Evidence map›Paper›PMID 36413080›Full record

ArticleRheumatology (Oxford, England)2023

Disproportionate articular pain is a frequent phenomenon in rheumatoid arthritis and responds to treatment with sarilumab.

Ernest Choy, Vivian Bykerk, Yvonne C Lee, Hubert van Hoogstraten, Kerri Ford, Amy Praestgaard, Serge Perrot, Janet Pope, Anthony Sebba

4 registry-linked trialsOpen access · hybridAbstract read
In one paragraph

Article in Rheumatology (Oxford, England), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
2.6field-weighted citation impact, top 10% 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.

NCT01061736 phase2 / phase3completednot on this map

A Randomized, Double-blind, Placebo-controlled, Multicenter, Two-part, Dose Ranging and Confirmatory Study With an Operationally Seamless Design, Evaluating Efficacy and Safety of SAR153191 on Top of Methotrexate (MTX) in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to MTX Therapy

TypeinterventionalSponsorSanofiRan2010 to 2013Enrolled1,675ConditionsRheumatoid ArthritisArmsSarilumab, Placebo (for sarilumab), Methotrexate, Folic Acid
NCT01146652 phase3completednot on this map

A Multi-center, Uncontrolled Extension Study Evaluating Efficacy and Safety of SAR153191 in Patients With Active Rheumatoid Arthritis (RA)

TypeinterventionalSponsorSanofiRan2010 to 2020Enrolled2,023ConditionsRheumatoid ArthritisArmsSAR153191 (REGN88)
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
NCT02332590 phase3completednot on this map

A Randomized, Double-blind, Parallel-group Study Assessing the Efficacy and Safety of Sarilumab Monotherapy Versus Adalimumab Monotherapy in Patients With Rheumatoid Arthritis

TypeinterventionalSponsorSanofiRan2015 to 2020Enrolled369ConditionsRheumatoid ArthritisArmsSarilumab, Adalimumab, Placebo (for sarilumab), Placebo (for adalimumab)
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 19 citations in OpenAlex.

  1. Observational
  2. Article
  3. Review
  4. Review
  5. Review
  6. Article
  7. Review
  8. Review
  9. Observational
  10. Non-inflammatory pain in inflammatory arthritis.Rheumatology (Oxford, England) · 2023
    Review
  11. Article
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

9 authors at 7 institutions in 4 countries.

Ernest ChoyCREATE Centre, Division of Infection and Immunity, Cardiff University School of Medicine, Cardiff, UK.ORCID 0000-0003-4459-8609
Vivian BykerkInflammatory Arthritis Centre, Hospital for Special Surgery, New York, NY, USA.
Yvonne C LeeDivision of Rheumatology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
Hubert van HoogstratenNeurology and Immunology, Sanofi, Bridgewater, NJ, USA.
Kerri FordMedical Affairs Immunology and Inflammation-Rheumatology, Rare Inflammatory Disorders, Sanofi, Bridgewater, NJ, USA.
Amy PraestgaardBiostatistics, Immunology, Sanofi, Cambridge, MA, USA.
Serge PerrotPain Center, Cochin Hospital, Paris University, Paris, France.
Janet PopeDivision of Rheumatology, Schulich School of Medicine, University of Western Ontario, St. Joseph's Health Care, London, ON, Canada.ORCID 0000-0003-1479-5302
Anthony SebbaDepartment of Rheumatology, University of South Florida, Tampa, FL, USA.
Sanofi (United States) · USCardiff University · GBHôpital Cochin · FRHospital for Special Surgery · USNorthwestern University · USUniversity of South Florida · USWestern University · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesIn some patients with RA, joint pain is more severe than expected based on the amount of joint swelling [referred to as disproportionate articular pain (DP)]. We assessed DP prevalence and the effects of sarilumab, an IL-6 inhibitor, on DP.

methodsData from RA patients treated with placebo or 200 mg sarilumab in the phase 3 randomized controlled trials (RCTs) MOBILITY and TARGET, adalimumab 40 mg or sarilumab 200 mg in the phase 3 RCT MONARCH and sarilumab 200 mg in open-label extensions (OLEs) were used. DP was defined as an excess tender 28-joint count (TJC28) over swollen 28-joint count (SJC28) of ≥7 (TJC28 - SJC28 ≥ 7). Treatment response and disease activity were determined for patients with and without DP.

resultsOf 1531 sarilumab 200 mg patients from RCTs, 353 (23%) had baseline DP. On average, patients with DP had higher 28-joint DAS using CRP (DAS28-CRP) and pain scores than patients without DP, whereas CRP levels were similar. After 12 and 24 weeks, patients with baseline DP treated with sarilumab were more likely to be DP-free than those treated with placebo or adalimumab. In RCTs, more sarilumab-treated patients achieved low disease activity vs comparators, regardless of baseline DP status. In OLEs, patients were more likely to lose rather than gain DP status.

conclusionAbout one-quarter of patients with RA experienced DP, which responded well to sarilumab. These data support the concept that other mechanisms (potentially mediated via IL-6) in addition to inflammation may contribute to DP in RA. TRIAL REGISTRATIONS: NCT01061736, NCT02332590, NCT01709578, NCT01146652.

Indexed as

Antirheumatic AgentsArthritis, RheumatoidAdalimumabAntibodies, Monoclonal, HumanizedArthralgiaHumansInterleukin-6MethotrexateTreatment OutcomeAdalimumabAntibodies, Monoclonal, HumanizedAntirheumatic AgentsInterleukin-6MethotrexatesarilumabanalgesiaIL-6painRAsarilumab

Identifiers

PMID36413080
PMCPMC10321097
OpenAlexW4309589253

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.