Experience with low-dose rituximab in off-label indications at two tertiary hospitals

Chay, J., Donovan, P., Cummins, L., Kubler, P. and Pillans, P. (2013) Experience with low-dose rituximab in off-label indications at two tertiary hospitals. Internal Medicine Journal, 43 8: 871-882. doi:10.1111/imj.12207


Author Chay, J.
Donovan, P.
Cummins, L.
Kubler, P.
Pillans, P.
Title Experience with low-dose rituximab in off-label indications at two tertiary hospitals
Journal name Internal Medicine Journal   Check publisher's open access policy
ISSN 1444-0903
1445-5994
Publication date 2013-08-01
Year available 2013
Sub-type Article (original research)
DOI 10.1111/imj.12207
Open Access Status Not yet assessed
Volume 43
Issue 8
Start page 871
End page 882
Total pages 12
Place of publication Richmond, VIC, Australia
Publisher Wiley-Blackwell Publishing Asia
Language eng
Abstract Background: Rituximab is a monoclonal antibody directed against B cells and is increasingly used to treat a variety of autoimmune conditions. Most published evidence reporting the successful use of rituximab in off-label indications has empirically used a high-dose regimen (either 375 mg/m(2) weekly for 4 weeks, or 1000 mg x 2), which is the approved course of treatment for lymphoma and rheumatoid arthritis patients.
Formatted abstract
Background: Rituximab is a monoclonal antibody directed against B cells and is increasingly used to treat a variety of autoimmune conditions. Most published evidence reporting the successful use of rituximab in off-label indications has empirically used a high-dose regimen (either 375 mg/m2 weekly for 4 weeks, or 1000 mg × 2), which is the approved course of treatment for lymphoma and rheumatoid arthritis patients.
Aims: The aims of this report are to review the indications, outcomes and adverse events of low-dose (500 mg twice, given 1–2 weeks apart), off-label use of rituximab in our institutions, and to review the available evidence.
Methods: We performed a retrospective audit of the off-label use of low-dose rituximab at two university teaching, tertiary referral hospitals, from mid-2008 until the end of 2011.
Results: Off-label rituximab was given to 52 patients (53 indications) across a heterogeneous group of autoimmune conditions. Outcomes were known for 46 conditions (affecting 45 patients), and of these, complete responses were observed in 16 (35%) conditions and a further 19 (41%) had a partial response. There was no response to rituximab in 11 (24%) patients. There were eight significant adverse events, mostly related to infectious complications.
Conclusion: This case series suggests that low-dose courses of rituximab can be used off-label to treat several severe and/or refractory immunological disorders with a reasonable safety profile; however, further trials are required in many off-label indications.
Keyword Off-label use
Rituximab
Autoimmune
Refractory granulomatous manifestations
Primary Sjogrens syndrome
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status Non-UQ

Document type: Journal Article
Sub-type: Article (original research)
Collection: School of Medicine Publications
 
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