title: Ten-year followup of infliximab therapy in rheumatoid arthritis patients with severe, longstanding refractory disease: a cohort study.
abstract: OBJECTIVE
  Our study describes the 10-year followup data of the Belgian Expanded Access Program (EAP) for infliximab (IFX), which included patients with active rheumatoid arthritis who were refractory to methotrexate. The objectives of the study were to evaluate the continuation rate, reasons for discontinuation, and longterm disease control under IFX treatment, and to study baseline characteristics associated with longterm successful IFX therapy.
  
  
  METHODS
  Between February 2000 and September 2001, 511 patients were enrolled in the Belgian IFX EAP, and 507 effectively started IFX therapy. Previously reported data showed that 160 patients were still treated with IFX after 7 years of followup. We describe the therapy status, reasons for IFX discontinuation, and the level of disease activity of this subgroup after 10 years of followup. Baseline characteristics of the total EAP cohort were used to describe variables associated with longterm successful IFX treatment.
  
  
  RESULTS
  After 10 years of followup, 110 of the 507 patients (21.7%) were still receiving IFX treatment. In the 7-year to 10-year period, which is the focus of the current study, 16 patients were lost to followup and 34 patients discontinued IFX treatment, mainly because of loss of efficacy. Patients successfully treated with IFX for 10 years had lower baseline values for 28-joint Disease Activity Score (DAS28), patient pain scale, physician visual analog scale, and Health Assessment Questionnaire in comparison with the rest of the study cohort. The mean DAS28 level of the subgroup still taking IFX after 10 years was 2.55 ± 1.01.
  
  
  CONCLUSIONS
  In the Belgian EAP, 21.7% of patients continued to receive maintenance IFX treatment after 10 years of followup. IFX provided good longterm disease control in these patients.
authors.affiliation: From Department of Rheumatology, Ghent University, Ghent; MSD Belgium BVBA; Department of Rheumatology, Pôle de Recherche en Rhumatologie, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain and Cliniques Universitaires Saint-Luc, Brussels; Skeletal Biology and Engineering Research Center, Department of Development and Regeneration KU Leuven; and Department of Rheumatology, University Hospitals Leuven, Leuven, Belgium.F. De Keyser, MD; J. De Kock, MD, Department of Rheumatology, Ghent University; H. Leroi, MSD Belgium BVBA, Brussels; P. Durez, MD, Department of Rheumatology, Pôle de Recherche en Rhumatologie, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain and Cliniques Universitaires Saint-Luc; R. Westhovens, MD, PhD, Skeletal Biology and Engineering Research Center, Department of Development and Regeneration KU Leuven; and Department of Rheumatology, University Hospitals Leuven. filip.dekeyser@ugent.be.
authors.forename: Filip
authors.initials: F
authors.lastname: De Keyser
authors.affiliation: From Department of Rheumatology, Ghent University, Ghent; MSD Belgium BVBA; Department of Rheumatology, Pôle de Recherche en Rhumatologie, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain and Cliniques Universitaires Saint-Luc, Brussels; Skeletal Biology and Engineering Research Center, Department of Development and Regeneration KU Leuven; and Department of Rheumatology, University Hospitals Leuven, Leuven, Belgium.F. De Keyser, MD; J. De Kock, MD, Department of Rheumatology, Ghent University; H. Leroi, MSD Belgium BVBA, Brussels; P. Durez, MD, Department of Rheumatology, Pôle de Recherche en Rhumatologie, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain and Cliniques Universitaires Saint-Luc; R. Westhovens, MD, PhD, Skeletal Biology and Engineering Research Center, Department of Development and Regeneration KU Leuven; and Department of Rheumatology, University Hospitals Leuven.
authors.forename: Joris
authors.initials: J
authors.lastname: De Kock
authors.affiliation: From Department of Rheumatology, Ghent University, Ghent; MSD Belgium BVBA; Department of Rheumatology, Pôle de Recherche en Rhumatologie, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain and Cliniques Universitaires Saint-Luc, Brussels; Skeletal Biology and Engineering Research Center, Department of Development and Regeneration KU Leuven; and Department of Rheumatology, University Hospitals Leuven, Leuven, Belgium.F. De Keyser, MD; J. De Kock, MD, Department of Rheumatology, Ghent University; H. Leroi, MSD Belgium BVBA, Brussels; P. Durez, MD, Department of Rheumatology, Pôle de Recherche en Rhumatologie, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain and Cliniques Universitaires Saint-Luc; R. Westhovens, MD, PhD, Skeletal Biology and Engineering Research Center, Department of Development and Regeneration KU Leuven; and Department of Rheumatology, University Hospitals Leuven.
authors.forename: Hermine
authors.initials: H
authors.lastname: Leroi
authors.affiliation: From Department of Rheumatology, Ghent University, Ghent; MSD Belgium BVBA; Department of Rheumatology, Pôle de Recherche en Rhumatologie, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain and Cliniques Universitaires Saint-Luc, Brussels; Skeletal Biology and Engineering Research Center, Department of Development and Regeneration KU Leuven; and Department of Rheumatology, University Hospitals Leuven, Leuven, Belgium.F. De Keyser, MD; J. De Kock, MD, Department of Rheumatology, Ghent University; H. Leroi, MSD Belgium BVBA, Brussels; P. Durez, MD, Department of Rheumatology, Pôle de Recherche en Rhumatologie, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain and Cliniques Universitaires Saint-Luc; R. Westhovens, MD, PhD, Skeletal Biology and Engineering Research Center, Department of Development and Regeneration KU Leuven; and Department of Rheumatology, University Hospitals Leuven.
authors.forename: Patrick
authors.initials: P
authors.lastname: Durez
authors.affiliation: From Department of Rheumatology, Ghent University, Ghent; MSD Belgium BVBA; Department of Rheumatology, Pôle de Recherche en Rhumatologie, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain and Cliniques Universitaires Saint-Luc, Brussels; Skeletal Biology and Engineering Research Center, Department of Development and Regeneration KU Leuven; and Department of Rheumatology, University Hospitals Leuven, Leuven, Belgium.F. De Keyser, MD; J. De Kock, MD, Department of Rheumatology, Ghent University; H. Leroi, MSD Belgium BVBA, Brussels; P. Durez, MD, Department of Rheumatology, Pôle de Recherche en Rhumatologie, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain and Cliniques Universitaires Saint-Luc; R. Westhovens, MD, PhD, Skeletal Biology and Engineering Research Center, Department of Development and Regeneration KU Leuven; and Department of Rheumatology, University Hospitals Leuven.
authors.forename: René
authors.initials: R
authors.lastname: Westhovens
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D015331:Cohort Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000069285:Infliximab; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use; D008875:Middle Aged; D010147:Pain Measurement; D019233:Retreatment; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; D000069285:Infliximab; D008727:Methotrexate
keywords: ANTIRHEUMATIC AGENTS; COHORT STUDY; INFLIXIMAB; LONGTERM CARE; RHEUMATOID ARTHRITIS