Off‐label use of rituximab in autoimmune disease in the Top End of the Northern Territory, 2008–2016

Wongseelashote, Sarah; Tayal, Vipin; Bourke, Peter

doi:10.1111/imj.13554

Cited by 11 publications

(15 citation statements)

References 31 publications

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“…However, the infection rate went up to 25% in NHPs under anti‐CD 20 Ab/tacrolimus regimen, although the difference was not statistically significant. Our triple immunosuppressant regimen (anti‐CD 20 Ab/tacrolimus/basiliximab) showed comparable safety with that described in a previous report, which presented a 27.3% bacterial or protozoal infection rate in patients who received anti‐CD20 Ab …”

Section: Discussionsupporting

confidence: 72%

Long‐term safety outcome of systemic immunosuppression in pig‐to‐nonhuman primate corneal xenotransplantation

Choi

Yoon

Lee

et al. 2018

Xenotransplantation

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Costimulatory blockade-based and anti-CD20 antibody/tacrolimus-based immunosuppressive therapies seem to be comparably safe with steroid therapy in nonhuman primates receiving corneal xenotransplantation, as they did not reactivate Rhesus Cytomegalovirus and maintained manageable systemic status. Although reactivation is rare, antiviral prophylaxis for simian varicella virus should be considered in immunocompromised hosts.

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Section: Discussionsupporting

confidence: 72%

Long‐term safety outcome of systemic immunosuppression in pig‐to‐nonhuman primate corneal xenotransplantation

Choi

Yoon

Lee

et al. 2018

Xenotransplantation

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“…1,4−6 The safety and e cacy of rituximab in the Top End of Northern Territory was examined in a retrospective descriptive study examining the off-label use of rituximab in patients with autoimmune diseases. 35 The authors of the study reported 18 episodes of infection in 66 patients, of whom, 41(62.1%) self-identi ed as Indigenous Australians. 35 A 'clinically signi cant response' was seen in 3 of the 4 patients treated for Lupus Nephritis.…”

Section: Discussionmentioning

confidence: 97%

“…35 The authors of the study reported 18 episodes of infection in 66 patients, of whom, 41(62.1%) self-identi ed as Indigenous Australians. 35 A 'clinically signi cant response' was seen in 3 of the 4 patients treated for Lupus Nephritis. Accepting the limitations of retrospective study and the inconsistent documentation of objective disease activity, the authors concluded that off-label use of rituximab for treatment of autoimmune diseases is common and safe in majority of cases.…”

Section: Discussionmentioning

confidence: 97%

Induction Therapy and Outcome of Proliferative Lupus Nephritis in the Top End of Northern Australia – A single centre study retrospective study

Xu¹,

Goh²,

Abeyaratne³

et al. 2021

Preprint

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BackgroundLupus nephritis is a common manifestation of Systemic Lupus Erythematosus. Mycophenolate is recommended by guidelines for induction therapy in patients with proliferative lupus nephritis and nephrotic range proteinuria Class V lupus nephritis. Indigenous Australians suffer disproportionally from systemic lupus erythematosus compared to non-Indigenous Australians. MethodsWe retrospectively identified patients with newly diagnosed biopsy-proven class III lupus nephritis, class IV lupus nephritis and class V lupus nephritis with nephrotic range proteinuria from 1st Jan 2010 to 31st Dec 2019 in our institution and examined for the patterns of prescribed induction therapy and clinical outcome. The primary efficacy outcome of interest was the incidence of complete response (CR) and partial response (PR) at one-year post diagnosis as defined by the Kidney Disease: Improving Global Outcome (KDIGO) guideline. Secondary efficacy outcome was a composite of renal adverse outcome in the follow-up period. Adverse effect outcome of interest was any hospitalisations secondary to infections in the follow-up period. Continuous variables were compared using Student’s t-test or Mann-Whitney U-test. Categorical variables were summarised using frequencies and percentages and assessed by Fisher’s exact test. Time-to-event data was compared using the Kaplan-Meier method and Log-rank test. Count data were assessed using the Poisson’s regression method and expressed as incident rate ratio.Results20 of the 23 patients included in the analysis were managed with mycophenolate induction upfront. Indigenous Australian patients (N=15), compared to non-Indigenous patients (N=5) received lower cumulative dose of mycophenolate mofetil over the 24 weeks (375g vs. 256g, p<0.05), had a non-significant lower incidence of complete remission at 12 months (60% vs. 40%, p=0.617), higher incidence of composite renal outcome (0/5 patients vs. 5/15 patients, p=0.20) and higher incidence of infection related hospitalisations, (incident rate ratio 3.66, 95% confidence interval 0.89-15.09, p=0.073). ConclusionMycophenolate as upfront induction in Indigenous Australian patients were associated with lower incidence of remission and higher incidence of adverse outcomes. These observations bring the safety and efficacy profile of mycophenolate in Indigenous Australians into question.

