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Lupus Sci Med. 2016 Sep 6;3(1):e000163. doi: 10.1136/lupus-2016-000163. eCollection 2016.

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

Author information

1
Unit of Clinical Therapy Research, Inflammatory Diseases, Department of Medicine , Karolinska Institutet, Karolinska University Hospital , Stockholm , Sweden.
2
Joint Academic Rheumatology Program and 4th Department of Medicine , Medical School, National and Kapodestrian University of Athens, Attikon University Hospital , Athens , Greece.
3
Department of Rheumatology , Amsterdam Rheumatology and Immunology Center , Amsterdam , The Netherlands.
4
Unit of Autoimmune Diseases , Hospital San Cecilio , Granada , Spain.
5
Autoimmune Systemic Diseases Unit, Internal Medicine Department , Hospital Universitario Central de Asturias , Oviedo , Spain.
6
Internal Medicine Department , University Hospital Sant Joan de Reus, Rovira i Virgili University (URV)-IISPV , Reus , Spain.
7
Pasaje Nueva Victoria, 2, 2do C , Jaén , Spain.
8
Rheumatology Unit, Department of Medicine , University of Padova , Padova , Italy.
9
Department of Medicine/Rheumatology and Clinical Immunology , Charite Universitaetsmedizin Berlin , Berlin , Germany.
10
Autoimmune Diseases Research Unit, Department of Internal Medicine , BioCruces Health Research Institute, Cruces University Hospital, University of the Basque Country , Barakaldo , Spain.
11
Institute of Rheumatology and Affine Sciences (IRSA), Catholic University of the Sacred Heart , Rome , Italy.
12
Service de Rhumatologie , Cliniques Universitaires Saint-Luc, Pôle de Pathologies Rhumatismales Inflammatoires et Systémiques, Université Catholique de Louvain , Brussels , Belgium.
13
Department of Rheumatology , C1-41, Leiden University Medical Center , Leiden , The Netherlands.
14
Division of Rheumatology, Department of Internal Medicine, Istanbul Medical Faculty, Istanbul University , Istanbul , Turkey.
15
University College London, The Rayne Building , London , UK.
16
Rheumatology Unit , San Camillo Hospital , Rome , Italy.
17
Copenhagen Lupus and Vasculitis Clinic, Center for Rheumatology and Spine Diseases, University of Copenhagen, Rigshospitalet , Copenhagen , Denmark.
18
Internal Department , Universitary 'Virgen de las Nieves' Hospital , Granada , Spain.
19
Department of Rheumatology, Faculty of Medicine , Albert Szent-Györgyi Health Centre, University of Szeged , Szeged , Hungary.
20
Rhumatologie Responsable de l'Unité de Recherche Clinique, Hôpitaux Universitaire Paris-Sud, Université Paris-Sud, INSERM U1184 , Paris , France.
21
Rheumatology Unit, Pisa , Italy.
22
Rheumatology Clinic, Skåne University Hospital , Lund , Sweden.
23
Internal Medicine Department , Hospital de Sabadell, Universitat Autonoma de Barcelona , Catalunya , Spain.
24
Department of Autoimmune Diseases , ICMiD, Josep Font Autoimmune Lab, CELLEX-IDIBAPS , Barcelona , Spain.
25
Carrer de les Sabateres, 9-1, Alaró , Islas Baleares , Spain.
26
Unidad de Enfermedades Autoinmunes Sistémicas, Hospital Universitario Miguel Servet de Zaragoza, Paseo Isabel la Católica , Zaragoza , Spain.
27
Department of Internal Medicine, Inmunopathological and Autoimmune Area , Hospital Universitario y Politecnico La Fe , Valencia , Spain.
28
UOC Reumatologia, Ospedale San Camillo, Circonvallazione Gianicolense n. 87 , Roma , Italy.
29
Department of Sperimental and Clinical Medicine , University of Florence , Firenze , Italy.
30
Department of Rheumatology , Institute of Medicine, University of Debrecen , Debrecen , Hungary.
31
Amsterdam Rheumatology and Immunology Center (ARC), VU University Medical Center , Amsterdam , The Netherlands.
32
Unit of Clinical Therapy Research, Inflammatory Diseases, Department of Medicine, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden; Rheumatology Clinic, Karolinska University Hospital, Stockholm, Sweden; Amsterdam Rheumatology and Immunology Center ARC, AMC mail F4-105, Amsterdam, The Netherlands.

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.

KEYWORDS:

DMARDs (biologic); Lupus Nephritis; Systemic Lupus Erythematosus

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