Ponesimod as add-on treatment in patients with active relapsing multiple sclerosis under dimethyl fumarate (POINT): A phase 3, randomized, placebo-controlled clinical trial
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11110%2F25%3A10500335" target="_blank" >RIV/00216208:11110/25:10500335 - isvavai.cz</a>
Result on the web
<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=NRKbvkYK6f" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=NRKbvkYK6f</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1016/j.msard.2025.106616" target="_blank" >10.1016/j.msard.2025.106616</a>
Alternative languages
Result language
angličtina
Original language name
Ponesimod as add-on treatment in patients with active relapsing multiple sclerosis under dimethyl fumarate (POINT): A phase 3, randomized, placebo-controlled clinical trial
Original language description
Background: Combining two oral therapies with different mechanisms could be an attractive treatment strategy for multiple sclerosis (MS) to increase efficacy; however, evidence of such efficacy and safety is lacking. Objectives: The phase 3 randomized, double-blind, placebo-controlled POINT study evaluated efficacy and safety of ponesimod 20 mg versus placebo as an add-on therapy to ongoing dimethyl fumarate (DMF) treatment in patients with active relapsing MS despite DMF monotherapy. Methods: Patients (18-55 years) were randomized (1:1) to ponesimod+DMF or placebo+DMF orally once-daily for <= 156 weeks. Primary endpoint was annualized relapse rate (ARR) at end-of-study (EOS). Secondary endpoints were 12-week confirmed disability accumulation (CDA), time-to-first confirmed relapse, and number of combined unique active lesions (CUALs) on brain Magnetic resonance imaging (MRI) at EOS. Results: The study was prematurely terminated due to slow recruitment; of 600 planned patients, 136 (23 %; [ponesimod: n = 68, placebo: n = 68]) were randomized. Primary endpoint (ARR) was not met (rate ratio, ponesimod+DMF versus placebo+DMF: 1.2; p = 0.5252). Ponesimod+DMF group showed a lower mean number of CUALs/year (rate ratio: 0.37; p = 0.0072). Other efficacy outcomes did not differ between the treatment groups. Adverse events (AEs) were comparable between groups (ponesimod+DMF: 48 [71.6 %]; placebo+DMF: 53 [77.9 %]); dizziness was the most commonly reported AE in the ponesimod+DMF group (10.4 %).
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30103 - Neurosciences (including psychophysiology)
Result continuities
Project
<a href="/en/project/LX22NPO5107" target="_blank" >LX22NPO5107: National institute for Neurological Research</a><br>
Continuities
P - Projekt vyzkumu a vyvoje financovany z verejnych zdroju (s odkazem do CEP)<br>I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Others
Publication year
2025
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Multiple Sclerosis and Related Disorders
ISSN
2211-0348
e-ISSN
2211-0356
Volume of the periodical
102
Issue of the periodical within the volume
October
Country of publishing house
NL - THE KINGDOM OF THE NETHERLANDS
Number of pages
9
Pages from-to
106616
UT code for WoS article
001541019200001
EID of the result in the Scopus database
2-s2.0-105011161878