Off‐label use of rituximab in a tertiary Queensland hospital
Identifieur interne : 001689 ( Main/Exploration ); précédent : 001688; suivant : 001690Off‐label use of rituximab in a tertiary Queensland hospital
Auteurs : S. J. Butterly ; P. Pillans [Australie] ; B. Horn [Australie] ; R. Miles ; J. SturtevantSource :
- Internal Medicine Journal [ 1444-0903 ] ; 2010-06.
English descriptors
- Teeft :
- Acute humoral rejection, Adult patients, Australasian, Authors journal compilation, Bilateral ptosis, Creatinine, Cryoglobulinaemic, Cryoglobulinaemic vasculitis, Cyclophosphamide, Cyclosporine, Fsgs, Glomerulosclerosis, Gravis, Haemolytic, Haemolytic anaemia, Haemolytic uremic syndrome, Humoral, Idiopathic thrombocytopenic purpura, Ivig, Lung syndrome, Lupus, Lupus nephritis, Lymphoproliferative disorder, Monoclonal, Monoclonal antibody, Myasthenia, Myasthenia gravis, Nephritis, Nephrotic, Nephrotic syndrome, Plasma exchange, Plasmapharesis, Platelet, Platelet count, Post transplant, Prednisolone, Previous treatment, Princess alexandra hospital, Proteinuria, Purpura, Recurrence, Recurrent fsgs, Refractory, Relapse, Remission, Renal, Renal function, Renal transplant, Rheumatoid arthritis, Rituximab, Rituximab treatment, Royal australasian college, Serum albumin, Syndrome, Systemic lupus erythematosus, Thrombocytopenic, Thrombotic, Thrombotic thrombocytopenic purpura, Thyroid acropathy, Transplant, Vasculitis.
Abstract
Background: Rituximab is a monoclonal antibody directed against CD20, a pan B lymphocyte marker. It is approved in Australia for treatment of CD20‐positive B cell non‐Hodgkin lymphoma and rheumatoid arthritis. There is increasing off‐label use of rituximab in conditions where B cells and autoantibodies play a role in the pathophysiology. Rituximab is not only expensive, but its safety in unregistered indications is uncertain. Methods: We performed a retrospective review of the off‐label use of rituximab approved by the High Cost Drug Subcommittee at the Princess Alexandra Hospital between 2005 and 2008. Cases of post transplant lymphoproliferative disorder were excluded. Results: A total of 28 patients received rituximab for a variety of off‐label indications. There were no reported cases of serious infusion reactions or other notable adverse events. The most favourable outcomes were seen in myasthenia gravis, shrinking lung syndrome, thrombotic thrombocytopenic purpura, prevention and treatment of renal transplant rejection and lupus nephritis. No benefit was observed in cases of focal segmental glomerulosclerosis (primary or post‐transplant recurrence) and post‐transplant recurrence of haemolytic uremic syndrome. There was limited benefit in cryoglobulinaemic vasculitis. The cost of off‐label use was in excess of $210 000. Conclusion: In the absence of formal clinical trials, decisions regarding off‐label use of rituximab are difficult. Our cases contribute to the published literature and should help provide clinicians with greater insights into which conditions are likely to respond. As can be seen in our series, rituximab benefits people with certain conditions; longevity and cost‐effectiveness are currently unknown.
Url:
DOI: 10.1111/j.1445-5994.2009.01988.x
Affiliations:
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J." last="Butterly">S. J. Butterly</name><affiliation><wicri:noCountry code="subField"></wicri:noCountry></affiliation></author><author><name sortKey="Pillans, P" sort="Pillans, P" uniqKey="Pillans P" first="P." last="Pillans">P. Pillans</name><affiliation></affiliation><affiliation wicri:level="1"><country wicri:rule="url">Australie</country></affiliation></author><author><name sortKey="Horn, B" sort="Horn, B" uniqKey="Horn B" first="B." last="Horn">B. Horn</name><affiliation wicri:level="1"><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Pharmacy, The University of Queensland, Brisbane, Queensland</wicri:regionArea><wicri:noRegion>Queensland</wicri:noRegion></affiliation></author><author><name sortKey="Miles, R" sort="Miles, R" uniqKey="Miles R" first="R." last="Miles">R. Miles</name><affiliation><wicri:noCountry code="no comma">Nephrology and</wicri:noCountry></affiliation></author><author><name sortKey="Sturtevant, J" sort="Sturtevant, J" uniqKey="Sturtevant J" first="J." last="Sturtevant">J. Sturtevant</name><affiliation><wicri:noCountry code="subField">and</wicri:noCountry></affiliation></author></analytic><monogr></monogr><series><title level="j" type="main">Internal Medicine Journal</title><title level="j" type="alt">INTERNAL MEDICINE JOURNAL</title><idno type="ISSN">1444-0903</idno><idno type="eISSN">1445-5994</idno><imprint><biblScope unit="vol">40</biblScope><biblScope unit="issue">6</biblScope><biblScope