PMID- 33225410
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20210604
IS  - 2193-8253 (Print)
IS  - 2193-6536 (Electronic)
IS  - 2193-6536 (Linking)
VI  - 10
IP  - 1
DP  - 2021 Jun
TI  - Effectiveness of Dimethyl Fumarate in Patients With Relapsing Multiple Sclerosis 
      Switching After Suboptimal Response to Glatiramer Acetate, Including Patients 
      With Early Multiple Sclerosis: Subgroup Analysis of RESPOND.
PG  - 169-182
LID - 10.1007/s40120-020-00223-2 [doi]
AB  - INTRODUCTION: This post hoc subset analysis of RESPOND evaluated the 
      effectiveness of dimethyl fumarate (DMF) 240 mg twice daily in patients with 
      relapsing multiple sclerosis (RMS) after suboptimal response to glatiramer 
      acetate (GA; "first switch" patients), including patients with early MS ("early 
      MS switch" patients). METHODS: Patients had discontinued GA due to suboptimal 
      response and initiated DMF treatment within 60 days after enrollment. Relapse 
      data were collected from medical records. First switch patients had had one prior 
      approved MS therapy (GA) before initiating DMF treatment. Early MS switch 
      patients were first switch patients with baseline Patient-Reported Expanded 
      Disability Status Scale (PR-EDSS) score </= 3.5, </= 1 relapses in the past 1 year, 
      or both. RESULTS: Among first switch patients (n = 231), the annualized relapse 
      rate (ARR) was 0.48 (95% confidence interval [CI] 0.40-0.58) for 12 months before 
      DMF initiation and 0.11 (95% CI 0.06-0.18) for 12 months after DMF initiation, a 
      78% decrease in ARR. Among early MS switch patients with baseline PR-EDSS 
      score </= 3.5 (n = 120), </= 1 relapses in the prior year (n = 219), or both 
      (n = 114), the ARRs (95% CIs) for 12 months before DMF initiation were 0.47 
      (0.37-0.59), 0.37 (0.32-0.44), and 0.39 (0.31-0.49), respectively; values for 
      12 months after DMF initiation were 0.06 (0.02-0.19), 0.09 (0.05-0.17), and 0.06 
      (0.02-0.20), respectively, an 87, 75, and 83% decrease in ARR. The proportion of 
      patients relapse-free 12 months after DMF initiation versus 12 months before were 
      94 versus 59% in first switch patients, and 97 versus 58%, 94 versus 63%, and 97 
      versus 61% in early MS switch patients in the PR-EDSS score </= 3.5, </= 1 relapses 
      in the prior year, or PR-EDSS score </= 3.5 and </= 1 relapses subgroups, 
      respectively. After 12 months of DMF treatment, most patient-reported outcomes 
      scores showed significant improvement. CONCLUSIONS: DMF may be an effective 
      treatment option in first switch and early MS switch patients with RMS who 
      experience a suboptimal response to GA. TRIAL REGISTRATION: ClinicalTrials.gov 
      identifier: NCT01903291.
FAU - Repovic, Pavle
AU  - Repovic P
AD  - Multiple Sclerosis Center, Swedish Neuroscience Institute, Seattle, WA, USA.
FAU - Robertson, Derrick
AU  - Robertson D
AD  - Multiple Sclerosis Division, Department of Neurology, University of South Florida 
      College of Medicine, Tampa, FL, USA.
FAU - Kresa-Reahl, Kiren
AU  - Kresa-Reahl K
AD  - Providence Multiple Sclerosis Center, Portland, OR, USA.
FAU - Cohan, Stanley L
AU  - Cohan SL
AD  - Providence Multiple Sclerosis Center, Portland, OR, USA.
FAU - Su, Ray
AU  - Su R
AD  - Biogen, Cambridge, MA, USA.
FAU - Avila, Robin
AU  - Avila R
AD  - Biogen, Cambridge, MA, USA.
FAU - Koulinska, Irene
AU  - Koulinska I
AD  - Biogen, Cambridge, MA, USA.
FAU - Mendoza, Jason P
AU  - Mendoza JP
AD  - Biogen, Cambridge, MA, USA. jason.mendoza@biogen.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT01903291
PT  - Journal Article
DEP - 20201123
PL  - New Zealand
TA  - Neurol Ther
JT  - Neurology and therapy
JID - 101637818
PMC - PMC8140000
OTO - NOTNLM
OT  - Annualized relapse rate
OT  - Dimethyl fumarate
OT  - Glatiramer acetate
OT  - Patient-reported outcomes
OT  - Relapsing multiple sclerosis
EDAT- 2020/11/24 06:00
MHDA- 2020/11/24 06:01
PMCR- 2020/11/23
CRDT- 2020/11/23 05:43
PHST- 2020/09/07 00:00 [received]
PHST- 2020/10/30 00:00 [accepted]
PHST- 2020/11/24 06:00 [pubmed]
PHST- 2020/11/24 06:01 [medline]
PHST- 2020/11/23 05:43 [entrez]
PHST- 2020/11/23 00:00 [pmc-release]
AID - 10.1007/s40120-020-00223-2 [pii]
AID - 223 [pii]
AID - 10.1007/s40120-020-00223-2 [doi]
PST - ppublish
SO  - Neurol Ther. 2021 Jun;10(1):169-182. doi: 10.1007/s40120-020-00223-2. Epub 2020 
      Nov 23.