Immunoglobulins are proteins derived from human blood plasma.
The plasma, processed from donated human blood, contains antibodies that protect the body against diseases.
Immunoglobulins are used to treat patients with a range of conditions including some immune deficiency disorders.
Some people think that some of the core features of autism and some of the associated conditions, such as gastrointestinal problems, are caused by or made worse by defective immune systems.
They also think that immunoglobulin therapy can be used to repair those defective immune systems in some autistic people.
There is some scientific evidence of a link between immune deficiency disorders and some autistic people but the nature of that link is unclear.
There is no high quality research evidence to suggest that immunoglobulin therapy has any effect on the core symptoms of autism.
There is a limited amount of high quality research evidence (a single, large, multi-site randomised controlled trial) to suggest that immunoglobulin therapy has no effect on bowel disorders in autistic individuals.
Immunoglobulins are expensive, inconvenient to use, and potentially harmful. In the UK, their use is restricted to patients who meet the priorities set out in the document, “Clinical guidelines for immunoglobulin use”, published by the Department of Health in 2011. This document makes no mention of autism.
We therefore strongly recommend that immunoglobulin therapy is not used as a treatment for autistic people because of the potential risks and the lack of proven benefit.
Please read our Disclaimer on Autism Interventions
According to the Department of Health (2011) immunoglobulin injections or infusions are used to treat patients with a wide range of immune deficiency disorders. These include
According to the University of Maryland Medical Centre (2017) immunoglobulins can also be used
Some people, such as Gupta et al (2010), believe that a subset of autistic individuals may have defective immune systems and that these defective immune systems cause or worsen the symptoms of autism and related conditions.
Red cell aplasia (condition characterised by a decrease in the number of red blood cells); Guillain-Barré syndrome (condition in which the body's immune system attacks part of the peripheral nervous system); haematological (concerning blood); Kawasaki disease (condition that causes swelling of the blood vessels of the heart); thymoma (tumour that affects the thymus gland).
Immunoglobulin injections or infusions are normally used to treat patients with a wide range of immune deficiency disorders. The treatment is designed to replace the immunoglobulin which is missing in those patients.
Some people believe that a subset of autistic individuals may also have insufficient immunoglobulin in their bodies. For example, Gupta et al (2010) stated
“Because patients with autism display IgG or IgG subclass deficiency, the presence of autoantibodies, and an increased production of proinflammatory cytokines and chemokines, and IVIG is used as a replacement therapy and plays an important immunomodulatory role in autoantibody production and proinflammatory chemokine and cytokine secretion, a good rationale exists for the use of IVIG in at least a subset of patients with autism.”
Please note: There is no scientific consensus on the underlying mechanism of action of immunoglobulins in the treatment of immune deficiency disorders.
There have been various claims made for the use of immunoglobulins as an intervention for autistic people. For example,
Immunoglobulins are proteins derived from human blood plasma. The plasma, processed from donated human blood, contains antibodies that protect the body against diseases.
Antibodies are substances made by the body's immune system in response to bacteria, viruses, fungus, animal dander, or cancer cells. Antibodies attach to the foreign substances so the immune system can destroy them.
According to the WebMD website, accessed on 19 May 2017, the five major types of antibodies are:
The body makes specific antibodies in response to specific illnesses. For example, the IgM antibody for glandular fever is different to the IgM for herpes. For this reason, the plasma used in immunoglobulins is collected from thousands of screened donors and is used to generate a single batch, providing a wide variety of antibodies to protect against a wide variety of pathogens. Immunoglobulin products are mostly made of IgG, and contain only trace amounts of IgA and IgM.
Immunoglobulins may be administered in a variety of ways
Immunoglobulins are sold under a variety of brand names, each of which may come in different strengths and be administered in different ways.
The dosage will depend on the nature of the condition being treated, the body weight of the patient, the brand of immunoglobulin being used and the treatment mechanism. Please see the document, “Clinical guidelines for immunoglobulin use” published by the Department of Health in 2011 for guidance on dosages and administration of different brands of immunoglobulin.
Herpes (any of a group of diseases caused by the herpes viruses); glandular fever (viral infection caused by the Epstein-Barr virus that can cause symptoms including swollen glands, fever, sore throat and fatigue); plasma (liquid part of the blood and lymphatic fluid).
The cost of using immunoglobulins will depend on a number of factors including the supplier, the brand, the dosage, and the length and frequency of treatment.
According to the BNF website accessed on 12 April 2018, the NHS indicative price for three of the commonly used brands was as follows
According to the Choosing Wisely website, accessed on 12 April 2018,
“The … procedure can cost more than $30,000 a year. Because the treatment provides only temporary protection, it must be repeated regularly and usually for the patient’s whole life.”
The amount of time it takes to use immunoglobulin therapy will depend on a number of factors including the overall length of treatment, the frequency of infusions and the time taken to administer a single infusion.
Immunoglobulin therapy is normally considered as a long-term treatment for immune dysfunction conditions because the infusions need to be repeated on a regular basis and usually for the patient’s whole life. In all of the studies we identified which included autistic participants, the researchers administered immunoglobulin therapy for a period between two to six months, with some suggesting that it needed to be continued for longer.
