Off-label use of rituximab for systemic lupus erythematosus in Europe

Research output: Contribution to journalReview article


Objectives: 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.


  • Monica Ryden-Aulin
  • Dimitrios Boumpas
  • Irene Bultink
  • Jose Luis Callejas Rubio
  • Luis Caminal-Montero
  • Antoni Castro
  • Agustín Colodro Ruiz
  • Andrea Doria
  • Thomas Dorner
  • Cristina Gonzalez-Echavarri
  • Elisa Gremese
  • Frederic A. Houssiau
  • Tom Huizinga
  • Murat Inanc
  • David Isenberg
  • Annamaria Iuliano
  • Soren Jacobsen
  • Juan Jimenez-Alonso
  • Laszlo Kovacs
  • Xavier Mariette
  • Marta Mosca
  • Joaquim Oristrell
  • Manuel Ramos-Casals
  • Javier Rascon
  • Guillermo Ruiz-Irastorza
  • Luis Sáez-Comet
  • Gonzalo Salvador Cervello
  • Gian Domenico Sebastiani
  • Danilo Squatrito
  • Gabriella Szucs
  • Alexandre Voskuyl
  • Ronald Van Vollenhoven
External organisations
  • Karolinska University Hospital
  • National and Kapodistrian University of Athens
  • Amsterdam Rheumatology and Immunology Center
  • Hospital Clínico Universitario San Cecilio
  • Asturias General Hospital
  • Rovira i Virgili University (URV)
  • Pasaje Nueva Victoria
  • University of Padova
  • Charité - University Medicine Berlin
  • University of the Basque Country
  • Catholic University of the Sacred Heart
  • Saint-Luc University Hospital
  • Leiden University Medical Centre
  • Istanbul University
  • Royal Free Hospital
  • Azienda Ospedaliera San Camillo Forlanini
  • University of Copenhagen
  • Albert Szent-György Medical University
  • Center For Immunology Of Viral Infections And Autoimmune Diseases
  • Autonomous University of Barcelona
  • Institutd' Investigacions Biomèdiques August Pi iSunyer (IDIBAPS)
  • Miguel Servet University Hospital
  • University and Polytechnic Hospital la Fe
  • University of Florence
  • University of Debrecen
  • Amsterdam UMC - Vrije Universiteit Amsterdam
  • Academic Medical Center of University of Amsterdam (AMC)
  • Skåne University Hospital
  • University of Pisa
Research areas and keywords

Subject classification (UKÄ) – MANDATORY

  • Rheumatology and Autoimmunity
Original languageEnglish
Article number000163
JournalLupus Science and Medicine
Issue number1
Publication statusPublished - 2016 Sep 1
Publication categoryResearch