Displaying One Session

E-Poster Discussion
Room
Station 3
Date
20.09.2019, Friday
Session Time
13:15 - 14:15
E-Poster Discussion No Topic Needed

WELCOME AND INTRODUCTION

Lecture Time
13:15 - 13:20
Room
Station 3
Date
20.09.2019, Friday
Session Time
13:15 - 14:15
Presentation Topic
No Topic Needed
E-Poster Discussion INGID

DEVELOPMENT OF SCIG RESOURCES FOR CONSUMERS AND HEALTH PROFESSIONALS

Lecture Time
13:20 - 13:30
Room
Station 3
Date
20.09.2019, Friday
Session Time
13:15 - 14:15
Board Number
212
Presentation Topic
INGID

Abstract

Background and Aims

Immunoglobulin replacement therapy (IRT) is used to treat adults and children with immunodeficiencies. IRT is administered using intravenous (IVIg) or subcutaneous immunoglobulin (SCIg). SCIg was not widely available in Australasia until 2013.

A need was identified for consistent, accurate and readily available SCIg education, plans and checklists. The aim is to provide sufficient patient and carer education, training and follow up, which is essential to ensure effective and safe home based SCIg therapy.

Methods

The Australasian Society of Clinical Immunology and Allergy (ASCIA) has developed SCIg resources since 2014, including ASCIA primary immunodeficiency (PID) e-training for health professionals.

An ASCIA working party was formed www.allergy.org.au/members/committees#wpai and members participated in two workshops (2017, 2018). Surveys of nurse specialists working with PID patients were conducted prior to the workshops to ascertain what resources should be developed or updated. Clinical consensus and published information have also guided resource development and updating.

Results

Several new resources have been developed, including a guide for health professionals on setting up a SCIg service in a hospital, plans and patient education.

These are available on the ASCIA website www.immunodeficiencies.org.au

Conclusions

Sufficient patient education and training at the initiation of SCIg therapy, and follow up care is essential to ensure patient safety and effective delivery of home based SCIg therapy. ASCIA SCIg resources assist nurse specialists, clinical immunologists and other health professionals in educating and training patients. These resources provide consistent, accurate and readily available information, training, plans and checklists, that are regularly reviewed and updated.

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E-Poster Discussion INGID

DEVELOPING A STANDARD OPERATING PROCEDURE FOR CLINICAL TRIAL ADVANCED THERAPY INVESTIGATIONAL MEDICINAL PRODUCT ADMINISTRATION; A SINGLE CENTRE EXPERIENCE.

Lecture Time
13:30 - 13:40
Room
Station 3
Date
20.09.2019, Friday
Session Time
13:15 - 14:15
Board Number
213
Presentation Topic
INGID

Abstract

Background and Aims

Background: University Collage London’s Institute of Child Health in collaboration with Great Ormond Street Hospital (UCL GOS ICH) has delivered autologous Retroviral (RV) and more recently Lentiviral (LV) Gene Modified CD34+ cells for over 15 years. During this time clinical practices have developed and changed and trials have become increasingly complex with the additional layer of commercialisation. In the last five years the UCL GOS ICH gene therapy trials programme has rapidly expanded and the amount of advanced therapy investigational medicinal product (ATIMP) delivery has also thus increased. Our team has gained extensive knowledge which we have used this to develop a standard operating procedure (SOP) to standardise the delivery of ATIMPs. During the last 15 years, the team have encountered challenges including changing protocols, collaboration with commercial companies, damaged product bags and multiple good clinical practice audits.

Methods

Methods: Our team of three nurses documented every step of the process multiple times, then a different nurse audited and monitored the process multiple times to ensure the SOP reflected current practice.

Results

Results: Various Corrective and Preventative Actions (CAPA) and audit findings have been utilised to facilitate change and used to develop this SOP that will effectively standardise and safely deliver our Gene Therapy autologous Lentiviral Gene Modified CD34+ ATIMPs to the patients.

Conclusions

Conclusions: The authors have developed an SOP that standardises the safe delivery of ATIMPs in the clinical area. It details receipt of ATIMP in the clinical area to the safe administration and subsequent documentation of the administration.

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E-Poster Discussion INGID

FACILITATED SUBCUTANEOUS IMMUNOGLOBULIN THERAPY IN A PATIENT WITH SEVERE IGG HYPERCATABOLISM

Lecture Time
13:40 - 13:50
Room
Station 3
Date
20.09.2019, Friday
Session Time
13:15 - 14:15
Board Number
214
Presentation Topic
INGID

Abstract

Background and Aims

Background: Having a good life quality (QoL) is indispensable in patients with primary immunodeficiency (PID), because the lack of it, could affect negatively the patient’s life. IgG replacement therapy in these patients by use of subcutaneous immunoglobulin (SCIG) has good results in maintaining optimal immunoglobulin G (IgG) levels.

Aim: In a patient with severe IgG hyper catabolism facilitated subcutaneous immunoglobulin (FSCIG) therapy was administrated and health related QoL evaluated.

