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 Before each infusion 100% U&E LFT CRP Urinalysis MRI head 1. 3-4 monthly if JCV >1.5 100% and treatment duration >18 months 2. 6 monthly if JCV >0.9 <1.5 3. 12 monthly if JCV negative 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 0/0 (100%) 6 monthly 4/4 (100%) 12 monthly 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 CIS and MRI activity RRMS: 1 relapse in RRMS: 2 significant RES MS lesions (McDonald MS) last 2 years and relapses in last 2 radiological activity years First line therapy No treatment (1) No treatment Beta interferon Beta interferon Cladribine (10, 17) Beta-interferon (2) Beta-interferon (8) Glatiramir acetate Glatiramir acetate Natalizumab (15) Glatiramir acetate (3) Dimethyl fumarate (4) Dimethyl fumarate Fingolimod (12) Dimethyl fumarate (4) Alemtuzumab Alemtuzumab (9) Ocrelizumab (7) Teriflunomide (5) Ocrelizumab(7) Ocrelizumab(7) Alternative first line No treatment Beta-interferon Beta-interferon Cladribine due to intolerance Beta-interferon Glatiramir acetate Glatiramir acetate Natalizumab (15) (11) Glatiramir acetate Dimethyl fumarate (4) Dimethyl fumarate (4) Fingolimod (13) Dimethyl fumarate Teriflunomide (5) Teriflunomide (5) Teriflunomide (5) Second line therapy Dimethyl fumarate Dimethyl fumarate (4) Alemtuzumab* Alemtuzumab* (disease activity Fingolimod (12) Alemtuzumab (9)* Ocrelizumab(7) Cladribine (16) despite being on Alemtuzumab (9)* Ocrelizumab(7) Cladribine (14) Natalizumab (16) DMT) Ocrelizumab(7) Cladribine Fingolimod Rescue therapy No change (19) No change (19) No change (19) No change (19) (continued activity Alemtuzumab* Alemtuzumab* Alemtuzumab* Alemtuzumab* despite being on Cladribine (14) Cladribine (14) Cladribine (14) Cladribine (14) second line DMT) Natalizumab (15) Natalizumab (15) Natalizumab (16) Natalizumab (16) HSCT (18) HSCT (18) HSCT (18) 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