Evidence map›Paper›PMID 29018564›Full record

ArticleRMD open2017

Achieving comprehensive disease control in patients with early and established rheumatoid arthritis treated with adalimumab plus methotrexate versus methotrexate alone.

Edward C Keystone, Ferdinand C Breedveld, Désirée van der Heijde, Ronald F van Vollenhoven, Paul Emery, Josef S Smolen, Iain Sainsbury, Stefan Florentinus, Hartmut Kupper, Kun Chen and 1 more

3 registry-linked trialsAbstract read
In one paragraph

Article in RMD open, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 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.

NCT00195663 phase3completednot on this map

A Prospective Multi-Centre Randomised, Double-Blind, Active Comparator-Controlled, Parallel-Groups Study Comparing the Fully Human Monoclonal Anti-TNFα Antibody Adalimumab Given Every Second Week With Methotrexate Given Weekly and the Combination of Adalimumab and Methotrexate Administered Over 2 Years in Patients With Early Rheumatoid Arthritis (PREMIER).

TypeinterventionalSponsorAbbVie (prior sponsor, Abbott)Ran2000 to 2012Enrolled799ConditionsEarly Rheumatoid ArthritisArmsAdalimumab, Methotrexate, Adalimumab placebo, Methotrexate placebo
NCT00195702 phase3completednot on this map

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Rheumatoid Arthritis Patients Currently Receiving Treatment With Methotrexate

TypeinterventionalSponsorAbbottRan2000 to 2010Enrolled619ConditionsRheumatoid ArthritisArmsAdalimumab, Placebo
NCT00420927 phase4completednot on this map

A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation With Methotrexate and Adalimumab Combination Therapy in Patients With Early Rheumatoid Arthritis (OPTIMA)

TypeinterventionalSponsorAbbottRan2006 to 2010Enrolled1,032ConditionsRheumatoid ArthritisArmsadalimumab, methotrexate, placebo
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Review
  4. Article
  5. 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

11 authors.

Edward C KeystoneDepartment of Rheumatology, University of Toronto, Toronto, Ontario, Canada.
Ferdinand C BreedveldDepartment of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.
Désirée van der HeijdeDepartment of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.
Ronald F van VollenhovenDepartment of Clinical Immunology and Rheumatology, Academic Medical Center, Amsterdam, The Netherlands.
Paul EmeryUniversity of Leeds and NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Institute of Rheumatic and Musculoskeletal Medicine, Leeds, UK.
Josef S SmolenDivision of Rheumatology, Department of Medicine III, Medical University of Vienna, Vienna, Austria.
Iain SainsburyGlobal Medical Affairs, AbbVie Ltd, Cambridge, UK.
Stefan FlorentinusGlobal Medical Affairs, AbbVie NDL, Amsterdam, The Netherlands.
Hartmut KupperPharmaceutical Development, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany.
Kun ChenData and Statistical Sciences, AbbVie Inc, North Chicago, Illinois, USA.
Arthur KavanaughDepartment of Rheumatology, University of California San Diego, La Jolla, California, USA.

Funding

Arthritis Research UK 18475Department of Health RC-PG-0407-10054Versus Arthritis 20639
6 · The paper itself

Abstract

objectiveTo evaluate the achievement of comprehensive disease control (CDC) following 1 year of treatment with adalimumab+methotrexate versus methotrexate alone and whether early achievement of remission (at week 24 or 26) is associated with CDC at week 52 in patients with either early or established rheumatoid arthritis (RA).

methodsPost hoc analyses were conducted in three clinical studies assessing treatment with adalimumab+methotrexate: DE019 (NCT00195702) enrolled patients with established RA who were methotrexate inadequate responders; OPTIMA (NCT00420927) and PREMIER (NCT00195663) enrolled methotrexate-naive patients with early RA. In OPTIMA, patients not achieving stable low disease activity at weeks 22 and 26 in the placebo+methotrexate group could receive open-label adalimumab+methotrexate for 52 weeks (Rescue ADA arm). CDC was defined as the simultaneous achievement of clinical remission (DAS28(CRP)<2.6), normal function (HAQ-DI<0.5) and absence of radiographic progression (ΔmTSS≤0.5).

resultsRegardless of disease duration, significantly more patients receiving adalimumab+methotrexate achieved CDC compared with methotrexate alone. In the adalimumab+methotrexate group, a numerically greater proportion of patients with early RA (~25%) versus established RA (14%) achieved CDC at 1 year; achievement of CDC was notably greater among patients who met criteria for remission at week 24 or 26 (~50% of patients with early RA and 39% with established RA).

conclusionTreatment with adalimumab+methotrexate increases the likelihood of achieving CDC in patients with either early or established RA. Clinical remission at week 24 or 26 is associated with achievement of CDC at week 52. TRIAL REGISTRATION NUMBER: DE019 (NCT00195702), OPTIMA (NCT00420927), PREMIER (NCT00195663); Post-results.

Indexed as

anti-TNFmethotrexaterheumatoid arthritistreatment

Identifiers

PMID29018564
PMCPMC5623327

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.