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

Abstract

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.

Rituximab in the treatment of Neuromyelitis optica: a multicentre Italian observational study

“…In such papers, lower doses of RTX showed to be effective; anyway, no comparison with higher doses is provided. Among the above-cited articles, one [35] included also patients with neurological diseases, among whom eight subjects diagnosed with NMO, in which reduced dosage of RTX achieved a relapse-free status in 4/8 patients, consistently with what we observed in our study. Various randomized controlled trials (RCTs) comparing different RTX dosage regimens in Rheumatoid Arthritis (RA) have been published, and two systematic review encompass them all [36,37].…”

“…To our knowledge, no other study exists-even considering non-neurologic autoimmune diseases-comparing RTX-A and RTX-B dosage regimens. However, several reports on effectiveness of a reduced dose of RTX (that is, 500 mg twice 2 weeks apart, 500 mg in a single infusion, or even lower doses) in various autoimmune conditions exist [33][34][35]. In such papers, lower doses of RTX showed to be effective; anyway, no comparison with higher doses is provided.…”

Off‐label use of tumour necrosis factor‐alpha inhibitors and anakinra at an Australian tertiary hospital

“…The audit used patient medical records (paper and electronic charts) to collect demographic data (age, sex), previous treatment, indication, anti‐TNFα/anakinra used, doses given, outcome and adverse event data. This methodology follows similar chart audits of the off‐label use of rituximab (monoclonal antibody against CD20 on B lymphocytes) at large tertiary hospitals …”

The double misfortune: time to improve off‐label immune intervention

“…Two articles in the current issue of the Journal highlight rapid change in practice with regard to off‐label use of one such agent, the B‐lymphocyte‐directed monoclonal antibody rituximab . B‐cell‐dependent immune pathologies represent a significant proportion of diseases in the ‘double misfortune’ category.…”

“…Chay and colleagues describe the effect of a policy decision taken by one DTC to limit doses to save money, among other considerations. Retrospective follow up of 52 patients who were treated for 53 separate indications suggests substantial therapeutic benefit with favourable outcome for many patients, although some antineutrophil cytoplasmic antibody (ANCA)‐vasculitis patients may not have achieved the same benefit as seen in published RCT with higher doses.…”