Title : In patients with multiple sclerosis, does the transition from brand name tecfidera to generic dimethyl fumerate result in statistically significant shifts in laboratory surveillance data, MRI imaging, patient-reported side effects, and compliance?
Abstract:
Background: Multiple sclerosis (MS) is an abnormal immune-mediated response that results in damage within the central nervous system causing physical limitations, cognitive changes, and psychological distress. With the advent of disease-modifying therapy (DMT), patients can experience delayed progression of disability and reduction in the incidence of relapse and severity, ultimately improving quality of life.
Objectives: To determine if there is a difference between outcomes regarding laboratory abnormalities, patient-reported side effects, and breakthrough disease observed on MRI in patients with relapsing and remitting MS (RRMS) who were taking brand name Tecfidera and have transitioned to generic dimethyl fumarate (DMF).
Design/Methods: This is a retrospective chart review of 200 patients with RRMS who were on Tecfidera for at least 12 months and then transitioned to DMF following FDA approval. This study compared the preceding 12-month data of absolute lymphocyte counts (ALC) and liver function tests (LFT) and the comparative ALC and LFTs following the transition to DMF at 3-month intervals. Lastly, patient-reported side-effects preceding and following the transition were recorded.
Results: 23% and 8% of patients on the generic formulation for >6 months demonstrated reductions in ALC below the lower limit of normal by 3- and 6-months post-transition, respectively. There was also no significant (p< 0.05) difference in LTF values at 6 months pre- and post-transition. 3% of patients experienced breakthrough disease on MRI after transitioning. Lastly, 23% and 29% of patients who had been on DMF for >6 months and <6 months, respectively had reported worsened side-effects.
Conclusions: Our research shows there is no significant difference in the monitored laboratory values or on MRI imaging after transitioning from Tecfidera to DMF. Though clinical measures did not reveal any significance, the subjective worsening of side effects experienced while on DMF compared to Tecfidera could lead to poor compliance and subsequent worsened outcomes.
Audience Take Away Notes:
- Patients with multiple sclerosis often endorse mistrust in generic medications and with many disease modifying therapies “going generic” evidence to support clinical equivalence may help ameliorate concerns and encourage compliance.
- Audience will learn the comparative data including lab abnormalities, reported side effects of treatment, and disease breakthrough on MRI in demonstrating differences between generic and brand name Tecfidera.
- Audience will also be able to compare clinical versus subjective outcomes and how it impacts medication compliance.
- This study will help armor patients and providers with the information they need to make an informed decision about treatment options.
- With evidence supporting equal outcomes, trust in generic medication efficiency may help encourage generic use which will help drive medication costs down as generic formulations are often more affordable than brand name.
