Evidence map›Paper›PMID 28879049›Full record

ArticleRMD open2017

Rituximab in early systemic sclerosis.

Maaike Boonstra, Jessica Meijs, Annemarie L Dorjée, Nina Ajmone Marsan, Anne Schouffoer, Maarten K Ninaber, Koen D Quint, Femke Bonte-Mineur, Tom W J Huizinga, Hans U Scherer and 1 more

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in RMD open, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 38 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 7 pooled it
3.3field-weighted citation impact, top 7% 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

38 citing papers in PubMed, 7 syntheses or guidelines pooled it, 68 citations in OpenAlex.

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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

11 authors at 2 institutions in 1 country.

Maaike BoonstraDepartment of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.
Jessica MeijsDepartment of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.
Annemarie L DorjéeDepartment of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.
Nina Ajmone MarsanDepartment of Cardiology, Leiden University Medical Center, Leiden, The Netherlands.
Anne SchouffoerDepartment of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.
Maarten K NinaberDepartment of Pulmonology, Leiden University Medical Center, Leiden, The Netherlands.
Koen D QuintDepartment of Dermatology, Leiden University Medical Center, Leiden, The Netherlands.
Femke Bonte-MineurDepartment of Rheumatology, Maasstad Hospital, Rotterdam, The Netherlands.
Tom W J HuizingaDepartment of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.
Hans U SchererDepartment of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.
Jeska K de Vries-BouwstraDepartment of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.
Leiden University Medical Center · NLMaasstad Ziekenhuis · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectives(1) Hypothesis testing of the potency of rituximab (RTX) in preventing fibrotic complications and (2) assessing acceptability and feasibility of RTX in early systemic sclerosis (SSc).

methodsA small, 24-month, randomised, double-blind, placebo-controlled, single-centre trial in patients with SSc diagnosed <2 years was conducted. Patients received RTX or placebo infusions at t=0, t=15 days and t=6 months. Patients were clinically evaluated every 3 months, with lung function tests and high-resolution CT every other visit. Skin biopsies were taken at baseline and month 3. Immunophenotyping of peripheral blood mononuclear cells was performed at every visit, except at months 9 and 18. Adverse events, course of skin and pulmonary involvement and B cell populations in skin and peripheral blood were evaluated.

resultsIn total 16, patients (rituximab n=8, placebo n=8) were included. Twelve patients had diffuse cutaneous SSc. Eighty-eight adverse events (RTX n=53, placebo n=35, p=0.22) and 11 serious adverse events (RTX n=7, placebo n=4, p=0.36) occurred. No unexpected RTX-related events were observed. Mean skin score over time did not differ between the groups. Over time, forced vital capacity and extent of lung involvement slightly improved with RTX, but this difference was insignificant. In peripheral blood B cells depletion was demonstrated.

conclusionsNo unexpected safety issues were observed with RTX in early SSc. Although this small trial could not confirm or reject potential efficacy of RTX in these patients, future placebo-controlled trials are warranted, specifically in the subgroup of patients with pulmonary involvement. TRIAL REGISTRATION NUMBER: EudraCT 2008-07180-16; Results.

Indexed as

B CellsSystemic SclerosisTreatment

Identifiers

PMID28879049
PMCPMC5574444
OpenAlexW2740737345

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.