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

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 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, G. Szűcs, Alexandre Voskuyl, Ronald Van Vollenhoven

Research output: Contribution to journalReview article

15 Citations (Scopus)

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 languageEnglish
Article number000163
JournalLupus Science and Medicine
Volume3
Issue number1
DOIs
Publication statusPublished - Sep 1 2016

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Off-Label Use
Systemic Lupus Erythematosus
Therapeutics
Registries
Rituximab
Lupus Nephritis
Immunosuppressive Agents
Biological Products
Adrenal Cortex Hormones
Communication
Research Personnel

ASJC Scopus subject areas

  • Immunology
  • Medicine(all)

Cite this

Ryden-Aulin, M., Boumpas, D., Bultink, I., Rubio, J. L. C., Caminal-Montero, L., Castro, A., ... Van Vollenhoven, R. (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

Off-label use of rituximab for systemic lupus erythematosus in Europe. / Ryden-Aulin, Monica; Boumpas, Dimitrios; Bultink, Irene; Rubio, Jose Luis Callejas; Caminal-Montero, Luis; Castro, Antoni; Ruiz, Agustín Colodro; Doria, Andrea; Dorner, Thomas; Gonzalez-Echavarri, Cristina; Gremese, Elisa; Houssiau, Frederic A.; Huizinga, Tom; Inanc, Murat; Isenberg, David; Iuliano, Annamaria; Jacobsen, Soren; Jimenez-Alonso, Juan; Kovacs, Laszlo; Mariette, Xavier; Mosca, Marta; Nived, Ola; Oristrell, Joaquim; Ramos-Casals, Manuel; Rascon, Javier; Ruiz-Irastorza, Guillermo; Sáez-Comet, Luis; Cervello, Gonzalo Salvador; Sebastiani, Gian Domenico; Squatrito, Danilo; Szűcs, G.; Voskuyl, Alexandre; Van Vollenhoven, Ronald.

In: Lupus Science and Medicine, Vol. 3, No. 1, 000163, 01.09.2016.

Research output: Contribution to journalReview article

Ryden-Aulin, M, Boumpas, D, 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, Kovacs, 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, Szűcs, G, Voskuyl, A & Van Vollenhoven, R 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
Ryden-Aulin M, Boumpas D, Bultink I, Rubio JLC, Caminal-Montero L, Castro A et al. Off-label use of rituximab for systemic lupus erythematosus in Europe. Lupus Science and Medicine. 2016 Sep 1;3(1). 000163. https://doi.org/10.1136/lupus-2016-000163
Ryden-Aulin, Monica ; Boumpas, Dimitrios ; Bultink, Irene ; Rubio, Jose Luis Callejas ; Caminal-Montero, Luis ; Castro, Antoni ; Ruiz, Agustín Colodro ; Doria, Andrea ; Dorner, Thomas ; Gonzalez-Echavarri, Cristina ; Gremese, Elisa ; Houssiau, Frederic A. ; Huizinga, Tom ; Inanc, Murat ; Isenberg, David ; Iuliano, Annamaria ; Jacobsen, Soren ; Jimenez-Alonso, Juan ; Kovacs, Laszlo ; Mariette, Xavier ; Mosca, Marta ; Nived, Ola ; Oristrell, Joaquim ; Ramos-Casals, Manuel ; Rascon, Javier ; Ruiz-Irastorza, Guillermo ; Sáez-Comet, Luis ; Cervello, Gonzalo Salvador ; Sebastiani, Gian Domenico ; Squatrito, Danilo ; Szűcs, G. ; Voskuyl, Alexandre ; Van Vollenhoven, Ronald. / Off-label use of rituximab for systemic lupus erythematosus in Europe. In: Lupus Science and Medicine. 2016 ; Vol. 3, No. 1.
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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.",
author = "Monica Ryden-Aulin and Dimitrios Boumpas 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 Laszlo Kovacs 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 G. Szűcs and Alexandre Voskuyl and {Van Vollenhoven}, Ronald",
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T1 - Off-label use of rituximab for systemic lupus erythematosus in Europe

AU - Ryden-Aulin, Monica

AU - Boumpas, Dimitrios

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 - Kovacs, Laszlo

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 - Szűcs, G.

AU - Voskuyl, Alexandre

AU - Van Vollenhoven, Ronald

PY - 2016/9/1

Y1 - 2016/9/1

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.

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