Background: Fingolimod is approved for the treatment of highly active relapsing-remitting multiple sclerosis in Europe. There is limited information on its effectiveness and safety in clinical practice within the UK.
Objective: To evaluate retrospectively the effectiveness and safety of fingolimod in patients with relapsing-remitting multiple sclerosis who were prescribed fingolimod by UK neurologists within the National Health Service.
Methods: This was a multicentre, observational study conducted in the UK. Patients were initiated on fingolimod 0.5 mg 12 months before inclusion in the study. Key efficacy outcomes included annualised relapse rate and the proportion of patients free from relapses, disability progression and clinical and radiological disease activity at 12 months following fingolimod initiation. Resource utilisation and safety outcomes were also assessed.
Results: In 12 months of treatment with fingolimod, the mean annualised relapse rate was reduced by 79%, the majority of patients were free from relapses (83.7%). Based on limited data, most patients were free from disability progression and clinical and radiological disease activity. More than 90% of patients continued on fingolimod. Lymphocyte count reductions and liver enzyme increases were observed.
Conclusion: Fingolimod was effective in reducing the disease activity in relapsing-remitting multiple sclerosis patients requiring an escalation from first-line therapies who were prescribed fingolimod in clinical practice in the UK.
Keywords: Multiple sclerosis; fingolimod; observational study; real-world; relapsing multiple sclerosis; relapsing–remitting multiple sclerosis.