Immunoglobulin infusions may be given as much as five times a day or only once every three weeks. Infusions can take between five and 30 minutes to administer depending on the brand and the mechanism used (intravenous versus subcutaneous).
Immunoglobulin therapy can cause a wide range of side effects. For example, according to the University of Maryland Medical Center (2017), immunoglobulin therapy can cause minor side effects, such as
It can also cause more significant side effects, such as
It can also cause potentially life-threatening side effects such as
For a full list of potential side effects please see University of Maryland Medical Center (2017) Immune globulin (Injection) . Baltimore, MD: University of Maryland Medical Center.
There are some contraindications (something which makes a particular treatment or procedure potentially inadvisable) for immunoglobulins. For example, according to the University of Maryland Medical Center (2017), immunoglobulin therapy may be contraindicated for individuals with “… kidney problems, anemia or blood clotting problems, diabetes, heart disease, atherosclerosis, a history of heart attack or stroke, idiopathic thrombocytopenic purpura (ITP), or protein problems such as paraproteinemia or hyperproteinemia”.
Aseptic meningitis syndrome (serous inflammation of the linings of the brain not caused by bacteria); atherosclerosis (build-up of fatty material inside your arteries); haemolysis (internal bleeding); haemolytic anaemia (anaemia caused by bleeding hyperproteinemia (increase in the concentration of protein in the bloodstream); idiopathic (relating to or denoting any disease or condition which arises spontaneously or for which the cause is unknown); thrombocytopenic purpura (blood disorder characterized by clotting in small blood vessels of the body); paraproteinemia (excessive quantities of paraprotein present in the blood).
Immunoglobulins are powerful drugs with some potentially dangerous side effects and are contraindicated for some groups of people. They are also in very short supply. For this reason, they should only be given by a qualified medical practitioner and in line with national guidelines.
In the UK, the use of immunoglobulins within the NHS is set out within the document, “Clinical guidelines for immunoglobulin use”, published by the Department of Health in 2011. These guidelines are designed to ensure that immunoglobulins are only provided to patients who meet clinical priorities, for example, those with life threatening conditions such as Kawasaki disease.
In the UK, immunoglobulins are not provided for the treatment of autistic people, unless they also happen to meet the clinical priorities set out in “Clinical guidelines for immunoglobulin use.” These guidelines make no separate mention of autism.
Immunoglobulins are powerful drugs with some potentially dangerous side effects. They are also contraindicated for some groups of people. For this reason, they should only be given by a qualified medical practitioner.
In the UK, the prescribing clinician will need to seek approval from other qualified medical personnel, such as the Medical Director and the Chief Pharmacist within a NHS trust, in line with Department of Health guidance.
According to Sewell et al (2014), the use of immunoglobulins as a treatment for immunological disorders began in the 1940s.
“Plasma fractionation for the preparation of albumin, clotting factors, and subcutaneous/intramuscular Ig began in the 1940s; industrial scale plasma fractionation started in 1943. Intravenous Ig (IVIg) was introduced in the early 1970s and became the driving market force in the 1990s when plasma-derived Factor VIII and Factor IX were increasingly replaced by recombinant products”.
We have yet to identify by whom and when the use of immune globulin for autistic people was first suggested but we think it is likely to have been in the late 1980s. The first study to appear in a peer-reviewed journal was Gupta et al. (1996).
We have identified seven studies of immunoglobulins as a treatment for autistic people published in English-language, peer-reviewed journals. These studies included more than 190 individuals aged from 2-17.
The most rigorous of these studies was Handen et al (2009) which stated that “Endpoint analysis revealed no significant differences across treatment groups on a modified global improvement scale (validated in irritable bowel syndrome studies), number of daily bowel movements, days of constipation, or severity of problem behaviors.”
There are a number of limitations to all of the research studies published to date. For example,
For a comprehensive list of potential flaws in research studies, please see ‘Why some autism research studies are flawed’.
At this stage research into the use of immune globulin as an intervention for autistic people is not a priority.
This section provides details of scientific studies into the effectiveness of this intervention for people with autism which have been published in English-language, peer-reviewed journals.
If you know of any other publications we should list on this page please email info@informationautism.org
Please note that we are unable to supply publications unless we are listed as the publisher. However, if you are a UK resident you may be able to obtain them from your local public library, your college library or direct from the publisher.
This section provides details of other publications on this topic.
You can find more publications on this topic in our publications database.
If you know of any other publications we should list on this page please email info@informationautism.org
Please note that we are unable to supply publications unless we are listed as the publisher. However, if you are a UK resident you may be able to obtain them from your local public library, your college library or direct from the publisher.
There is some evidence of a link between immune deficiency disorders and some autistic people but the nature of that link is unclear. For example, in 2016, Mandy and Lai noted
“There is now increasing evidence suggesting a central role of immune dysregulation in ASC. Neuro-immune processes are not only key to the neurobiological characteristics of individuals with ASC themselves but such processes may also play a contributing’ role in atypical neurodevelopment as early as the gestational period and may explain the pathogenesis of the autism phenotype in a subgroup of individuals”.