title: Off-label use of rituximab for systemic lupus erythematosus in Europe.
abstract: OBJECTIVE
  Rituximab (RTX) is a biological treatment used off-label in patients with systemic lupus erythematosus (SLE). This survey aimed to investigate the off-label use of RTX in Europe and compare the characteristics of patients receiving RTX with those receiving conventional therapy.
  
  
  METHODS
  Data on patients with SLE receiving RTX were taken from the International Registry for Biologics in SLE retrospective registry and complemented with data on patients with SLE treated with conventional therapy. For nationwide estimates of RTX use in patients with SLE, investigators were asked to provide data through case report forms (CRFs). Countries for which no data were submitted through CRFs, published literature and/or personal communication were used, and for European countries where no data were available, estimates were made on the assumption of similarities with neighbouring countries.
  
  
  RESULTS
  The estimated off-label use of RTX in Europe was 0.5%-1.5% of all patients with SLE. In comparison with patients with SLE on conventional therapy, patients treated with RTX had longer disease duration, higher disease activity and were more often treated with immunosuppressives. The most frequent organ manifestations for which either RTX or conventional therapy was initiated were lupus nephritis followed by musculoskeletal and haematological. The reason for treatment was, besides disease control, corticosteroid-sparing for patients treated with conventional therapy.
  
