Subcutaneous immuno-globulin therapy at home
Chronic respiratory conditions with antibody deficiency can be treated with replacement therapy at home rather than in hospital
In this article…
- The benefits of offering treatment at home
- How the programme was implemented
- The future direction for subcutaneous immunoglobulin therapy
Lorraine Ozerovitch is a clinical nurse specialist in respiratory infection and immunology, Royal Brompton and Harefield Foundation Trust.
Ozerovitch L (2013) Subcutaneous immunoglobulin therapy at home. Nursing Times; 109: 49/50, 20-21.
Subcutaneous immunoglobulin (SCIg)replacement therapy is a new clinical service development in adult respiratory care undertaken at the Royal Brompton and Harefield Foundation Trust. SCIg therapy reduces appropriate patients’ susceptibility to recurrent acute and chronic respiratory infections.
Patients with specific chronic respiratory conditions and antibody deficiency can be treated with SCIg therapy at home, rather than with intravenous immunoglobulin (IVIg) therapy in hospital. Using a personalised teaching programme and managing the daily demands of the clinical service promotes greater concordance with treatment. With over 34% of our immunoglobulin therapy patients now
on SCIg replacement therapy, this treatment innovation has brought about high levels of patient satisfaction and cost savings to trust budgets.
- This article has been double-blind peer reviewed
- Figures and tables can be seen in the attached print-friendly PDF file of the complete article in the ‘Files’ section of this page
5 key points
- Immuno-globulins are antibodies prepared from plasma that help keep the body free from infection
- Before the introduction of antibiotics, patients diagnosed with antibody deficiency died prematurely from acute respiratory infections
- Subcutaneous immuno-globulin (SCIg) therapy reduces patients’ susceptibility to recurrent acute and chronic respiratory infections
- Managing their own treatment gives patients greater control over their condition and promotes concordance
- Delivering SCIg therapy at home saves the NHS money and is popular with patients
At the Royal Brompton and Harefield Foundation Trust, adult patients with bronchiectasis associated with antibody deficiencies have historically been treated with intravenous immunoglobulin (IVIg) therapy to reduce their susceptibility to recurrent respiratory infections. Immunoglobulin are antibodies prepared from plasma that help keep the body healthy and free from infection.
IVIg is usually administered every three weeks in a day unit. It takes approximately two to six hours to administer, depending on the dose. Over the past four years a new service option has been implemented: subcutaneous immunoglobulin (SCIg) replacement therapy offers patients the opportunity to administer weekly therapy in the comfort of their homes, taking only an hour or two to administer and causing minimal disruption to both their personal and professional lives.
Although SCIg replacement therapy is an established treatment within the immunology arena, it has rarely been offered to a group of patients with specific chronic respiratory conditions who have antibody deficiencies. Our service innovation has been particularly helpful to patients with poor venous access, is suitable for busy parents who find it difficult to attend hospital during school hours, and is convenient and discreet for individuals attending college or travelling overseas.
Immunoglobulin therapy options
Before the introduction of antibiotics, patients diagnosed with antibody deficiency died prematurely from acute respiratory infections. Repeated lung infections from bacteria such as Streptococcus pneumoniae and Haemophilus influenzae, drives an inflammatory process, which may lead to the development and progression of bronchiectasis (Fig 1) (Ozerovitch and Wilson, 2011).
Immunoglobulins were initially given by intramuscular injection but these were painful on administration and poorly tolerated. The early IVIg injections were available in the 1980s and became the most effective treatment, with a direct impact on patient survival rates (Pourpak et al, 2006). Today, developments in the manufacturing process mean that immunoglobulin replacement therapies are well tolerated, no matter which administrative route patients choose to receive.
From the time SCIg became available in the late 1990s, this administrative route has been compared with IVIg; clinical trials have shown it to be equivalent in terms of serum immunoglobulin concentrations achieved and in prevention against serious bacterial infections in patients with antibody deficiency (Chapel et al, 2000).
For some patients, a local injection site reaction occurs following administration of SCIg but this is usually short lived and well tolerated. SCIg treatment effectiveness has been shown to be comparable to IVIg treatment (Table 1), with respect to annual rates of serious bacterial infections such as pneumonia. However, patients receiving SCIg treatment have reported better quality-of-life outcomes in terms of reduced time spent admitted to hospital, on antibiotics and fewer days missed from work or school (Eades-Perner et al, 2007; Gardulf et al, 2006).
Implementation of a home SCIg therapy programme
Before starting the service I visited other immunology centres to understand how they deliver their SCIg service. The views of patients undergoing IVIg therapy were then sought to see whether they would consider switching their treatment delivery to a home therapy SCIg option. Having explored the feasibility and potential demand for this new service, a team consisting of a ward manager, nursing staff, administrator, pharmacist, procurement manager, directorate manager and consultant immunologist explored how to move the initiative forward.
Treatment guidelines were written and accepted by the trust’s drug and therapeutic committee, and standard operating procedures (SOPs) outlining the nursing responsibilities and the teaching programme were drawn up. The SOPs included:
- Management of adverse events;
- Letters of notifications to GPs; and
- Test papers for patients and infusion partners to complete to ensure they fully understood the treatment regimen.
Home-care contracts were then established and infusion equipment purchased. The role of home care is to deliver immunoglobulin and ancillaries to patients’ homes while removing any clinical waste material, for example, sharps bins.
Standard letters to primary care trusts were written, detailing the new home therapy option for patients. This would be a financially attractive package, saving an estimated £4,000-6,000 per patient per year. Further financial savings have been made from patients who required hospital transport but are now treated at home.
