OBJECTIVES: Many axial spondylarthritis (axSpA) patients receive a conventional synthetic DMARD (csDMARD) in combination with a TNF inhibitor (TNFi). However, the value of this co-therapy remains unclear. The objectives were to describe the characteristics of axSpA patients initiating a first TNFi as monotherapy compared with co-therapy with csDMARD, to compare one-year TNFi retention and remission rates, and to explore the impact of peripheral arthritis. METHODS: Data was collected from 13 European registries. One-year outcomes included TNFi retention and hazard ratios (HR) for discontinuation with 95% CIs. Logistic regression was performed with adjusted odds ratios (OR) of achieving remission (Ankylosing Spondylitis Disease Activity Score (ASDAS)-CRP < 1.3 and/or BASDAI < 2) and stratified by treatment. Inter-registry heterogeneity was assessed using random-effect meta-analyses, combined results were presented when heterogeneity was not significant. Peripheral arthritis was defined as ≥1 swollen joint at baseline (=TNFi start). RESULTS: Amongst 24 171 axSpA patients, 32% received csDMARD co-therapy (range across countries: 13.5% to 71.2%). The co-therapy group had more baseline peripheral arthritis and higher CRP than the monotherapy group. One-year TNFi-retention rates (95% CI): 79% (78, 79%) for TNFi monotherapy vs 82% (81, 83%) with co-therapy (P < 0.001). Remission was obtained in 20% on monotherapy and 22% on co-therapy (P < 0.001); adjusted OR of 1.16 (1.07, 1.25). Remission rates at 12 months were similar in patients with/without peripheral arthritis. CONCLUSION: This large European study of axial SpA patients showed similar one-year treatment outcomes for TNFi monotherapy and csDMARD co-therapy, although considerable heterogeneity across countries limited the identification of certain subgroups (e.g. peripheral arthritis) that may benefit from co-therapy.

Center of Rheumatic Diseases University of Medicine and Pharmacy Bucharest Romania

Centre for Rheumatology Research University Hospital

Clinical Epidemiology Division Department of Medicine Solna Karolinska Institutet

Clinical Epidemiology Division Department of Medicine Solna Karolinska Institutet Stockholm

Copenhagen Center for Arthritis Research Center for Rheumatology and Spine Diseases Centre for Head and Orthopaedics Copenhagen University Hospital Rigshospitalet Glostrup

DANBIO and Copenhagen Center for Arthritis Research Center for Rheumatology and Spine Diseases Centre of Head and Orthopedics Copenhagen University Hospital Rigshospitalet Glostrup

Department for Rheumatology and Immunology Inselspital University Hospital Bern Bern Switzerland

Department for Rheumatology University Hospital Reykjavik Iceland

Department of Clinical Medicine Aarhus University Aarhus Denmark

Department of Clinical Medicine Faculty of Health and Medical Sciences University of Copenhagen Copenhagen Denmark

Department of Clinical Medicine University of Copenhagen Copenhagen Denmark

Department of Rheumatology Aarhus University Hospital

Department of Rheumatology Amsterdam UMC location VUmc Amsterdam Netherlands

Department of Rheumatology and Inflammation Research Institute of Medicine Sahlgrenska Academy University of Gothenburg Gothenburg Sweden

Department of Rheumatology and Inflammation Research Sahlgrenska Academy University of Gothenburg Gothenburg Sweden

Department of Rheumatology Hospital Garcia de Orta Almada

Department of Rheumatology University Hospital Zurich University of Zurich Zurich Switzerland

Department of Rheumatology University Medical Centre Ljubljana

Department of Rheumatology University of Lisbon Lisbon Portugal

Division of Rheumatology and Research Diakonhjemmet Hospital Oslo

Division of Rheumatology and Research Diakonhjemmet Hospital Oslo Norway

Division of Rheumatology Department of Medicine Celal Bayar University Manisa Turkey

Division of Rheumatology Department of Medicine Hospital of Southern Norway Trust Kristiansand Norway

Division of Rheumatology Department of Medicine Kahramanmaras Sutcu Imam University Kahramanmaras Turkey

Division of Rheumatology Geneva University Hospital Geneva Switzerland

Faculty of Medicine Charles University Prague

Faculty of Medicine University of Iceland Reykjavik Iceland

Faculty of Medicine University of Ljubljana Ljubljana Slovenia

Health Technology Assessment Agency of Carlos 3 Institute of Health Madrid Spain

Institute of Biostatistics and Analyses Ltd Brno Czech Republic

Institute of Rheumatology and Department of Rheumatology Faculty of Medicine Charles University Prague Czech Republic

Rheumatology Department Hospital de Santa Maria Centro Hospitalar Universitario Lisboa Norte EPE Lisboa Portugal; Rheumatology Research Unit Instituto de Medicina Molecular Faculdade de Medicina Universidade de Lisboa Lisboa Portugal

Rheumatology Inflammation Center Helsinki University Hospital Helsinki Finland

Rheumatology Service Hospital Clinico Universitario Santiago de Compostela Spain

Rheumatology Theme Inflammation and Ageing Karolinska University Hospital Stockholm Sweden

Rheumatology Unit Department of Clinical Internal Anesthesiological and Cardiovascular Sciences Sapienza University of Rome Rome Italy

Rheumatology Unit DETO University of Bari Bari Italy

Sfanta Maria Hospital University of Medicine and Pharmacy Bucharest Romania

University of Eastern Finland Faculty of Health Sciences and Jyvaskyla Central Hospital Jyvaskyla Finland

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