  
  CONCLUSIONS
  RTX use for SLE in Europe is restrictive and appears to be used as a last resort in patients for whom other reasonable options have been exhausted.
authors.affiliation: Unit of Clinical Therapy Research, Inflammatory Diseases, Department of Medicine , Karolinska Institutet, Karolinska University Hospital , Stockholm , Sweden.
authors.forename: Monica
authors.initials: M
authors.lastname: Rydén-Aulin
authors.affiliation: Joint Academic Rheumatology Program and 4th Department of Medicine , Medical School, National and Kapodestrian University of Athens, Attikon University Hospital , Athens , Greece.
authors.forename: Dimitrios
authors.initials: D
authors.lastname: Boumpas
authors.affiliation: Department of Rheumatology , Amsterdam Rheumatology and Immunology Center , Amsterdam , The Netherlands.
authors.forename: Irene
authors.initials: I
authors.lastname: Bultink
authors.affiliation: Unit of Autoimmune Diseases , Hospital San Cecilio , Granada , Spain.
authors.forename: Jose Luis
authors.initials: JL
authors.lastname: Callejas Rubio
authors.affiliation: Autoimmune Systemic Diseases Unit, Internal Medicine Department , Hospital Universitario Central de Asturias , Oviedo , Spain.
authors.forename: Luis
authors.initials: L
authors.lastname: Caminal-Montero
authors.affiliation: Internal Medicine Department , University Hospital Sant Joan de Reus, Rovira i Virgili University (URV)-IISPV , Reus , Spain.
authors.forename: Antoni
authors.initials: A
authors.lastname: Castro
authors.affiliation: Pasaje Nueva Victoria, 2, 2do C , Jaén , Spain.
authors.forename: Agustín
authors.initials: A
authors.lastname: Colodro Ruiz
authors.affiliation: Rheumatology Unit, Department of Medicine , University of Padova , Padova , Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Doria
authors.affiliation: Department of Medicine/Rheumatology and Clinical Immunology , Charite Universitaetsmedizin Berlin , Berlin , Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Dörner
authors.affiliation: Autoimmune Diseases Research Unit, Department of Internal Medicine , BioCruces Health Research Institute, Cruces University Hospital, University of the Basque Country , Barakaldo , Spain.
authors.forename: Cristina
authors.initials: C
authors.lastname: Gonzalez-Echavarri
authors.affiliation: Institute of Rheumatology and Affine Sciences (IRSA), Catholic University of the Sacred Heart , Rome , Italy.
authors.forename: Elisa
authors.initials: E
authors.lastname: Gremese
authors.affiliation: Service de Rhumatologie , Cliniques Universitaires Saint-Luc, Pôle de Pathologies Rhumatismales Inflammatoires et Systémiques, Université Catholique de Louvain , Brussels , Belgium.
authors.forename: Frederic A
authors.initials: FA
authors.lastname: Houssiau
authors.affiliation: Department of Rheumatology , C1-41, Leiden University Medical Center , Leiden , The Netherlands.
authors.forename: Tom
authors.initials: T
authors.lastname: Huizinga
authors.affiliation: Division of Rheumatology, Department of Internal Medicine, Istanbul Medical Faculty, Istanbul University , Istanbul , Turkey.
authors.forename: Murat
authors.initials: M
authors.lastname: Inanç
authors.affiliation: University College London, The Rayne Building , London , UK.
authors.forename: David
authors.initials: D
authors.lastname: Isenberg
authors.affiliation: Rheumatology Unit , San Camillo Hospital , Rome , Italy.
authors.forename: Annamaria
authors.initials: A
authors.lastname: Iuliano
authors.affiliation: Copenhagen Lupus and Vasculitis Clinic, Center for Rheumatology and Spine Diseases, University of Copenhagen, Rigshospitalet , Copenhagen , Denmark.
authors.forename: Søren
authors.initials: S
authors.lastname: Jacobsen
authors.affiliation: Internal Department , Universitary 'Virgen de las Nieves' Hospital , Granada , Spain.
authors.forename: Juan
authors.initials: J
authors.lastname: Jimenéz-Alonso
authors.affiliation: Department of Rheumatology, Faculty of Medicine , Albert Szent-Györgyi Health Centre, University of Szeged , Szeged , Hungary.
authors.forename: Lászlo
authors.initials: L
authors.lastname: Kovács
authors.affiliation: Rhumatologie Responsable de l'Unité de Recherche Clinique, Hôpitaux Universitaire Paris-Sud, Université Paris-Sud, INSERM U1184 , Paris , France.
authors.forename: Xavier
authors.initials: X
authors.lastname: Mariette
authors.affiliation: Rheumatology Unit, Pisa , Italy.
authors.forename: Marta
authors.initials: M
authors.lastname: Mosca
authors.affiliation: Rheumatology Clinic, Skåne University Hospital , Lund , Sweden.
authors.forename: Ola
authors.initials: O
authors.lastname: Nived
authors.affiliation: Internal Medicine Department , Hospital de Sabadell, Universitat Autonoma de Barcelona , Catalunya , Spain.
authors.forename: Joaquim
authors.initials: J
authors.lastname: Oristrell
authors.affiliation: Department of Autoimmune Diseases , ICMiD, Josep Font Autoimmune Lab, CELLEX-IDIBAPS , Barcelona , Spain.
authors.forename: Manuel
authors.initials: M
authors.lastname: Ramos-Casals
authors.affiliation: Carrer de les Sabateres, 9-1, Alaró , Islas Baleares , Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Rascón
authors.affiliation: Autoimmune Diseases Research Unit, Department of Internal Medicine , BioCruces Health Research Institute, Cruces University Hospital, University of the Basque Country , Barakaldo , Spain.
authors.forename: Guillermo
authors.identifier: 0000-0001-7788-1043
authors.initials: G
authors.lastname: Ruiz-Irastorza
authors.affiliation: Unidad de Enfermedades Autoinmunes Sistémicas, Hospital Universitario Miguel Servet de Zaragoza, Paseo Isabel la Católica , Zaragoza , Spain.
authors.forename: Luis
authors.initials: L
authors.lastname: Sáez-Comet
authors.affiliation: Department of Internal Medicine, Inmunopathological and Autoimmune Area , Hospital Universitario y Politecnico La Fe , Valencia , Spain.
authors.forename: Gonzalo
authors.initials: G
authors.lastname: Salvador Cervelló
authors.affiliation: UOC Reumatologia, Ospedale San Camillo, Circonvallazione Gianicolense n. 87 , Roma , Italy.
authors.forename: Gian Domenico
authors.initials: GD
authors.lastname: Sebastiani
authors.affiliation: Department of Sperimental and Clinical Medicine , University of Florence , Firenze , Italy.
authors.forename: Danilo
authors.initials: D
authors.lastname: Squatrito
authors.affiliation: Department of Rheumatology , Institute of Medicine, University of Debrecen , Debrecen , Hungary.
authors.forename: Gabriella
authors.initials: G
authors.lastname: Szücs
authors.affiliation: Amsterdam Rheumatology and Immunology Center (ARC), VU University Medical Center , Amsterdam , The Netherlands.
authors.forename: Alexandre
authors.initials: A
authors.lastname: Voskuyl
authors.affiliation: Unit of Clinical Therapy Research, Inflammatory Diseases, Department of Medicine, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden; Rheumatology Clinic, Karolinska University Hospital, Stockholm, Sweden; Amsterdam Rheumatology and Immunology Center ARC, AMC mail F4-105, Amsterdam, The Netherlands.
authors.forename: Ronald
authors.initials: R
authors.lastname: van Vollenhoven
keywords: DMARDs (biologic); Lupus Nephritis; Systemic Lupus Erythematosus