Off-Label Use of Intravenous Immunoglobulin (IVIG)
Last Updated: November 12, 2018
Result type: Tools
Off-label IVIG for Neurological Conditions:
- Studies suggest that IVIG treatment for neurological conditions is promising, but compelling evidence that IVIG works to improve most neurological conditions is lacking.
- Evidence suggests that IVIG may be better than plasma exchange for the treatment of pediatric Guillain-Barré Syndrome, and IVIG is shown to be more effective than placebo for the treatment of multiple sclerosis in adults.
- IVIG is no better than placebo for Alzheimer disease, encephalitis, or post-polio syndrome.
- The results for epilepsy, myasthenia gravis, and chronic inflammatory demyelinating polyneuropathy are mixed, making it unclear whether or not IVIG is an effective treatment.
Off-label IVIG for Hematological Conditions:
- No evidence was found for aplastic anemia, autoimmune neutropenia, hyperhemolysis after transfusion, and acquired hemophilia.
- A limited amount of evidence was found for blood conditions affecting a fetus or newborn. Overall, the evidence on IVIG for these specific conditions compared with other treatment options was mixed.
Off-label IVIG for Autoimmune or Inflammatory Conditions:
- Evidence indicates that the off-label use of IVIG may be effective in some autoimmune diseases but not in others.
- IVIG improves outcomes for patients with systemic lupus erythematosus, and it improves cardiac outcomes in infants of mothers with antiphospholipid syndrome during pregnancy.
- Limited evidence does not show a benefit with IVIG for dermatomyositis, myasthenia gravis, polymyositis, Kawasaki disease, Sydenham chorea, or cardiac complications of acute rheumatic fever.
Off-label IVIG for Non-neurological Paraneoplastic Disorders:
- No evidence was found, so it is not known whether or not IVIG is effective in treating non-neurological paraneoplastic disorders.
Off-label IVIG for Dermatological Conditions:
- Evidence is scarce and based mainly on non-randomized studies or small randomized controlled studies.
- For Stevens-Johnson syndrome or toxic epidermal necrolysis, IVIG treatment — alone or combined with corticosteroids — did not show survival benefit, but there may be a positive correlation between high-dose IVIG and some clinical benefits.
- For bullous pemphigoid, IVIG reduces the time-to-treatment reduction compared with placebo.
- For polymyositis or dermatomyositis, IVIG with corticosteroids improves muscle strength and the biochemical profile compared with placebo or corticosteroids alone (IVIG alone compared with placebo does not).
Off-label IVIG for Recurrent Spontaneous Abortion:
- Whether IVIG improves the chances of live birth in women who have experienced repeated miscarriage is unclear.
- Some studies show no difference in live birth rates with IVIG compared with placebo and other treatments.
- Other studies show a significant improvement in rates of live birth with IVIG compared with no IVIG.
- Studies that included obstetrical, perinatal, and neonatal outcomes found no important differences between groups treated with IVIG and those not treated with IVIG.
Off-label IVIG for Solid Organ Transplant Rejection:
- Limited evidence shows no difference in renal effect with IVIG and rituximab compared with placebo in patients with chronic, antibody-mediated rejection following renal transplant.
- Limited evidence shows an improvement in renal function in patients with chronic, antibody-mediated rejection following renal transplant with IVIG versus methylprednisolone.