title: Cancer risk in patients with spondyloarthritis treated with TNF inhibitors: a collaborative study from the ARTIS and DANBIO registers.
abstract: BACKGROUND
  Safety data on cancer risks following tumour necrosis factor α inhibitors (TNFi) in patients with spondyloarthritis (SpA) (here defined as ankylosing spondylitis (AS), undifferentiated spondarthropaties (SpA UNS), psoriatic arthritis (PsA)) are scarce. Our objective was to assess risks for cancer overall and for common subtypes in patients with SpA treated with TNFi compared with TNFi-naïve patients with SpA and to the general population.
  
  
  METHODS
  From the Swedish (Anti-Rheumatic Therapy in Sweden (ARTIS)) and Danish (DANBIO) biologics registers, we assembled 8703 (ARTIS=5448, DANBIO=3255) patients with SpA initiating a first TNFi 2001-2011. From the Swedish National Patient and Population Registers we assembled a TNFi-naïve SpA cohort (n=28,164) and a Swedish age-matched and sex-matched general population comparator cohort (n=131 687). We identified incident cancers by linkage with the nationwide Swedish and Danish Cancer Registers 2001-2011, and calculated age-standardised and sex-standardised incidence ratios as measures of relative risk (RR).
  
  
  RESULTS
  Based on 1188 cancers among the TNFi-naïve patients with SpA, RR of cancer overall was 1.1 (95% CI 1.0 to 1.2). Based on 147 cancers among TNFi initiators with SpA, RR versus TNFi-naïve was 0.8 (95% CI 0.7 to 1.0) and results were similar for AS and PsA when analysed separately. Site-specific cancer RRs: prostate 0.5 (95% CI 0.3 to 0.8), lung 0.6 (95% CI 0.3 to 1.3), colorectal 1.0 (95% CI 0.5 to 2.0), breast 1.3 (95% CI 0.9 to 2.0), lymphoma 0.8 (95% CI 0.4 to 1.8) and melanoma 1.4 (95% CI 0.7 to 2.6).
  
  
  CONCLUSIONS
  In patients with SpA, treatment with TNFi was not associated with increased risks of cancer, neither overall nor for the six most common cancer types.
authors.affiliation: Rheumatology Unit, Department of Medicine, Solna, Karolinska Institutet at Karolinska University Hospital, Stockholm, Sweden.|Clinical Epidemiology Unit, Department of Medicine, Solna, Karolinska Institutet, Stockholm, Sweden.
authors.forename: Karin
authors.initials: K
authors.lastname: Hellgren
authors.affiliation: Department of Rheumatology, Herlev and Gentofte University Hospital, Hellerup, Denmark.|The Parker Institute, Bispebjerg and Frederiksberg, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Lene
authors.initials: L
authors.lastname: Dreyer
authors.affiliation: Clinical Epidemiology Unit, Department of Medicine, Solna, Karolinska Institutet, Stockholm, Sweden.
authors.forename: Elizabeth V
authors.initials: EV
authors.lastname: Arkema
authors.affiliation: Department of Rheumatology, Herlev and Gentofte University Hospital, Hellerup, Denmark.|The Parker Institute, Bispebjerg and Frederiksberg, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Bente
authors.initials: B
authors.lastname: Glintborg
authors.affiliation: Department of Rheumatology and Inflammation Research, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
authors.forename: Lennart T H
authors.initials: LT
authors.lastname: Jacobsson
authors.affiliation: The Parker Institute, Bispebjerg and Frederiksberg, University of Copenhagen, Copenhagen, Denmark.|Department of Rheumatology, Lund University Hospital, Lund, Sweden.
authors.forename: Lars-Erik
authors.initials: LE
authors.lastname: Kristensen
authors.affiliation: Rheumatology Unit, Department of Medicine, Solna, Karolinska Institutet at Karolinska University Hospital, Stockholm, Sweden.|Swedish Medical Products Agency, Uppsala, Sweden.
authors.forename: Nils
authors.initials: N
authors.lastname: Feltelius
authors.affiliation: DANBIO Registry, Center for Rheumatology and Spine Diseases, Centre for Head and Orthopaedics, Rigshospitalet, Glostrup, Denmark.|Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Merete Lund
authors.initials: ML
authors.lastname: Hetland
authors.affiliation: Rheumatology Unit, Department of Medicine, Solna, Karolinska Institutet at Karolinska University Hospital, Stockholm, Sweden.|Clinical Epidemiology Unit, Department of Medicine, Solna, Karolinska Institutet, Stockholm, Sweden.
authors.forename: Johan
authors.initials: J
authors.lastname: Askling
mesh_terms: D000068879:Adalimumab / Q000627:therapeutic use; D000328:Adult; D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D015535:Arthritis, Psoriatic / Q000188:drug therapy*; D001943:Breast Neoplasms / Q000453:epidemiology; D000068582:Certolizumab Pegol / Q000627:therapeutic use; D015331:Cohort Studies; D015179:Colorectal Neoplasms / Q000453:epidemiology; D003718:Denmark / Q000453:epidemiology; D000068800:Etanercept / Q000627:therapeutic use; D005260:Female; D006801:Humans; D015994:Incidence; D000069285:Infliximab / Q000627:therapeutic use; D008175:Lung Neoplasms / Q000453:epidemiology; D008223:Lymphoma / Q000453:epidemiology; D008297:Male; D008545:Melanoma / Q000453:epidemiology; D008875:Middle Aged; D009369:Neoplasms / Q000453:epidemiology*; D011471:Prostatic Neoplasms / Q000453:epidemiology; D012042:Registries; D018570:Risk Assessment; D013167:Spondylitis, Ankylosing / Q000188:drug therapy*; D013548:Sweden / Q000453:epidemiology; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*
chemical_list: D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; D014409:Tumor Necrosis Factor-alpha; C529000:golimumab; D000069285:Infliximab; D000068879:Adalimumab; D000068800:Etanercept; D000068582:Certolizumab Pegol
keywords: Ankylosing Spondylitis; Anti-TNF; Outcomes research; Psoriatic Arthritis; Spondyloarthritis