Evidence map›Paper›PMID 34330322›Full record

ArticleArthritis research & therapy2021

An open-label study to evaluate biomarkers and safety in systemic sclerosis patients treated with paquinimod.

Roger Hesselstrand, Jörg H W Distler, Gabriela Riemekasten, Dirk M Wuttge, Marie Törngren, Helén C Nyhlén, Fredrik Andersson, Helena Eriksson, Birgitta Sparre, Helén Tuvesson and 1 more

Registry-linked trialOpen access · goldAbstract readMulticenter Study
In one paragraph

Article in Arthritis research & therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01487551 (An Open-Label Study to Evaluate Biomarkers and Safety in Systemic Sclerosis Patients Treated With ABR-215757), which is not on this map. Cited by 28 papers.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed
3.9field-weighted citation impact, top 6% 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.

NCT01487551 phase2completednot on this map

An Open-Label Study to Evaluate Biomarkers and Safety in Systemic Sclerosis Patients Treated With ABR-215757 (Paquinimod)

TypeinterventionalSponsorActive Biotech ABRan2011 to 2013Enrolled9ConditionsSystemic SclerosisArmspaquinimod
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 42 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 5 institutions in 3 countries.

Roger HesselstrandDepartment of Rheumatology, Skåne University Hospital and Lund University, Lund, Sweden. roger.hesselstrand@med.lu.se.
Jörg H W DistlerUniversity of Erlangen-Nuremberg, Erlangen, Germany.
Gabriela RiemekastenUniversitätsklinikum Lübeck, Lübeck, Germany.
Dirk M WuttgeDepartment of Rheumatology, Skåne University Hospital and Lund University, Lund, Sweden.
Marie TörngrenActive Biotech AB, Lund, Sweden.
Helén C NyhlénActive Biotech AB, Lund, Sweden.
Fredrik AnderssonActive Biotech AB, Lund, Sweden.
Helena ErikssonActive Biotech AB, Lund, Sweden.ORCID 0000-0001-9899-7600
Birgitta SparreActive Biotech AB, Lund, Sweden.
Helén TuvessonActive Biotech AB, Lund, Sweden.
Oliver DistlerDepartment of Rheumatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.
Active Biotech (Sweden) · SELund University · SEFriedrich-Alexander-Universität Erlangen-Nürnberg · DEUniversity of Lübeck · DEUniversity of Zurich · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo evaluate the changes in disease-related biomarkers and safety of paquinimod, an oral immunomodulatory compound, in patients with systemic sclerosis (SSc).

methodsIn this open-label, single-arm, multicenter study, SSc patients with a rapidly progressive disease received paquinimod for 8 weeks. Blood and skin biopsies were collected at baseline, during treatment, and at follow-up for the analyses of type I interferon (IFN) activity, chemokine (C-C motif) ligand 2 (CCL2), and the number of myofibroblasts. The safety of paquinimod was evaluated throughout the study.

resultsNine SSc patients were enrolled and completed the study treatment with paquinimod at 3 mg/day for 8 weeks. After the treatment, a reduction of type I IFN activity in the plasma from one patient with elevated baseline IFN activity was recorded. A trend towards reduced IFN activity in the skin after treatment was also observed in patients. The serum level of CCL2 was reduced in 7 of 9 patients after paquinimod treatment. There was a median reduction of 10% of the number of myofibroblasts in skin biopsies at week 8 compared to baseline. No change in modified Rodnan skin score and quality of life was detected in the study. Reported adverse events (AEs) were mild to moderate and expected with the most common being arthralgia (n = 3) and headache (n = 3), and C-reactive protein (CRP) increase.

conclusionsAnalysis of biomarkers before and after treatment suggest reduced type I IFN activity and reduced number of myofibroblasts in lesional skin. Paquinimod was overall well tolerated with mild to moderate and expected AEs.

trial registrationClinicalTrials.gov, NCT01487551 . Registered on 7 September 2011.

Indexed as

QuinolinesScleroderma, SystemicBiomarkersHumansQuality of LifeTreatment OutcomeBiomarkerspaquinimodQuinolinesClinical trialPaquinimodSkin fibrosisSystemic sclerosis

Identifiers

PMID34330322
PMCPMC8325221
OpenAlexW3183804034

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.