title: Efficacy and effectiveness of tumour necrosis factor inhibitors in the treatment of rheumatoid arthritis in randomized controlled trials and routine clinical practice.
abstract: Efficacy of TNF inhibitors in the treatment of RA assessed in randomized controlled trials (RCTs) may not be fully comparable to routine care owing to the stringent inclusion criteria. The objective of this study was to observe the effectiveness of TNF inhibitors in real-world patients and assess the patients' potential eligibility for the RCTs.
  
  
  
  RA patients starting a TNF-inhibitor treatment between 2004 and 2014 were identified from the National Register for Biologic Treatment in Finland, which is a longitudinal observational cohort study. Effectiveness was measured using the ACR and EULAR response criteria and by studying the proportion of patients reaching DAS28 remission. The patients' baseline characteristics were compared against the inclusion criteria of 27 RCTs.
  
  
  
  EULAR moderate and good treatment responses at 6 months were achieved by 69 and 40% of the users of the first TNF inhibitor, respectively. ACR20, ACR50 and ACR70 responses were reached by 48, 27 and 13%, respectively. DAS28 remission was reached by 47%. Only 7.6-44% of the patients would have been potentially eligible for the RCTs. The eligible patients had better treatment responses compared with the non-eligible patients. Different TNF inhibitors were mostly equipotent, but the usage of MTX co-therapy had a major influence on treatment response.
  
  
  
  Only a small proportion of patients would have been eligible for RCTs, and the efficacy of TNF inhibitors assessed in them cannot be generalized directly into Finnish routine health care.
authors.affiliation: Faculty of Pharmacy, University of Helsinki, Helsinki.
authors.forename: Kalle J
authors.initials: KJ
authors.lastname: Aaltonen
authors.affiliation: Faculty of Pharmacy, University of Helsinki, Helsinki.
authors.forename: Suvi
authors.initials: S
authors.lastname: Ylikylä
authors.affiliation: Faculty of Pharmacy, University of Helsinki, Helsinki.
authors.forename: Jaana
authors.initials: J
authors.lastname: Tuulikki Joensuu
authors.affiliation: Department of Internal Medicine, Centre for Rheumatic Diseases, Tampere University Hospital.|School of Medicine, University of Tampere, Tampere.
authors.forename: Pia
authors.initials: P
authors.lastname: Isomäki
authors.affiliation: Department of Rheumatology, Turku University Hospital, Turku.
authors.forename: Laura
authors.initials: L
authors.lastname: Pirilä
authors.affiliation: School of Medicine, University of Tampere, Tampere.|Department of Rheumatology, Päijät-Häme Central Hospital, Lahti.
authors.forename: Markku
authors.initials: M
authors.lastname: Kauppi
authors.affiliation: Department of Rheumatology, Jyväskylä Central Hospital, Jyväskylä.|Faculty of Health Sciences, University of Eastern Finland, Kuopio.
authors.forename: Tuomas
authors.initials: T
authors.lastname: Rannio
authors.affiliation: Department of Medicine, Helsinki University Central Hospital.|Faculty of Medicine, University of Helsinki, Helsinki, Finland.
authors.forename: Kari
authors.initials: K
authors.lastname: Eklund
authors.affiliation: Faculty of Pharmacy, University of Helsinki, Helsinki.
authors.forename: Marja
authors.initials: M
authors.lastname: Blom
authors.affiliation: Department of Medicine, Helsinki University Central Hospital.|Faculty of Medicine, University of Helsinki, Helsinki, Finland.
authors.forename: Dan
authors.initials: D
authors.lastname: Nordström
mesh_terms: D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D001685:Biological Factors / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D005387:Finland; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; D001685:Biological Factors; D014409:Tumor Necrosis Factor-alpha
keywords: anti-TNF; methotrexate; outcomes research; randomized controlled trials; rheumatoid arthritis