title: Improvement in patient-reported outcomes after rituximab in rheumatoid arthritis patients: An open-label assessment of 175 patients.
abstract: OBJECTIVE
  Patient-reported outcomes (PROs) reflect treatment efficacy from the patients' perspective. The objective was to assess PROs improvement with rituximab in rheumatoid arthritis.
  
  
  METHODS
  Patients with long-standing rheumatoid arthritis received rituximab 1000mg twice at 2 weeks interval, and were assessed over 6 months. PROs including physical PROs (pain, functional assessment, physical quality of life) and mental or mixed aspects (fatigue, sleep and mental quality of life) were assessed. Standardized response means were calculated. Early improvement in PROs was used to predict EULAR response at 6 months.
  
  
  RESULTS
  For the 175 patients (mean age 54.6±10.6 years, mean disease duration 12.9±9.3 years), the plateau of efficacy of rituximab on PROs was reached at week 12, and the effect was more prominent on physical PROs (e.g., pain standardized response means -0.75 [95% confidence interval -0.91; -0.60]), than on sleep (-0.43; [-0.56; -0.29]). It was not possible to accurately predict 6-month EULAR response by early improvement in PROs.
  
  
  CONCLUSIONS
  Rituximab was effective on PROs with an early effect. PROs reflecting physical aspects were more modulated by this biologic than other PROs (fatigue, sleep or mental quality of life). Links between sleep difficulties, fatigue and RA should be further studied.
authors.affiliation: Sorbonne universités, UPMC université Paris 06, 75005 Paris, France; Institut Pierre-Louis d'épidémiologie et de santé publique, 75646 Paris cedex 13, France; Department of rheumatology, Pitié-Salpêtrière Hospital, AP-HP, 47-83, boulevard de l'Hôpital, 75013 Paris, France. Electronic address: laure.gossec@psl.aphp.fr.
authors.forename: Laure
authors.initials: L
authors.lastname: Gossec
authors.affiliation: Sorbonne universités, UPMC université Paris 06, 75005 Paris, France; Institut Pierre-Louis d'épidémiologie et de santé publique, 75646 Paris cedex 13, France; Department of rheumatology, Pitié-Salpêtrière Hospital, AP-HP, 47-83, boulevard de l'Hôpital, 75013 Paris, France.
authors.forename: Agnès
authors.initials: A
authors.lastname: Danré
authors.affiliation: Montpellier I University, Lapeyronie University Hospital, UMR5535, 34295 Montpellier, France.
authors.forename: Bernard
authors.initials: B
authors.lastname: Combe
authors.affiliation: Inserm U905, Rouen University Hospital, 76031 Rouen, France.
authors.forename: Xavier
authors.initials: X
authors.lastname: Le Loët
authors.affiliation: Centre hospitalier Lyon Sud, 69495 Pierre-Benite, France.
authors.forename: Jaques
authors.initials: J
authors.lastname: Tebib
authors.affiliation: Université de Strasbourg, hôpitaux universitaires de Strasbourg, 67000 Strasbourg, France.
authors.forename: Jean
authors.initials: J
authors.lastname: Sibilia
authors.affiliation: Inserm U1012, université Paris-Sud 11, hôpital Bicêtre, AP-HP, 94270 Le Kremlin-Bicêtre, France.
authors.forename: Xavier
authors.initials: X
authors.lastname: Mariette
authors.affiliation: Rheumatology B Department, Paris-Descartes University, Cochin Hospital, AP-HP, Paris, France.
authors.forename: Maxime
authors.initials: M
authors.lastname: Dougados
mesh_terms: D000328:Adult; D000368:Aged; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use; D008775:Methylprednisolone / Q000627:therapeutic use; D008875:Middle Aged; D063868:Patient Outcome Assessment; D000069283:Rituximab / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D000069283:Rituximab; D008775:Methylprednisolone; D008727:Methotrexate
keywords: Pain; Quality of life; Rheumatoid arthritis; Rituximab; Sleep