ArticleEuropean journal of clinical pharmacology2013
Available evidence and outcome of off-label use of rituximab in clinical practice.
Article in European journal of clinical pharmacology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
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11 citing papers in PubMed, 24 citations in OpenAlex.
- Neutropenic events associated with new anticancer treatments, from pathophysiology to practice: a scoping review-NEW Group (Neutropenic Events Working Group).Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025Article
- An update on the incidence, risk factors and mechanisms of rituximab-associated neutropenia.Archives of medical science : AMS · 2024Article
- Real-life drug retention rate and safety of rituximab when treating rheumatic diseases: a single-centre Swiss retrospective cohort study.Arthritis research & therapy · 2023Article
- Preliminary study on the efficacy of rituximab in the treatment of idiopathic membranous nephropathy: A single-centre experience.Frontiers in endocrinology · 2023Article
- Off-label use of rituximab in patients with systemic lupus erythematosus with extrarenal disease activity: a retrospective study and literature review.Frontiers in medicine · 2023Article
- Off-Label Use of Rituximab in Patients with Different Types of Nephropathies in a Tertiary Hospital: A Retrospective Study.Journal of clinical medicine · 2021Article
- Use of non-formulary high-cost medicines in an Australian public hospital.International journal of clinical pharmacy · 2019Article
- Neuromyelitis optica spectrum disorders associated with other autoimmune diseases.Rheumatology international · 2015Review
- Early-onset neutropenia induced by rituximab in a patient with lupus nephritis and hemolytic anemia.Case reports in rheumatology · 2015Article
- Outcomes of off-label drug uses in hospitals: a multicentric prospective study.European journal of clinical pharmacology · 2014Article
- Behçet's syndrome pathophysiology and potential therapeutic targets.Internal and emergency medicine · 2014Review
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Authors and funding
9 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo analyze the therapeutic indications for off-label use of rituximab, the available evidence for its use, the outcomes, and the cost.
methodsThis was a retrospective analysis of patients treated with rituximab for off-label indications from January 2007 to December 2009 in two tertiary hospitals. Information on patient characteristics, medical conditions, and therapeutic responses was collected from medical records. Available evidence for the efficacy of rituximab in each condition was reviewed, and the cost of treatment was calculated.
resultsA total of 101 cases of off-label rituximab use were analyzed. The median age of the patients involved was 53 [interquartile range (IQR) 37.5-68.0] years; 55.4 % were women. The indications for prescribing rituximab were primarily hematological diseases (46 %), systemic connective tissue disorders (27 %), and kidney diseases (20 %). Available evidence supporting rituximab treatment for these indications mainly came from individual cohort studies (53.5 % of cases) and case series (25.7 %). The short-term outcome (median 3 months, IQR 2-4 months) was a complete response in 38 % of cases and partial response in 32.6 %. The highest short-term responses were observed for systemic lupus erythematosus and membranous glomerulonephritis, and the lowest was for neuromyelitis optica, idiopathic thrombocytopenic purpura, and miscellaneous indications. Some response was maintained in long-term follow-up (median 23 months IQR 12-30 months) in 69.2 % of patients showing a short-term response. Median cost per patient was €5,187.5 (IQR €5,187.5-7,781.3).
conclusionsIn our study, off-label rituximab was mainly used for the treatment of hematological, kidney, and systemic connective tissue disorders, and the response among our patient cohort was variable depending on the specific disease. The level of evidence supporting the use of rituximab for these indications was low and the cost was very high. We conclude that more clinical trials on the off-label use of rituximab are needed, although these may be difficult to conduct in some rare diseases. Data from observational studies may provide useful information to assist prescribing in clinical practice.
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