Methods

Methods: 35 year-old common variable immunodeficiency (CVID) patient. History of recurrent infections treated with intravenous immunoglobulin (IVIG). Due to protein hyper catabolism she couldn’t maintain optimal IgG levels so it was changed to combined therapy (IVIG 40 g/21 days + SCIG 8g/week; 2g/kg/month). The patient lives in a village 50 km far from the hospital and with a complicated familial environment, requiring psychological support. Due to the important deterioration of QoL, the treatment was changed to FSCIG, with a goal of maintaining IgG through above 400 mg/dL, in absence of recurrent infections, with a lower IgG dose. FSCIG was started at a dose of 25g/15 days (1g/kg/month). QoL was evaluated with SF-36 v.2.0.

Results

Results: During a 4 month follow-up, after self-administered FSCIG at home, maintained IgG levels were 513 mg/dL. According to SF-36 improvement of health related QoL was detected in 21 of 36 items. There were no new infectious complications. FSCIG was well tolerated.

Conclusions

Conclusion: The use of FSCIG is a possible alternative in highly IgG hyper catabolic patients, improving the QoL, maintaining acceptable IgG through levels with lower doses.

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E-Poster Discussion INGID

THE ROLE OF THE CLINICAL RESEARCH NURSE IN ADVANCED THERAPY INVESTIGATIONAL MEDICINAL PRODUCT CLINICAL TRIALS; A SINGLE CENTRE REFLECTION.

Lecture Time
13:50 - 14:00
Room
Station 3
Date
20.09.2019, Friday
Session Time
13:15 - 14:15
Board Number
215
Presentation Topic
INGID

Abstract

Background and Aims

Background: The National Institute for Health Research (NIHR) describes clinical research nurses as vital to delivering research with one of their strategic goals being “improve awareness and understanding of the speciality of clinical research nursing and its contribution and impact”. Advanced therapy investigational medicinal product (ATIMP) clinical trials are high risk requiring additional considerations.

Methods

Methods: I used a model of reflection, literature searches and learning from wider teams who participate in gene therapy trials alongside maximising opportunities to speak to gene therapy research nurses in other global leading centres.

Results

Results: I have divided the research nurse (RN) role into four sections. Education; an RN must be a clinical expert in ATIMP clinical trials, regulatory standards, monitoring and good clinical practice (GCP) audits. Part of the specialised role is to educate others including patients, families and the wider multidisciplinary team. Documentation; an RN must understand and sufficiently document the consent process ensuring the added risks of ATIMP clinical trials are understood and reflected in source data. They must thoroughly document the delivery of each ATIMP in the source data. Organisation; an RN must ensure that traceability is transparent and robust, and ensure the patient journey is according to the clinical trial protocol. Timely reporting of adverse events is critical. Challenges; frequent changes to clinical trial protocols means an RN must be adaptable and skilled at troubleshooting.

Conclusions

Conclusions: An RN in ATIMP clinical trials needs a willingness to learn and teach, strong organisational and documentation skills and an ability to rapidly overcome challenges.

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E-Poster Discussion INGID

PATIENT-REPORTED QUALITY OF LIFE (QOL) FOLLOWING EXPERIENCE OF MANUAL PUSH METHOD WITH SUBCUTANEOUS IMMUNOGLOBULIN (SCIG) ADMINISTRATION IN PATIENTS WITH PRIMARY OR SECONDARY IMMUNODEFICIENCY

Lecture Time
14:00 - 14:10
Room
Station 3
Date
20.09.2019, Friday
Session Time
13:15 - 14:15
Board Number
216
Presentation Topic
INGID

Abstract

Background and Aims

Subcutaneous immunoglobulin (SCIg) is common among patients with primary or secondary immunodeficiency (PID/SID) and can be infused via pump or manual push. Here, we describe patient-reported quality of life (QOL) in a PID/SID cohort following transition to manual push from intravenous immunoglobulin (IVIg), pump-infused SCIg or no treatment (newly diagnosed).

Methods

Patients with any degree of experience of manual push completed two questionnaires on QOL and side effects: a hospital developed questionnaire and the Short Form Health Survey (SF-36). Both questionnaires were completed anonymously, 0–9 months after starting manual push.

Results

Of the patients who completed the QOL questionnaire (25/49), 7 were IgG-naïve and 18 were on IgG prior to manual push (12 transitioned from IVIg, 1 from pump-infused SCIg and 5 from both). The majority of those previously on IgG treatment preferred manual push (78%; 14/18), citing increased convenience and fewer side effects as reasons. Overall, patients reported that manual push: saved time (80%; 20/25); offered greater flexibility (80%; 20/25); and had a positive financial impact (72%; 18/25). Over half reported manual push made taking the correct dose easier (56%; 14/25) and they felt less fatigued (52%; 13/25). Most would recommend manual push over other forms of administration (67%; 16/24). For SF-36 completers (N=24), mental component summary and physical component summary scores were the same or better than the general population in 67% (16/24) and 29% (7/24), respectively.

Conclusions

Patient-reported QOL improved in most patients following transition to manual push, with the majority recommending manual push over other forms of administration.

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E-Poster Discussion No Topic Needed

CLOSURE

Lecture Time
14:10 - 14:15
Room
Station 3
Date
20.09.2019, Friday
Session Time
13:15 - 14:15
Presentation Topic
No Topic Needed