Early MRI outcomes in participants with a first clinical demyelinating event at risk of multiple sclerosis in the ORACLE-MS study.
First clinical demyelinating event
ORACLE-MS
cladribine tablets
lesions
magnetic resonance imaging
multiple sclerosis
Journal
Multiple sclerosis journal - experimental, translational and clinical
ISSN: 2055-2173
Titre abrégé: Mult Scler J Exp Transl Clin
Pays: United States
ID NLM: 101668877
Informations de publication
Date de publication:
Historique:
received:
28
09
2020
accepted:
09
01
2021
entrez:
15
3
2021
pubmed:
16
3
2021
medline:
16
3
2021
Statut:
epublish
Résumé
In the Phase 3, 96-week ORACLE-MS study, cladribine tablets 10 mg (3.5 or 5.25 mg/kg cumulative dosage over two years) significantly reduced lesions associated with multiple sclerosis versus placebo in participants following a first clinical demyelinating event (FCDE). To determine the timing of effects of cladribine tablets on lesion activity assessed by magnetic resonance imaging (MRI). This Compared to placebo, cladribine tablets 3.5 mg/kg treatment appeared to lead to a trend of reductions in the mean number of T1 Gd+ lesions by Week 13 (first post-baseline scan: 0.37 vs. 1.00), new or enlarging T2 (0.20 vs. 1.01) and combined unique active (0.29 vs. 1.91) lesions by Week 24. Low lesion counts were maintained with cladribine tablets throughout 96 weeks. Similar results were observed with the 5.25 mg/kg dosage. In participants with an FCDE, cladribine tablets appeared to reduce lesion numbers within 13 weeks (time of first evaluation).
Sections du résumé
BACKGROUND
BACKGROUND
In the Phase 3, 96-week ORACLE-MS study, cladribine tablets 10 mg (3.5 or 5.25 mg/kg cumulative dosage over two years) significantly reduced lesions associated with multiple sclerosis versus placebo in participants following a first clinical demyelinating event (FCDE).
OBJECTIVE
OBJECTIVE
To determine the timing of effects of cladribine tablets on lesion activity assessed by magnetic resonance imaging (MRI).
METHODS
METHODS
This
RESULTS
RESULTS
Compared to placebo, cladribine tablets 3.5 mg/kg treatment appeared to lead to a trend of reductions in the mean number of T1 Gd+ lesions by Week 13 (first post-baseline scan: 0.37 vs. 1.00), new or enlarging T2 (0.20 vs. 1.01) and combined unique active (0.29 vs. 1.91) lesions by Week 24. Low lesion counts were maintained with cladribine tablets throughout 96 weeks. Similar results were observed with the 5.25 mg/kg dosage.
CONCLUSION
CONCLUSIONS
In participants with an FCDE, cladribine tablets appeared to reduce lesion numbers within 13 weeks (time of first evaluation).
Identifiants
pubmed: 33717501
doi: 10.1177/2055217321990852
pii: 10.1177_2055217321990852
pmc: PMC7925953
doi:
Types de publication
Journal Article
Langues
eng
Pagination
2055217321990852Informations de copyright
© The Author(s) 2021.
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