title: Long-term costs and outcomes in psoriatic arthritis patients not responding to conventional therapy treated with tumour necrosis factor inhibitors: the extension of the Psoriatic Arthritis Cost Evaluation (PACE) study.
abstract: OBJECTIVE
  Poor information on long-term outcomes and costs on tumour necrosis factor (TNF) inhibitors in psoriatic arthritis (PsA) are available. Our aim was to evaluate long-term costs and benefits of TNF- inhibitors in PsA patients with inadequate response to conventional treatment with traditional disease-modifying anti-rheumatic drugs (tDMARDs).
  
  
  METHODS
  Fifty-five out of 107 enrolled patients included in the study at one year, completed the 5-year follow-up period. These patients were enrolled in 8 of 9 centres included in the study at one year. Patients aged older than 18 years, with different forms of PsA and failure or intolerance to tDMARDs therapy were treated with anti-TNF agents. Information on resource use, health-related quality of life (HRQoL), disease activity, function and laboratory values were collected at baseline and through the 5 years of therapy. Costs (expressed in Euro 2011) and utility (measured by EQ-5D instrument) before TNF inhibitor therapy and after 1 and 5 years were compared.
  
  
  RESULTS
  The majority of patients (46 out of 55; 83.6%) had a predominant or exclusive peripheral arthritis and 16.4% had predominant or exclusive axial involvement. There was a statistically significant improvement of the most important clinical variables after 1 year of follow-up. These improvements were maintained also after 5 years. The direct costs increased by approximately €800 per patient-month after 1 year, the indirect costs decreased by €100 and the overall costs increased by more than €700 per patient-month due to the cost of TNF inhibitor therapy. Costs at 5 year were similar to the costs at 1 year. The HRQoL parameters showed the same trends of the clinical variables. EQ-5D VAS, EQ-5D utility and SF-36 PCS score showed a significant improvement after 1 year, maintained at 5 years. SF-36 MCS showed an improvement only at 5 years.
  
  
  CONCLUSIONS
  The results of our study suggest that TNF blockers have long-term efficacy. The higher cost of TNF inhibitor therapy was balanced by a significant improvement of HRQoL, stable at 5 years of follow-up. Our results need to be confirmed in larger samples of patients.
authors.affiliation: Rheumatology Department of Lucania, San Carlo Hospital of Potenza and Madonna delle Grazie Hospital of Matera, Potenza and Matera, Italy. i.olivieri@ospedalesancarlo.it.
authors.forename: Ignazio
authors.initials: I
authors.lastname: Olivieri
authors.affiliation: Researh Centre on Public Health (CESP), University of Milan-Bicocca, and Fondazione Charta, Milan, Italy.
authors.forename: Paolo A
authors.initials: PA
authors.lastname: Cortesi
authors.affiliation: Department of Pharmaceutical Chemistry and Toxicology, University Federico II of Naples, Italy.
authors.forename: Simona
authors.initials: S
authors.lastname: de Portu
authors.affiliation: Rheumatic Disease Unit, Arcispedale Santa Maria Nuova, Reggio Emilia, Italy.
authors.forename: Carlo
authors.initials: C
authors.lastname: Salvarani
authors.affiliation: Rheumatology Unit II, University of Cagliari, Monserrato, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Cauli
authors.affiliation: Rheumatology Unit, Department of Healthy Sciences, University of Molise, Campobasso, Italy.
authors.forename: Ennio
authors.initials: E
authors.lastname: Lubrano
authors.affiliation: Dipartimento di Clinica e Terapia Medica, Rheumatology Unit, Università di Roma 'La Sapienza', Rome, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Spadaro
authors.affiliation: Rheumatic Disease Unit, 2nd Division of Medicine, Prato Hospital, Prato, Italy.
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Cantini
authors.affiliation: Researh Centre on Public Health (CESP), University of Milan-Bicocca, and Fondazione Charta, Milan, Italy.
authors.forename: Roberta
authors.initials: R
authors.lastname: Ciampichini
authors.affiliation: Rheumatology Department of Lucania, San Carlo Hospital of Potenza and Madonna delle Grazie Hospital of Matera, Potenza and Matera, Italy.
authors.forename: Maria Stefania
authors.initials: MS
authors.lastname: Cutro
authors.affiliation: Rheumatology Unit II, University of Cagliari, Monserrato, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Mathieu
authors.affiliation: Rheumatology Department, University of Florence, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Matucci-Cerinic
authors.affiliation: Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Padova, Italy.
authors.forename: Leonardo
authors.initials: L
authors.lastname: Punzi
authors.affiliation: Rheumatology Research Unit, University Federico II of Naples, Italy.
authors.forename: Raffaele
authors.initials: R
authors.lastname: Scarpa
authors.affiliation: Researh Centre on Public Health (CESP), University of Milan-Bicocca, and Fondazione Charta, Milan, Italy.
authors.forename: Lorenzo G
authors.initials: LG
authors.lastname: Mantovani
mesh_terms: D000328:Adult; D000893:Anti-Inflammatory Agents / Q000191:economics* / Q000627:therapeutic use*; D015535:Arthritis, Psoriatic / Q000175:diagnosis / Q000188:drug therapy* / Q000191:economics* / Q000276:immunology / Q000523:psychology; D003362:Cost-Benefit Analysis; D016527:Drug Costs; D057915:Drug Substitution / Q000191:economics*; D005260:Female; D006295:Health Resources / Q000191:economics / Q000706:statistics & numerical data; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D018803:Models, Economic; D011788:Quality of Life; D012074:Remission Induction; D013997:Time Factors; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors* / Q000276:immunology
chemical_list: D000893:Anti-Inflammatory Agents; D014409:Tumor Necrosis Factor-alpha