Evidence map›Paper›PMID 25886874›Full record

Trial reportBMC musculoskeletal disorders2015

Do COX-2 inhibitors provide additional pain relief and anti-inflammatory effects in patients with rheumatoid arthritis who are on biological disease-modifying anti-rheumatic drugs and/or corticosteroids? Post-hoc analyses from a randomized clinical trial with etoricoxib.

Tore K Kvien, Maria Greenwald, Paul M Peloso, Hongwei Wang, Anish Mehta, Arnold Gammaitoni

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC musculoskeletal disorders, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00264147 (A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Parallel-Group, 12-Week Study to Assess the Clinically Effective Dose Range of Etoricoxib and to Assess Its Safety and Tolerability in Patients With Rheumatoid Arthritis), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
2.1field-weighted citation impact, top 14% 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.

NCT00264147 phase2completednot on this map

A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Parallel-Group, 12-Week Study to Assess the Clinically Effective Dose Range of Etoricoxib and to Assess Its Safety and Tolerability in Patients With Rheumatoid Arthritis

TypeinterventionalSponsorOrganon and CoRan2006 to 2008Enrolled761ConditionsRheumatoid ArthritisArmsetoricoxib, Comparator: placebo, Comparator: diclofenac
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 15 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. 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

6 authors at 3 institutions in 2 countries.

Tore K KvienDepartment of Rheumatology, Diakonhjemmet Hospital, Box 23, Vinderen, N-0319, Oslo, Norway. t.k.kvien@medisin.uio.no.
Maria GreenwaldDesert Medical Advances, Palm Desert, CA, USA. greenwald.maria@gmail.com.
Paul M PelosoClinical Research, Merck & Co., Inc., Kenilworth, NJ, USA. paul.peloso@abbvie.com.
Hongwei WangClinical Research, Merck & Co., Inc., Kenilworth, NJ, USA. hwwang73@yahoo.com.
Anish MehtaClinical Research, Merck & Co., Inc., Kenilworth, NJ, USA. anish_mehta@merck.com.
Arnold GammaitoniClinical Research, Merck & Co., Inc., Kenilworth, NJ, USA. agammaitoni@nuvoresearch.com.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USDesert Medical Imaging · USDiakonhjemmet Hospital · NO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOur objective was to evaluate the effect of background biological disease-modifying anti-rheumatic drugs (bDMARDs) and/or corticosteroids (CS) on response to nonsteroidal anti-inflammatory drugs (NSAIDs) in rheumatoid arthritis (RA) patients.

methodsThe following efficacy endpoints were evaluated using time-weighted change from baseline in a 12-week, randomized controlled clinical trial with etoricoxib: Patient Global Assessment of Pain, Swollen Joint Count, Tender Joint Count, Health Assessment Questionnaire. The following three treatment groups were evaluated: placebo, pooled etoricoxib 10/30/60 mg, and etoricoxib 90 mg. Screening values, values post flare, as well as changes after treatment were analyzed.

resultsOf the 1014 patients screened, 761 were randomized; 50% were on no background bDMARDs and/or CS therapy, 23% used bDMARDs, 34% used CS, and 8% used both bDMARDs and CS. It was demonstrated that RA patients on bDMARDs or CS had similar pain levels at screening as patients without this co-medication. They experienced flare upon NSAID withdrawal and demonstrated dose-dependent pain improvement with etoricoxib.

conclusionThese results support that RA patients receiving bDMARDs or CS may still require the use of concomitant analgesics to treat pain. Clinicians should continue to monitor and treat pain even after initiating a bDMARD and/or CS.

trial registration[clinicaltrials.gov; NCT00264147].

Indexed as

AnalgesicsArthralgiaArthritis, RheumatoidBiological ProductsColombiaCyclooxygenase 2 InhibitorsDisease ProgressionDose-Response Relationship, DrugDouble-Blind MethodDrug Therapy, CombinationEtoricoxibHealth StatusHumansNorth AmericaPain MeasurementPyridinesAnalgesicsBiological ProductsCyclooxygenase 2 InhibitorsEtoricoxibPyridinesSulfones

Identifiers

PMID25886874
PMCPMC4344787
OpenAlexW2061417002

What OpenQuestion holds

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LicenceCC BY
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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.