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

Monica Ryden-Aulin; Dimitrios T 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; László Kovács; Xavier Mariette; Marta Mosca; Ola Nived; Joaquim Oristrell; Manuel Ramos-Casals; Javier Rascon; Guillermo Ruiz-Irastorza; Luis Sáez-Comet; Gonzalo Salvador Cervello; Gian Domenico Sebastiani; Danilo Squatrito; Gabriella Szucs; Alexandre E Voskuyl; Ronald F van Vollenhoven

doi:10.1136/lupus-2016-000163

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

Monica Ryden-Aulin, Dimitrios T 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, László Kovács, Xavier MarietteMarta Mosca, Ola Nived, Joaquim Oristrell, Manuel Ramos-Casals, Javier Rascon, Guillermo Ruiz-Irastorza, Luis Sáez-Comet, Gonzalo Salvador Cervello, Gian Domenico Sebastiani, Danilo Squatrito, Gabriella Szucs, Alexandre E Voskuyl, Ronald F van Vollenhoven

Department of Clinical Medicine

32 Citations (Scopus)

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Abstract

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.

Original language	English
Article number	000163
Journal	Lupus Science and Medicine
Volume	3
Issue number	1
Number of pages	9
DOIs	https://doi.org/10.1136/lupus-2016-000163
Publication status	Published - 2016

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Off-label use of rituximab for systemic lupus erythematosus in EuropeFinal published version, 685 KBLicence: CC BY-NC

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Ryden-Aulin, M., Boumpas, D. T., Bultink, I., Rubio, J. L. C., Caminal-Montero, L., Castro, A., Ruiz, A. C., Doria, A., Dorner, T., Gonzalez-Echavarri, C., Gremese, E., Houssiau, F. A., Huizinga, T., Inanc, M., Isenberg, D., Iuliano, A., Jacobsen, S., Jimenez-Alonso, J., Kovács, L., ... van Vollenhoven, R. F. (2016). Off-label use of rituximab for systemic lupus erythematosus in Europe. Lupus Science and Medicine, 3(1), [000163]. https://doi.org/10.1136/lupus-2016-000163

Ryden-Aulin, M, Boumpas, DT, Bultink, I, Rubio, JLC, Caminal-Montero, L, Castro, A, Ruiz, AC, Doria, A, Dorner, T, Gonzalez-Echavarri, C, Gremese, E, Houssiau, FA, Huizinga, T, Inanc, M, Isenberg, D, Iuliano, A, Jacobsen, S, Jimenez-Alonso, J, Kovács, L, Mariette, X, Mosca, M, Nived, O, Oristrell, J, Ramos-Casals, M, Rascon, J, Ruiz-Irastorza, G, Sáez-Comet, L, Cervello, GS, Sebastiani, GD, Squatrito, D, Szucs, G, Voskuyl, AE & van Vollenhoven, RF 2016, 'Off-label use of rituximab for systemic lupus erythematosus in Europe', Lupus Science and Medicine, vol. 3, no. 1, 000163. https://doi.org/10.1136/lupus-2016-000163

@article{f6765ccc77084df39f6a223be289b021,

title = "Off-label use of rituximab for systemic lupus erythematosus in Europe",

abstract = "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.",

author = "Monica Ryden-Aulin and Boumpas, {Dimitrios T} and Irene Bultink and Rubio, {Jose Luis Callejas} and Luis Caminal-Montero and Antoni Castro and Ruiz, {Agust{\'i}n Colodro} and Andrea Doria and Thomas Dorner and Cristina Gonzalez-Echavarri and Elisa Gremese and Houssiau, {Frederic A.} and Tom Huizinga and Murat Inanc and David Isenberg and Annamaria Iuliano and Soren Jacobsen and Juan Jimenez-Alonso and L{\'a}szl{\'o} Kov{\'a}cs and Xavier Mariette and Marta Mosca and Ola Nived and Joaquim Oristrell and Manuel Ramos-Casals and Javier Rascon and Guillermo Ruiz-Irastorza and Luis S{\'a}ez-Comet and Cervello, {Gonzalo Salvador} and Sebastiani, {Gian Domenico} and Danilo Squatrito and Gabriella Szucs and Voskuyl, {Alexandre E} and {van Vollenhoven}, {Ronald F}",

year = "2016",

doi = "10.1136/lupus-2016-000163",

language = "English",

volume = "3",

journal = "Lupus Science and Medicine",

issn = "2053-8790",

publisher = "BMJ Publishing Group",

number = "1",

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TY - JOUR

T1 - Off-label use of rituximab for systemic lupus erythematosus in Europe

AU - Ryden-Aulin, Monica

AU - Boumpas, Dimitrios T

AU - Bultink, Irene

AU - Rubio, Jose Luis Callejas

AU - Caminal-Montero, Luis

AU - Castro, Antoni

AU - Ruiz, Agustín Colodro

AU - Doria, Andrea

AU - Dorner, Thomas

AU - Gonzalez-Echavarri, Cristina

AU - Gremese, Elisa

AU - Houssiau, Frederic A.

AU - Huizinga, Tom

AU - Inanc, Murat

AU - Isenberg, David

AU - Iuliano, Annamaria

AU - Jacobsen, Soren

AU - Jimenez-Alonso, Juan

AU - Kovács, László

AU - Mariette, Xavier

AU - Mosca, Marta

AU - Nived, Ola

AU - Oristrell, Joaquim

AU - Ramos-Casals, Manuel

AU - Rascon, Javier

AU - Ruiz-Irastorza, Guillermo

AU - Sáez-Comet, Luis

AU - Cervello, Gonzalo Salvador

AU - Sebastiani, Gian Domenico

AU - Squatrito, Danilo

AU - Szucs, Gabriella

AU - Voskuyl, Alexandre E

AU - van Vollenhoven, Ronald F

PY - 2016

Y1 - 2016

N2 - 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.

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.

U2 - 10.1136/lupus-2016-000163

DO - 10.1136/lupus-2016-000163

M3 - Review

C2 - 27651920

AN - SCOPUS:84987678542

SN - 2053-8790

VL - 3

JO - Lupus Science and Medicine

JF - Lupus Science and Medicine

IS - 1

M1 - 000163

ER -

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

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