title: Cost-effectiveness of infliximab versus conventional combination treatment in methotrexate-refractory early rheumatoid arthritis: 2-year results of the register-enriched randomised controlled SWEFOT trial.
abstract: OBJECTIVE
  To estimate the incremental cost-effectiveness of infliximab versus conventional combination treatment over 21 months in patients with methotrexate-refractory early rheumatoid arthritis.
  
  
  METHODS
  In this multicentre, two-arm, parallel, randomised, active-controlled, open-label trial, rheumatoid arthritis patients with <1 year symptom duration were recruited from 15 rheumatology clinics in Sweden between October 2002 and December 2005. After 3-4 months of methotrexate monotherapy, patients not achieving low disease activity were randomised to addition of infliximab or sulfasalazine+hydroxychloroquine (conventional treatment group). Costs of drugs, healthcare use, and productivity losses were retrieved from nationwide registers, while EuroQol 5-Dimensions utility was collected quarterly.
  
  
  RESULTS
  Of 487 patients initially enrolled, 128 and 130 were randomised to infliximab and conventional treatment, respectively. The infliximab group accumulated higher drug and healthcare costs (€27,487 vs €10,364; adjusted mean difference €16,956 (95% CI 14,647 to 19,162)), while productivity losses did not differ (€33,804 vs €29,220; €3961 (95% CI -3986 to 11,850)), resulting in higher societal cost compared to the conventional group (€61,291 vs €39,584; €20,916 (95% CI 12,800 to 28,660)). Mean accumulated quality-adjusted life-years (QALYs) did not differ (1.10 vs 1.12; adjusted mean difference favouring infliximab treatment 0.01 (95% CI -0.07 to 0.08)). The incremental cost-effectiveness ratios for the infliximab versus conventional treatment strategy were €2,404,197/QALY from the societal perspective and €1,948,919/QALY from the healthcare perspective.
  
  
  CONCLUSIONS
  In early, methotrexate-refractory rheumatoid arthritis, a treatment strategy commencing with addition of infliximab, as compared to sulfasalazine+hydroxychloroquine, was not cost-effective over 21 months at willingness to pay levels generally considered acceptable.
  
  
  BACKGROUND
  NCT00764725.
authors.affiliation: Clinical Epidemiology Unit, Department of Medicine, Karolinska Institutet, Stockholm, Sweden.
authors.forename: Jonas K
authors.initials: JK
authors.lastname: Eriksson
authors.affiliation: Section of Rheumatology, Department of Clinical Sciences Lund, Lund University, Lund, Sweden.
authors.forename: Johan A
authors.initials: JA
authors.lastname: Karlsson
authors.affiliation: Rheumatology Unit, Department of Medicine, Karolinska Institutet, Stockholm, Sweden.
authors.forename: Johan
authors.initials: J
authors.lastname: Bratt
authors.affiliation: Section of Rheumatology, Department of Clinical Sciences Lund, Lund University, Lund, Sweden Section of Orthopedics, Department of Clinical Sciences Lund, Lund University, Lund, Sweden.
authors.forename: Ingemar F
authors.initials: IF
authors.lastname: Petersson
authors.affiliation: Department of Medicine, ClinTRID, Karolinska Institutet, Stockholm, Sweden.
authors.forename: Ronald F
authors.initials: RF
authors.lastname: van Vollenhoven
authors.affiliation: Department of Learning, Informatics and Medical Education (LIME), Karolinska Institutet, Stockholm, Sweden.
authors.forename: Sofia
authors.initials: S
authors.lastname: Ernestam
authors.affiliation: Section of Rheumatology, Department of Clinical Sciences Lund, Lund University, Lund, Sweden.
authors.forename: Pierre
authors.initials: P
authors.lastname: Geborek
authors.affiliation: Clinical Epidemiology Unit, Department of Medicine, Karolinska Institutet, Stockholm, Sweden.
authors.forename: Martin
authors.initials: M
authors.lastname: Neovius
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000191:economics / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000191:economics / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000191:economics; D003362:Cost-Benefit Analysis; D016527:Drug Costs; D004359:Drug Therapy, Combination; D005260:Female; D017048:Health Care Costs; D006296:Health Services / Q000191:economics / Q000706:statistics & numerical data; D006801:Humans; D006886:Hydroxychloroquine / Q000191:economics / Q000627:therapeutic use*; D000069285:Infliximab; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use; D008875:Middle Aged; D019057:Quality-Adjusted Life Years; D018582:Sick Leave / Q000191:economics; D012460:Sulfasalazine / Q000191:economics / Q000627:therapeutic use*; D017211:Treatment Failure; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; D012460:Sulfasalazine; D006886:Hydroxychloroquine; D000069285:Infliximab; D008727:Methotrexate
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