Evidence map›Paper›PMID 38599654›Full record

ArticleRMD open2024

Long-term clinical and radiological effectiveness and safety of ultralow doses of rituximab in rheumatoid arthritis: observational extension of the REDO trial.

Nathan den Broeder, Lise Verhoef, Yaël A de Man, Marc R Kok, Rogier Thurlings, Wilfred van der Weele, Bart Jf van den Bemt, Frank Hj van den Hoogen, Aatke van der Maas, Alfons A den Broeder

Open access · goldAbstract read
In one paragraph

Article in RMD open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 26% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 2 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
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

10 authors at 5 institutions in 2 countries.

Nathan den BroederRheumatology, Sint Maartenskliniek, Nijmegen, Gelderland, Netherlands n.denbroeder@maartenskliniek.nl.ORCID 0000-0001-7126-2209
Lise VerhoefRheumatology, Sint Maartenskliniek, Nijmegen, Gelderland, Netherlands.
Yaël A de ManRheumatology, Ziekenhuisgroep Twente, Almelo, Netherlands.
Marc R KokRheumatology, Maasstad Ziekenhuis, Rotterdam, Zuid-Holland, Netherlands.ORCID 0000-0003-2394-6926
Rogier ThurlingsRheumatology, Radboudumc, Nijmegen, Netherlands.
Wilfred van der WeeleRheumatology, Reade, Amsterdam, Noord-Holland, Netherlands.
Bart Jf van den BemtPharmacy, Sint Maartenskliniek, Nijmegen, Netherlands.
Frank Hj van den HoogenRheumatology, Sint Maartenskliniek, Nijmegen, Gelderland, Netherlands.
Aatke van der MaasRheumatology, Sint Maartenskliniek, Nijmegen, Gelderland, Netherlands.
Alfons A den BroederRheumatology, Sint Maartenskliniek, Nijmegen, Gelderland, Netherlands.
Sint Maartenskliniek · NLMaasstad Ziekenhuis · NLRadboud University Nijmegen · NLReade · NLZiekenhuis Groep Twente · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe REDO trial (REtreatment with Rituximab in RhEmatoid arthritis: Disease Outcome after Dose Optimisation) showed similar disease activity for retreatment with ultralow doses (200 mg and 500 mg per 6 months) compared with standard low-dose rituximab (RTX, 1000 mg per 6 months). We performed an observational extension study of the REDO trial to assess long-term effectiveness.

methodsPatients from the REDO trial were followed from start of the trial to censoring in April 2021. RTX use was at the discretion of patient and rheumatologist using treat to target. The primary outcome was disease activity (disease activity score in 28 joints C-reactive protein (DAS28-CRP)), analysed using a longitudinal mixed model by original randomisation and time-varying RTX dose. The original DAS28-CRP non-inferiority (NI) margin of 0.6 was used. RTX dose and persistence, safety and radiological outcomes were also assessed.

findingsData from 126 of 142 REDO patients was collected from 15 December 2016, up to 30 April 2021. Drop-outs continued treatment elsewhere (n=3) or did not consent (n=13).Disease activity did not differ by original randomisation group: 1000 mg mean DAS28-CRP (95% CI) of 2.2 (2.0 to 2.5), 500 mg 2.3 (2.1 to 2.4) and 200 mg 2.4 (2.2 to 2.5). Lower time-varying RTX dose was associated with higher DAS28-CRP (0.22 (95% CI 0.05 to 0.40) higher for 200 mg/6 months compared with 1000 mg/6 months), but remained within the NI-margin. RTX persistence was 93%. Median RTX dose was 978 mg (IQR 684-1413) per year, and no association was found between RTX dose and adverse events or radiological damage.

interpretationLong-term use of ultralow doses of RTX is effective in patients with rheumatoid arthritis responding to standard dose RTX.

Indexed as

Antirheumatic AgentsArthritis, RheumatoidHumansRadiographyRituximabTreatment OutcomeAntirheumatic AgentsRituximabArthritis, RheumatoidBiological TherapyRituximab

Identifiers

PMID38599654
PMCPMC11015170
OpenAlexW4394687891

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.