nhsbt extracorporeal photopheresis (ecp) service in the ... · nhsbt sts clinical team . dr khaled...

Dr Therese Callaghan

NHSBT extracorporeal photopheresis (ECP) service in the

transplant setting BBTS 2013


NHSBT Specialist Therapeutic Services (STS)

• Five STS units in England • Bristol, Leeds, Sheffield, North West

(Liverpool/Manchester), Oxford • Range of therapeutic apheresis services – plasma

exchange, red cell exchange, stem cell harvest, ECP


NHSBT STS Clinical Team

Dr Khaled El-Ghariani Clinical Director

Vacant post (Dr Massey ECP)

Cons. Haematologist

Bristol

Dr Sylvia Benjamin Cons. Haematologist

Oxford

Dr Therese Callaghan Cons. Haematologist

Liverpool & Manchester

Dr Khaled El-Ghariani Cons. Haematologist

Sheffield

Dr Moji Gesinde Cons. Haematologist

Leeds


Chief Nurse

Patient Services

STS

Service Development Manager

STS

Senior Nurse Manager

Lead Nurse

Bristol

Lead Nurse

Oxford

Lead Nurse

Liverpool & Manchester

Lead Nurse

Leeds and Sheffield

STS Business Support

Manager

STS

Senior Customer Services

Administrator

5X Nurse Practitioners

1x Unit

Assistant

8 X Nurse Practitioners

2x Unit

Assistants


1x Unit

Assistant


2x Unit

Assistant


1x Unit

Assistant

STS QA Manager

Lead Quality Specialist

Clinical Director


What is extracorporeal photopheresis?

• Leucocytes collected by apheresis, irradiated, then returned to patient

• Reinfused leucocytes have immunomodulatory effect • First reported use 1987 in cutaneous T-Cell

lymphoma (CTCL) • Subsequently used in other T-cell mediated diseases

including Graft versus Host Disease (GVHD) post transplant


ECP procedure

• Blood drawn into cell separator instrument – centrifuged – leucocytes/mononuclear cells collected (buffy coat) – red cells & plasma returned to the patient

• Buffy coat treated with photosensitising agent 8-MOP (UVADEX) • Photoactivation by UVA light • Treated leucocytes returned to patient


Potential Applications of ECP

• Malignancy – CTCL – mycosis fungoides, Sezary syndrome

• GVHD – Chronic – Acute

• Solid organ transplant rejection • Autoimmune

– Progressive systemic sclerosis, SLE, RA, psoriatic arthritis, pemphigus vulgaris

• Other


Current role of ECP in GVHD

• BCSH guidelines 2012 recommendation – second line treatment in both chronic and acute GVHD

• ASFA Guidelines 2012 – skin : ECP accepted as second line – non-skin: role of ECP not established

• UK Photopheresis Expert Group consensus statement 2008 recommendation – Chronic extensive GVHD (Seattle criteria), refractory, dependent on

or intolerant of corticosteroids, affecting skin, mucous membranes (mouth/eye), liver

– Not first line – Not acute


ECP in chronic GVHD

• Initially fortnightly paired treatments for 3 months

• Assess for response 3 monthly • Depending on response – keep fortnightly,

reduce to monthly or stop


ECP in acute GVHD

• Not currently recommended by consensus group but recommended as second line by BCSH

• Optimal treatment schedule not established • One regimen - weekly cycles for minimum 8

weeks, continue till maximum response


ECP - risks

• Bleeding • Red cell loss • Vascular access problems • Light sensitivity


Extracorporeal photopheresis provision

• 150 centres worldwide • UK includes :

– London – Rotherham – Manchester (NHSBT) – Glasgow – Newcastle upon Tyne – Belfast – Birmingham – Bristol (NHSBT) – (Oxford 2013, NHSBT)


NHSBT ECP Service • North West

– Main Unit at The Christie (all NW patients) – On site machine at Central Manchester Foundation Trust

