Completion of sections 1 – 5 would indicate a ’5 criterion audit’.
A completed audit cycle would be indicated if sections 1 – 8 had been attempted.
The relatively new oral sphingosine receptor modulating drug fingolimod is being used more commonly in patients with highly active relapsing-remitting multiple sclerosis (RRMS). The landscape of MS treatment is currently in flux as new oral therapies, such as alemtuzumab, fingolimod and dimethyl fumarate, all jostle for a position with the established parenteral MS treatments. Currently fingolimod is used as therapy in patients who have high disease activity on at least one other disease modifying therapy (DMT). The Scottish Medicines Consortium’s most recently approved advice on the use of fingolimod identifies these non-responders as patients who have:
-Failed to respond to a full course of their previous DMT (normally at least 1 year). This failure to respond to a previous DMT should include at least 1 relapse in the previous year, and an MRI with at least 9 T2-hyperintense lesions in cranial magnetic resonance imaging (MRI) or at least 1 Gadolinium-enhancing lesion.
-A non-responder could also be defined as a patient with an unchanged of increased relapse rate or ongoing severe relapses, as compared to the previous year.1
Fingolimod is a relatively new and expensive treatment and as such, it is important that SMC guidance regarding its usage is adhered to. The SMC advice for fingolimod focuses on the two landmark trials; FREEDOMS and TRANSFORMS2,3, which compare fingolimod to placebo and the DMT interferon beta-1a respectively, laying out the limitations for its use as stated above.
When patients are switched onto fingolimod therapy from other DMTs, there is the need to leave a washout period if the previous therapy in especially immunosuppressive. In the case of beta-interferon and glatiramer acetate, there is no need for a washout period before commencing fingolimod. The monoclonal antibody therapy natalizumab on the other hand, has a long elimination half life and pronounced immune effects which can lead to severe and potentially life threatening infections such as progressive multifocal leukoencephalopathy (PML) caused by the John Cunningham Virus (JC Virus).The product literature for fingolimod states that a washout period of between 2 and 3 months should be observed after discontinuation on natalizumab and the commencement of fingolimod.4 Further studies showing that there is an increased risk of relapse in patients who have an extended washout period between natalizumab therapy and fingolimod have been conducted in practice. The TOFINGO study suggests that the risk of relapse increases as the washout period is extended from 8 to 16 and finally 24 weeks. These suggest that a shorter washout period should be observed to minimise this risk.5,6 This audit will determine whether the SMC advice regarding the switching criteria for fingolimod are being adhered to in practice in the west of Scotland RRMS population. In patients who have previously been treated with natalizumab therapy, the washout period observed before switching to fingolimod will also be determined.
1: Scottish Medicines Consortium (SMC) advice, “Fingolimod 0.5mg hard capsules (SMC No.(1038/15))”, Reviewed 06/03/15. Accessed via http://www.scottishmedicines.org.uk/ on 03/06/15
2: (FREEDOMS) Kappos et al. A Placebo-Controlled Trial of Oral Fingolimod in Relapsing Multiple Sclerosis, N Engl J Med. 2010;362:387-401