RT Journal Article
SR Electronic
T1 Off-label use of rituximab for systemic lupus erythematosus in Europe
JF Lupus Science & Medicine
FD Lupus Foundation of America
SP e000163
DO 10.1136/lupus-2016-000163
VO 3
IS 1
A1 Monica Rydén-Aulin
A1 Dimitrios Boumpas
A1 Irene Bultink
A1 Jose Luis Callejas Rubio
A1 Luis Caminal-Montero
A1 Antoni Castro
A1 Agustín Colodro Ruiz
A1 Andrea Doria
A1 Thomas Dörner
A1 Cristina Gonzalez-Echavarri
A1 Elisa Gremese
A1 Frederic A Houssiau
A1 Tom Huizinga
A1 Murat Inanç
A1 David Isenberg
A1 Annamaria Iuliano
A1 Søren Jacobsen
A1 Juan Jimenéz-Alonso
A1 Lászlo Kovács
A1 Xavier Mariette
A1 Marta Mosca
A1 Ola Nived
A1 Joaquim Oristrell
A1 Manuel Ramos-Casals
A1 Javier Rascón
A1 Guillermo Ruiz-Irastorza
A1 Luis Sáez-Comet
A1 Gonzalo Salvador Cervelló
A1 Gian Domenico Sebastiani
A1 Danilo Squatrito
A1 Gabriella Szücs
A1 Alexandre Voskuyl
A1 Ronald van Vollenhoven
YR 2016
UL http://lupus.bmj.com/content/3/1/e000163.abstract
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.