Evidence map›Paper›PMID 28326189›Full record

ArticleRMD open2017

Sarilumab improves patient-reported outcomes in rheumatoid arthritis patients with inadequate response/intolerance to tumour necrosis factor inhibitors.

Vibeke Strand, Matthew Reaney, Chieh-I Chen, Clare W J Proudfoot, Sophie Guillonneau, Deborah Bauer, Erin Mangan, Neil M H Graham, Hubert van Hoogstraten, Yong Lin and 2 more

Registry-linked trialOpen access · goldAbstract read
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. It is linked to trial NCT01709578 (A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing the Efficacy and Safety of Sarilumab Added to Non-biologic DMARD Therapy in Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF-α Antagonists), which is not on this map. Cited by 24 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 2 pooled it
4.6field-weighted citation impact, top 5% 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.

NCT01709578 phase3completednot on this map

A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing the Efficacy and Safety of Sarilumab Added to Non-biologic DMARD Therapy in Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF-α Antagonists

TypeinterventionalSponsorSanofiRan2012 to 2015Enrolled546ConditionsRheumatoid ArthritisArmsSarilumab, placebo, hydroxychloroquine, methotrexate, sulfasalazine
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 2 syntheses or guidelines pooled it, 42 citations in OpenAlex.

  1. Pooled it
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  15. Pain: A Review of Interleukin-6 and Its Roles in the Pain of Rheumatoid Arthritis.Open access rheumatology : research and reviews · 2021
    Review
  16. Potential role of interferons in treating COVID-19 patients.International immunopharmacology · 2021
    Review
  17. Repositioned Drugs for COVID-19-the Impact on Multiple Organs.SN comprehensive clinical medicine · 2021
    Review
  18. Review
  19. Review
  20. Observational
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

12 authors at 7 institutions in 4 countries.

Vibeke StrandStanford University School of Medicine , Palo Alto, California , USA.
Matthew ReaneySanofi , Guildford , UK.
Chieh-I ChenRegeneron Pharmaceuticals, Inc , Tarrytown, New York , USA.
Clare W J ProudfootSanofi , Guildford , UK.
Sophie GuillonneauSanofi , Chilly-Mazarin , France.
Deborah BauerSanofi Genzyme , Bridgewater, New Jersey , USA.
Erin ManganRegeneron Pharmaceuticals, Inc , Tarrytown, New York , USA.
Neil M H GrahamRegeneron Pharmaceuticals, Inc , Tarrytown, New York , USA.
Hubert van HoogstratenSanofi Genzyme , Bridgewater, New Jersey , USA.
Yong LinSanofi Genzyme , Bridgewater, New Jersey , USA.
César Pacheco-TenaUniversidad Autónoma de Chihuahua , Chihuahua , Mexico.
Roy FleischmannMetroplex Clinical Research Center and University of Texas Southwestern Medical Center , Dallas, Texas , USA.
Regeneron (United States) · USSanofi (United States) · USSanofi (United Kingdom) · GBAutonomous University of Chihuahua · MXSanofi (France) · FRStanford University · USThe University of Texas Southwestern Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate effects of the anti-interleukin-6 receptor monoclonal antibody sarilumab administered with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) on patient-reported outcomes (PROs) in the TARGET trial in patients with rheumatoid arthritis (RA) with inadequate response or intolerance to tumour necrosis factor inhibitors (TNF-IR).

methods546 patients (81.9% female, mean age 52.9 years) were randomised to placebo, sarilumab 150 or 200 mg subcutaneously every 2 weeks + csDMARDs. PROs included patient global assessment (PtGA); pain and morning stiffness visual analogue scales; Health Assessment Questionnaire Disability Index (HAQ-DI); Short Form-36 Health Survey (SF-36); FACIT-Fatigue (FACIT-F); Work Productivity Survey-Rheumatoid Arthritis (WPS-RA) and Rheumatoid Arthritis Impact of Disease (RAID). Changes from baseline at weeks 12 and 24 were analysed using a mixed model for repeated measures; post hoc analyses included percentages of patients reporting improvements ≥ minimum clinically important differences (MCID) and scores ≥ normative values.

resultsSarilumab + csDMARDs doses resulted in improvements from baseline at week 12 vs placebo + csDMARDs in PtGA, pain, HAQ-DI, SF-36 and FACIT-F that were maintained at week 24. Sarilumab improved morning stiffness and reduced the impact of RA on work, family, social/leisure activities participation (WPS-RA) and on patients' lives (RAID). Percentages of patients reporting improvements ≥MCID and ≥ normative scores were greater with sarilumab than placebo.

conclusionsIn patients with TNF-IR RA, 150 and 200 mg sarilumab + csDMARDs resulted in clinically meaningful patient-reported benefits on pain, fatigue, function, participation and health status at 12 and 24 weeks that exceeded placebo + csDMARDs, and were consistent with the clinical profile previously reported. TRIAL REGISTRATION NUMBER: NCT01709578; Results.

Indexed as

Anti-TNFDMARDs (biologic)Outcomes researchPatient perspectiveRheumatoid Arthritis

Identifiers

PMID28326189
PMCPMC5353328
OpenAlexW2593835974

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.