Evidence map›Paper›PMID 32404343›Full record

Trial reportAnnals of the rheumatic diseases2020

Adalimumab dose tapering in patients with rheumatoid arthritis who are in long-standing clinical remission: results of the phase IV PREDICTRA study.

Paul Emery, Gerd R Burmester, Esperanza Naredo, Luigi Sinigaglia, Ivan Lagunes, Franziska Koenigsbauer, Philip G Conaghan

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IVMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Annals of the rheumatic diseases, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02198651 (A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected Via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis), which is not on this map. Cited by 21 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 2 pooled it
3.5field-weighted citation impact, top 6% 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.

NCT02198651 phase4completednot on this map

A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected Via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) Subjects (PREDICTRA)

TypeinterventionalSponsorAbbVieRan2015 to 2018Enrolled149ConditionsRheumatoid Arthritis, Musculoskeletal and Connective Tissue DiseasesArmsAdalimumab, Placebo
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 2 syntheses or guidelines pooled it, 36 citations in OpenAlex.

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  10. Characteristics of patients who developed transient anti-adalimumab antibodies.Journal of ophthalmic inflammation and infection · 2025
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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

7 authors at 7 institutions in 5 countries.

Paul EmeryLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK p.emery@leeds.ac.uk.ORCID 0000-0002-7429-8482
Gerd R BurmesterDepartment of Rheumatology and Clinical Immunology, Charité-Universitätsmedizin, Berlin, Germany.
Esperanza NaredoDepartment of Rheumatology, Joint and Bone Research Unit, Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain.
Luigi SinigagliaDepartment of Rheumatology and Medical Sciences, Centro Specialistico Ortopedico Traumatologico Pini-CTO, Milan, Italy.
Ivan LagunesGlobal Medical Affairs Rheumatology, AbbVie Inc, North Chicago, Illinois, USA.
Franziska KoenigsbauerData and Statistical Sciences, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany.
Philip G ConaghanLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.ORCID 0000-0002-3478-5665
AbbVie (Germany) · DEAbbVie (United States) · USCharité - Universitätsmedizin Berlin · DEHospital Universitario Fundación Jiménez Díaz · ESIstituto Ortopedico Gaetano Pini · ITNIHR Leeds Musculoskeletal Biomedical Research Unit · GBUniversity of Leeds · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo investigate the association between baseline disease activity and the occurrence of flares after adalimumab tapering or withdrawal in patients with rheumatoid arthritis (RA) in sustained remission.

methodsThe PREDICTRA phase IV, randomised, double-blind (DB) study (Im

resultsOf 146 patients treated during the OL-LI period, 122 were randomised to taper (n=102) or withdrawal (n=20) arms. Patients had a mean 12.9 years of active disease and had received adalimumab for a mean of 5.4 years (mean 2.2 years in sustained remission). Overall, 37 (36%) and 9 (45%) patients experienced a flare in the taper and withdrawal arms, respectively (time to flare, 18.0 and 13.3 weeks). None of the DB baseline disease characteristics or adalimumab concentration was associated with flare occurrence after adalimumab tapering. Approximately half of the patients who flared regained clinical remission after 16 weeks of open-label rescue adalimumab. The safety profile was consistent with previous studies.

conclusionsApproximately one-third of patients who tapered adalimumab versus half who withdrew adalimumab experienced a flare within 36 weeks. Time to flare was numerically longer in the taper versus withdrawal arm. Baseline MRI inflammation was not associated with flare occurrence. TRIAL REGISTRATION NUMBER: NCT02198651, EudraCT 2014-001114-26.

Indexed as

Symptom Flare UpAdalimumabAdultAgedAntirheumatic AgentsArthritis, RheumatoidDouble-Blind MethodFemaleHumansMaleMiddle AgedRemission InductionAdalimumabAntirheumatic Agentsanti-TNFdisease activityDMARDs (biologic)rheumatoid arthritis

Identifiers

PMID32404343
PMCPMC7392484
OpenAlexW3024203084

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.