Background Intravenous immunoglobulins (IVIg) are widely used to treat immunodeficiencies and autoimmune and/or inflammatory diseases, representing a significant economic burden for hospitals.
Purpose Disclosing the use of IVIg in a tertiary hospital: adequacy of labelling indications and economic impact.
Material and methods Retrospective study (January–December 2015). Descriptive analysis of IVIg use per patient and indications and associated costs were studied. IVIg adequacy of use was established based on the British Clinical guidelines for immunoglobulin use, 2nd edition, July 2011 update. Collected data, from the medical records, included sex, age, IVIg indication, posology, cumulative dose and treatment cost per patient.
Results 140 patients (aged 62.6 (3.1 to 91.8) years, 40.7% men) received IVIg (56% in hospital). IVIg posology when used as replacement therapy ranged from 100 to 400 mg/kg every 3–5 weeks. When used as immunomodulatory, posology ranged from 1 to 2 g/kg, as a single dose or monthly administrations.
Label indications were 62% (87/140): primary immunodeficiencies (68/87), idiopathic thrombocytopenic purpura (7/87), Guillain–Barré syndrome (5/87), secondary immunodeficiency (5/87) and Kawasaki disease (2/87). Off-label indications supported by clinical evidence were 20% (28/140): myasthenia gravis (9/28), chronic inflammatory demyelinating polyradiculoneuropathy (5/28), inflammatory myopathies (5/28), multifocal motor neuropathy (2/28), stiff person syndrome (2/28), renal transplant rejection mediated by antibodies (2/29), Lambert–Eaton syndrome (1/28), autoimmune haemolytic anaemia (1/28) and staphylococcal toxic shock (1/28).
Off-label indications not sufficiently supported by clinical evidence were 12% (17/140): systemic lupus erythematosus (6/17), systemic vasculitis (6/17), paraneoplastic syndrome (3/17), acute disseminated encephalomyelitis (1/17) and refractory childhood epilepsy (1/17). Indication was not properly established in 6% (8/140) of cases. 66.295 g of IVIg were dispensed in 2015, with a cost of €1 732 897. Label indications assumed 33% of dispensed IVIg and 42% of cost. Off-label indications both supported and not supported by clinical evidence assumed 47% and 16% of dispensed IVIg, and 33% and 19% of cost, respectively. IVIg used in a not properly established indication assumed 4% of dispensed IVIg and 6% of cost.
Conclusion Off-label IVIg indications were frequent in our hospital (32%), with an important economic impact (52%), and higher than label indications. It would be useful implementing an updated IVIg protocol, listing indications supported by scientific evidence to facilitate application of IVIg treatment in off-label indications.
No conflict of interest
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