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.

1 van der Horst Bruinsma MD PhD Department of Rheumatology Radboud University Medical Center Nijmegen the Netherlands

A Ciurea MD Department of Rheumatology University Hospital Zurich University of Zurich Zurich Switzerland

A G Loft MD PhD Department of Rheumatology Aarhus University Hospital and Department of Clinical Medicine Aarhus University Aarhus Denmark

A J Geirsson MD Department of Rheumatology University Hospital Reykjavik Iceland

B Gudbjornsson MD PhD Centre for Rheumatology Research Landspitali University Hospital and Faculty of Medicine University of Iceland Reykjavik Iceland

B 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

C Codreanu MD PhD Center for Rheumatic Diseases University of Medicine and Pharmacy Bucharest Romania

C Sanchez Piedra MD PhD Research Unit Spanish Society of Rheumatology Madrid Spain

E G Favalli MD PhD Division of Clinical Rheumatology ASST Gaetano Pini CTO Institute Milan Italy

E 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

F Iannone MD PhD Rheumatology Unit DETO University of Bari Italy

G T Jones PhD G J Macfarlane MD PhD Aberdeen Centre for Arthritis and Musculoskeletal Health University of Aberdeen Aberdeen United Kingdom

H Direskeneli MD Department of Rheumatology Marmara University School of Medicine Istanbul Turkey

H Relas MD PhD K Eklund MD PhD Inflammation Center Department of Rheumatology Helsinki University Hospital Helsinki Finland

J Askling MD PhD Department of Medicine Solna Karolinska Institutet Stockholm Sweden

K M Fagerli MD PhD Department of Rheumatology and Research Diakonhjemmet Hospital Oslo Norway

K Pavelka MD PhD Institute of Rheumatology and Department of Rheumatology 1st Faculty of Medicine Charles University Prague Czech Republic

L M Ørnbjerg MD PhD K Rugbjerg MSc PhD S Georgiadis PhD S H Rasmussen PhD Copenhagen Center for Arthritis Research Centre for Rheumatology and Spine Diseases Centre of Head and Orthopaedics Copenhagen University Hospital Glostrup Denmark

L M Ørnbjerg MD PhD K Rugbjerg MSc PhD S Georgiadis PhD S H Rasmussen PhD Copenhagen Center for Arthritis Research Centre for Rheumatology and Spine Diseases Centre of Head and Orthopaedics Copenhagen University Hospital Glostrup Denmark;

L Nekvindova MD PhD Department of Rheumatology 1st Faculty of Medicine Charles University Prague and Institute of Biostatistics and Analyses Ltd Brno Czech Republic

M J Nissen MD PhD Department of Rheumatology Geneva University Hospital Geneva Switzerland

M J Santos MD PhD Department of Rheumatology Hospital Garcia de Orta Almada Portugal

M 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

M Pombo Suarez MD PhD Rheumatology Service Hospital Clinico Universitario Santiago de Compostela Spain

M Tomšič MD PhD Z Rotar MD PhD Department of Rheumatology University Medical Centre Ljubljana and Faculty of Medicine University of Ljubljana Ljubljana Slovenia

N Yilmaz MD Department of Rheumatology Demiroglu Bilim University Istanbul Turkey

R Ionescu MD PhD Carol Davila University of Medicine and Pharmacy Bucharest Romania

T Rusman MSc Department of Rheumatology Amsterdam UMC VU University Medical Centre Amsterdam the Netherlands

U Lindström MD PhD Department of Rheumatology and Inflammation Research University of Gothenburg Sahlgrenska Academy Gothenburg Sweden

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