Forth Valley Royal Hospital Natalizumab Audit and DMT Protocol - - PowerPoint PPT Presentation

Forth Valley Royal Hospital Natalizumab Audit and DMT Protocol Update

Tim Soane Neurology Registrar, Forth Valley Royal Hospital

Background

• I have just started a post at FVRH
• It seemed like a good time to review the MS service
• Identified main issues raised by MS nurses
• And then focused on the most achievable

Aims

• Improve the monitoring and experience of Natalizumab

patients

• Provide pharmacy with a DMT prescribing algorithm

Natalizumab Monitoring

• Current situation:

– “Infection screen” FBC, U&E, LFT and CRP; MSU taken 3 days before every infusion – JCV status 6 monthly – MRI frequency dependent upon PML risk

Natalizumab Audit

Criteria Frequency Standard Infection screen FBC U&E LFT CRP Urinalysis Before each infusion 100% MRI head

• 1. 3-4 monthly if JCV >1.5

and treatment duration >18 months

• 2. 6 monthly if JCV >0.9

<1.5

• 3. 12 monthly if JCV

negative 100% JCV determination 6 monthly 100% Antibody monitoring As indicated 100%

Natalizumab Audit

Criteria Results Urine monitoring 25/28 (89%) Blood monitoring 28 /28 (100%) MRI head 3-4 monthly 6 monthly 12 monthly 0/0 (100%) 4/4 (100%) 17/24 (71%) JCV determination 28/28 (100%) Antibody monitoring 0 (0%)

Natalizumab Audit

• Protocol violations

– 3 patients did not have documented MSUs before every infusion – Six patients MRI scans were delayed by 1 month, and one patient by 2 months

• These delays were caused by combination of patients cancelling scans and

radiology delays

Natalizumab Audit

• Do we need to do infection screen every month?

– Patients travel up to 3 hours for bloods and MSU 3 days before infusion

Natalizumab Audit

• 2/28 patients had slightly elevated bilirubin levels
• 18/28 patients had transient or persistent low grade

lymphocytosis

• 4/28 patients had transient neutrophilia
• 9/28 patients had growth on urine cultures – all bar one

were symptomatic and received abx

• 3 infusions were delayed due to chest infections and

shingles – all symptomatic

Natalizumab Audit

• Unofficial information gathering from other MS centres in

Scotland identified that only Aberdeen engaged in monthly blood tests, with other centres ranging from 3 monthly to 6 monthly

Natalizumab Audit

• Outcome

– We removed monthly infection screening from the protocol – Patients will have monthly bloods to monitor for abnormal LFTs etc for first 12 months – Patients established for over 12 months on natalizumab will have 3 monthly bloods taken on day of infusion – Saves patients considerable travelling and time – Saves NHS FVRH money

DMT Protocol update

• No Bluteq system in Scotland
• No equivalent NHS England DMT algorithm
• FVRH Pharmacy requested an algorithm to enable them

to understand our prescribing behaviour

DMT Protocol Update

DMT Protocol Update

• Differences

– Recent restriction in Alemtuzumab use – Ocrelizumab is licensed in Scotland for RRMS – No Daclizumab any more – Fingolimod can be used first line in RES MS – DMF can be used for any form of RRMS

DMT Protocol Update

Presentation CIS with multiple MRI lesions CIS and MRI activity (McDonald MS) RRMS: 1 relapse in last 2 years and radiological activity RRMS: 2 significant relapses in last 2 years RES MS First line therapy No treatment (1) Beta-interferon (2) No treatment Beta-interferon (8) Glatiramir acetate (3) Dimethyl fumarate (4) Teriflunomide (5) Beta interferon Glatiramir acetate Dimethyl fumarate (4) Alemtuzumab Ocrelizumab(7) Beta interferon Glatiramir acetate Dimethyl fumarate Alemtuzumab (9) Ocrelizumab(7) Cladribine (10, 17) Natalizumab (15) Fingolimod (12) Ocrelizumab (7) Alternative first line due to intolerance (11) No treatment Beta-interferon Glatiramir acetate Dimethyl fumarate Teriflunomide (5) Beta-interferon Glatiramir acetate Dimethyl fumarate (4) Teriflunomide (5) Beta-interferon Glatiramir acetate Dimethyl fumarate (4) Teriflunomide (5) Cladribine Natalizumab (15) Fingolimod (13) Second line therapy (disease activity despite being on DMT) Dimethyl fumarate Fingolimod (12) Alemtuzumab (9)* Ocrelizumab(7) Dimethyl fumarate (4) Alemtuzumab (9)* Ocrelizumab(7) Cladribine Alemtuzumab* Ocrelizumab(7) Cladribine (14) Fingolimod Alemtuzumab* Cladribine (16) Natalizumab (16) Rescue therapy (continued activity despite being on second line DMT) No change (19) Alemtuzumab* Cladribine (14) Natalizumab (15) HSCT (18) No change (19) Alemtuzumab* Cladribine (14) Natalizumab (15) HSCT (18) No change (19) Alemtuzumab* Cladribine (14) Natalizumab (16) HSCT (18) No change (19) Alemtuzumab* Cladribine (14) Natalizumab (16) HSCT (18)

Summary

• Updated Natalizumab protocol
• Generated DMT treatment Algorithm
• What next?

– Ensure all other protocols up to date – Expand consultant led service – currently only DMT clinic – Improved integration with rehabilitation services

• Thank you