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Real-World Analysis Affirms the High Persistence and Adherence Observed with Diroximel Fumarate in Patients with
Brittney Lager1, Jacob Liseno1, Ivan Božin2
1AcariaHealth, Orlando, FL, USA.
Introduction:
Adherence to disease-modifying therapies is key for achieving optimal outcomes in multiple sclerosis (MS). Diroximel fumarate (DRF) is an oral fumarate approved for treatment of relapsing forms of MS. It has the same pharmacologically active metabolite as dimethyl fumarate (DMF) and similar efficacy and safety profiles, but with demonstrated fewer gastrointestinal (GI) related adverse events (AEs). There are limited data characterizing persistence and adherence to DRF in the real world.
Methods:
This retrospective analysis of the AcariaHealth Specialty Pharmacy Program included patients with MS initiating DRF from 1 December 2019 to 30 January 2021. This analysis evaluated persistence, measured as proportion of patients remaining on therapy; discontinuation rate due to GI AEs; and adherence measured by proportion of days covered (PDC).
Results:
Overall, 1143 patients were included; 433 (37.9%) patients had been treated with prior DMF and switched to DRF. Persistence was high in both groups: the estimated proportion of patients remaining on DRF at 16 months was 82.3% [95% confidence internal (CI) 77.2-86.3%], and 90.1% (95% CI 82.2-94.6%) in the DMF to DRF group. Fifty-two (4.5%) patients overall and 15 (3.5%) in the DMF switch subgroup discontinued DRF due to GI AEs. Mean PDC was 90.8% (95% CI 89.2-92.5%), and 85.4% (95% CI 83.3-87.4%) of patients achieved PDC ≥ 80% in the overall population. In the DMF to DRF group, mean PDC was 90.7% (95% CI 88.0-93.5%), and 84.8% (95% CI 81.4-88.1%) of patients achieved PDC ≥ 80%.
Conclusion:
In this analysis of > 1000 patients treated with DRF in real-world clinical practice, overall persistence at 16 months was high, treatment discontinuation due to GI AEs was low, and patients were highly adherent to therapy. Of 433 patients who switched from DMF to DRF, most (> 90%) were able to tolerate and persist on DRF after switching. Graphical abstract available for this article.
Insights
Diroximel fumarate (DRF) shows high persistence and adherence in real-world multiple sclerosis (MS) treatment. Most patients switching from dimethyl fumarate (DMF) to DRF tolerated the new therapy, with low discontinuation rates due to gastrointestinal adverse events.
Area of Science:
- Neurology
- Pharmacology
- Real-world evidence studies
Background:
- Optimal outcomes in multiple sclerosis (MS) depend on adherence to disease-modifying therapies.
- Diroximel fumarate (DRF) is an oral fumarate for relapsing MS, sharing the active metabolite with dimethyl fumarate (DMF).
- DRF demonstrates similar efficacy and safety to DMF but with reduced gastrointestinal (GI) adverse events (AEs); however, real-world data on DRF persistence and adherence are limited.
Purpose of the Study:
- To characterize real-world persistence and adherence to diroximel fumarate (DRF) in patients with multiple sclerosis (MS).
- To evaluate discontinuation rates due to GI AEs among patients initiating DRF.
- To assess the outcomes for patients switching from dimethyl fumarate (DMF) to DRF.
Main Methods:
- Retrospective analysis of the AcariaHealth Specialty Pharmacy Program.
- Included patients with MS initiating DRF between December 1, 2019, and January 30, 2021.
- Evaluated persistence (proportion of patients remaining on therapy), discontinuation due to GI AEs, and adherence (proportion of days covered, PDC).
Main Results:
- 1143 patients were included; 433 switched from DMF to DRF.
- 16-month persistence was high: 82.3% overall and 90.1% in the DMF-to-DRF group.
- Low discontinuation due to GI AEs (4.5% overall, 3.5% in DMF switchers). Mean PDC was 90.8% overall, with 85.4% achieving ≥80% PDC.
Conclusions:
- Real-world data show high persistence and adherence to DRF in over 1000 MS patients.
- Treatment discontinuation due to GI AEs was low.
- Over 90% of patients switching from DMF to DRF tolerated and persisted on therapy.
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