From the FDA Drug Label
The efficacy of fingolimod was demonstrated in 2 studies that evaluated once-daily doses of fingolimod 0.5 mg and 1.25 mg in patients with relapsing-remitting MS (RRMS).
The annualized relapse rate was significantly lower in patients treated with fingolimod than in patients who received placebo.
Time to onset of 3-month confirmed disability progression was significantly delayed with fingolimod treatment compared to placebo.
The patient, SW, has a history of Transient Ischemic Attack (TIA) and atrial fibrillation, and is currently on apixaban and amiodarone. Considering the patient's medical history and lack of efficacy on Interferon (Rebif), Fingolimod (Gilenya) may be an appropriate alternative Disease-Modifying Therapy (DMT) agent for SW. However, it is crucial to carefully evaluate the potential risks and benefits, particularly given the patient's history of cardiovascular events.
- Key considerations:
- Fingolimod has shown efficacy in reducing annualized relapse rate and delaying disability progression in patients with RRMS.
- The patient's history of TIA and atrial fibrillation may require careful monitoring and management while on fingolimod.
- Potential interactions between fingolimod and the patient's current medications, including apixaban and amiodarone, should be carefully evaluated. 1
From the Research
For a patient with Relapsing-Remitting Multiple Sclerosis (RRMS) who has a history of TIA and atrial fibrillation on apixaban and amiodarone, and who has shown lack of efficacy on Interferon (Rebif), an appropriate alternative Disease-Modifying Therapy would be Dimethyl Fumarate (Tecfidera). This medication is an oral disease-modifying agent that has been shown to reduce clinical relapse and disability progression in patients with RRMS, as demonstrated in the DEFINE and CONFIRM trials 2. The patient's history of TIA and atrial fibrillation makes certain other MS medications problematic, particularly fingolimod (which can cause bradycardia and is contraindicated in patients with certain cardiac conditions) and natalizumab (which carries thrombotic risks). Dimethyl Fumarate has an acceptable tolerability profile, with the most common tolerability issues being flushing and gastrointestinal events, which appear to be largely manageable 2. Some key points to consider when prescribing Dimethyl Fumarate include:
- It is an oral medication, which may be more convenient for some patients compared to injectable therapies
- It has been shown to reduce MRI measures of disease activity, including new T1/hypointense lesions and T2/hyperintense lesions
- It has a relatively low risk of serious adverse events, although monitoring for potential side effects such as lymphopenia is necessary
- The medication may cause gastrointestinal events, which can be managed with dose titration and symptomatic treatment In contrast to other options, such as glatiramer acetate, Dimethyl Fumarate has been shown to have a more favorable efficacy profile in terms of reducing relapse rates and disability progression, making it a more suitable choice for patients who have failed interferon therapy 3, 4. Additionally, Dimethyl Fumarate does not have significant interactions with anticoagulants like apixaban or antiarrhythmics like amiodarone, making it a safer choice for patients with a history of TIA and atrial fibrillation. Overall, Dimethyl Fumarate is a suitable alternative Disease-Modifying Therapy for patients with RRMS who have failed interferon therapy and have a history of TIA and atrial fibrillation.