PMID- 36334241
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231121
IS  - 2193-8253 (Print)
IS  - 2193-6536 (Electronic)
IS  - 2193-6536 (Linking)
VI  - 12
IP  - 1
DP  - 2023 Feb
TI  - Real-World Analysis Affirms the High Persistence and Adherence Observed with 
      Diroximel Fumarate in Patients with Multiple Sclerosis.
PG  - 145-159
LID - 10.1007/s40120-022-00413-0 [doi]
AB  - 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.
CI  - (c) 2022. The Author(s).
FAU - Lager, Brittney
AU  - Lager B
AUID- ORCID: 0000-0001-8002-7876
AD  - AcariaHealth, Orlando, FL, USA.
FAU - Liseno, Jacob
AU  - Liseno J
AD  - AcariaHealth, Orlando, FL, USA.
FAU - Bozin, Ivan
AU  - Bozin I
AD  - Biogen, Cambridge, MA, USA.
FAU - England, Sarah M
AU  - England SM
AD  - Biogen, Cambridge, MA, USA.
FAU - Shankar, Sai L
AU  - Shankar SL
AUID- ORCID: 0000-0003-3249-8360
AD  - Biogen, Cambridge, MA, USA.
FAU - Mendoza, Jason P
AU  - Mendoza JP
AUID- ORCID: 0000-0003-2526-5542
AD  - Biogen, Cambridge, MA, USA.
FAU - Lewin, James B
AU  - Lewin JB
AUID- ORCID: 0000-0002-2352-9113
AD  - Biogen, Cambridge, MA, USA. jim.lewin@biogen.com.
LA  - eng
PT  - Journal Article
DEP - 20221105
PL  - New Zealand
TA  - Neurol Ther
JT  - Neurology and therapy
JID - 101637818
CIN - Neurol Ther. 2023 Dec;12(6):2195-2197. PMID: 37707706
PMC - PMC9837354
OTO - NOTNLM
OT  - Adherence
OT  - Dimethyl fumarate
OT  - Diroximel fumarate
OT  - Gastrointestinal side effects
OT  - Multiple sclerosis
OT  - Real-world treatment
OT  - Tolerability
COIS- Brittney Lager and Jacob Liseno are employees of AcariaHealth. Ivan Bozin, Sarah 
      M. England, Sai L. Shankar, Jason P. Mendoza, and James B. Lewin are employees of 
      and hold stock/stock options in Biogen.
EDAT- 2022/11/06 06:00
MHDA- 2022/11/06 06:01
PMCR- 2022/11/05
CRDT- 2022/11/05 12:28
PHST- 2022/08/18 00:00 [received]
PHST- 2022/10/14 00:00 [accepted]
PHST- 2022/11/06 06:00 [pubmed]
PHST- 2022/11/06 06:01 [medline]
PHST- 2022/11/05 12:28 [entrez]
PHST- 2022/11/05 00:00 [pmc-release]
AID - 10.1007/s40120-022-00413-0 [pii]
AID - 413 [pii]
AID - 10.1007/s40120-022-00413-0 [doi]
PST - ppublish
SO  - Neurol Ther. 2023 Feb;12(1):145-159. doi: 10.1007/s40120-022-00413-0. Epub 2022 
      Nov 5.