Evidence map›Paper›PMID 23168581›Full record

Trial reportMolecular medicine (Cambridge, Mass.)2012

Safety and efficacy of ARA 290 in sarcoidosis patients with symptoms of small fiber neuropathy: a randomized, double-blind pilot study.

Lara Heij, Marieke Niesters, Maarten Swartjes, Elske Hoitsma, Marjolein Drent, Ann Dunne, Jan C Grutters, Oscar Vogels, Michael Brines, Anthony Cerami and 1 more

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Molecular medicine (Cambridge, Mass.), 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 4 pooled it
5.4field-weighted citation impact, top 4% 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

39 citing papers in PubMed, 4 syntheses or guidelines pooled it, 110 citations in OpenAlex.

  1. Pooled it
  2. The effects of pharmacological interventions on quality of life and fatigue in sarcoidosis: a systematic review.European respiratory review : an official journal of the European Respiratory Society · 2020
    Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. Review
  8. Use of fatigue assessment scale and small fiber neuropathy screening list in Japanese patients with sarcoidosis.Sarcoidosis, vasculitis, and diffuse lung diseases : official journal of WASOG · 2025
    Article
  9. Article
  10. Article
  11. Review
  12. Article
  13. Review
  14. Management of neurosarcoidosis: a clinical challenge.Current opinion in neurology · 2019
    Review
  15. Article
  16. Role of the β Common (βc) Family of Cytokines in Health and Disease.Cold Spring Harbor perspectives in biology · 2018
    Review
  17. Review
  18. Article
  19. Article
  20. Patient reported outcome measures (PROMs) in sarcoidosis.Sarcoidosis, vasculitis, and diffuse lung diseases : official journal of WASOG · 2017
    Review
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 6 institutions in 2 countries.

Lara HeijDepartment of Anesthesiology, Leiden University Medical Center, Leiden, the Netherlands.
Marieke Niesters
Maarten Swartjes
Elske Hoitsma
Marjolein Drent
Ann Dunne
Jan C Grutters
Oscar Vogels
Michael Brines
Anthony Cerami
Albert Dahan
Leiden University Medical Center · NLAraim Pharmaceuticals (United States) · USDiakonessenhuis hospital · NLMaastricht University · NLSt. Antonius Ziekenhuis · NLUniversity Medical Center Utrecht · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

ARA 290 (a peptide designed to activate the innate repair receptor that arrests injury and initiates cytoprotection, antiinflammation and healing) reduces allodynia in preclinical neuropathy models. We studied the safety and efficacy of ARA 290 to reduce symptoms of small fiber neuropathy (SFN) in patients with sarcoidosis. A total of 22 patients diagnosed with sarcoidosis and symptoms of SFN were enrolled in a double-blind, placebo-controlled exploratory trial consisting of three times weekly intravenous dosing of ARA 290 (2 mg; n = 12) or placebo (n = 10) for 4 wks. Inclusion criteria were a diagnosis of neuropathy and a spontaneous pain score of ≥5 (Brief Pain Inventory [BPI]). Endpoints assessed were changes in pain intensity and the small fiber neuropathy screening list (SFNSL) score, quality of life (SF-36), depressive symptoms (Inventory of Depressive Symptomatology [IDS]) and fatigue (Fatigue Assessment Scale [FAS]). No safety concerns were raised by clinical or laboratory assessments. The ARA 290 group showed significant (p < 0.05) improvement at wk 4 in SFNSL score compared with placebo (Δ -11.5 ± 3.04 versus Δ -2.9 ± 3.34 [standard error of the mean]). Additionally, the ARA 290 group showed a significant change from baseline in the pain and physical functioning dimensions of the SF-36 (Δ -23.4 ± 5.5 and Δ -14.6 ± 3.9, respectively). The mean BPI and FAS scores improved significantly but equivalently in both patient groups. No change was observed in the IDS. ARA 290 appears to be safe in patients with sarcoidosis and can reduce neuropathic symptoms.

Indexed as

Double-Blind MethodFemaleHumansMaleMiddle AgedNervous System DiseasesPeptidesPilot ProjectsPlacebosSarcoidosisSensationSurveys and QuestionnairesTreatment OutcomePeptidesPlacebos

Identifiers

PMID23168581
PMCPMC3563705
OpenAlexW1814675358

What OpenQuestion holds

Textmetadata
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.