Evidence map›Paper›PMID 29746672›Full record

Trial reportRheumatology (Oxford, England)2018

Two years of sarilumab in patients with rheumatoid arthritis and an inadequate response to MTX: safety, efficacy and radiographic outcomes.

Mark C Genovese, Janet van Adelsberg, Chunpeng Fan, Neil M H Graham, Hubert van Hoogstraten, Janie Parrino, Erin K Mangan, Alberto Spindler, Tom W J Huizinga, Désirée van der Heijde and 1 more

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Rheumatology (Oxford, England), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

17 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Guideline
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Review
  7. Secondary immunodeficiencies and infectious considerations of biologic immunomodulatory therapies.Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology · 2023
    Review
  8. Article
  9. Role of Interleukin 6 Inhibitors in the Management of Rheumatoid Arthritis.Journal of clinical rheumatology : practical reports on rheumatic & musculoskeletal diseases · 2021
    Article
  10. Repurpose but also (nano)-reformulate! The potential role of nanomedicine in the battle against SARS-CoV2.Journal of controlled release : official journal of the Controlled Release Society · 2021
    Review
  11. Article
  12. Article
  13. Review
  14. Review
  15. Article
  16. Review
  17. 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.

Mark C GenoveseDivision of Immunology and Rheumatology, Stanford University Medical Center, Palo Alto, CA.
Janet van AdelsbergRegeneron Pharmaceuticals, Inc., Tarrytown, NJ.
Chunpeng FanSanofi Genzyme, Bridgewater, NJ, USA.
Neil M H GrahamRegeneron Pharmaceuticals, Inc., Tarrytown, NJ.
Hubert van HoogstratenSanofi Genzyme, Bridgewater, NJ, USA.
Janie ParrinoRegeneron Pharmaceuticals, Inc., Tarrytown, NJ.
Erin K ManganRegeneron Pharmaceuticals, Inc., Tarrytown, NJ.
Alberto SpindlerCentro Medico Privado de Reumatologia, Tucumán, Argentina.
Tom W J HuizingaDepartment of Rheumatology, Leiden University Medical Centre, Leiden, the Netherlands.
Désirée van der HeijdeDepartment of Rheumatology, Leiden University Medical Centre, Leiden, the Netherlands.
EXTEND study investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objectives: To examine 2-year safety, efficacy and radiographic outcomes of sarilumab in adults with RA and inadequate response to MTX (MTX-IR). Methods: In the randomized, placebo-controlled MOBILITY trial, MTX-IR patients received subcutaneous sarilumab (150 or 200 mg) or placebo every 2 weeks (q2w) plus MTX for up to 1 year. Upon study completion, patients could enrol in the open-label, long-term extension study (EXTEND, NCT011046652), in which all patients received sarilumab 200 mg q2w plus MTX. Dose reduction to 150 mg q2w was allowed for abnormal laboratory findings and per investigator's discretion. Results: Of 1197 patients participating in MOBILITY, 901 entered EXTEND. Over the 2-year period, treatment-emergent adverse events (TEAEs) and serious AEs occurred at rates of 279.6 events per 100 patient-years and 16.6 events per 100 patient-years, respectively. The most common TEAEs were neutropenia, injection site erythema, increased alanine aminotransferase and upper respiratory tract infections. After 1 year in the open-label, long-term extension, disease activity reached similar levels regardless of initial treatment. Modified total Sharp scores at year 1 were maintained through year 2. Best radiographic outcomes were observed in patients initially randomized to sarilumab 200 mg q2w. After dose reduction, 89.4% of patients continued the study through 2 years. Conclusion: Sarilumab safety through year 2 was consistent with IL-6 receptor blockade. Clinical response was similar irrespective of initial treatment, and radiographic progression stabilized. Patients initiated on sarilumab 200 mg q2w had the best radiographic outcomes. Dose reduction allowed most patients to continue with the study.

Indexed as

Antibodies, Monoclonal, HumanizedAntirheumatic AgentsArthritis, RheumatoidDisease ProgressionDose-Response Relationship, DrugDouble-Blind MethodFemaleFollow-Up StudiesHumansInjections, SubcutaneousMaleMethotrexateMiddle AgedRadiographySeverity of Illness IndexTime FactorsAntibodies, Monoclonal, HumanizedAntirheumatic AgentsMethotrexatesarilumab

Identifiers

PMID29746672
PMCPMC6055572

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Registered trials

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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.