(Manchester Royal Infirmary and Royal Manchester Children’s Hospital)

• Bristol – Adult NHSBT ECP Unit on Southmead Hospital site – On site machine Bristol Royal Hospital for Children


NHSBT ECP Service • Referral from hospital team to NHSBT consultant • Patient assessed by consultant – desktop/clinic • Accepted for ECP- treatment plan, prescription,

consented • Start of treatment agreed • Procedures undertaken by STS nursing staff • Formal assessment of response every 3 months

(joint clinics in Manchester)


NHSBT ECP Service - funding

• NHS England • Funding agreed for indications approved by

UK Photopheresis Expert Group consensus statement - chronic GvHD, CTCL

• Other indications – individual funding request (IFR)


North West ECP Activity 2012/2013

Procedure Type Number of Procedures Number of Patients Onsite 1078 (91%) 60 (88%) Offsite (adult) 18 (1%) 3 (5%) Paediatric 88 (8%) 5 (7%) Total 1184 68


Bristol ECP activity

2012/2013 (from Sept 2012)

Procedure Type Number of Procedures Number of Patients Onsite 139 (83%) 14 (82%) Offsite (adult) 26 (16%) 2 (12%) Paediatric 2 (1%) 1 (6%) Total 167 17


NHSBT ECP activity 2012/2013

Procedure Type Number of Procedures Number of Patients North West Bristol North West Bristol Onsite 1078 139 60 14 Offsite (adult) 18 26 3 2 Paediatric 88 2 5 1 Total 1184 167 68 17 Total procedures = 1351 (85 patients)


A couple of cases....


• 6 year old girl • Microvillus inclusion disease with subsequent

intestinal failure • Small bowel transplant - 31st January 2012

Birmingham Children’s Hospital • August 2012 - increased stoma losses, prolapsed

stoma fever and abdominal pains, widespread rash • No graft rejection on intestinal biopsy • Skin GVHD diagnosed

ECP Case 1


ECP Case 1 • Treatment for skin GVHD

– Steroids – Aug 2012 – Mesenchymal Stem Cells x4 – ECP commenced September 2012 until February

2013 at Rotherham • Good clinical response • ECP discontinued due to acute illness requiring in-

patient admission – autoimmune haemolytic anaemia (AIHA)


AIHA • 24 - 48h transfusion requirement • Required crossmatching at NHSBT Bristol • Received rituximab x4 and then

cyclophosphamide x2 • Relapse of skin GVHD – all over – blistering

on back and face


Treatment for Skin: Mar 2013 • Methylprednisolone ,Campath, MSCs x1 • Stabilised • Transferred to Manchester Children’s

Hospital April 2013 for re-commencement of ECP provided by NHSBT

• Required blood priming or pre-transfusion – crossmatching at NHSBT Liverpool


ECP progress • April 2013 – 2 paired sessions • May 2013 – 2 paired session attempted • June 2013 – 2 paired sessions attempted • July 2013 – 2 paired sessions • August 2013 – 2 paired sessions • September 2013 – issues with procedure –

high platelet count • Steroids down to 0.3mg/kg


ECP Case 2 • Male age 50, severe gout • Hand transplant December 2012 • Maintenance immunosuppression (prednisolone, tacrolimus, sirolimus,

MMF) • 4 rejection episodes treated with high dose steroids (prednislone 60

mg) + alemtuzumab • Glucose intolerance, Cushingoid, CMV infection


ECP Case 2 • July 2013 • Referred to NHSBT Manchester for ECP – aim to taper off steroids • IFR agreed to by Commissioner September 2013 • Has had weekly 2-day cycles ECP x 4 at Christie Unit • Prednisolone reduced from 25 mg (maintenance dose) to 5mg • Plan for further 2 more cycles at fortnightly intervals


Acknowledgements

• Dr Denise Bonney, Royal Manchester Children’s Hospital

• Dr Girish Gupte, Birmingham Children’s Hospital

• Mrs Sandra Jones, NHSBT


Thank you

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