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

Abstract

ObjectivesRituximab (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.MethodsData 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.ResultsThe 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.ConclusionsRTX 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.

Outcomes of rituximab therapy in refractory lupus: A meta-analysis

“…Data from Ryden-Aulin et al study about the off-label use of RTX for SLE in Europe showed that RTX is used in 4% to 20% of SLE patients in Sweden, up to 11% in Spain, and 7% in the U.K. Moreover, adoption of RTX for management of SLE ranged from 1% to 4% in other European countries (58). The off-label use of RTX in SLE is enabled by its favorable safety profile and the documented benefit that led to its approval by the FDA and the European Medicines Agency for the treatment of rheumatoid arthritis and ANCA-associated vasculitis (20,21).…”

Rituximab utilization for approved and off‐label nononcology indications and patients’ experiences with the Patient Alert Card

“…Rituximab (MabThera ® /Rituxan ® ), a chimeric monoclonal antibody that targets and depletes CD20‐positive B cells, has a safety profile that is well characterized and established in the approved oncology indications (non‐Hodgkin's lymphoma, chronic lymphocytic leukemia) and autoimmune indications (rheumatoid arthritis [RA], granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA], and pemphigus vulgaris [newly approved]) . Due to its mechanism of action, rituximab is also used off label by healthcare providers (HCPs) to treat other autoimmune conditions, often in patients who are refractory to approved treatments.…”

Extent and patterns of off-label use of rituximab for SLE

“…Percentage of patients with systemic lupus erythematosus receiving rituximab in 12 European countries 1 .…”

“…The ongoing search for effective therapies for systemic lupus erythematosus (SLE) is illustrated by a recent study by Ryden-Aulin et al 1 investigating the off-label use of rituximab for SLE in Europe. Effective, safe and affordable treatments are urgently needed for SLE.…”

“…The new publication by Ryden- Aulin et al 1 represents an important step in addressing this deficiency. An international group of rheumatologists and autoimmune disease specialists used the International Registry for Biologics In SLE (IRBIS), a retrospective and prospective registry launched in 2010, to survey patients with SLE from across European countries.…”