Audit on Use of Fingolimod in Treatment of Relapsing-Remitting MS - - PowerPoint PPT Presentation

Audit on Use of Fingolimod in Treatment of Relapsing-Remitting MS in University Hospitals Coventry and Warwickshire

Omar Salim ST5 Neurology

Aims

§ To assess the ‘real world’ experience of Fingolimod

use in University Hospitals Coventry and Warwickshire – a terBary centre for MS § To assess compliance with naBonal guidelines

§

To assess safety and efficacy

Standards

NICE [TA254] April 2012 - Fingolimod for the treatment of highly active relapsing–remitting multiple sclerosis

“Treatment of highly active relapsing-remitting multiple sclerosis in patients who have high disease activity despite treatment with at least one disease modifying therapy or in those initiated under specialist supervision)”

NICE Guidelines on Fingolimod

Treatment of highly active relapsing-remitting multiple sclerosis in patients who have high disease activity despite treatment with at least one disease modifying therapy or in those with rapidly evolving severe relapsing-remitting multiple sclerosis (initiated under specialist supervision)

Methods

§ Using electronic patient records, patients were identified § Inclusion criteria:

§ Diagnosis of Relapse-Remitting MS § Duration of Fingolimod treatment of at least 12 months § Treatment starting between March 2013 – July 2017 107 patients were identified, 82 of them had Fingolimod for at least 12 months

Data Collected

§ Demographics

§ Gender § Age at diagnosis of RRMS

§ Pre-Fingolimod

§ Previous DMT § Reason for star?ng Fingolimod

§ Fingolimod

§ Date started § Age at commencement § Date stopped

§ EDSS pre and during treatment

§ Post-Fingolimod

§ Reason for stopping § Treatment changed to § Escala?on/De-escala?on of treatment

§ Monitoring on Fingolimod

§ Macular oedema monitoring § at 3 -4 months § Pre Initiation if history of Diabetes or Uveitis § First dose cardiac monitoring § ALT checked every 6 months and if evidence of derangement § Timing of MRI monitoring of disease activity § EDSS pre and during treatment § Lowest lymphocytes count § Action taken if pregnancy during therapy

5 10 15 20 25 30 35 2013 2014 2015 2016 2017 2018

Number of patients

M F

Fingolimod commencement

A total of 107 patients with MS have been prescribed Fingolimod at UHCW 82 of 107 have taken Fingolimod for at least 12 months (range 12- 63 months) Average use is 32 months

10 20 30 40 50 60 70 10 20 30 40 50 60 70 80 90 Number of months Number of patients

Female 72% Male 28%

Gender

Demographics

Age distribution

Range: 14- 58 Average: 33

10 20 30 40 50 60 70 20 40 60 80 100 120

Age at diagnosis

Dx of RRMS Age at commencement of Fingolimod Range: 16- 61 Average: 40.7

10 20 30 40 50 60 70 20 40 60 80 100 120

Age at commencement

19% 17% 11% 5% 25% 10% 11% 2%

Tysabri Rebif Copaxone Aubagio Avonex Betaferon Tecfidera Plegridy

Previous DMTs prior to Fingolimod

2 4 6 8 10 12 14 Tecfidera Aubagio Relapsed on fingolimod

17 Patients on other Oral DMTS were switched to Fingolimod

72% 27% 1% Ongoing Stopped unknown

Treatment status of All Fingolimod Patients

10 20 30 40 50 60 Ongoing stopped

70 patients were changed to Fingolimod from Injectable DMTs

Cladrabine 5% Aubagio 6% N/A 6% Tyasbri 11% Tecfidera 11% none 28% Lemtrada 33%

18 patients were changed to the treatment below

Cladrabine 1 Aubagio 1 N/A 1 Tyasbri 2 Tecfidera 2 none 5 Lemtrada 6

Reason for switching to Fingolimod

1 1 4 13 18 70 10 20 30 40 50 60 70 80 Allergic reaction patient choice side effects Disease Activity on MRI High Risk of PML Relapse Number of patients

Patient choice and Allergy reasons were initially Tysabri patients

20 Pa&ents were switched from Natalizumab to Fingolimod

2 4 6 8 10 12 14 16 18 20 Physician advice (High risk of PML) Pt choice feared risk

• f PML)

Reason for switching

Cladrabine 5% Continued 35% Continued but relpased 20% Lemtrada 30% No Rx 10%

Current status of those 20 Patients whom were switched from Natalizumab to Fingolimod

Fingolimod was stopped/changed in 28 out of 107 patients

2 4 6 8 10 12 14

Macular oedema Deteriorating vision Non-compliance Allergic reaction Deranged LFTs Disease progression MRI Disease activity Lymphopenia S/E Relapse Percentage of patients (%)

Reasons for cessation

Relapses on Fingolimod

• 27 pa1ents had relapses
• 14 out of 27 con1nued on Fingolimod
• 3 went on to Natalizumab
• 10 switched to Alemtuzumab

52% 37% 11% Fingolimod continued Lemtrada Tysabri

5 10 15

Lemtrada None Cladrabine Tecfidera Tysabri Aubagio Percentage of patients (%)

Treatment post-Fingolimod

Macular oedema screening with OCT at 3-4 months from initiating Fingolimod 52% 45% 3% Performed Delayed N/A 97% had Macular Oedema screening, 52% within recommended timescale

ALT check every 6/12 78% 18% 2% 2% 4% Yes Delayed Rx ceased early 9 months

Lymphocyte count

0.00 0.50 1.00 1.50 2.00 2.50 20 40 60 80 100 120

Lymphocyte count Number of patients Average lymphocyte count from 107 patients received Fingolimod was 0.26

10 20 30 40 50 60 70

<12 months 12-15 months >15 months

Number of patients

Monitoring with MRI : Duration post- Fingolimod initiation

Since 2016, patients have repeat scan within 12 months and annually thereafter

Conclusions

§ Compliance with prescribing

• 100% compliance with indications as per NICE

§ Adverse events

– Generally well tolerated – All patients tolerated 1st dose

§ Monitoring

– One patient was identified with MO and Fingolimod was stopped (screening done at 5 months) – Macular oedema screening identified as requiring improvement – Improvements identified since 2016 in MRI monitoring at 12 months but needs more!

§ Clinical effectiveness

– Data suggests fewer rates of relapse and therefore effective as a second line DMT – Those who were changed from Tysabri to Fingolimod benefited less well compared to other DMTs

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