Evidence map›Paper›PMID 28361468›Full record

ArticleRheumatology and therapy2017

Impact of Participation in the Adalimumab (Humira) Patient Support Program on Rheumatoid Arthritis Treatment Course: Results from the PASSION Study.

Filip Van den Bosch, Andrew J K Ostor, Siegfried Wassenberg, Naijun Chen, Chen Wang, Vishvas Garg, Jasmina Kalabic

Erratum issued Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Rheumatology and therapy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT01383421 (A Post-Marketing Observational Study), which is not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
3.1field-weighted citation impact, top 9% 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.

NCT01383421 completednot on this map

A Post-Marketing Observational Study (PMOS) to Determine the Effectiveness and Patient Satisfaction With Adalimumab Treatment in Patients With Rheumatoid Arthritis (PASSION Study)

TypeobservationalSponsorAbbVie (prior sponsor, Abbott)Ran2011 to 2016Enrolled1,036ConditionsRheumatoid Arthritis
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 35 citations in OpenAlex.

  1. Pooled it
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  6. Observational
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 5 institutions in 4 countries.

Filip Van den BoschGhent University Hospital and VIB Center for Inflammation Research, Ghent, Belgium. filip.vandenbosch@ugent.be.
Andrew J K OstorAddenbrooke's Hospital, Cambridge, UK.
Siegfried WassenbergRheumazentrum, Ratingen, Germany.
Naijun ChenAbbVie Inc., North Chicago, IL, USA.
Chen WangAbbVie Inc., North Chicago, IL, USA.
Vishvas GargAbbVie Inc., North Chicago, IL, USA.
Jasmina KalabicAbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany.
AbbVie (United States) · USAbbVie (Germany) · DEAddenbrooke's Hospital · GBFachklinik 360° · DEVIB-UGent Center for Inflammation Research · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPatients with rheumatoid arthritis (RA) who are treated with adalimumab (ADA) are offered a proprietary patient support program (PSP, AbbVie Care

methodsPASSION was a 78-week post-marketing observational study of RA patients with an insufficient response to ≥1 DMARD newly initiating ADA in routine clinical care that was conducted in Europe, Israel, Mexico, Puerto Rico, and Australia. One prior biologic DMARD was allowed. The primary endpoint was percentage of patients achieving the minimal clinically important difference (MCID; improvement of ≥0.22 compared to baseline) in Health Assessment Questionnaire (HAQ) Disability Index (HAQ-DI) at week 78. Additionally, multiple clinical and patient-reported outcomes (PROs) were evaluated over time. Patients were categorized based on their participation in the PSP: ever (PSP users) vs. never (PSP non-users). Safety events were monitored throughout the study.

resultsOverall, 42.8% of PSP users achieved the MCID in HAQ-DI at week 78 (improvement of at least 0.22 compared to baseline). From 1025 enrolled, 48.7% of patients were PSP users while treated with ADA. The percentage of patients achieving MCID in the HAQ-DI was higher in PSP users vs. PSP non-users (48.1 vs. 37.8%) at week 78 (p < 0.001, NRI). Most of the studied clinical outcomes and PROs showed significant improvements (p < 0.05) from baseline to week 78 favoring PSP users over PSP non-users.

conclusionsIn patients with moderate-to-severe RA who initiated ADA, improvements in clinical, functional, and PROs were achieved in real-world settings with significantly greater improvements among PSP users in comparison with PSP non-users.

fundingAbbVie.

trial registrationClinicalTrials.gov identifier, NCT01383421.

Indexed as

AdalimumabPatient support programRheumatoid arthritis

Identifiers

PMID28361468
PMCPMC5443730
OpenAlexW2600578385

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.