High Continuation Rate, Good Disease Control after Switching from Natalizumab to Fingolimod

Background: GILENYA* (fingolimod) is approved in Canada for the treatment of RRMS. The GILENYA* Go Program^TM was launched in March 2011 to provide patient support services, reinforce patient adherence to recommended monitoring and coordinate first-dose observation (FDO) at specialized FDO centres.

Objectives: The present analysis evaluated the adherence and tolerability of fingolimod in the subset of patients who were previously treated with natalizumab. The objective was to assess the continuation rate on fingolimod after natalizumab withdrawal.

Methods: Data were collected and analyzed for patients enrolled in the Canadian Gilenya* Go Program^TM from the time of first patient enrollment in March 2011 to October 2013.

Results: At data cutoff, 243/1989 fingolimod-treated patients reported prior natalizumab as their most recent treatment. Duration on natalizumab was not obtained. 70% were female; mean age was 42 years. Patient-reported reasons for discontinuing natalizumab (n=171) were unspecified adverse effects (35%), anti-JCV antibody positivity (18%), lack of efficacy (18%), infusion-related (12%), adverse effects (allergic reaction, shingles, other, 9%), concerns about PML risk (5%), neutralizing antibodies (2%), and other (1%). During the 33-month observation period, the continuation rate on fingolimod was 83.0%. Mean time to withdrawal of fingolimod (n=40) was 225 days. Reasons for withdrawal were AEs (22/40, 55%), physician or patient request (20%), lack of efficacy (17.5%), and no reason given (7.5%). Women were more likely than men to discontinue fingolimod (19% vs. 10%). There was one withdrawal at first dose due to AV block. AEs associated with fingolimod discontinuation post first dose included palpitations (n=4), low lymphocyte count (n=4), headache/migraine (n=2), oral Herpes infection (n=2) and other infections (n=3). Three patients withdrew due to MS-related symptoms (relapse, optic neuritis, incontinence). 

Conclusions:

• Oral fingolimod is associated with good tolerability in patients discontinuing natalizumab.
• 83% of patients are successfully maintained on fingolimod in clinical practice.
• The high continuation rate is comparable to the 1-year continuation rate in TRANSFORMS (89%),¹ and the 2-year continuation rate in FREEDOMS (81%).² 

*Gilenya is a registered trademark

References

1. Cohen et al. N Engl J Med 2010;362:402-15.

2. Kappos et al. N Engl J Med 2010;362:387-401.