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“…Fourteen references [10,14,[28][29][30][31][32][33][34][35][36][37][38][39] published between 1999 and 2018, were included. At least one study was conducted in each Australian state or territory with the exception of the ACT and Tasmania.…”

Section: Review Of the Literaturementioning

confidence: 99%

“…Fourteen studies focused on certain populations including pregnant women [31], paediatric patients [10,14,32]. palliative care patients [29,30] and patients with dermatological conditions [33], psychiatric disorders [34] and autoimmune or other conditions [30,[35][36][37][38][39].…”

Section: Review Of the Literaturementioning

confidence: 99%

The extent to which off-patent registered prescription medicines are used for off-label indications in Australia: A scoping review

2021

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Aim The aim of this scoping review was to determine the extent of off-patent prescription medicine use beyond registered indications in various Australian clinical settings. Method The review followed the Joanna Briggs Institute approach and reported using PRISMA Extension for Scoping Reviews. Online databases were used to identify published literature about off-patent registered prescription medicines used for off-label indications in Australian public hospital, community and primary healthcare settings. In addition, empirical data from the Queensland and the South Australian state-wide medicine formularies were screened for the same medication/off-label indication dyads identified in the literature, and other locally approved uses. Results Overall, fourteen studies were included, conducted in public hospitals (n = 11), palliative care units (n = 2) and the community setting (n = 1). There were 213 reports extracted from the literature describing off-patent registered prescription medicines used for off-label indications, representing 128 unique medication/off-label indication dyads and 32 different medicines. Of these, just five medication/off-label indication dyads were approved for use on both the Queensland and South Australian state-wide medicine formularies, with 12 others only approved for use in Queensland and 16 others only approved for use in South Australia. Further examination of these state-wide formularies demonstrated that the use of off-patent registered prescription medicines beyond registered indications is more extensive than has been reported to date in the literature. There were 28 additional medication/off-label indication dyads approved on the Queensland state-wide medicine formulary and 14 such examples approved for use in South Australia. Of these, just two medication/off-label indication dyads were approved for use on both formularies. Conclusion The extent to which off-patent registered prescription medicines have been repurposed in clinical settings for off-label indications in Australia is greater than previously reported in the literature. Usage and funded availability of certain medication/off-label indication dyads, varies across Australia. These results further expose the two tiered system of medicines regulation in Australia, and its impact on equity of access to medicines. Further research is required to support policy change to encourage submission of registration updates for off-patent prescription medicines.

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Off‐label use of rituximab in autoimmune disease in the Top End of the Northern Territory, 2008–2016

Abstract: Rituximab has been used off-label for a range of autoimmune diseases in this population with a high proportion of Aboriginal patients successfully and safely in the majority of cases.

Cited by 11 publications

References 31 publications

Long‐term safety outcome of systemic immunosuppression in pig‐to‐nonhuman primate corneal xenotransplantation

Long‐term safety outcome of systemic immunosuppression in pig‐to‐nonhuman primate corneal xenotransplantation

Induction Therapy and Outcome of Proliferative Lupus Nephritis in the Top End of Northern Australia – A single centre study retrospective study

The extent to which off-patent registered prescription medicines are used for off-label indications in Australia: A scoping review

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