unit="page" from="443">443</biblScope><biblScope unit="page" to="452">452</biblScope><biblScope unit="page-count">10</biblScope><publisher>Blackwell Publishing Asia</publisher><pubPlace>Melbourne, Australia</pubPlace><date type="published" when="2010-06">2010-06</date></imprint><idno type="ISSN">1444-0903</idno></series></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">1444-0903</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="Teeft" xml:lang="en"><term>Acute humoral rejection</term><term>Adult patients</term><term>Australasian</term><term>Authors journal compilation</term><term>Bilateral ptosis</term><term>Creatinine</term><term>Cryoglobulinaemic</term><term>Cryoglobulinaemic vasculitis</term><term>Cyclophosphamide</term><term>Cyclosporine</term><term>Fsgs</term><term>Glomerulosclerosis</term><term>Gravis</term><term>Haemolytic</term><term>Haemolytic anaemia</term><term>Haemolytic uremic syndrome</term><term>Humoral</term><term>Idiopathic thrombocytopenic purpura</term><term>Ivig</term><term>Lung syndrome</term><term>Lupus</term><term>Lupus nephritis</term><term>Lymphoproliferative disorder</term><term>Monoclonal</term><term>Monoclonal antibody</term><term>Myasthenia</term><term>Myasthenia gravis</term><term>Nephritis</term><term>Nephrotic</term><term>Nephrotic syndrome</term><term>Plasma exchange</term><term>Plasmapharesis</term><term>Platelet</term><term>Platelet count</term><term>Post transplant</term><term>Prednisolone</term><term>Previous treatment</term><term>Princess alexandra hospital</term><term>Proteinuria</term><term>Purpura</term><term>Recurrence</term><term>Recurrent fsgs</term><term>Refractory</term><term>Relapse</term><term>Remission</term><term>Renal</term><term>Renal function</term><term>Renal transplant</term><term>Rheumatoid arthritis</term><term>Rituximab</term><term>Rituximab treatment</term><term>Royal australasian college</term><term>Serum albumin</term><term>Syndrome</term><term>Systemic lupus erythematosus</term><term>Thrombocytopenic</term><term>Thrombotic</term><term>Thrombotic thrombocytopenic purpura</term><term>Thyroid acropathy</term><term>Transplant</term><term>Vasculitis</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Background: Rituximab is a monoclonal antibody directed against CD20, a pan B lymphocyte marker. It is approved in Australia for treatment of CD20‐positive B cell non‐Hodgkin lymphoma and rheumatoid arthritis. There is increasing off‐label use of rituximab in conditions where B cells and autoantibodies play a role in the pathophysiology. Rituximab is not only expensive, but its safety in unregistered indications is uncertain. Methods: We performed a retrospective review of the off‐label use of rituximab approved by the High Cost Drug Subcommittee at the Princess Alexandra Hospital between 2005 and 2008. Cases of post transplant lymphoproliferative disorder were excluded. Results: A total of 28 patients received rituximab for a variety of off‐label indications. There were no reported cases of serious infusion reactions or other notable adverse events. The most favourable outcomes were seen in myasthenia gravis, shrinking lung syndrome, thrombotic thrombocytopenic purpura, prevention and treatment of renal transplant rejection and lupus nephritis. No benefit was observed in cases of focal segmental glomerulosclerosis (primary or post‐transplant recurrence) and post‐transplant recurrence of haemolytic uremic syndrome. There was limited benefit in cryoglobulinaemic vasculitis. The cost of off‐label use was in excess of $210 000. Conclusion: In the absence of formal clinical trials, decisions regarding off‐label use of rituximab are difficult. Our cases contribute to the published literature and should help provide clinicians with greater insights into which conditions are likely to respond. As can be seen in our series, rituximab benefits people with certain conditions; longevity and cost‐effectiveness are currently unknown.</div></front></TEI><affiliations><list><country><li>Australie</li></country></list><tree><noCountry><name sortKey="Butterly, S J" sort="Butterly, S J" uniqKey="Butterly S" first="S. J." last="Butterly">S. J. Butterly</name><name sortKey="Miles, R" sort="Miles, R" uniqKey="Miles R" first="R." last="Miles">R. Miles</name><name sortKey="Sturtevant, J" sort="Sturtevant, J" uniqKey="Sturtevant J" first="J." last="Sturtevant">J. Sturtevant</name></noCountry><country name="Australie"><noRegion><name sortKey="Pillans, P" sort="Pillans, P" uniqKey="Pillans P" first="P." last="Pillans">P. Pillans</name></noRegion><name sortKey="Horn, B" sort="Horn, B" uniqKey="Horn B" first="B." last="Horn">B. Horn</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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