RT Journal Article T1 Off-label use of rituximab for systemic lupus erythematosus in Europe A1 Ryden-Aulin, Monica A1 Boumpas, Dimitrios A1 Bultink, Irene A1 Rubio, Jose Luis Callejas A1 Caminal-Montero, Luis A1 Castro, Antoni A1 Colodro Ruiz, Agustin A1 Doria, Andrea A1 Domer, Thomas A1 Gonzalez-Echavarri, Cristina A1 Gremese, Elisa A1 Houssiau, Frederic A. A1 Huizinga, Tom A1 Inana, Murat A1 Isenberg, David A1 Luliano, Annamaria A1 Jacobsen, Soren A1 Jimenez-Alonso, Juan A1 Kovacs, Laszlo A1 Mariette, Xavier A1 Mosca, Marta A1 Nived, Ola A1 Oristrell, Joaquim A1 Ramos-Casals, Manuel A1 Rascon, Javier A1 Ruiz-Irastorza, Guillermo A1 Saez-Comet, Luis A1 Salvador Cervello, Gonzalo A1 Ruiz-Irastorza, Guillermo A1 Saez-Comet, Luis A1 Cervello, Gonzalo Salvador A1 Sebastiani, Gian Domenico A1 Squatrito, Danilo A1 Szucs, Gabriella A1 Voskuyl, Alexandre A1 van Vollenhoven, Ronald AB 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. PB Bmj publishing group SN 2053-8790 YR 2016 FD 2016-01-01 LK http://hdl.handle.net/10668/19040 UL http://hdl.handle.net/10668/19040 LA en DS RISalud RD Apr 6, 2025