigate the distribution of patient-reported outcomes (PROs) in patients with axial spondyloarthritis (axSpA) initiating a tumor necrosis factor inhibitor (TNFi), to assess the proportion reaching PRO “remission” across registries and treatment series, and to compare patients registered to fulfill the modified New York (mNY) criteria for ankylosing spondylitis (AS) vs patients with nonradiographic axSpA (nr-axSpA).

Methods Fifteen European registries contributed PRO scores for pain, fatigue, patient global assessment (PtGA), Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI), Bath AS Functional Index (BASFI), and Health Assessment Questionnaire (HAQ) from 19,498 patients with axSpA. Changes in PROs and PRO remission rates (definitions: ≤ 20 mm for pain, fatigue, PtGA, BASDAI, and BASFI; ≤ 0.5 for HAQ) were calculated at 6, 12, and 24 months of treatment.

Results Heterogeneity in baseline characteristics and outcomes between registries were observed. In pooled data, 6 months after the start of a first TNFi, pain score was reduced by approximately 60% (median at baseline/6/12/24 months: 65/25/20/20 mm) in patients on treatment. Similar patterns were observed for fatigue (68/32/30/25 mm), PtGA (66/29/21/20 mm), BASDAI (58/26/21/19 mm), BASFI (46/20/16/16 mm), and HAQ (0.8/0.4/0.2/0.2). Patients with AS (n = 3281) had a slightly better response than patients with nr-axSpA (n = 993). The Lund Efficacy Index (LUNDEX)-adjusted remission rates at 6 months for pain/fatigue/PtGA/BASDAI/BASFI/HAQ were 39%/30%/38%/34%/35%/48% for the AS cohort and 30%/21%/26%/24%/33%/47% for the nr-axSpA cohort. Better PRO responses were seen with a first TNFi compared to a second and third TNFi.

Conclusion Patients with axSpA starting a TNFi achieved high PRO remission rates, most pronounced in those fulfilling the mNY criteria and for the first TNFi.

Key Indexing Terms:
  • axial spondyloarthritis
  • patient-reported outcome measures
  • tumor necrosis factor inhibitors
  • Accepted for publication October 13, 2022.
  • Copyright © 2023 by the Journal of Rheumatology
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One-Third of European Patients With Axial Spondyloarthritis Reach Pain Remission With Routine Care Tumor Necrosis Factor Inhibitor Treatment
Lykke Midtbøll Ørnbjerg, Kathrine Rugbjerg, Stylianos Georgiadis, Simon Horskjær Rasmussen, Ulf Lindström, Karel Pavelka, Neslihan Yilmaz, Ennio Giulio Favalli, Michael J. Nissen, Brigitte Michelsen, Elsa Vieira-Sousa, Gareth T. Jones, Ruxandra Ionescu, Heikki Relas, Carlos Sanchez-Piedra, Matija Tomšič, Arni Jon Geirsson, Irene van der Horst-Bruinsma, Johan Askling, Anne Gitte Loft, Lucie Nekvindova, Haner Direskeneli, Florenzo Iannone, Adrian Ciurea, Karen Minde Fagerli, Maria José Santos, Gary J. Macfarlane, Catalin Codreanu, Kari Eklund, Manuel Pombo-Suarez, Ziga Rotar, Bjorn Gudbjornsson, Tamara Rusman, Mikkel Østergaard, Merete Lund Hetland
The Journal of Rheumatology Aug 2023, 50 (8) 1009-1019; DOI: 10.3899/jrheum.220459

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One-Third of European Patients With Axial Spondyloarthritis Reach Pain Remission With Routine Care Tumor Necrosis Factor Inhibitor Treatment
Lykke Midtbøll Ørnbjerg, Kathrine Rugbjerg, Stylianos Georgiadis, Simon Horskjær Rasmussen, Ulf Lindström, Karel Pavelka, Neslihan Yilmaz, Ennio Giulio Favalli, Michael J. Nissen, Brigitte Michelsen, Elsa Vieira-Sousa, Gareth T. Jones, Ruxandra Ionescu, Heikki Relas, Carlos Sanchez-Piedra, Matija Tomšič, Arni Jon Geirsson, Irene van der Horst-Bruinsma, Johan Askling, Anne Gitte Loft, Lucie Nekvindova, Haner Direskeneli, Florenzo Iannone, Adrian Ciurea, Karen Minde Fagerli, Maria José Santos, Gary J. Macfarlane, Catalin Codreanu, Kari Eklund, Manuel Pombo-Suarez, Ziga Rotar, Bjorn Gudbjornsson, Tamara Rusman, Mikkel Østergaard, Merete Lund Hetland
The Journal of Rheumatology Aug 2023, 50 (8) 1009-1019; DOI: 10.3899/jrheum.220459
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Keywords

AXIAL SPONDYLOARTHRITIS
PATIENT-REPORTED OUTCOME MEASURES
TUMOR NECROSIS FACTOR INHIBITORS

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