Evidence map›Paper›PMID 41787239›Full record

ArticleNeurology and therapy2026

Efficacy of Ublituximab in People with Highly Active Relapsing Multiple Sclerosis.

Hans-Peter Hartung, Derrick Robertson, Lawrence Steinman, Douglas L Arnold, Peiqing Qian, Sibyl Wray, Edward Fox, Christopher A Garner, Yihuan Xu, Koby Mok and 3 more

2 registry-linked trialsAbstract read
In one paragraph

Article in Neurology and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03277248 phase3completednot on this map

Phase III: UbLiTuximab in Multiple Sclerosis Treatment Effects (ULTIMATE II STUDY)

TypeinterventionalSponsorTG Therapeutics, Inc.Ran2017 to 2020Enrolled545ConditionsRelapsing Multiple Sclerosis (RMS)ArmsUblituximab, Teriflunomide, Oral Placebo, IV Placebo
NCT03277261 phase3completednot on this map

Phase III: UbLiTuximab In Multiple Sclerosis Treatment Effects (ULTIMATE I STUDY)

TypeinterventionalSponsorTG Therapeutics, Inc.Ran2017 to 2020Enrolled549ConditionsRelapsing Multiple Sclerosis (RMS)ArmsUblituximab, Teriflunomide, Oral Placebo, IV Placebo
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Hans-Peter HartungDepartment of Neurology, Medical Faculty, Heinrich Heine University Düsseldorf, Moorenstraße 5, 40225, Düsseldorf, Germany. hans-peter.hartung@uni-duesseldorf.de.
Derrick RobertsonUniversity of South Florida, Tampa, FL, USA.
Lawrence SteinmanStanford University, Stanford, CA, USA.
Douglas L ArnoldNeuroRx Research, Montreal, Canada.
Peiqing QianSwedish Neuroscience Institute, Seattle, WA, USA.
Sibyl WrayHope Neurology, Knoxville, TN, USA.
Edward FoxTG Therapeutics, New York, NY, USA.
Christopher A GarnerTG Therapeutics, New York, NY, USA.
Yihuan XuTG Therapeutics, New York, NY, USA.
Koby MokTG Therapeutics, New York, NY, USA.
Anne GockeTG Therapeutics, New York, NY, USA.
Bruce A C CreeUCSF Weill Institute for Neurosciences, University of California San Francisco, San Francisco, CA, USA.
Enrique AlvarezUniversity of Colorado, Aurora, CO, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPeople with highly active multiple sclerosis benefit from early treatment with highly efficacious disease-modifying therapies. Here we present data on the efficacy of ublituximab versus teriflunomide in a subgroup of participants with highly active disease at baseline.

methodsPooled post hoc analyses of the phase 3 ULTIMATE I (N = 549) and II (N = 545) studies evaluated efficacy measures at weeks 12 and 96 in participants with highly active disease, defined as ≥ 2 relapses in the year prior and ≥ 1 gadolinium-enhancing (Gd+) T1 lesion at baseline.

resultsIn the highly active disease population, the unadjusted annualized relapse rates (ARR) at week 96 were 0.145 and 0.496 for the ublituximab (n = 88) and teriflunomide (n = 80) groups, respectively (70.8% relative reduction, P < 0.001). The number (least squares means) of gadolinium-enhancing T1 lesions per scan for ublituximab versus teriflunomide was 0.114 versus 0.683 at week 12 (83.3% relative reduction) and 0.038 versus 0.875 at week 96 (95.6% relative reduction; both P < 0.001). Corresponding values for new/enlarging T2 lesions (ublituximab versus teriflunomide) were 1.754 versus 4.127 at week 12 (57.5% relative reduction) and 0.568 versus 6.367 at week 96 (91.1% relative reduction, both P < 0.001). No evidence of disease activity-3 (NEDA-3) rates with ublituximab versus teriflunomide were 29.5% versus 10.1% (P = 0.001) at week 12 and 77.9% versus 16.4% (P < 0.001) at week 96 (weeks 24-96, re-baselined).

conclusionUblituximab was associated with significant treatment benefits across multiple efficacy measures versus teriflunomide in participants with highly active disease at baseline.

trial registrationClinical trial registry: ULTIMATE I and II ClinicalTrials.gov numbers, NCT03277261 (registration date September 7, 2017) and NCT03277248 (registration date September 7, 2017).

Indexed as

Annualized relapse rateAnti-CD20Highly active diseaseMultiple sclerosisNo evidence of disease activityRadiologic diseaseUblituximab

Identifiers

PMID41787239
PMCPMC13172083

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.