Patients are given a personalised teaching programme in hospital by the clinical nurse specialist on how to administer SCIg replacement therapy at home. This programme details knowing:
- How to store and draw up the product;
- When not to infuse;
- How to manage and report adverse events; and
- The importance of recording batch numbers.
The CNS’ additional nursing responsibilities lie in:
- Liaising with the pharmacy department to maintain prescriptions;
- Troubleshooting service concerns;
- Maintaining patient entries on the local and national databases; and
- Attending the trust’s immunoglobulin demand-management panel meetings.
Patients are welcome to call the CNS for advice, especially if they have an opportunistic respiratory infection and need antibiotic guidance. Also, if they have concerns about their treatment administration regimen once at home, they can call to discuss adapting their treatment approach.
Box 1 outlines key points in setting up a home SCIg service.
SCIg service outcome
The benefits of this project are that it places patients’ requirements first and patients are empowered to take charge of their treatment. Patients understand the treatment regimen is more intense, with weekly injections rather than infusions every three weeks, but managing their own treatment gives them greater control over their condition and promotes concordance with treatment. Some patients will bring their infusion log books to clinic to show the consultant immunologist how they are getting on with their treatment; for others, changes to their personal circumstances may mean the delivery of the treatment requires adjustment.
Patients can administer their SCIg every 7-10 days, making the treatment regimen more flexible and giving them the opportunity to infuse around a two-week holiday. This treatment regimen requires blood to be taken every three months to ensure immunoglobulin trough levels remain within therapeutic range. Other blood markers are also checked to ensure patients are well and free from viral infections.
In some instances GP surgeries report their results to the service lead, which reduces a patient’s burden of attending regular hospital phlebotomy clinics. As this treatment is safe to administer at home, with minimal adverse events being reported, patients only need to be clinically reviewed once every six months - as long as their trough levels remain within an acceptable range and their underlying condition remains stable.
Our first SCIg service survey was conducted in May 2012 to explore patient satisfaction with the service option. A 61% (18 patients) postal response rate was achieved, the average age of participants was 47 years and there was an equal gender ratio. Our service users came from Ireland and counties in the west and south-west of England. Our main findings were that 94% strongly agreed that they preferred the SCIg replacement therapy option to IVIg treatment and that 89% would strongly recommend SCIg therapy to other patients considering it.
One patient’s response stated that: “SCIg [therapy] allowed me more freedom: I can choose the time and place that I want to administer the treatment rather than spending all day at the hospital every three weeks. I also used hospital transport and waited several hours to get home.”
When asked whether there were any downsides to receiving SCIg therapy, 72% of responders reported there were none but others remarked on infusion frequency, pain associated with needle insertion and lack of sleep on the day of treatment.
The future direction of SCIg replacement therapy is exciting; newer ways of delivering it have been explored, such as a rapid-push technique, which takes less time.
Hyaluronidase-facilitated administration assists with immunoglobulin uptake to overcome large volumes being administered at a single site and is suitable for patients who receive large weekly infusion volumes (Misbah et al, 2009). In addition, a new concentrated product has been manufactured to reduce the weekly volume requirement and, combined with the rapid-push technique, has the potential to reduce the weekly treatment burden to every second week.
Studies into IVIg show increased doses reduce lung-function decline and exacerbation frequency in patients with immune deficiencies and chronic comorbidities (Chen et al, 2011; Orange et al, 2011; Lucas et al, 2010).
The introduction of SCIg replacement therapy at the Royal Brompton and Harefield Foundation Trust has given respiratory patients with antibody deficiencies choice over their treatment delivery options. This therapy option constitutes a cost-saving opportunity to the NHS and has resulted in a high level of treatment satisfaction to our patient population.
Chapel H et al (2000) The comparison of the efficacy and safety of intravenous versus subcutaneous immunoglobulin replacement therapy. Journal of Clinical Immunology; 20: 94-100.
Chen Y et al (2011) Longitudinal decline in lung function in patients with primary immunoglobulin deficiencies. Journal of Allergy and Clinical Immunology; 127: 6, 1414-1416.
Eades-Perner A et al (2007) The European internet-based patient and research database for primary immunodeficiencies: results 2004-06. Clinical and Experimental Immunology; 147, 306-312.
Gardulf A et al (2006) Replacement IgG therapy and self-therapy at home improve the health-related quality of life in patients with primary antibody deficiencies. Allergy and Clinical Immunology; 6: 6, 434-442.
Lucas M et al (2010) Infection outcomes in patients with common variable immunodeficiency disorders: relationship to immunoglobulin therapy over 22 years. Journal of Allergy and Clinical Immunology; 125, 1354-1360.
Misbah S et al (2009) Subcutaneous immunoglobulin: opportunities and outlook. Clinical and Experimental Immunology; 158: Suppl. 1, 51-59.
Orange J et al (2011) Use of intravenous immunoglobulin in human disease: a review of evidence by members of the primary immunodeficiency committee of the American academy of allergy, asthma and immunology. Journal of Allergy and Clinical Immunology; 117, S525-553.
Ozerovitch L and Wilson R (2011) Managing bronchiectasis. Independent Nurse; 22: 18-20.
Pourpak Z et al (2006) Effect of regular intravenous immunoglobulin therapy on prevention of pneumonia in patients with common variable immunodeficiency. Journal of Microbiology, Immunology and Infection; 39: 2, 114-120.