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• W2041265898 abstract "ABSTRACT Background There has been an increase in the demand for new immunomodulatory drugs for the treatment of immune‐mediated inflammatory diseases. Many of these indications represent the off‐label use of immunomodulatory drugs. Aim To evaluate the spectrum of requests, clinical outcomes and costs for the hospital‐approved, off‐label use of immunomodulatory drugs. Method A list of all new individual patient use approvals at a Sydney teaching hospital (February 2005 to June 2006) was obtained and the approved immunomodulatory drugs were selected for audit. A literature review was conducted to determine the level of evidence available for the approved immunomodulatory drugs. Results 61 individual patient use approvals for off‐label immunomodulatory drugs were analysed. The most commonly requested drugs were infliximab (n = 22), mycophenolate (n = 13), rituximab (n = 10) and cyclosporin (n = 7). These drugs were initiated for treatment of a heterogeneous group of serious medical disorders. 10 hospital departments initiated the requests. The cost of new approvals was $458 301, accounting for 61% of the total cost of $749 236 for off‐label immunomodulatory drugs within the study period. The most expensive drugs were rituximab, infliximab and mycophenolate. Efficacy reports were available for 64% of approvals and a favourable therapeutic response was observed in 74% of cases. 4 deaths occurred and significant treatment‐related adverse events were noted in 24% of cases. High‐level evidence supported the use of immunomodulatory drugs for 41 individual patient use approvals. Conclusion Off‐label use of immunomodulatory drugs was diverse and supported by good evidence in over 50% of cases. Methods used to assess the response to immunomodulatory drugs were suboptimal and non‐standardised. Formalising the supply of immunomodulatory drugs may enable aggregation of data to inform future decisions and resource allocation." @default.
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• W2041265898 date "2009-06-01" @default.
• W2041265898 modified "2023-09-27" @default.
• W2041265898 title "Hospital Supply of Off-label Immunomodulatory Drugs" @default.
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• W2041265898 doi "https://doi.org/10.1002/j.2055-2335.2009.tb00437.x" @default.
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