Evidence map›Paper›PMID 23666316›Full record

Trial reportClinical rheumatology2013

Induction of response with etanercept-methotrexate therapy in patients with moderately active rheumatoid arthritis in Central and Eastern Europe in the PRESERVE study.

Karel Pavelka, Zoltan Szekanecz, Nemanja Damjanov, Maria Majdan, Evgeny Nasonov, Vadim Mazurov, Tibor Fabo, Eustratios Bananis, Heather Jones, Annette Szumski and 4 more

Registry-linked trialAbstract readClinical TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Clinical rheumatology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00565409 (A Randomized, Double-Blind Study Comparing the Safety & Efficacy of Once-Weekly Etanercept 50 mg, Etanercept 25 mg, & Placebo in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis), which is not on this map. Cited by 11 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 5 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.

NCT00565409 phase4completednot on this map

A Randomized, Double-Blind Study Comparing the Safety & Efficacy of Once-Weekly Etanercept 50 mg, Etanercept 25 mg, & Placebo in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis

TypeinterventionalSponsorPfizerRan2008 to 2011Enrolled834ConditionsArthritis, RheumatoidArmsEtanercept, Methotrexate, Placebo
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Pooled it
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  6. Review
  7. Observational
  8. Article
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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

14 authors.

Karel PavelkaInstitute of Rheumatology and Clinic of Rheumatology, Charles University, Na Slupi 4, 12850, Prague 2, Czech Republic. pavelka@revma.cz
Zoltan Szekanecz
Nemanja Damjanov
Maria Majdan
Evgeny Nasonov
Vadim Mazurov
Tibor Fabo
Eustratios Bananis
Heather Jones
Annette Szumski
Boxiong Tang
Sameer Kotak
Andrew S Koenig
Radu Vasilescu

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Biologics have mainly been assessed in patients with severe rheumatoid arthritis (RA) globally. Less attention has been paid to moderately active disease, especially in Central and Eastern Europe (CEE). Access to biologics and the disease features of RA patients may differ in CEE, relative to other regions. We assessed the clinical and patient-reported outcomes (PROs) of treatment from CEE patients in the multinational PRESERVE study ( NCT00565409 ). Patients with moderate RA 28-joint disease activity score ((DAS28) erythrocyte sedimentation rate (ESR) >3.2 and ≤5.1) despite methotrexate (MTX) treatment received open-label etanercept (ETN) 50 mg QW + MTX for 36 weeks. Low disease activity (DAS28 low disease activity (LDA) ≤3.2) and remission (DAS28 ESR <2.6) were assessed. PROs included Health Assessment Questionnaire Disability Index (HAQ-DI), patient global assessment (PGA), EuroQol-5 Dimension (EQ-5D), pain visual analogue scale (VAS), Medical Outcomes Study sleep questionnaire (MOS Sleep), Functional Assessment of Chronic Illness Therapy (FACIT), and Work Productivity and Activity Impairment for RA (WPAI-RA). Descriptive summary statistics were employed. Of the 834 enrolled patients, 302 were from CEE. At baseline, CEE patients had similar disease states versus the overall population. By week 36, LDA was achieved by 87 %, remission by 67 %, and normal HAQ-DI (≤0.5) by 53 % of patients. Mean scores (SDs) for PROs significantly improved by week 36 as follows: HAQ-DI total by -0.6 (0.5); PGA by -2.4 (2.1); EQ-5D total index by 0.2 (0.2). Pain VAS, MOS Sleep, FACIT, and WPAI-RA also showed significant improvements. In conclusion, induction therapy with ETN + MTX led to DAS28 LDA, remission, and improvements in PROs in most CEE patients with moderately active RA despite treatment with MTX. These results are similar to the overall study population in the PRESERVE trial.

Indexed as

Activities of Daily LivingAdministration, OralAdultAgedAntirheumatic AgentsArthritis, RheumatoidBlood SedimentationDrug Administration ScheduleEtanerceptEurope, EasternFemaleHumansImmunoglobulin GMaleMethotrexateMiddle AgedAntirheumatic AgentsEtanerceptImmunoglobulin GMethotrexateReceptors, Tumor Necrosis Factor

Identifiers

What OpenQuestion holds

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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.