Trial reportJournal of neurology2026
Efficacy and safety of ofatumumab in participants with relapsing multiple sclerosis and breakthrough disease on oral fingolimod or fumarates: results from the ARTIOS study.
Trial report in Journal of neurology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04353492 (A Single-arm, Prospective, Multicentre, Open-label Study to Evaluate Ofatumumab Treatment Effectiveness and Patient-reported Outcomes), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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A Single-arm, Prospective, Multicentre, Open-label Study to Evaluate Ofatumumab Treatment Effectiveness and Patient-reported Outcomes (PRO) in Patients With Relapsing Multiple Sclerosis (RMS) Transitioning From Fumarate-based RMS Approved Therapies or Fingolimod
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Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundInitiating high-efficacy disease-modifying therapies (DMTs) early in relapsing multiple sclerosis (RMS) can reduce inflammation and limit disability progression; however, moderate-efficacy oral DMTs remain common first-line treatments. Ofatumumab demonstrated superior efficacy and tolerable safety in the phase 3 ASCLEPIOS trials, although few participants (≤ 5%) transitioned from oral DMTs. ARTIOS evaluated the efficacy and safety of ofatumumab in adults with RMS switching from fingolimod or fumarates following breakthrough disease.
methodsARTIOS was a phase 3b, open-label, single-arm, multicenter, noncomparative study. Primary endpoint was annualized relapse rate (ARR); secondary endpoint was safety.
results562 adults on fingolimod (n = 181) or fumarates (n = 381) with breakthrough disease, defined as ≥ 1 relapse in prior year or ≥ 2 relapses in prior 2 years and/or magnetic resonance imaging (MRI) evidence of disease activity in prior year, were enrolled. The primary endpoint was met, with a low ARR overall (0.06; 95% CI: 0.05-0.08; p < 0.0001) and by prior DMT (fingolimod: 0.09; 95% CI: 0.06-0.1; fumarates: 0.06; 95% CI: 0.04-0.08), despite greater baseline disease severity with fingolimod. Ofatumumab resulted in near-complete suppression of MRI lesions, and 90.9% of participants achieved no evidence of disease activity, regardless of prior DMT. Six-month confirmed disability worsening occurred in few participants (7.3%). Safety outcomes were consistent with those of prior studies; most treatment-emergent adverse events (TEAEs) were mild to moderate, serious TEAEs were uncommon (5.9%), and rates of treatment discontinuations and interruptions were low.
conclusionsARTIOS complements the ASCLEPIOS studies and supports ofatumumab following switch from oral DMTs.
trial registrationClinicalTrials.gov, NCT04353492; April 20, 2020.
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